Outlook: Clinical Trials

Pharmacy Times, October 2010 Diabetes, Volume 76, Issue 10

Dutasteride Improved Hair Growth in Men With Male Pattern Hair Loss

The results of a randomized, doubleblind, phase 3 study of 153 men showed that dutasteride, when compared with placebo, improved hair growth when used as a treatment for male pattern hair loss.3 Study subjects ranging in age from 18 to 49 years were randomized to treatment with dutasteride 0.5 mg daily or placebo for 6 months. Efficacy was determined by mean change of hair counts, subject assessment, and photographic assessment by investigators and panels.

After 6 months of treatment, dutasteride increased mean hair counts by 12.2/cm2 compared with an increase of 4.7/cm2 in the placebo group (P = .0319). Dutasteride also demonstrated superiority over placebo in subject selfassessment and investigator and panel photographic assessment. Adverse events were similar between groups. The authors concluded that dutasteride was safe and effective in improvement of hair growth in the treatment of male pattern hair loss. PT

Naltrexone Plus Bupropion— An Option for Obesity

The results of a 56-week, double-blind, randomized trial showed that combination therapy with naltrexone and bupropion in a sustained-release formulation may be a treatment option for obesity.1 A total of 1742 subjects were randomized to receive either sustainedrelease naltrexone 32 mg per day plus sustained- release bupropion 360 mg per day combined in fixed-dose tablets (n = 583), sustained-release naltrexone 16 mg per day plus sustained-release bupropion 360 mg per day combined in fixed-dose tablets (n = 578), or placebo twice daily (n = 581). Subjects were men and women aged 18 to 65 years with body mass index (BMI) of 30 to 45 mg/kg2 and uncomplicated obesity or a BMI of 27 to 45 mg/kg2 with dyslipidemia or hypertension. In addition to the study treatment, subjects engaged in exercise and followed a mild hypocaloric diet. The primary end points of the study included percentage change in body weight and proportion of subjects achieving a decrease in body weight of at least 5% at week 56.

At 56 weeks, 870 subjects had completed the study, and 1453 were included in the primary analysis. In the placebo group, mean change in body weight was -1.3%, compared with -6.1% and -5.0% in the naltrexone 32 mg plus bupropion group and the naltrexone 16 mg plus bupropion groups, respectively (P <.0001 vs placebo). Additionally, 16% of subjects receiving placebo had a decrease in body weight of at least 5% compared with 48% and 39% of patients receiving naltrexone 32 mg plus bupropion and naltrexone 16 mg plus bupropion, respectively (P <.0001 vs placebo).

The most frequently reported adverse event in the combination therapy groups was nausea.

Dutasteride Improved Hair Growth in Men with Male Pattern Hair Loss Rosiglitazone Plus Metformin for Prevention of Type 2 Diabetes

Results from a recent study demonstrate that, in patients with impaired glucose tolerance, low-dose combination therapy with rosiglitazone and metformin is effective in the prevention of type 2 diabetes.2

In this double-blind, randomized clinical trial, 207 patients with impaired glucose tolerance were randomized to receive either rosiglitazone 2 mg and metformin 500 mg twice daily or placebo for a median of 3.9 years. The primary end point of time to development of diabetes was measured via oral glucose tolerance test or 2 fasting plasma glucose values of 7.0 mmol/L or greater.

In the rosiglitazone plus metformin group, 14% of patients developed diabetes compared with 39% in the placebo group (P <.0001). Additionally, 80% of patients in the active-treatment group returned to normal glucose tolerance compared with 53% in the placebo group (P <.0002).

The change in beta-cell function was measured by the insulin secretionsensitivity index and did not differ between the active-treatment group and the placebo group. There was an increase in the incidence of diarrhea reported in the active-treatment group compared with placebo (16% vs 6% [P = .0253]).

Dr. Reed received her Doctor of Pharmacy degree from the University of the Sciences in Philadelphia and currently works as a medical editor in the greater Philadelphia area.

References

1. Greenway FL, Fujioka K, Plodowski RA, et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595-605.

2. Zinman B, Harris SB, Neuman J, et al. Low-dose combination therapy with rosiglitazone and metformin to prevent type 2 diabetes mellitus (CANOE trial): a double-blind randomised controlled study. Lancet. 2010;376(9735):103-111.

3. Eun HC, Kwon OS, Yeon JH, et al. Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: a randomized, double-blind, placebo-controlled, phase III study. J Am Acad Dermatol. 2010;63(2):252-258.