NSAIDs Linked To Increased Risk Of Erectile Dysfunction

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Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Pain / Anesthetics;  IT / Internet / E-mail;  Heart Disease
Article Date: 04 Mar 2011 – 0:00 PST

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Men who take non-steroidal anti-inflammatory drugs three times a day for more than three months are 2.4 times more likely to have erectile dysfunction compared to men who do not take those drugs regularly, according to a Kaiser Permanente study published online in The Journal of Urology.

While previous research showed a trend toward this same finding, this observational study used electronic health records, an automated pharmacy database and self-reported questionnaire data to examine NSAID use and ED in an ethnically diverse population of 80,966 men aged 45 to 69 years throughout California.

After controlling for age, race, ethnicity, smoking status, diabetes, hypertension, heart disease, high cholesterol and body mass index, the researchers found that ED was 1.4 times more likely – a modest risk – among regular NSAID users compared to men who did not take the drugs regularly. This association was consistent across all age groups.

“This study is a great example of how we work to understand the safety and effectiveness of what we recommend for our patients. We went into this study thinking we would find the opposite effect: that NSAIDs would have a protective effect because they protect against heart disease, which is also linked to ED,” said study senior author Steven J. Jacobsen, MD, PhD, an epidemiologist and director of research for Kaiser Permanente Southern California. “The next step is to dive a bit deeper to understand the underlying physiology of what might be happening with these drugs.”

Erectile dysfunction is a common problem in many middle-aged and elderly men. According to the National Institutes of Health, approximately 5 percent of 40-year-old men and between 15 and 25 percent of 65-year-old men experience ED on a long-term basis.

However, the researchers caution that men should not stop taking NSAIDs based on this study.

“There are many proven benefits of non steroidals in preventing heart disease and for other conditions. People shouldn’t stop taking them based on this observational study. However, if a man is taking this class of drugs and has ED, it’s worth a discussion with his doctor,” Jacobsen said.

Notes:

Study authors included: Joseph M. Gleason, MD, and Howard Jung, MD, from the Kaiser Permanente Los Angeles Medical Center; Jeffrey M. Slezak, MS; Kristi Reynolds, PhD, MPH, Reina Haque, PhD, MPH, Virginia P. Quinn, PhD, MPH, and Steven J. Jacobsen, MD, PhD, with the Kaiser Permanente Southern California Department of Research Evaluation; Ronald K. Loo, MD, Kaiser Permanente Downey Medical Center; and Stephen K. Van Den Eeden, PhD with the Kaiser Permanente Northern California Division of Research.

Source:
Kaiser Permanente

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Virtually The Same Percentage Of Surveyed Rheumatologists Selected Enbrel And Humira As The Most Efficacious Agent For The Treatment Of RA

Main Category: Arthritis / Rheumatology
Article Date: 03 Mar 2011 – 1:00 PST

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that virtually the same percentage of surveyed rheumatologists selected Amgen/Pfizer/Takeda’s Enbrel (43 percent) and Abbott/Eisai’s Humira (42 percent) as the most efficacious agent for the treatment of rheumatoid arthritis. The shrinking gap in the percentage of surveyed rheumatologists who favor Enbrel over Humira in terms of efficacy suggests that Humira is threatening Enbrel’s sales-leading position in rheumatoid arthritis. Nevertheless, physicians continue to regard Enbrel as the agent with the best overall clinical profile, owing to the strength of its perceived safety and tolerability advantages over Humira.

The findings from Decision Resources’ analysis of the rheumatoid arthritis drug market also reveal that a slightly higher percentage of surveyed managed care organizations’ (MCOs) pharmacy directors selected Humira (50 percent) over Enbrel (40 percent) as the most efficacious rheumatoid arthritis agent. In contrast, no surveyed pharmacy directors selected rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera) or tocilizumab (Roche/Chugai’s Actemra/RoActemra) as the most efficacious agent for the indication. The prescription of both agents is restricted primarily to patients who are refractory to treatment with tumor necrosis factor-alpha (TNF-alpha) inhibitors.

“Rheumatologists’ perceptions of tocilizumab’s efficacy are likely influenced by the drug’s infrequent use, given its recent launch in 2010 and less-favorable tier positioning, as well as payer-imposed cost-control measures,” said Decision Resources Analyst Irene Koulinska, M.D. “Although tocilizumab has demonstrated efficacy in clinical trails comparable to that of the TNF-alpha inhibitors, less familiarity with the agent is the likely driver behind the low number of surveyed rheumatologists who selected it as having the best efficacy or best overall clinical profile among currently available therapies.”

The findings also reveal that, based on clinical data and the opinions of interviewed thought leaders, Enbrel is the current gold-standard therapy for the treatment of rheumatoid arthritis, due to its strongest clinical profile among key marketed agents for the indication. However, owing to its competitive advantages in safety and tolerability, Bristol-Myers Squibb’s subcutaneous formulation of Orencia will displace Enbrel and will earn Decision Resources’ proprietary clinical gold-standard status for rheumatoid arthritis in 2014, following its expected launch for the indication later this year.

Over the next decade, the rheumatoid arthritis drug market will experience modest annual growth as sales will increase from $8.8 billion in 2009 to $12 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan. In 2009, sales of the TNF-alpha inhibitors accounted for 75 percent of major-market sales as they continue to dominate as first-line biological agents but as the number of effective alternative biologics and novel oral immunomodulators increases, the market share of TNF-alpha inhibitors will fall by 2019. The interleukin-6 inhibitor Actemra/RoActemra, the most recent novel entrant to the rheumatoid arthritis market, is forecast to emerge as the preferred biologic for TNF-alpha-refractory patients and will earn blockbuster sales of $1.5 billion in 2019.

Source:
Decision Resources, Inc.



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Update On Preclinical Finding And Development Timeline For PCI-45292

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 03 Mar 2011 – 4:00 PST

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Pharmacyclics, Inc. (Nasdaq: PCYC) announced that further advancement of PCI-45292, a Btk inhibitor with exceptionally potent anti-arthritis activity in mice and rats, has been suspended following results from the current set of preclinical toxicology studies. The company hopes to have a new clinical development candidate identified within approximately 6 months.

PCI-45292 has been under preclinical development for approximately 1 year as a potential new agent for the treatment of immune mediated diseases. A recent evaluation of tissues from animals dosed with PCI-45292 has revealed an undesirable target-organ effect. The effect, which was noted at all dose levels in a rat animal model, but absent in another animal model, precludes establishing a starting dose for human clinical trials.

The undesired effect observed with PCI-45292 has not been observed with our Btk Inhibitor PCI-32765 even at higher dose levels in preclinical safety studies and is not considered to be related to the inhibition of Btk. Our broad clinical development for PCI-32765 in B-cell malignancies in particular in chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma continues as outlined in our last quarterly update.

We have readily identified the portion of the PCI-45292 molecule directly responsible for these target organ changes. We have now turned our attention to evaluating a related series of molecules with the focus on eliminating the target-organ effect. Our commitment to advancing a safe and effective Btk inhibitor into the clinic for immune mediated diseases remains strong.

“While we are disappointed with the delay of the program we are pleased with the quality of the research that was able to identify this effect early in development, allowing us to make adjustments pre-clinically. We remain dedicated to developing important, new targeted therapies that are safe and effective and advance the standard of care for patients,” said Bob Duggan, Chairman of the Board and Chief Executive Officer.

Source: Pharmacyclics, Inc



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‘Prehabilitation’ Puts Patients In Better Shape For Knee Replacement Surgery

Main Category: Arthritis / Rheumatology
Article Date: 02 Mar 2011 – 2:00 PST

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A comprehensive “prehabilitation” exercise program for patients with severe knee arthritis can improve strength and functional ability before knee replacement surgery, reports a study in the February issue of The Journal of Strength and Conditioning Research, official research journal of the National Strength and Conditioning Association. The journal is published by Lippincott Williams Wilkins, a part of Wolters Kluwer Health.

The physical gains from exercise before knee replacement may translate into improved recovery after surgery, suggests the new study by Ann M. Swank, Ph.D., CSCS, and colleagues of University of Louisville, Ky.

Increased Leg Strength Leads to Better Functioning and Decreased Pain

The study included 71 patients scheduled for knee replacement surgery because of severe osteoarthritis that could not be managed with pain medications. One group was randomly assigned to a comprehensive prehabilitation program, consisting of light resistance training, flexibility and step exercise, and light walking.

Patients in this “pre-rehab” group exercised three times per week, in the clinic and at home, for four to eight weeks before knee replacement surgery. Patients in the comparison group received standard preoperative care, with instructions to continue their usual activities. The two groups were compared for knee strength and performance on standard functional tests.

When tested one week before surgery, patients who went through the prehabilitation program showed improvements in several key outcomes. In particular, they had a significant ten percent increase in extension strength in the leg scheduled for knee replacement. In contrast, the comparison group had an ten percent decrease in extension strength.

Prehabilitation was also associated with improvement in some functional tests, including the ability to get up from a chair and to climb a set of stairs. Other functional tests, such as walking speed and going downstairs, showed no significant improvement.

In addition, patients in the prehabilitation group also had less pain when performing the functional tests. For patients receiving standard care, performance on some functional tests actually decreased in the weeks before surgery-possibly reflecting increased pain scores.

Osteoarthritis of the knee is a very common condition in older adults, causing pain and gradual declines in the ability to perform everyday tasks. When pain becomes so severe that medications no longer provide relief, knee replacement surgery is the only option. By that time, reduced leg strength may be present for several years-not only decreasing functional ability, but increasing the risk of falls.

Previous studies have evaluated exercise programs to improve leg strength and functional ability before knee replacement surgery, but with limited success. For the new study, Dr. Swank and colleagues developed a comprehensive, progressive short-term exercise program specifically designed to increase leg strength and functional ability.

The results show significant improvements in strength and functioning in the weeks before knee replacement surgery. Strengthening of the leg undergoing knee replacement may be a particularly important factor-exercise may reduce the strength imbalance between legs, thus contributing to the functional improvement. (Although even with exercise, the surgical leg remains significantly weaker than the other leg.)

Dr. Swank and colleagues outline a recommended routine for progressive exercise in patients scheduled for knee replacement surgery. They note that the prehabilitation program was designed to be “easily accessible” and “easily transferred to a home environment.” Although their study didn’t compare postoperative recovery, the researchers note, “Increases in leg strength and performance of functional tasks before [knee replacement] surgery may result in improved postoperative recovery because preoperative performance of functional tasks has been shown to be a predictor of postoperative performance of functional tasks.”

Source:
Wolters Kluwer Health: Lippincott Williams Wilkins

National Strength and Conditioning Association



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Computed Tomographic Colonography Recommended For Colon Cancer Screening

Main Category: Colorectal Cancer
Also Included In: Medical Devices / Diagnostics;  Medicare / Medicaid / SCHIP
Article Date: 02 Mar 2011 – 4:00 PST

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Despite the absence of Medicare coverage, hospital use of computed tomographic colonography (CTC), commonly referred to as virtual colonoscopy, is on the rise, according to a study in the March issue of the Journal of the American College of Radiology. Colorectal cancer is the second leading cause of cancer deaths in the U.S. CTC, a minimally invasive alternative to optical colonoscopy for colorectal cancer screening, employs virtual reality technology to produce a 3-D visualization that permits a thorough evaluation of the entire colon and rectum.

Data on the provision of colorectal cancer screening services by nonfederal, general hospitals were analyzed using the 2005 to 2008 American Hospital Association annual surveys. In addition, in 2009, exploratory interviews were conducted with representatives from radiology departments at nine hospitals; six that provided CTC and three that did not. Researchers found that in 2008, 17 percent of hospitals offered CTC, up from 13 percent in 2005. Sixty-nine percent of hospitals that offered CTC in 2008 also offered optical colonoscopy services. Factors motivating the adoption of CTC included a desire to provide an alternative screening option for frail, elderly patients and patients with failed optical colonoscopy; long waits for optical colonoscopy; and promising evidence on CTC published in peer-reviewed literature. Lack of reimbursement was a commonly cited barrier.

“Our study is unique in that we show expansion even in the absence of Medicare reimbursement for CTC for general screening. CTC’s relatively easy implementation coupled with patient acceptance makes CTC a tool that holds promise for the future of colorectal cancer prevention,” said Megan McHugh, PhD, lead author of the study.

CTC is proven in clinical trials to be as accurate as standard colonoscopy at detecting clinically significant lesions in average risk patients and is endorsed by the American Cancer Society as a recommended colon cancer screening test. Yet, Medicare does not cover seniors for CTC. As policymakers and others consider ways to increase colorectal cancer screening, it is important to understand US hospitals’ readiness to offer CTC and the factors that facilitate or impede adoption.

Source:
Heather Curry
American College of Radiology / American Roentgen Ray Society nd educational improvement.






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4SC Presents Final Phase IIa Data On Vidofludimus In Inflammatory Bowel Disease Study At The 6th ECCO IBD Conference

Main Category: Crohn’s / IBD
Also Included In: Immune System / Vaccines;  Arthritis / Rheumatology
Article Date: 01 Mar 2011 – 3:00 PST

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4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, announces the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease (IBD) with vidofludimus, an oral inhibitor of interleukin-17 (IL-17) release and DHODH, including the secondary endpoints comprising the analysis of CDAI (Crohn’s disease, CD) and CAI (ulcerative colitis, UC) disease scores, change of prednisolone intake and threshold doses, safety, pharmacokinetics and biomarkers. The data support the previously reported top-line primary endpoint result, which was achieved with a total response rate of 88.5%. These were presented last week at the 6th ECCO IBD Conference in Dublin, Ireland.

— Primary objective of the ENTRANCE study in 26 CD and UC patients was to assess vidofludimus’ remission maintenance potential in steroid-dependant IBD patients upon steroid weaning

— Primary endpoint was met with an 88.5% total response rate (complete and partial responders), supported by secondary endpoint results demonstrating a clear clinical benefit for treated IBD patients

— Required relapse-free prednisolone doses at the end of vidofludimus therapy were significantly lower than average doses needed prior to study entry * Average prednisolone consumption dramatically dropped over the course of the treatment period

— Prednisolone threshold doses of partial responders at the end of the treatment were significantly reduced compared to documented threshold doses prior to study entry

— Vidofludimus was safe and well tolerated by all patients

Entrance Trial Final Data

The top-line results from the exploratory, open-label, single-arm ENTRANCE Phase IIa study, announced in November 2010, demonstrated a 88.5% total response rate with vidofludimus versus an average placebo response rate of approximately 20% across published benchmark clinical trials, in steroid-dependant IBD patients. 53.9% (14 out of 26) of patients were complete responders, 34.6% (9 out of 26) of patients were partial responders (34.6%), and 11.5% (3 out of 26) of patients were evaluated as non-responders. No variation in response rates across the sub-disease populations of Crohn’s disease (85.7%) and ulcerative colitis (91.7%) over the 12 week treatment period was observed.

CDAI/CAI disease score development was in-line with the assignment of patients to the categories complete, partial, and non-responders. All 26 evaluable patients, excluding the three non-responders, reached a relapse-free prednisolone dose which was significantly (p


Vidofludimus was safe and well tolerated by all patients. No clinically relevant changes of pulse rate, blood pressure, electrocardiography, body temperature, hematology and biochemistry were recorded. A total of 75 adverse events (AEs) were reported (53 mild, 18 moderate, 4 severe) of which 19 AEs were judged by investigators as ‘possibly’ or ‘probably’ drug-related. These included isolated cases of nasopharyngitis, abdominal pain, fatigue, insomnia, glucosuria, leucocyturia, microhematuria, musculoskeletal pain, myalgia, tachycardia, and dyspepsia. No drug-related serious adverse events (SAEs) were reported.

Dr Bernd Hentsch, Chief Development Officer of 4SC, commented, ‘The ENTRANCE study has produced encouraging data with vidofludimus in inflammatory bowel disease, an indication that is underserved for patients and is lacking effective and safe drugs especially in long-term remission maintenance therapy. These data provide early evidence that our oral therapy vidofludimus could provide such an alternative and we look forward to assessing the potential of this compound in further IBD trials.’

Notes

About Vidofludimus

Vidofludimus (4SC-101) is a novel, orally administered small molecule for the treatment of autoimmune disorders such as rheumatoid arthritis and inflammatory bowel disease. The therapeutic efficacy of vidofludimus is based on a dual principle. Vidofludimus inhibits the expression of interleukin- 17 (IL-17), a pro-inflammatory cytokine that has a crucial pathogenic role in a variety of autoimmune diseases. Vidofludimus also inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme of the pyrimidine biosynthesis, thereby halting the proliferation of activated T and B cells which are involved in the pathology of autoimmune disorders. The combination of two mechanisms of action provides an innovative therapeutic approach with broad clinical potential in various autoimmune diseases.

In addition to the Phase II study in inflammatory bowel disease, Vidofludimus is also currently being evaluated in the randomised, double-blind, placebo-controlled Phase IIb COMPONENT study in patients with rheumatoid arthritis in combination with methotrexate. Preliminary results are expected to be reported in Q2 2011.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the gastrointestinal tract. The main forms are Crohn’s disease (CD) and ulcerative colitis (UC). These chronic diseases are constituted by acute-disease flare ups which include abdominal pain, rectal bleeding, diarrhoea, weight loss, fatigue and other extra-intestinal symptoms and symptom-free phases. It is assumed that a deregulated immune response results in inflammatory mediators that attack the patient’s intestinal mucosa and trigger the symptoms. For both, CD and UC, the pro-inflammatory cytokine interleukin-17 (IL-17) has been demonstrated to play a crucial role in pathogenesis.

CD is characterised by an inflammatory affliction of part or the whole of the digestive tract and is currently incurable. Approximately 0.9 million people in the seven major industries suffer from various CD symptoms and mostly contract the disease between the ages of 20 and 40. CD leads to a considerable reduction in quality of life, but may also involve severe complications requiring immediate surgery. Current therapeutic options for patients are largely limited to the use of anti-inflammatory corticosteroids or immunosuppressants applied either systemically or locally for the treatment of the symptoms, as well as the application of biological agents (e.g. TNF-alpha targeting antibodies).

UC afflicts specifically the large intestine or colon that includes characteristic ulcers or open sores. UC occurs in approximately 1.4 million patients in the seven major industries and is currently treated with anti-inflammatory drugs, immunosuppressants and biological agents targeting specific components of the immune response. Colectomy (partial or total removal of the large bowel through surgery) is occasionally necessary and is considered to be a cure for the disease.

Source:

4SC AG



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