September 28, 2007

• Treating Obstructive Sleep Apnea, Preventing Heart Attacks And Strokes
  (EurekAlert) -- Researchers in Brazil have found that treating patients who suffer from obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) dramatically reduces early indications of atherosclerosis in just months, linking OSA directly to the hardening or narrowing of the arteries. Until now, no study has demonstrated such a direct relationship between the two.
  

• Report Assails F.D.A. Oversight Of Clinical Trials
  (New York Times) -- In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
  

• Good Transplant Outcomes Possible In HIV-Infected Patients
  (Medscape/Reuters) -- A number of centers have eliminated HIV infection as a contraindication to transplantation, and findings from a new review suggest that transplant outcomes can be good in HIV-infected recipients.
  

• The Science Of Appetite
  (Time) -- Somewhere in your brain, there's a cupcake circuit. how it works is not entirely clear, and you couldn't see it even if you knew where to look. But it's there all the same—and it's a powerful thing. You didn't pop out of the womb prewired for cupcakes, but long ago, early in your babyhood, you got your first taste of one, and instantly a series of sensory, metabolic and neurochemical fireworks went off.
  

• Encysive Pharmaceuticals To Conduct Phase III Study With Thelin In PAH
  (Encysive) -- The company has been discussing possible protocols for the trial, to be called STRIDE 5, with its Scientific Advisory Board and other experts. The company will now work with the FDA to finalize the protocol. After the Company has concluded its protocol discussions with the FDA, it will announce the details of the study, including timing and the number of patients.
  

• Breathing New Life Into Lungs
  (LA Times) -- The next generation of refined artificial lungs are built on understanding the art of breathing.
  

• Tissue-Growth Gene Tied To Scleroderma
  (HealthDay News) -- The study does implicate the connective-tissue growth factor (CTGF) gene in scleroderma, which affects some 30,000 Americans and is estimated by the Scleroderma Foundation to cause 10,000 deaths in the United States annually.
  

• Researchers Say Emotional Stress May Be Harmful To The Heart
  (WebMD) -- "In the hospital, I see people under all sorts of stress all the time -- and I see what happens to bodies under stress," Brotman says. "Our study illustrates how important the body's stress responses are in precipitating cardiovascular effects."
  

• Diuretics in Obstructive Sleep Apnea With Diastolic Heart Failure
  (Medscape) -- Upper airway edema might contribute to pharyngeal collapsibility and account for the high prevalence of obstructive sleep apnea (OSA) in patients with heart disease. The aim of this study was to evaluate if intensive unloading with diuretics improves sleep-disordered breathing and increases pharyngeal caliber in patients with severe OSA and diastolic heart failure.
  

•   UK Government Task Force To Explore Presumed Consent For Organ Donation
  (The Daily Telegraph) -- Everyone will automatically have their organs taken for transplant unless they have registered their objections under plans being considered by the Government, it will be announced today.
  

• FDA OKs Warfarin Sensitivity Lab Test
  (UPI) -- The U.S. Food and Drug Administration has approved a genetic test that determines a patient's sensitivity to the "blood-thinning" drug warfarin.
  

• Teva Provides Update On Edratide For Systemic Lupus Erythematosus
  (Teva Pharmaceutical) -- Teva Pharmaceutical Industries Ltd. announced today that the Company's synthetic peptide, edratide (TV-4710), did not meet its primary endpoint in the PRELUDE trial, a Phase 2 clinical trial in patients with systemic lupus erythematosus. The drug candidate, administered as a subcutaneous weekly injection, was shown to be safe and well-tolerated.
  

• New Sickle Cell Treatment
  (HOI 19) -- Researchers at Virginia Commonwealth University are testing a new agent as a possible treatment for sickle cell disease. It’s called 5-Hydroxymethyl-2-Furfural, or 5HMF. Medicinal Chemist Donald Abraham, Ph.D., says the molecule occurs naturally as a breakdown product in plants and some foods.
  

• A New Take On Life -- Rossville Woman Looks To Live With PAH
  (Journal and Courier) -- "It was really tough. I tried to keep upbeat, but that's always easier said than done," she said. "Everyone has a picture of what they want their life to be like and it usually doesn't include being sick."
  

• Bosentan For Inoperable Chronic Thromboembolic Pulmonary Hypertension And Post-Pulmonary Endarterectomy Pulmonary Hypertension
  (Doctor's Guide) -- The dual endothelin receptor antagonist bosentan provides significantly improved haemodynamics and decreased pulmonary vascular resistance in patients with inoperable chronic thromboembolic pulmonary hypertension and with post-pulmonary endarterectomy pulmonary hypertension, according to presented here at the European Society of Cardiology Congress.
  

• Possible Key To Autoimmune Disease
  (ScienceDaily) -- A human peptide that acts as a natural antibiotic against invading microbes can also bind to the body's own DNA and trigger an immune response in the absence of an infection, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reports in an early online publication in Nature.
  

• CardioMEMS Announces Start Of CHAMPION Pivotal Study Of Wireless Pressure Sensing For Heart Failure Monitoring
  (CardioMEMS) -- The wireless HF sensor is a proprietary miniature device which is implanted into the patient’s pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using CardioMEMS’ proprietary electronic monitoring system.
  

• Bid To Stay Fen-Phen Judgment Fails
  (Lexington Herald-Leader) -- A three-judge panel of the Kentucky Court of Appeals has denied an emergency motion by three suspended lawyers to stay the collection of a $42 million judgment against them.
  

• Encysive Pharmaceuticals Announces Launch Of THELIN In Spain
  (Encysive) -- Encysive Pharmaceuticals today announced the commercial availability of THELIN(r) 100 mg tablets in Spain for the treatment of pulmonary arterial hypertension.
  

• Advance Reported In Heart Valves For Children
  (HealthDay News) -- Such a valve would help children with certain birth defects avoid repeated valve replacement surgeries.
  

• New Drug No Substitute For Standard Blood-Clot Therapy
  (HealthDay News) -- Three studies on the new anti-clotting medication idraparinux found the drug was effective at treating deep vein thrombosis (DVT) and for the long-term prevention of blood clots. But it was not as effective as the usual treatment for potentially life-threatening pulmonary embolisms.
  

• New Zeal In Organ Procurement Raises Fears
  (Washington Post) -- Donation groups say they walk a fine line, but critics see potential for abuses.
  

• Placebo Use In Clinical Trials May Cause Problems In Patients With Pulmonary Hypertension
  (EurekAlert) -- The analysis showed that placebo-treated patients were 1.81 times more likely to suffer a clinical worsening, including a decline in pulmonary hemodynamic parameters and a decrease in 6-minute walk distance.
  

• Keyhole Boost For Heart Patients
  (BBC) -- Surgeons at King's College London were able to insert a replacement valve directly into the heart, avoiding the dangers of lengthy open heart surgery.
  

• Small Incisions Make Heart Valve Surgery Safer
  (HealthDay News) -- Heart valve surgery using only two tiny openings significantly reduces the risk of death for people who have had previous cardiac surgery, Belgian surgeons report.
  

• Weight Gain May Spell Trouble For Heart Failure Patients
  (HealthDay News) -- Patients who gain as little as two pounds over the course of a few weeks may require hospitalization within the month, according to heart researchers. Heart failure patients who gain more than 10 pounds are eight times more likely than heart failure patients with stable weights to need hospitalization.
  

• Hospitalists Taking Over Role Played By Primary Care Physicians
  (Washington Post) -- Although many patients may resent not having their doctor at their bedside, just when they need him or her the most, the hospitalist movement, by most accounts, is here to stay.
  

• Researchers Find Better Way To Deliver Blood Thinner
  (HealthDay News) -- A new gene-based dosing formula for the anti-clotting drug warfarin should make it easier to prescribe the correct dose of the blood thinner, researchers say.
  

• Aspreva Provides Update On Lupus Nephritis Development Program
  (Aspreva) -- Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) today announced that Aspreva and Roche have decided not to proceed with a regulatory submission at this time for CellCept as an induction therapy for lupus nephritis.

• Sildenafil Produces Significant Haemodynamic Response In Patients With PAH Treated With Bosentan
  (Doctor's Guide) -- A single oral dose of sildenafil has beneficial haemodynamic effects when added to bosentan in patients with PAH pulmonary arterial hypertension (PAH), according to study results presented here at the European Society of Cardiology (ESC) Congress.
  

• Pain Patients At Risk For Sleep Apnea
  (ScienceDaily) -- We found that sleep-disordered breathing was common when chronic pain patients took prescribed opioids," explains lead author Lynn R. Webster, MD.
  

• Cutting Salt Won't Affect Foods' Safety
  (HealthDay News) -- Cutting down on salt in processed foods may result in products that are healthier for consumers' hearts, but manufacturers have long been concerned about the longevity of these de-salted products.
  

• Bosentan (Tracleer) Slows Progression of Pulmonary Arterial Hypertension
  (MedPage Today) -- "The results of our trial confirm for the first time that early diagnosis and treatment of pulmonary arterial hypertension have an impact on a relevant endpoint such as clinical worsening, even for those patients who present with mild symptoms," said cardiologist Nazzareno Galie, M.D., of the University of Bologna in Italy.
  

• Encysive Pharmaceuticals Receives Written Response From FDA On Its Request For Formal Dispute Resolution For THELIN
  (Encysive) -- The FDA's reviewer agreed with the decision of the Division of Cardiovascular and Renal Products that, while the data provided in the NDA are suggestive of the effectiveness of Thelin, it did not provide the substantial evidence of effectiveness needed for approval.
  

• Rheumatoid Arthritis, Lupus: Gene Link
  (WebMD) -- Researchers now report that some rheumatoid arthritis patients and lupus patients share a variation in the STAT4 gene, which is part of the immune system.
  

• Study Links Body-Building Antioxidant To PAH
  (Charlottesville Daily Progress) -- Researchers have discovered that high doses of N-acetylcysteine can trick blood vessels into thinking they’re not getting enough oxygen. That reaction can lead to pulmonary arterial hypertension, a potentially fatal condition that causes high blood pressure in the arteries carrying blood into the lungs.
  

• Aradigm And Lung Rx Agree To Develop AERx Essence(R) Technology For Use In PAH
  (Yahoo/Business Wire) -- Aradigm will initiate, and is responsible for conducting and funding, a study that includes a bridging clinical trial comparing the AERx Essence technology to the nebulizer used in an ongoing TRIUMPH Phase 3 registration trial, a study of inhaled treprostinil in patients with severe PAH being conducted at approximately 42 centers in the United States and Europe.
  

• Experts Say Birth Defect Risks Outweigh Benefits Of SSRIs
  (OpEdNews) -- Drug makers looking to increase profits with the sale of selective serotonin reuptake inhibitor antidepressants to pregnant women claim that untreated depression poses a grave risk to the unborn fetus, but a new study reports that the use of antidepressants, and not the depression itself, increases the risk of lower fetal age and preterm birth.
  

• Fen-Phen Lawyers Seek Ruling's Stay
  (Lexington Herald-Leader) -- In court documents filed last week, William Gallion and Shirley Cunningham Jr., want the state Court of Appeals to grant a stay and an emergency hearing so a lower court's decision saying they owe more than 400 former clients at least $42 million -- plus 8 percent interest -- could be stopped.
  

• First PAH Functional Class II Population Study Emphasizes Need To Diagnose And Treat PAH Early
  (Actelion) -- At the 2007 European Society of Cardiology congress in Vienna, Actelion Ltd has presented full results from a Phase IIIb trial1 which demonstrated that six months of treatment with bosentan (Tracleer®) in patients with mildly symptomatic WHO functional class II Pulmonary Arterial Hypertension significantly delayed time to clinical worsening and reduced the number of patients worsening to WHO functional class III/IV.
  

• Encysive Pharmaceuticals Announces Completion of Patient Enrollment in Phase II Diastolic Heart Failure Trial
  (Encysive) -- Sitaxsentan is being tested on approximately 150 DHF patients at approximately 40 study centers. The primary efficacy objective of the study is change in treadmill exercise time at week 24 of treatment. A Data Safety Monitor Board has conducted two reviews of the Phase II trial with no recommended changes to the study plan.
  

•   Dedicated Unit For Pulmonary Hypertension Opens In Dublin, Ireland
  (Belfast Telegraph) -- Around 200 people are currently being treated for the condition, which affects the heart and lungs.
  

• Growing Living-Tissue Heart Valves A Reality In 3-5 Years: Study
  (Yahoo/AFP) -- The whole procedure -- harvesting cells from bone marrow, growing tissue, and surgically implanting the heart muscle or valve -- could take as little as six weeks and could become routine within three-to-five years, they reported.
  

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