Outlook: Clinical Trials
NOVEMBER 18, 2010
Michele Reed, PharmD
Combined Beta-Blocker and Behavioral Management Treatment for Migraine
Recent data from a randomized, placebo-controlled, clinical trial showed that combined treatment with a beta-blocker and behavioral migraine management improved the outcomes of acute migraine treatment. 1
Study subjects (n = 232) recorded at least 3 migraines with disability per month during a run-in period and were randomized to 1 of 4 treatments, including a beta-blocker, matched placebo, behavioral migraine management plus placebo, or behavioral migraine management plus betablocker. The primary outcome of the study was change in migraines per 30 days.
Results showed that the addition of combined beta-blocker and behavioral migraine management improved outcomes compared with optimized acute treatment alone (-3.3 migraines/30 days, 95% confidence interval [CI], -3.2 to -3.5). The addition of a beta-blocker alone (-2.1 migraines/30 days, 95% CI, -1.9 to -2.2) or behavioral migraine management alone (-2.2 migraines/30 days, 95% CI, -2.0 to -2.4) did not show statistically significant improvement in outcomes.
Investigators concluded that the addition of combined beta-blocker plus behavioral migraine management improved outcomes in the treatment of frequent migraine.
Safety and Efficacy of Fondaparinux for Superficial Vein Thrombosis
In a recent randomized, double-blind trial, the efficacy and safety of fondaparinux for superficial vein thrombosis of the leg was evaluated.2 Investigators randomized 3002 study subjects to receive either fondaparinux or placebo. Subjects in the fondaparinux group received a daily dose of 2.5 mg for 45 days.
The primary endpoint of the study was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep vein thrombosis (DVT), or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis at day 47. The primary safety outcome was major bleeding.
Study results showed that the primary efficacy outcome occurred in 0.9% in the fondaparinux group compared with 5.9% in the placebo group. This resulted in a relative risk reduction of 85% for the fondaparinux group (95% confidence interval [CI], 74 to 92; P <.001). With the exception of death, the incidence of each component of the primary efficacy outcome was significantly lower in the fondaparinux group compared with the placebo group. The incidence of death was 0.1% in both groups. Additionally, the rate of pulmonary embolism (PE) or DVT was 0.2% in the fondaparinux group compared with 1.3% in the placebo group (95% CI, 50 to 95; P <.001) resulting in an 85% lower rate of PE or DVT with fondaparinux compared with placebo. Major bleeding was seen in 1 patient from each group.
Revaccination with Pneumococcal Conjugate Vaccine in HIV-Infected Adults
Results from a recent clinical trial showed that revaccination with the 7-valent pneumococcal conjugate vaccine (PCV) was only transiently more immunogenic than the 23-valent pneumococcal polysaccharide vaccine (PPV) in adults infected with HIV.3
In this clinical trial, HIV-infected adults (median CD4 cell count, 533 cells/mm3) who had been vaccinated with PPV 3 to 8 years earlier were randomized to receive PCV (n = 131) or PPV (n = 73). Twenty-five HIV-uninfected adults without prior pneumococcal vaccination received 1 dose of PCV.
Investigators defined a positive response as a ≥2-fold increase in capsule-specific immunoglobulin G (IgG) and postvaccination level of ≥1000 ng/mL for at least 2 of the 4 serotypes.
Results of the clinical trial showed that HIV-infected patients achieved a higher frequency of positive antibody responses to PCV compared with PPV (57% vs 36%; P = .004). Additionally, a greater mean change in IgG concentration from baseline to day 60 was seen in HIV-infected patients for serotypes 4, 9V, and 19F, but not for serotype 14. Outcomes were similar by day 180. Responses to PCV were greater for all serotypes in patients not infected with HIV.
Investigators concluded that there is a need for a pneumococcal vaccine with more vigorous and sustained immunogenicity for HIV-infected patients.
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.
1. Holroyd KA, Cottrell CK, O’Donnell FJ, et al. Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ. 2010;341:c4871.
2. Decousus H, Prandoni P, Mismetti P, et al. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010;363(13):1222-1232.
3. Crum-CianfloneNF, Huppler Hullsiek K, Roediger M, et al. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010;202(7):1114-1125.
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