March 17th, 2014
Studies Provide Little Support for Guidelines on Dietary Fats and Supplements
Larry Husten, PHD
The precise cardiovascular effect of dietary fats and supplements has been the subject of heated controversy. Although there is no strong supporting evidence from clinical trials, current guidelines tend to discourage or minimize the role of saturated fats and trans fats and to encourage the intake of omega-3 polyunsaturated fatty acids. Two new studies published today help clarify […]
March 17th, 2014
Phase 4 Actelion Study Misses Primary Endpoint
Larry Husten, PHD
Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint. The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil. According to the company, a 17% risk […]
March 17th, 2014
Meta-Analysis Finds Few Side Effects Caused by Statins
Larry Husten, PHD
Although clinical trials have consistently demonstrated the benefits of statins, especially in secondary prevention, the perception that the drugs can cause serious side effects has prompted some patients to discontinue or not take the drugs. Now, in a paper published in the European Journal of Preventive Cardiology, a new meta-analysis of existing trials offers some […]
March 14th, 2014
Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery
Larry Husten, PHD
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]
March 13th, 2014
rAAA Patients More Likely to Get Surgery and Survive in the U.S. Than in England
Larry Husten, PHD
Patients with a ruptured abdominal aortic aneurysm (rAAA) have better outcomes in the United States than in England according to a new study published in the Lancet. Researchers at the University of London compared hospital data from 11,799 rAAA patients in England with 23,838 rAAA patients in the U.S. They found that U.S. patients were more likely than […]
March 12th, 2014
Clinical Trials For Diabetes Drugs Need To Consider Heart Failure
Larry Husten, PHD
Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. That belief is no longer widely held, however, and the FDA now requires cardiovascular […]
March 10th, 2014
Azithromycin, Levofloxacin Linked to Increased Risks for Arrhythmia and Mortality Compared with Amoxicillin
Nicholas Downing, MD
Azithromycin and levofloxacin carry higher arrhythmia and mortality risks than amoxicillin, according to an observational study in the Annals of Family Medicine. The FDA issued a cardiac warning on azithromycin in March 2013. Researchers studied nearly 1.8 million U.S. veterans (mean age, 57) who received outpatient prescriptions for one of the three antibiotics from 1999 to […]
March 10th, 2014
Generic Lipitor Recalled Again
Nicholas Downing, MD
Ranbaxy has recalled over 60,000 bottles of generic atorvastatin after a pharmacist found a 20-mg tablet in a sealed bottle labeled with the 10-mg dose. The FDA considers this a class II recall, indicating “a remote chance of severe adverse consequences or death due to the product flaw,” Reuters reports.
March 6th, 2014
Vena Cava Filters Reduce Pulmonary Emboli But Increase VTE Recurrence Tenfold
Inferior vena cava filters seem to offer protection against death from pulmonary embolism when compared with anticoagulant therapy, but they have no significant effect on all-cause mortality. In addition, the filters are associated with higher rates of recurrent venous thromboembolism, according to an article in the Journal of the American College of Cardiology. Researchers examined data […]
March 3rd, 2014
A New Approach for the Statin-Intolerant Patient?
Andrew M. Kates, MD
Andy Kates wonders if a new type of individual patient trial can help to identify whether a patient’s myalgia is caused by statin use.