The
phentermine, an
appetite suppressant, has been widely applied in Korea since 2004. However, there have been relatively few reports about the efficacy and the safety of
phentermine in Korea. The aim of this study is to verify the effect of
phentermine on
weight reduction and the safety in Korean patients. This randomized, double-blind, placebo- controlled study had been performed between February and July, 2005, in Seoul on 68 relatively healthy obese adults whose body mass index was 25 kg/m2 or greater. They received
phentermine-HCl 37.5 mg or placebo once daily with behavioral
therapy for
obesity. The primary endpoints were the changes of
body weight and waist circumference from the baseline in the intention-to-treat population. Mean decrease of both
body weight and waist circumference in
phentermine-treated subjects were significantly greater than that of placebo group (weight: -6.7 +/- 2.5 kg, p < 0.001; waist circumference: -6.2 +/- 3.5 cm, p < 0.001). Significant number of subjects in
phentermine group accomplished
weight reduction of 5% or greater from the baseline and 10% or more (p < 0.001). There were no significant differences in systolic and diastolic blood pressure between the groups (p = 0.122 for systolic BP; p = 0.219 for diastolic BP). Dry mouth and
insomnia were the only statistically significant adverse events that occurred more frequently in
phentermine group. Most side effects of
phentermine were mild to moderate in intensity. Short-term
phentermine administration induced significant
weight reduction and reduction of waist circumference without clinically problematic adverse events on relatively healthy Korean obese people.