The U.S. FDA has issued an advisory recommending a lower dose for products containing the hypnotic zolpidem, such as Ambien, Ambien CR, Edluar, and Zolpimist. In Canada, zolpidem is sold under the trade name Sublinox. Dosing for Intermezzo, a zolpidem formulation for middle-of-the-night awakening, is unaffected.
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Alemtuzumab: phase III results
April 10, 2013The results of the phase III trials, CARE MS-I and CARE MS-II, show that alemtuzumab significantly reduces relapse rate by about 50% compared to interferon-beta-1a SC (Cohen et al. Lancet 2012; 380:1819-1828).
Disease activity-free rates at 1 and 2 years
March 23, 2013REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, SAN DIEGO, CA, MARCH 16-23, 2013 – An emerging metric in MS research is the proportion of patients who are disease-activity free (DAF), defined as no relapses, no MRI activity (T2 or Gd+ T1 lesions) and no sustained EDSS progression. One of the first uses was an analysis of the AFFIRM dataset, which reported a two-year DAF rate of 37% with natalizumab versus 7% with placebo (Havrdova et al. Lancet Neurol 2009;8:254-260).
Second-line switching: three reports
March 23, 2013REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, SAN DIEGO, CA, MARCH 16-23, 2013 – Natalizumab is commonly used following first-line treatment failure/intolerance, but switching may be advisable after two years in patients with anti-JC virus antibody positivity. However, switching therapies is challenging in practice due to the risk of increased disease activity upon natalizumab withdrawal.