New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 NIH Stops AIM-HIGH Trial • May 26, 2011 The AIM-HIGH trial, which stands for Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health, enrolled 3,414 participants with a history of cardiovascular disease who were taking a statin drug to keep their LDL cholesterol low. Study participants also had low HDL cholesterol and high triglycerides. Patients were randomly assigned to either high dose, extended-release niacin (Niaspan) in gradually increasing doses up to 2,000 mg per day (1,718 people) or a placebo treatment (1,696 people). All participants were prescribed simvastatin (Zocor), and 515 participants were given a second LDL cholesterol-lowering drug, ezetimibe (Zetia), in order to maintain LDL cholesterol levels at the target range between 40-80 mg/dL. NIH Stops AIM-HIGH Trial • The study’s DSMB concluded that high dose, extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular-related complications in this trial. The rate of clinical events was the same in both treatment groups, and there was no evidence that this would change by continuing the trial andthe DSMB recommended that the NHLBI end the study. • There was also a small and unexplained increase in ischemic stroke rates in the high dose, extended-release niacin group. – The Coronary Drug Project Trial with IR niacin found an increase in A Fib which might explain the stroke risk? Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Recent FDA Approval • May 27, 2011 The FDA approved Dificid (fidaxomicin) tablets by Optimer Pharmaceuticals for the treatment of Clostridium difficile-associated diarrhea (CDAD). – The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin. – Dificid, a macrolide antibacterial, should be taken 200 mg two times a day for 10 days with or without food. Cost ~ $2,800.00 – The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea. FDA Safety Update Simvastatin • SEARCH was a seven-year, randomized, double-blind clinical trial comparing the efficacy and safety of simvastatin 80 mg to simvastatin 20 mg, with or without vitamin B12 and folate, in survivors of myocardial infarction. • At the end of the trial, the incidence of major vascular events was 25.7% in the 20-mg group versus 24.5% in the 80-mg group [RR=0.094, 95% CI (0.88, 1.01); p=0.10]. Due in part to greater use of off-study LDL-C lowering medication in the simvastatin 20 mg group versus the 80-mg group, the difference in mean levels of LDL-C between the two treatment groups was 13 mg/dL instead of the expected difference of 20 mg/dL. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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