There is good news for the smoking cessation drug varenicline (Chantix). Following concern about neuropsychiatric side effects, the FDA sponsored two epidemiologic studies that evaluated the risk of neuropsychiatric hospitalizations associated with the drug. Neither study found a difference in risk of neuropsychiatric hospitalization between varenicline and nicotine replacement therapy, although hospitalization was the only endpoint evaluated and they did not rule out an increased risk of other neuropsychiatric events. While reassuring, the FDA is recommending that health care professionals and patients continue to follow the recommendations previously established and monitor for neuropsychiatric symptoms when prescribing or using varenicline. The manufacturer is conducting a large safety study of the drug to assess neuropsychiatric adverse effects but the results will not be available until 2017 (www.fda.gov/Drugs/DrugSafety/). In related news, the inexpensive partial nicotine agonist cytisine is an effective adjunct to smoking cessation, according to a new study in the New England Journal of Medicine. Cytisine is extracted from the seeds of Cysisus laborinum L. (Golden Rain acacia) and has been available worldwide for years, particularly in Eastern Europe, where it can be purchased for $6-$15 per course. Researchers randomized 740 smokers to cytisine or matching placebo for 25 days along with counseling. The rate of sustained 12 months abstinence was 8.4% in the cytisine group compared with 2.4% in the placebo group (P = 0.01). GI side effects were slightly more prevalent in the treatment group. The authors conclude that cytisine was more effective than placebo for smoking cessation and may be "an affordable treatment to advance smoking cessation globally" (N Engl J Med 2011;365:1193-1200).
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