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KMID : 0388120050140030155
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Journal of Korean Society for the Study of Obesity
2005 Volume.14 No. 3 p.155 ~ p.162
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Double-blind, Parallel-group, Placebo-controlled Multi-center Clinical Trial for Evaluating the Efficacy and Safety of Phentermine Hydrochloride in Obese Patients
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Choi Chang-Jin
Kim Kyung-Soo
Kim Sung-Rae
Kang Jae-Heon
Park Hye-Soon
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Abstract
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Double-blind, Parallel-group, Placebo-controlled Multicenter Clinical Trial for Evaluating the Efficacy and Safety of Phentermine Hydrochloride (Adipex®) in Obese Patients.
Background: Phentermine is a sympathomimetic amine used as an appetite suppressant for short term therapy.
The aim of this study is to evaluate the efficacy and safety of phentermine in Korean obese patients.
Methods: This study was a 12-week, double blind, multi-center placebo-controlled clinical trial followed by a 2 week screening period. Patients with a body mass index of either greater than 30 kg/m2 or between 27 and 30 kg/m2 with controlled hypertension, diabetes and hyperlipidemia were considered eligible. Participants of 119 obese patients were randomized either to phentermine (59 patients) or placebo (60 patients) at 4 participating centers.
Results: After 12 weeks of treatment, mean weight reduction at 12 week was 7.94 ± 7.31 kg among phentermine group and 0.91 ± 5.88 kg among placebo group ( P < 0.001). In phentermine group, 73.6% of patients lost 5% or more of their initial body weight in contrast to 15.1% in placebo group. Phentermine-induced weight reduction was not associated with any significant improvements in serum level of fasting glucose and lipid profile compared to placebo. Changes in blood pressure were not different among the two groups, however, pulse rate was significantly elevated in phentermine group. The drop out rate was 11.7% for both groups. Among the reported adverse events in phentermine group, dry mouth
(22.0%) was significantly higher compared with placebo group (5.0%) ( P < 0.001).
Conclusion: Phentermine is well tolerated and is considered to be an effective short term therapy for managing obesity among the Korean population.
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KEYWORD
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Obesity, Weight Loss, Phentermine, Efficacy, Safety, Double-blind
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