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 Dronedarone - Multaq New Safety Concern July 7, 2011 Paris, France Sanofi, maker of dronedarone (Multaq), has suspended its phase 3b trial of its antiarrhythmic drug due to a significant increase in cardiovascular events seen in patients randomized to dronedarone. The PALLAS trial (begun 7-2010) was testing the drug in ~10,000 patients with permanent atrial fibrillation and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF. Events during the PALLAS study as of June 30, 2011.(FDA MedWatch 7-21-2011) CV Death, Myocardial Infarction, Stroke, Systemic Embolism* Death, Unplanned CV Hospitalization* Multaq N=1572 n (%) Placebo N=1577 n (%) Hazard Ratio/NNH 32 (2) 14 (0.9) 2.3/91 0.009 118 (7.5) 81 (5.1) 1.5/42 0.006 Death 16 (1) 7 (0.4) 2.3 0.065 Myocardial Infarction 3 (0.2) 3 (0.2) 1.0 1 Stroke 17 (1.1) 7 (0.4) 2.4/143 0.047 Heart Failure Hospitalization 34 (2.2) 15 (1) 2.3/84 0.008 *coprimary endpoints p-value Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Dronedarone - Multaq Sept 22, 2011 The European Medicines Agency (EMA) recommends restricting the use of the antiarrhythmic medication dronedarone. The committee states that because of the increased risk of liver, lung, and cardiovascular adverse events, dronedarone "should only be prescribed after alternative treatment options have been considered." Patients currently taking dronedarone should have their treatment reassessed by their physician at their next scheduled visit Pitavastatin - Livalo by Kowa and Lilly • A synthetic competitive lipophilic 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. • Pitavastatin elimination half-life is 10 to 12 hours • The effect of pitavastatin on cardiovascular morbidity and mortality has not been determined. • Pitavastatin is administered orally once daily, with or without food, at any time of day. The dosage range is 1 to 4 mg once daily. The maximum dosage is 4 mg per day. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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