Outlook: Clinical Trials

Pharmacy TimesDecember 2011 Heart Health
Volume 77
Issue 12

Cytisine for Smoking Cessation

In a single-center, randomized, doubleblind, placebo-controlled trial, investigators studied the efficacy and safety of cytisine for smoking cessation.1 Study subjects were randomized to receive cytisine (n = 340) or matching placebo (n = 340) for 25 days. Additionally, participants in both groups received a minimal amount of counseling throughout the study. The primary outcome measure was sustained smoking abstinence for 12 months after the end of treatment.

The study demonstrated a sustained 12-month abstinence rate of 8.4% in the cytisine group compared with 2.4% in the placebo group (difference, 6.0 percentage points; 95% confidence interval [CI], 2.7-9.2; P = .001). Gastrointestinal adverse events were reported more frequently in the cytisine group (difference, 5.7 percentage points; 95% CI, 1.2-10.2). Investigators concluded that in this single-center study, cytisine was more effective than placebo for smoking cessation, and it may be a lower-cost option for patients seeking smoking cessation support.

Referral To A Commercial Weight Loss Provider vs Standard Care

A parallel group, non-blinded, randomized, controlled trial was conducted to assess the effect of primary care referral to a commercial weight loss treatment provider.2 Study subjects (n = 772) were recruited by primary care practices in Australia, Germany, and the United Kingdom. Subjects were randomized to either 12 months of standard care or 12 months of free membership to a commercial program (Weight Watchers). Subjects also received 12 months of follow-up. The primary end point was weight change over 12 months.

Subjects in the commercial program lost twice as much weight as did those in the standard care group. Mean weight change at 12 months was -5.06 kg for those in the commercial program versus -2.25 kg for those receiving standard care (adjusted difference -2.77 kg, 95% CI -3.50 to -2.03). Investigators concluded that referral by a primary health care professional to a commercial weight loss program can offer a clinically useful early intervention for weight management in overweight and obese individuals.

Timing of Antiretroviral Therapy in HIV Infected Adults With TB

A recent clinical trial tested the hypothesis that the timing of antiretroviral therapy (ART) initiation would significantly affect mortality among adults not previously exposed to ART with newly diagnosed tuberculosis (TB) and CD4 T-cell counts less than or equal to 200/mm3.3

Study subjects were randomized to either early or later treatment. Early treatment with stavudine, lamivudine, and efavirenz began 2 weeks after beginning TB treatment, and later treatment began 8 weeks after beginning TB treatment. The primary end point of the study was survival.

Results showed that the risk of death was significantly lower in the group receiving earlier ART: 59 deaths among 332 patients (18%) compared with 90 deaths among 329 patients (27%) in the later ART group (hazard ratio, 0.62; 95% CI; 0.44-0.86; P = .006). Investigators concluded that initiating early treatment significantly improved survival among the study population.

Oral Teriflunomide For Relapsing MS

A recent randomized, controlled clinical trial evaluated the efficacy of teriflunomide for relapsing multiple sclerosis (MS).4 The study population included subjects (n = 1088) aged 18 to 55 years with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least 1 relapse in the previous year or at least 2 relapses in the previous 2 years. Subjects were randomized to 7 or 14 mg of teriflunomide or placebo once daily for 108 weeks. The primary end point was the annualized relapse rate.

The study demonstrated that teriflunomide reduced the annualized relapse rate (0.54 for placebo vs 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P <.001 for both comparisons with placebo). Both teriflunomide doses were superior to placebo on a range of end points measured by magnetic resonance imaging (MRI). Serious infections were reported in 1.6%, 2.5%, and 2.2% of patients in the teriflunomide 7 mg, teriflunomide 14 mg, and placebo groups, respectively. Investigators concluded that teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity when compared with placebo. PT

Dr. Reed received her doctor of pharmacy degree from the University of the Sciences in Philadelphia, Pennsylvania, and currently works as a medical editor in the greater Philadelphia area.


  • Blanc FX, Sok T, Laureillard D, et al. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011;365(16):1471-1481.
  • O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303.
  • West R, Zatonski W, Cedzynska M, et al. Placebo-controlled trial of cytisine for smoking cessation. N Engl J Med. 2011;365(13):1193-1200.
  • Jebb SA, Ahern AL, Olson AD, et al. Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial [published online ahead of print September 7, 2011]. Lancet. 2011;378(9801):1485-1492.

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