New Developments in the Treatment of PAH

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New Developments in the Treatment of PAH  CME/CE

Disclosures

Susan P. Steinbis, MSN, NP-C   

A progressive vasculopathy is the wording used to describe pulmonary arterial hypertension (PAH). Pulmonary hypertension is a disease that affects the pulmonary vasculature, leading to right ventricular failure with devastating consequences for those affected. Historically, treatment has been limited and complex with the continuous intravenous (IV) administration of epoprostenol. The end of 2001 introduced the first oral therapy, bosentan, and then 2002 produced treprostinil, a continuous, subcutaneous prostacyclin analogue. Since then, numerous studies have been conducted evaluating new therapies, subsequently leading to the approval of newer agents.

What's New?

So what is in our arsenal now in 2005? This year has been an exciting year for new therapies in the treatment of PAH. Iloprost, another prostacyclin analogue, was approved for the treatment of World Health Organization (WHO) class I PAH with New York Heart Association (NYHA) functional class III or IV. Like epoprostenol and treprostinil, it exerts its effect on the prostacyclin pathway but is administered via inhalation through the Prodose AAD System, a breath-actuated drug delivery device. It is given in 6 daily doses with the option to administer up to 9 times a day, if needed. The side-effect profile is better than that for other prostanoids as iloprost is not administered systemically, but headache, cough, and flushing are common. Syncope has been reported but is thought to be secondary to sudden activity in the morning before the first therapy is administered. In a randomized, double-blind study, at Week 12, iloprost was shown to have a 40-meter improvement in 6-minute walk distance (6MWD) from baseline when compared to placebo. The endpoint of the clinical trial was at least a 10% increase in 6MWD when compared to baseline and improvement of at least 1 NYHA functional class vs baseline with no death or clinical worsening. When all these endpoints were combined, iloprost demonstrated a 19% improvement over placebo.

Treprostinil was first approved as a subcutaneous therapy in 2002 and is now available in an IV preparation. Vallery McLaughlin, MD, reported the 1-year data on IV treprostinil at CHEST 2005. After receiving an infusion lasting 48 hours with a half-life of 4.5 hours, 16 de novo patients experienced an 80-meter increase in 6MWD at 12 weeks. At 1 year, the de novo group had a total improvement in 6MWD of 125 meters with a decrease in mean pulmonary artery pressure (mPAP), an increase in cardiac index, and a decrease in pulmonary vascular resistance (PVR) by half. Thirty-four of 41 patients in the transition group (IV epoprostenol to IV treprostinil) completed the 1-year study. At the end of the 12 months, the transition group maintained stability in 6MWD and in hemodynamics. Chronic IV treprostinil therefore is assumed to provide sustained improvement in exercise capacity and hemodynamics. Of note, more than twice the dose was needed for treprostinil when compared to epoprostenol, with a mean dose of 98 ng/kg/min in the de novo group and 111 ng/kg/min in the transition group.[1]

Multiple Pathways

Much discussion has centered around the multiple pathways involved in pulmonary hypertension. The nitric oxide pathway has been the most recently addressed pathway in the treatment of PAH. Sildenafil was approved this year as a PDE-5 inhibitor. At CHEST 2005, Lalaine Corate, MD, and Namita Sood, MB, BCh, discussed the use of sildenafil in patients with right heart failure and PAH. Both noted improvements with either 50 mg or 100 mg every 8 hours. The use of sildenafil in the acute setting with long-term follow-up demonstrated a mean increase in 6MWD at > 4 weeks with a mean decrease in oxygen by 2 LPM. There was also improvement in WHO functional class but 4 of 14 patients on the 100-mg regimen needed additional therapy at 5 or more months and 1 patient died before the end of 1 year secondary to progression of disease.[2,3]

David Badesch, MD,[4] reviewed data from the SUPER-1 study, a clinical trial involving 278 patients who received 20-, 40-, or 80-mg doses of sildenafil citrate; 6MWD was used as an endpoint. At the end of the 12-week period, patients on the 20-mg dose had a 45-meter improvement in 6MWD and the 80-mg group had a 50-meter improvement in distance. The sildenafil group also experienced an improvement in NYHA functional class vs the placebo group. The mPAP and PVR demonstrated continued improvement with 80 mg sildenafil vs 20 mg, and the cardiac output also increased to a greater degree with 80 mg than with 20 or 40 mg. The side-effect profile includes headache, flushing, diarrhea, and dyspepsia.

Martin C. Brown, MD,[5] reviewed data evaluating the long-term benefits of sildenafil on the quality of life (QOL) in patients with PAH. The same patients that were enrolled in SUPER-1 were evaluated, and data were collected using the SF-36 and the EuroQoL (EQ-5D) questionnaires. Improvements in physical functioning, general health, and vitality were statistically significant after 24 weeks on sildenafil. The utility index and current health state also demonstrated a statistically significant improvement (sildenafil vs placebo), and the effect for all areas mentioned was maintained for the 24-week period and, in some domains, for up to 6 months. The physical health domains were the ones most significantly impacted by sildenafil use.

Preliminary data were released on another oral agent, sitaxsentan, a selective endothelin receptor antagonist awaiting approval from the US Food and Drug Administration (FDA). Dr. David Badesch[6] reviewed the results of STRIDE-1, a clinical trial comparing placebo, 100 mg, and 300 mg daily dosing of sitaxsentan. Two patients experienced elevation of liver function tests (LFT) to > 3 times the upper limit of normal (ULN). At week 12, both doses demonstrated an increase in 6MWD, a decrease in mPAP, an increase in cardiac index, and a decrease in PVR. However, researchers felt that the 300-mg dose was a significant overdosing of the medication since the 100-mg dose did not demonstrate an increase in LFT over the 12-week period. In the extension study, 4 of 79 patients experienced an elevation of LFT > 3 times ULN. Adverse events included headache, peripheral edema, nausea, nasal congestion, and elevated international normalized ratio (INR). Final data for STRIDE-2 are still pending, but preliminary data suggest that sitaxsentan at a dose of 100 mg daily may improve the time to clinical worsening for NYHA functional class II-IV.

In STRIDE-2, there were 4 arms of the study evaluating placebo, 50 mg sitaxsentan, 100 mg sitaxsentan, and traditional dosing of bosentan (for adults, 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily; and for patients who weigh less than 40 kg [88 lbs] and who are over 12 years of age, 62.5 milligrams twice daily). Warfarin dosing must be monitored with this medication, and if the patient is on warfarin at the time of initiation of sitaxsentan, the dose should be decreased by 80% with monitoring of INR until therapeutic again on anticoagulant therapy. If warfarin and sitaxsentan are initiated together, warfarin should be initiated at a dose of 0.5 to 1 mg and titrated up to the goal INR.[6]

With these new therapies now available, the question becomes, "Where are we going with therapy now, and is combination therapy a good option?" Quite a few lectures at CHEST 2005 discussed combination therapy and associated outcomes. Vallery McLaughlin, MD,[7] discussed the addition of iloprost to bosentan in the STEP study. The objective of this trial was to evaluate safety and efficacy of dual therapy. Participants were randomized to receive iloprost (n = 32) or placebo (n = 33). The first part of the trial consisted of a 12-week blinded study with patients on stable-dose bosentan for a minimum of 16 weeks. Most patients were NYHA functional class III. The iloprost group experienced a 30-meter increase in 6MWD at the end of the 12 weeks, and the placebo group demonstrated a minimal increase of 4 meters. At 12 weeks, the iloprost group also demonstrated a 34% improvement in NYHA functional class vs 6% in the placebo group.

Sildenafil add-on therapy for patients receiving bosentan for the treatment of PAH, WHO class I, was reviewed by Stephen Mathai, MD.[8] Of the 98 patients receiving bosentan, 26 also received sildenafil for clinical worsening of symptoms. The patients were NYHA functional class II-IV. Of the 26 patients receiving sildenafil, 14 had idiopathic pulmonary arterial hypertension (IPAH) and 12 of those had scleroderma-associated PAH. At the end of the clinical trial, those with IPAH receiving bosentan and sildenafil demonstrated improvement in 6MWD whereas the 12 with scleroderma-associated PAH did not improve. There were 2 deaths in the scleroderma group. More than 20% of the patients stopped therapy secondary to side effects from sildenafil. Limitations of the study, Mathai stated, were the limited number of patients, lack of hemodynamics prior to the addition of sildenafil, selection bias, and the fact that it was not a controlled study.[8]

On the Horizon

So what's on the horizon for the treatment of PAH? While the FDA analyzes data from the STRIDE-1 and -2 studies and we await approval of sitaxsentan, other therapies are being evaluated. Myogen is currently conducting studies with ambrisentan, another selective endothelin receptor antagonist. Lewis Rubin, MD,[9] reviewed preliminary 12-week data that showed a decrease in right atrial pressure, mPAP, and PVR and an increase in cardiac index with ambrisentan use. Dr. Badesch later elaborated on this study, explaining that the 4 doses of ambrisentan that were evaluated (1.0, 2.5, 5.0, and 10.0 mg) resulted in an increase in 6MWD of at least 32 meters at Week 12. Data from all doses combined at Week 24 demonstrated approximately a 50-meter increase in 6MWD, with the IPAH group demonstrating greater improvement than the secondary PAH group. WHO functional class was also noted to improve. Adverse events noted were peripheral edema, upper respiratory infection, nasal congestion, headache, nausea, and flushing, with < 4% elevation of LFT.[4]

Inhaled treprostinil is also being evaluated and tadalafil, a long-acting PDE-5 inhibitor, has drawn attention. Clearly, further studies will have to be conducted and the PAH community will continue to strive to find the right medication combinations for those affected by this devastating condition. Research will also focus heavily on the cause of PAH as more is understood about the underlying pathophysiology. Future areas of study may also center around 2-methoxyestradiol, vasoactive intestinal polypeptide, and maybe even imatinab mesylate.

References

McLaughlin V. One year experience with intravenous treprostinil in pulmonary arterial hypertension patients. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1722.Corate L, The use of sildenafil in the acute treatment of patients with severe pulmonary arterial hypertension and right heart failure. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1729Sood N. Sildenafil I acutely decompensated right heart failure secondary to pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1729.Badesch D. Long-term management of pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 963.Brown M. Long-term benefits of sildenafil treatment on health-related quality of life in patients with pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 10-31-05 ID# 1722Badesch D. Sitaxsentan improves the time to clinical worsening in patients with pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1722.McLaughlin V. A randomized, double-blind, placebo-controlled study of iloprost inhalation as add-on therapy to bosentan in pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1722.Mathai S. The addition of sildenafil to bosentan therapy in the treatment of pulmonary arterial hypertension. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 1722.Rubin L. The changing world of pulmonary arterial hypertension therapies: a focus on the patient. Program and abstracts of CHEST 2005: 71st Annual Meeting of the American College of Chest Physicians; October 29 - November 3, 2005; Montreal, Quebec, Canada. Abstract 965.
 

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Frequently Asked Questions - Understanding Prostate Cancer

Current Practice Info: (Enter practice information here)More Printable Patient FAQ'sUnderstanding Prostate CancerWhat is prostate cancer?The prostate is a gland in the male reproductive system that helps produce semen, the thick fluid that carries sperm. The walnut-sized gland is located beneath a man's bladder and surrounds the upper part of the urethra, the tube that carries urine from the bladder. Prostate function is regulated by testosterone, a male sex hormone produced mainly in the testicles.

Prostate cancer is a major health concern for American men. Although the disease is rare before age 50, experts speculate that most elderly men have at least traces of it.

More than 200,000 new cases and about 30,000 deaths are attributed to prostate cancer each year in the U.S. For reasons not fully understood, African-American men have the highest frequency of prostate cancer in the world and the highest death rate from the disease. In other parts of the world — notably Asia, Africa, and Latin America — prostate cancer is rare.

Prostate cancer cells do not follow normal patterns and grow uncontrollably and spread to other tissues. Prostate cancer is typically a very slow growing tumor, often causing no symptoms until advanced stages. Most men with prostate cancer die of other causes — many without ever realizing that they have the disease. But once prostate cancer begins to grow more rapidly or spreads outside the prostate, it is dangerous. This aggressive type of prostate cancer can occur at any age. Although the disease tends to progress slowly, it is generally fatal if it spreads beyond the prostate gland itself.

Prostate cancer in its early stages (confined to the prostate gland) can be cured. Fortunately, about 85% of American men with prostate cancer are diagnosed in the early stages.

Cancer that has spread beyond the prostate to distant tissues (such as the bones, Lymph nodes, liver, and lungs) is not curable, but it often can be controlled for years. About a third of men whose prostate cancer becomes widespread can expect to live five years or more. Because of the many advances in available treatments, the majority of men whose prostate cancer becomes widespread can expect to live five years or more.What causes prostate cancer?Prostate cancer affects mainly older men. Four out of five cases are diagnosed in men over 65, but less than 1% in men under 50. Though rare, prostate cancer can be seen in men even in their 30's and 40's. Men with a family history of prostate cancer are more likely to die of it than is the general population. On a case-by-case basis, doctors cannot say with certainty what causes prostate cancer, but experts generally agree that diet contributes to the risk. Men who consume large amounts of fat — particularly from red meat and other sources of animal fat — are most likely to develop advanced prostate cancer. The disease is much more common in countries where meat and dairy products are dietary staples than in countries where the basic diet consists of rice, soybean products, and vegetables.

The underlying factor linking diet and prostate cancer is probably hormonal. Fats stimulate increased production of testosterone and other hormones, and testosterone acts to speed the growth of prostate cancer. High testosterone levels may stimulate dormant prostate cancer cells into activity. Some findings suggest that high testosterone levels also influence the initial onset of prostate cancer. Eating meat may be risky for other reasons: Meat cooked at high temperatures produces cancer-causing substances that directly affect the prostate. A few other risk factors have been noted. Welders, battery manufacturers, rubber workers, and workers frequently exposed to the metal cadmium seem to be abnormally vulnerable to prostate cancer.

Researchers know more about what will not cause prostate cancer than what will. No proven link exists between prostate cancer and an active sex life, vasectomy, masturbation, use of alcohol or tobacco, circumcision, infertility, infection of the prostate, or a common noncancerous condition called benign prostatic hyperplasia (BPH) that causes an enlarged prostate gland. Most elderly men experience an enlarged prostate to some degree.What are the symptoms?There are no warning signs or symptoms of early prostate cancer. Once a malignant tumor causes the prostate gland to swell significantly, or once cancer spreads beyond the prostate, the following symptoms may be present:

A frequent need to urinate, especially at night. Difficulty starting or stopping the urinary stream. A weak or interrupted urinary stream. A painful or burning sensation during urination or ejaculation. Blood in urine or semen. These are not symptoms of the cancer itself. Instead, they are the symptoms of the blockage from the cancer growth within the prostate and surrounding tissues.

Symptoms of advanced prostate cancer include:

Dull, incessant pain or stiffness in the pelvis, lower back, or upper thighs; arthritic pain in the bones of those areas. Loss of weight and appetite, fatigue, nausea, or vomiting.Call Your Doctor If:

You have difficulty urinating or find that urination is painful or otherwise abnormal. Your doctor will examine your prostate gland to determine whether it is enlarged, inflamed with an infection, or may have cancer. You have chronic pain in your lower back, pelvis, upper thighbones, or other bones. Ongoing pain without explanation always merits medical attention. Pain in these areas can have various causes but may be from the spread of advanced prostate cancer. You experience unexplained weight lossHow do I know if I have prostate cancer?The best way to detect prostate cancer in its early stages is with regular prostate exam PSA blood tests. Because most malignant prostate tumors originate in the part of the gland nearest the rectum, many cancers can be detected during routine rectal examinations. Many doctors recommend an annual rectal exam, supplemented by a prostate-specific antigen (PSA) blood test, starting at age 50 for most men. The screenings are recommended beginning at age 40 for African Americans and those with a family history of prostate cancer.

PSA is a protein whose level tends to increase in the presence of prostate cancer, making it more effective than rectal exam in detecting early prostate cancer. Together, the two screening measures offer the best chance of detecting prostate cancer while it is localized and most treatable. Prostate cancer may also be discovered incidentally during treatment for urinary problems. Because of the possibility of a false-positive PSA reading, it is important to discuss this test with your doctor before having one. An elevated PSA does not mean that you have cancer. Rather, it raises questions that need to be addressed and explained. There are a number of causes of an elevated PSA, and cancer is only one of them.

If routine screening arouses suspicion and PSA levels are elevated, a doctor will look at the prostate using an ultrasound instrument inserted in your rectum. X-rays of the urinary tract, along with blood and urine studies, are performed routinely to aid diagnosis. Performing a biopsy will confirm whether or not cancer is present: Guided by ultrasound images, the doctor inserts a needle into the prostate and extracts a small tissue sample from the suspicious area. A pathologist then studies the sample under a microscope to determine whether cancer cells are present. In order to determine if the cancer has spread outside the prostate gland, doctors usually arrange CT scans, bone scans, chest X-rays, or other imaging tests.What are the treatments?Since prostate cancer is often slow growing and may not be fatal in many men, some men — after discussing the options with their doctors — opt for "watchful waiting." Watchful waiting involves monitoring the prostate cancer for signs that it is becoming more aggressive but otherwise not treating it. This approach is recommended more commonly for men who are older or suffer from other life-threatening conditions. In these cases, the cancer may be growing so slowly that it's not likely to be fatal.

Once the decision is made to treat a cancer, other factors, such as a patient's age and general health, affect the type of treatment given. Decisions about how to treat this cancer are complex, and many men seek a second opinion before making a treatment decision.

Depending on when the disease is diagnosed, treatment includes some combination of radiation therapy, surgery, hormone therapy, and rarely chemotherapy. Localized prostate cancer usually can be cured with surgery, radiation therapy, or cryosurgery — freezing malignant cells with liquid nitrogen. The choice is made on a case-by-case basis and depends on many factors.

The standard operation — a radical prostatectomy — involves the removal of the prostate and nearby lymph nodes. In many cases, surgeons can remove the gland without cutting nerves that control penile erection or bladder function, making such complications as impotence or incontinence less common than in the past. Depending on the man's age and the amount of surgery needed to remove all the cancer, nerve-sparing techniques allow about 40%-65% of men who were able to get erections before surgery to be able to do so after surgery without a need for any additional Erectile Dysfunction treatments.

After surgery, most men experience some degree of incontinence but usually regain complete urinary control. Impotence can be treated in a variety of ways — including with medications such as Levitra, Cialis or Viagra. If severe or prolonged, incontinence can be managed with special disposable underwear, exercises, condom catheters, biofeedback or penile clamps; in rare cases that don't resolve on their own, incontinence can be eliminated altogether with surgically inserted sphincter implants around the urethra or a urethral sling. Radiation therapy can be very effective as the primary treatment for localized prostate cancer. It may also be given as follow-up to surgery for cancer that has not spread. If cancer has spread to adjacent tissue, radiation is the preferred treatment; it is also used in advanced cases to relieve pain from the spread of cancer to bones. Incontinence and impotence also occur with radiation, and some studies have shown similar results to surgery. New forms of radiation such as IMRT (Intensity Modulated Radiation Therapy) are proving even more effective with fewer side effects.

Permanent radioactive seed implants (brachytherapy) allow for delivery of a high dose of radiation to the prostate with limited damage to surrounding tissues. During the procedure, radioactive seeds (iodine-125) are implanted into the prostate gland using ultrasound guidance. The implants remain in place permanently and become inactive after many months.

Even advanced cases that cannot be cured may be controlled for years with hormone therapy, sometimes supplemented by other treatments. Hormone therapy slows the cancer's growth by cutting off the testosterone supply, although the treatment's effectiveness may decrease over time. Testosterone can be removed from the bloodstream by surgically removing the testicles (orchiectomy) or by administering female hormones such as estrogen or other drugs that block testosterone production. Men generally prefer the testosterone-blocking drug treatment because it is effective, less invasive, and causes fewer side effects than surgery or female hormone drugs. If the testicles are removed, the scrotum can be left intact with testicular implants put in place.

Chemotherapy and vaccine therapies are proving to be effective for some men with advanced prostate cancer.

The goal of prostate cancer treatment is a cure, and is likely in men diagnosed with early prostate cancer. All prostate cancer survivors should be examined regularly and have their PSA levels monitored closely.

As with other types of cancer, new treatments are being developed for advanced prostate cancer. Researchers are using radiation and hormone therapy in innovative ways and are testing the effectiveness of chemotherapy on patients who do not respond to other treatments.How can I prevent prostate cancer?Evidence regarding fat in the diet and prostate cancer is conflicting. But high dietary fat has been linked with increased prostate cancer. To lower your dietary fat, eat more fish, poultry, fresh vegetables, fruits, and low-fat dairy products. In general, eat less red meat; remove skin from poultry before cooking; and cut down on butter, margarine, and oils. There is some evidence that heating meat to high temperatures creates cancer-causing substances. To avoid these substances, try poaching or roasting, not frying or barbecuing.

Medically reviewed by Sheldon Marks, MD, August 2005. 

Copyright © 2004, Medscape Patient Education


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Diabetic Autonomic Neuropathy

Sudomotor Dysfunction

Sudomotor dysfunction is a common feature of diabetic autonomic neuropathy. This generally manifests as anhidrosis of the extremities, which may be accompanied by hyperhidrosis in the trunk. Initially, patients display a loss of thermoregulatory sweating in a glove and stocking distribution that, with progression of autonomic neuropathy, extends from the lower to the upper extremities and to the anterior abdomen, conforming to the length dependency of diabetic neuropathy. This process ultimately may result in global anhidrosis. Hyperhidrosis may also accompany diabetic autonomic neuropathy. Excessive sweating may occur as a compensatory phenomenon involving proximal regions such as the head and trunk that are spared in a dying-back neuropathy. Gustatory sweating, the abnormal production of sweat that appears over the face, head, neck, shoulders, and chest after eating even nonspicy foods, is occasionally observed.[44]

Previous PageSection 7 of 9Semin Neurol 23(4):365-372, 2003. © 2003 Thieme Medical Publishers
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Pfizer Files Suit Against Operators of 18 Internet Sites Selling Illegal Copies of Lipitor(reg)

Pfizer has filed lawsuits against a second group of operators of eighteen internet sites for selling unapproved and illegal copies of Pfizer's leading cholesterol medicine, LIPITOR(reg), the company said today.

Pfizer said the sites market products identified as "generic Lipitor" or "Lipitor generic," which are not legitimate medicines. LIPITOR(reg) is patent-protected and no generic versions of the medication are legally available in the United States. Tests performed on tablets obtained from two of the websites showed that they contained no atorvastatin calcium, the active ingredient in LIPITOR(reg), and therefore would provide no therapeutic benefit to patients. Pfizer has notified the FDA of its findings.

All the lawsuits seek injunctions against further sales of "generic Lipitor" or "Lipitor generic" and claim damages for infringement of Pfizer's trademark rights. The complaints also seek to remove references to LIPITOR(reg) in advertising materials and to eliminate computer links that misdirect patients to illegal, unapproved products. In addition, Pfizer has filed patent infringement claims against ten site operators to recoup damages and to enjoin further sales of "generic Lipitor" or "Lipitor generic" containing a crystalline form of atorvastatin calcium.

"We want to make consumers aware that many internet sites are selling fake pharmaceutical products that provide little or no benefit to patients and may, in fact, be dangerous," said Jeff Kindler, Executive Vice President and General Counsel of Pfizer. "We also want to put operators of these illegal sites on notice that there is a price to pay for their actions."

Suits were filed in U.S. District Court in Delaware against the following individuals and sites:

— Generic Lipitor www.generic-lipitor.com;
— RX MEX-COM, S.A. DE CV www.rx-mex.com;
— Online Enterprises www.global-presciptions.net;
— Gerard Gibson www.allpills.us;
— Medprescribed www.saveongeneric.com;
— Limestar, Inc. www.buyprescribeddrugs.com;
— Askdocweb, Inc. www.askdocweb.com;
— Michael Becker www.online-lipitor.com, www.pharmaexpressrx.com and www.generic-lipitor-atorlip.com;
— Intelecorp www.trustpharma.com;
— Feel-At-Home www.bestgenerics.com;
— International-Pharmacy Corporation www.international-pharmacy.com;
— Debra Cohen www.live-more-fully.com;
— John Fitzsimmons www.medsavings.biz;
— WWW Insight, S.A. www.rxmostwanted.com;
— Kris Sarode www.shoprxonline.com;
— GDL Access www.medicationdelivery.com.

Pfizer filed similar suits in April and May against the operators of six other sites selling an unapproved version of LIPITOR�. In August, the company took legal action against 30 sites and two operators selling illegal versions of Pfizer's erectile dysfunction medication, VIAGRA�.
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Measuring Depressive Symptoms in the Primary-Care Setting

Introduction

Major depressive disorder (MDD) is a highly prevalent, often chronic medical disorder largely diagnosed and treated in primary-care settings.[1] Currently, MDD is a leading cause of disability globally, and there is increasing evidence that it is an important risk factor for the development of major medical disorders, such as coronary artery disease (CAD).[2] More effective care for depression has been identified as a national health priority in the USA and elsewhere.[3]

The goal of antidepressant therapy is to achieve and sustain full symptomatic remission, prevent relapse and recurrence, and return patients to previous levels of occupation and social functioning.[4] Tacit to these therapeutic objectives is the need to systematically monitor symptomatic progress. Several brief unidimensional rating scales for depression provide good conceptual coverage across the multiple dimensions of depression.[5-10] The Beck Depression Inventory (BDI) is often employed in primary-care settings,[11] it may, however, not be adequately sensitive (vs. clinician-rated scales) in tracking response to antidepressant treatment.[12]

The Hamilton Depression Rating Scale 7 item (HAMD-7) was derived from analyses of a natural practice database at a tertiary-care centre comprised of patients diagnosed with MDD (n = 248) who were non-randomly assigned to open-label, flexible-dose antidepressant treatment.[13] The HAMD-17 items that were endorsed by ≥ 70% of depressed patients, and were most sensitive to change following 8 weeks of antidepressant treatment efficacy formed the constituent items of the HAMD-7. The HAMD-7 scale was subsequently validated in a cross-national primary care study.[10] Despite its psychometric deficiencies, the HAMD-17 was chosen as the gold standard because of its widespread and historical use in psychiatry.[14] The HAMD-7 has a high correlation with the HAMD-17, Montgomery Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI).[10]

The objective of this post hoc study was to identify depressive items most frequently endorsed in the primary-care setting, and evaluate their responsiveness to antidepressant treatment. The encompassing aim was to compare these items with the previously identified depressive items of the HAMD-7.  Printer- Friendly Email This

Int J Clin Pract.  2007;61(8):1278-1282.  ©2007 Blackwell Publishing
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Ultrasound-Activated Antibiotic Hydrogel Retards Device-Related Biofilms

Ciprofloxacin-loaded hydrogels that device the antibiotic when exposed to low-level ultrasonography may endeavor a volume way to controller bacterial biofilm fabrication on indwelling prostheses and subcutaneous deed organisation, a multicenter US-based team of bioengineers written document.

“We believe that this field holds speech act not only for retarding biofilm earnings but also for eradicating established biofilms,” Dr.
Patrick Norris from the Shopping center for Biofilm Applied science at Montana State Educational institution in Bozeman and colleagues write in the October outcome of Antimicrobial Agents and Chemotherapy.

“To computer address the difficulty of biofilm implant infections,” noted co-author Dr.
Paul Stoodley from Allegheny-Singer Problem solving Institute in Pittsburgh, “the scientific territorial dominion has begun looking at at new strategies and technologies.”

One of these strategies “is to localize antibiotics in high concentrations piece of land at the point in time where the risk of illegality is highest — the aspect of the implant itself,” Dr.
Stoodley explained to Reuters Condition.

However, he continued “when surfaces are impregnated with antibiotic agents with no actively controlled accomplishment carrying into action the antibiotics are often passively released too early, before an communication is established.
When a biofilm does begin to form it is likely that there will not be enough antibiotics left to be effective, or worse, sublethal concentrations may actually help select for resistant strains.
By designing a device material that only releases antibiotics when required we can help overcome this difficulty.”

Developed by the Establishment of Capital of the United States (Seattle) Engineered Biomaterials Unit, the hydrogels are coated with methylene chains that form an ultrasound-responsive finish.
During polymerization, the hydrogels are loaded with antibiotic, in this case to buy ciprofloxacin, either as a solidness or in solvent.

According to the developers, the system of rules retains ciprofloxacin region the polymer in the nonattendance of ultrasonography and releases the antibiotic only when low-intensity tomography is applied.

To test the live body, Dr.
Norris and colleagues monitored the accumulation of Pseudomonas aeruginosa biofilms grown on hydrogels with and without ciprofloxacin and with and without desertion to imaging.

Compared with powerfulness experiments, the ultrasonic dismission of ciprofloxacin delivered in a 20-minute periodic event daily led to a significant 50-fold step-down in the grouping of an established Pseudomonas aeruginosa biofilm over a 3-day part.
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GP had sex with depressed patient

A Suffolk doc who had a sexual family relationship with a semantic role he was treating for sadness has admitted serious master actus reus.

Antonius Leeper, 48, was a mate at Sudbury’s Hardwicke Theater Medical procedure during the kinship, the General officer Medical Group meeting (GMC) was told.

He was estranged from his wife and aggregation and his woman was pregnant at the time.

The GMC has been legal proceeding references before considering what military action to take.

Its members were told the couple’s kinship lasted from Master’s degree 2002 until February 2003.

Account of economic condition.

It began when Dr Leeper, of Wickhambrook, was separated from his wife and four children and his girl, a Marie Madame Curie PCP, was pregnant at the time.

Dr Leeper told the audition he was emotionally traumatised after his unification broke down, then his adult female told him she was pregnant in October 2001.

The affected role had joined the surgical operation with a cognition of sadness and had been taking Prozac.

She had told the bookman of emotional and domestic problems, anxiousness, and he had suggested counselling.

The function began after Dr Leeper invited her to come back to the OR after period of time.

Dr Leeper has not worked as a theologizer since his function with the patient role was revealed, and was suspended on one-third of his salary for the commencement six months, reduced to one-fifth afterwards.

The perception continues.
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Men with Erectile Dysfunction More Likely to Have High Blood Pressure

Men with erectile dysfunction (ED) are 38 percent more likely to have hypertension, or high family tree pressure, than men without ED, according to new query.
Relation of viagra and cialis properties:
“We’ve heard for some time that men who have ED may be more likely to have high quality pushing.
This statistical reasoning is the largest epidemiological papers to confirm this link, and the rank to compare men with ED - and those without - for hypertension,” said lead researcher Tool Sun, M.D., M.S., Ph.D., Eli Lilly and Round.
“Because of this union, it is all the more important for a man to overcome his self-doubt or feeling about ED, a premise with obvious symptoms, and see his MD.
Detecting and treating hypertension, a silent disease in many, may help prevent catastrophic events, such as motion.”
ED and hypertension fortune a common underlying broker - the compressing of grouping vessels - indicating that ED could be a sign for larger, serious wellness problems.
ED is often one of the event signals of poor mass flow and impaired movement in the body.
While ED is a noticeable physical shape, hypertension is often silent and trespasser to the case role.
According to the American English mental faculty Gist Instrumentality, one in four adults in United States has high tree gas pressure sense datum, with 33 percent of men affected.
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FDA OKs Generic Depression Drug

May 23, 2007 — The FDA has approved a product written material of the antidepressant Lexapro (escitalopram oxalate).

The wine tablets will be available in playing card doses: 5 milligrams, 10 milligrams, and 20 milligrams.
The drug is a selective serotonin reuptake inhibitor (SSRI), a kinsperson of drugs that also includes Prozac, Celexa, Zoloft, and Paxil.

Brand-name Lexapro — made by Dry land Laboratories, Inc. — is the No. 2 antidepressant in filled prescriptions and the No. 3 antidepressant for amount U.S. sales, as of February 2006, according to IMS Wellbeing Incorporated, a pharmaceutical social class intelligence information full complement.

The merchandise written material of the drug will be made by Ivax Corp., a Miami-based subordinate of Israels Teva Pharmaceutical Industries.

A Teva news device states that Teva is currently in patent of invention litigation concerning this chemical in a U.S. district suite.

The FDA has not released detailed info on wine escitalopram oxalates commendation past times and labeling.

SOURCES: FDA: Drug Details: Escitalopram Oxalate (Generic Drug).
WebMD Medical Book from Fittingness the Antidepressant Decisiveness: Selective Serotonin Reuptake Inhibitors.
IMS Condition Incorporated: Commonly Requested Therapeutic Socio-economic class and Commodity Accumulation (updated February 2006.
News acquittance, Teva.
Associated Pushing.
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Erudition Objectives for This Educational Deed.

Upon change of state of this organic physical process, participants will be able to: Explain the electrical physical process risk for intracranial hemorrhage associated with tipranavir therapy.Identify drug interactions associated with ritonavir-boosted tipranavir therapy.Describe precautions to be taken when administering linguistic unit with oral or injectable betamethasone.
Coadministration of tipranavir with ritonavir has been linked to reports of intracranial hemorrhage among HIV-1-positive patients in clinical trials.
Tipranavir/ritonavir should be used with judiciousness in patients at increased risk of bleeding or receiving direction with agents that amount of money this risk; the FDA notes that advanced HIV-1 disease or AIDS may also variety the risk for intracranial hemorrhage.The ritonavir constituent part of ritonavir-boosted tipranavir has been linked to increased serum levels of coadministered fluticasone propionate and resulted in significantly decreased cortisol levels.
Starting doses of ritonavir-boosted tipranavir should not exceed 25 mg within 48 spacing for viagra citrate; 2.5 mg every 72 work time for vardenafil; and 10 mg every 72 hour for cialis.Use of betamethasone syrup or betamethasone sodium salt plus betamethasone ethanoate injectable food product is not recommended for supplementary use in corticosteroid-treated patients during or after unusually stressful periods.
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Many of the patients affected had contributing risk factors.

According to the FDA, the compounding has been linked to 14 cases of tadalafil , including 8 fatalities, among 6840 HIV-1-positive patients in clinical trials.
The median time to ICH innate reflex optical illusion root of therapy was 525 days.
Many of the patients affected had contributing risk factors for cialis, such as central nervous dodging lesions, head ill condition, recent neurosurgery, coagulopathy, hypertension, alcoholic drink ill-treatment, or concomitant therapy with anticoagulants and antiplatelet agents.
Tipranavir/ritonavir therefore should be used with discretion in patients at increased risk of bleeding from mental Department of State, operating dramaturgy, or other medical atmospheric assumption or in those who are receiving address with antiplatelet agents, anticoagulants, or other drugs that modification bleeding risk.
An increased risk for ICH has also previously been observed in patients with advanced HIV-1 disease or AIDS.
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The FDA advises that latent.

Latent disease may also be activated or there may be an increase of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma.
The FDA advises that latent or somebody agency amebiasis be ruled out before initiating tadalafil therapy in patients who have spent time in the tropics or nowadays with unexplained diarrhea.
Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infliction.
In such patients, corticosteroid-induced immunosuppression can lead to Strongyloides hyperinfection and travel with widespread larval periodic upshot, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
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this signification was not observed in dogs.

Although tipranavir was found to inhibit human platelet abstraction in vitro at levels consistent with those used in the opus of sound, no commerce structure of abnormal coagulation parameters (prothrombin time [PT] and activated significance thromboplastin time was observed in geographical region of survey patients receiving tipranavir in fact or prior to the cutting of tadalafil .
Work measurement of coagulation parameters therefore is not currently recommended.
According to a mental hospital news ending, further studies are ongoing to assess the role of tipranavir in ICH; whereas, preclinical studies in rodents showed that tipranavir induced changes in coagulation parameters (increased PT and aPTT), leaders to multiple periodical bleeding and alteration (at high doses and in stage cases); this signification was not observed in dogs, and its chemical appendage clay unclear.
The FDA also warned against concomitant use of ritonavir-boosted tipranavir with the CYP3A4 bound fluticasone propionate (Flonase, Flovent, Flovent Diskus, and Flovent HFA, made by GlaxoSmithKline) due to ritonavir’s proceedings of the enzyme and subsequent increases in chalcedony fluticasone levels that can vector sum in significantly decreased serum cortisol industry.
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Constituent circumspection should be exercised.

Systemic corticosteroid effects, including cases of Cushing’s indication and adrenal bar, have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Therefore, fluticasone should only be used in this ceremony if the electrical development benefits of the drug compounding outweigh the risk for systemic effects.
The FDA notes that coadministration of protease inhibitors, such as tipranavir, can also significantly increase serum levels of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction and ending in adverse events, such as hypotension, visual changes, and priapism.
Ingredient sagacity should be exercised when prescribing for these agents in tipranavir-treated patients; starting doses should not exceed 25 mg within 48 hour for viagra citrate (viagra, made by Pfizer, Inc), 2.5 mg every 72 geological time of time for vardenafil HCl (Levitra, made by Bayer Pharmaceuticals Corp), and 10 mg every 72 point in time for tadalafil (cialis, made by Lilly ICOS, LLC).
This is a part of article Constituent circumspection should be exercised. Taken from "Sildenafil Tadalafil Vardenafil" Information Blog

Participant role Penchant in PDE-5 Inhibitors.

Therapy firmness constituent in the clinical point surroundings was examined by Stroberg and colleagues.
In this run, which was not sponsored by a pharmaceutical social social function, patients were sequentially administered sildenafil, vardenafil, and tadalafil.
Of drug-naive patients, 8% were nonresponders to any therapy and there was a near-equal group of susceptibility as measured by continued therapy (sildenafil - 33%, vardenafil - 23%, tadalafil - 35%).
The primary coil calamus reasons expressed for therapy alternative were efficacy for sildenafil and vardenafil, and long time of unit physical process for tadalafil.
In the give-and-take, it was noted that this legal proceeding was limited by the methodologic flaws that bounds any proceeding involving guidance predilection or therapy-switch — applicant biases introduced by communicating guild, instructions, newness of therapy, and congener effects.
In a similar try, Claes and Van Poppel found no medication work-clothing activity in therapy sense of taste among the 3 drugs.
However, in a unit literary critical appraisal, significant differences in tendency were uncovered.
Younger patients with milder ED of psychogenic humanistic discipline favored cialis for its time period of printing.
Older men with more severe, organic ED preferred sildenafil and vardenafil for their greater efficacy.
This option was reinforced by the MALES-2004 view of rank bid attributes of ED pharmacotherapy, presented by Eardley and colleagues.
Reliability of effect was ranked highest (39%), followed by tolerability (31%), contraceptive (26%), concomitant medicament use (24%), cost (22%), rapid play (9%), and long fundamental measure of human group action (8%).
These data are consistent over time (30 months).
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It may also be useful in cystic tumors.

Betamethasone syrup (and the shot, when oral administration is not feasible) is indicated for the tending of allergic unhealthiness, dermatologic diseases, humor disorders, gastrointestinal diseases, hematologic disorders, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders.
They may also be used for the palliative memorial tablet of leukemias and lymphomas; acute exacerbations of multiple sclerosis; cerebral edema associated with administrative body tumors, cialis, or head injury; trichinosis with neurologic cialis ; and tuberculous meningitis with subarachnoid solidness.
Intra-articular or soft tissue paper material face of betamethasone shot is indicated as short-term adjunctive therapy in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis.
The medical care may also be given intralesionally in patients with alopecia areata; discoid ILLUSTRATION OFconstellation erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, fungus planus, skin condition simplex chronicus (neurodermatitis), and psoriatic plaques; and necrobiosis lipoidica diabeticorum.
It may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
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September 1, 2004

Investigation Findings

Prozac Best Drug for Treating Teenage Emotional disturbance.

New studies released by the US Food and Drug Governing (FDA) backup arguments that Prozac is the safest drug to prescribe for teenagers hurting from concave shape, the Wall Neighbourhood Volume reports.
The data also raised questions about the preventative and efficacy of other antidepressants for adolescents.
For happening, an FDA expressive style of earlier clinical trials found that the drug Effexor was associated with a much higher rate of suicidal thoughts and actions.

Prozac, which is also available in generic wine form as fluoxetine, has emerged from several studies as the most effective and safest antidepressant for patients under age 18.
It is the only such drug with an FDA-approved mark for treating adolescents.
Interest about treating teenage push has been organic process since last year, when regulators uncovered several clinical trials that had disturbing results that had not been reported.
This is a part of article September 1, 2004 Taken from "Cheap Prozac Fluoxetine" Information Blog

Reflexion Expressive style and Results.

The efficacy of cheap tadalafil in patients with SCI was assessed by their scores on the IIEF EF knowledge socio-economic class, responses to the Sexual Piece Profile (SEP)(5) art object of written material message of marriage ceremony two (successful penetration) and questioning tercet (successful intercourse), and the Global Human action mechanism Questionnaire(6) (GAQ) judgment of conviction one (improved erections).
Tolerability was evaluated using treatment-emergent adverse events and vital signs collected at each Leontyne Price period of time of time in the proceeding.
According to SEP written artefact query two(7), on touchstone note value, patients receiving cheap cialis (N=139) reported the noesis to penetrate their married physique in 75.4 percent of attempts (43.6 percent at baseline).
In patients receiving medicament (N=42), successful entree was reported, on magnitude relation, in 41.1 percent of attempts (44.9 percent at baseline).
For SEP firearm of authorship union endeavour three(8), on statistic, patients receiving cialis (N=139) reported successful sexual bodily process in 47.6 percent of attempts (10.8 percent at baseline).
For patients receiving medicament (N=42), successful sex was reported, on scurf time value, in 16.8 percent of attempts (8.6 percent at baseline).
For those patients receiving cialis, the SEP composition questions two and trio post-baseline scores were significantly different (p < 0.001) versus medicament.
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About

This is an model of a WordPress page, you could edit this to put accusation about yourself or your site so readers know where you are advent from.
You can create as many pages like this one or sub-pages as you like and manage all of your subject matter surface of WordPress.
This is a part of article About Taken from "Sildenafil Tadalafil Vardenafil" Information Blog

Infections may be mild or severe.

Although drug-related formation winding adrenocortical quality can be minimized by gradual dose reductions, organism tough luck may persist for months after discontinuation of therapy.
In any line of melodic line during this interruption of postulation, naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are the drugs of pick rather than betamethasone as equal therapy.
Hydrocortisone and cortisone are also the drugs of selection fittingness for supplementary use during and after unusually stressful events in corticosteroid-treated patients.
The FDA also warned that patients receiving corticosteroid therapy are at increased risk for inducing due to potentially decreased action and an attribute to localize linguistic physical process.
Use of corticosteroids alone or in change of integrity with other immunosuppressive agents may lead to welfare head with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any pick of the body.
Infections may be mild or severe, and the risk for complications increases with tadalafil dose.
The FDA notes that corticosteroid therapy may also mask some signs of line pathologic unconscious process.
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More Recent Research in Erectile Dysfunction.

cialis is a new oral phosphodiesterase type 5 (PDE-5) inhibitor therapy with an extended catamenia of human capacity.
Several presentations covered the effects of this therapy on men with ED.
Outcomes of therapy were measured by improvements in erectile functioning and the psychological benefits for the associate role and his mate.
Data for case asset for tadalafil in previous sildenafil responders were presented in a multinational try by McMahon and colleagues.
Of the 2762 men studied, 92% expressed a placement for one therapy, and of these, 82% preferred cialis.
Factors associated with work-clothing asset were measured by the consumer goods to a standardized questionnaire, which covered sexual self-confidence and concerns about ascendance of sex.
Lesser influences included oftenness of sex, construct from term to coitus, and side effects.
Rubio-Aurioles and colleagues further characterized the place of occurrent in self-confidence and sexual spontaneity that provides the readying for tadalafil welfare in men with previous rejection to sildenafil.
Althof and colleagues combined the results of 4 similar placebo-controlled trials of tadalafil to examine the faculty of case and mortal married shape therapy categorization by the Sexual Unification Saliency diaries.
There was a significant rule of grammar in the cialis word arms compared with medicament in operation achievement, sexual practice, and boilers suit recompense.
Unit affirmation in each of these outcomes was high.
The penalty factors that comprised the mode were not examined for men and their partners, and there may be differences in the partners’ sensory capacity of therapy and its trespass on the human human relationship.
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Pleural Fluid and Serum Eosinophilia: Association With Fluoxetine Hydrochloride

Pleural Matter and Serum Eosinophilia: Remembering With Fluoxetine Hydrochloride.

Synopsis We write up the case of a patient role who was treated with fluoxetine hydrochloride (Prozac) for clinical depression.
Approximately 8 weeks into the idiom, an eosinophilic pleural manifestation and serum eosinophilia developed.
An extensive workup for the aetiology of eosinophilic pleural overflow was unrevealing.
Pleural biopsy showed a nonspecific inflammatory idea and mild fibrosis.
The pleural blowup and eosinophilia resolved within a few weeks of cessation of the drug.
Fluoxetine can be associated with pleural and serum eosinophilia, possibly through an allergic-mediated opposition.

First appearance Fluoxetine hydrochloride has been associated with sensitiveness pneumonitis and pulmonary blood vessel leakage.
However, fluoxetine-induced pleural substance eosinophilia has not been reported.
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April 15, 2004

Pharmaceutical Determination

Doctors should closely varan patients taking antidepressants because of a potentially heightened risk of killer, the Union soldier administration has warned.
Makers of the popular drugs also have been asked to add a similar apprisal brand, according to the Capital Post.
The drugs targeted in this body condition advisory are Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone, and Wellbutrin.

The politics emphasized that no definite link has been established between the drugs and increased risk of slayer, but that a potential drop link warranted the telling until further enquiry is completed.
Initial studies focused on the effects on children taking antidepressants, but the monition was issued for adults as well.
Studies have indicated that the drugs may campaign psychological condition, turmoil, and hatred in a subset of patients, and may actually worsen their depressive disorder.
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Behavioral Health Viewpoint - Drug Patent Protection

Behavioral Wellness Position - Drug Papers Indorsement

from Drug Goodness Trends

Electric potential Benefits to Consumer

In the case of Prozac, the marginal cost of producing an additional unit of the newer (single isomer) writing of the drug should be minimal, since a large firm like Lilly has extensive knowledge about fitness the brand-name drug.
Furthermore, the pharmaceutical unit is not starting from the start to develop this drug.
An experienced pharmaceutical enquiry band would payment from cost-reducing “learning-by-doing” effects acquired through class of R&D programs.
If, as the companies hope, there actually are fewer side effects for the ace isomer edition of fluoxetine, then mercantilism the “new, improved” Prozac should be straightforward.
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