A 12-Week Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of the Efficacy and Safety of Appetite Suppressant, New Formulation of Pentermine 30mg Diffuse Controlled Release in the Treatment of Korean Obese Patients
Abstract Number: 1716-P
Authors: JUN GOO KANG, CHEOL-YOUNG PARK, HAE RI LEE, OHK HYUN RYU, SEONG JIN LEE, CHUL SIK KIM, EUN GYOUNG HONG, HYEON KYU KIM, DOO-MAN KIM, JAE MYUNG YOO, SUNG-HEE IHM, MOON GI CHOI, HYUNG JOON YOO
Institutions: Chuncheon, Republic of Korea, Jongro-Gu, Republic of Korea
Results: Obesity is a disease associated with a significant public health problem. Several methods have been tried in order to treat obesity and its related disorders. One of such attempt is an appetite-suppressing drug. However, US FDA has removed fenfluramin from the market in 1997, due to side effects of valvular heart and did not approve cannabinoid 1 receptor, rimonabant due to concerns over potential psychological side effects. A new formulation of phentermine HCl 30mg diffusion controlled release(DCR) is based on the patented NYSCAP microencapsulation technology, by which the phentermine hydrochloride is formulated into micropellets which individually have a coated membrane to ensure sustained blood concentrations.
This study was a 12-week randomized, double-blind, placebo-controlled phase 3 trial and was designed to evaluate the efficacy and safety of phentermine DCR in Korean obese patients. 98 subjects were enrolled among obese(a BMI of either greater than 30 kg/m2 or between 27 and 30 kg/m2 with controlled diabetes, and dyslipidemia) patients. The efficacy was evaluated by the differences of body weight, waist circumference and change of % body weight, blood pressure and lipid profiles between baseline and after medications.
After 12 weeks treatment, mean decrease of body weight and waist circumference in phentermine group was significantly greater than that of placebo group (9.3±3.4kg, p < 0.001; 8.31±3.61cm, p < 0.001). In phentermine group, 95.8% of patients lost 5% or more of their initial body weight in contrast to 20.8% in placebo group. Changes in blood pressure were not different among the two groups, however total cholesterol and LDL-cholesterol were significantly improved in phentermine group. The common adverse events were dry mouth, vertigo, insomnia, constipation, headache and nausea. Most adverse events were mild to moderate, transient and trivial.
This result showed that short-term Phentermine DCR administration resulted in significant weight reduction without clinically severe adverse events on Korean obese patients.