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KMID : 0928320100100020097
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Korean Journal of Health Promotion and Disease Prevention
2010 Volume.10 No. 2 p.97 ~ p.103
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Postmarketing Surveillance Study on the Efficacy and Safety of Phendimetrazine in Patients with Obesity
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Kim Bum-Soo
Kim Young-Sik
Ahn Eun-Sook
Roh Young-Jun
Jung Seong-Gil
Kim Jin-Mok
Kang Moon-Kook
Ahn In-Soon
Park Young-Kyu
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Abstract
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Background: In Korea, phendimetrazine has been widely used for the treatment of obesity in primary care since 2001. However, there have been very few studies on the safety and efficacy of phendimetrzine. In order to investigate the safety and efficacy of phendimetrazine prescribed in primary care, a postmarketing surveillance
study was undertaken.
Methods: A total of 1,015 (male 41, female 974) patients with obesity (BMI≥27) were enrolled from 28 primary care physicians in Korea from September 2006 to November 2007. The patients were regularly observed to ascertain the safety and efficacy of phendimetrazine at intervals of 4, 8 and 12 weeks.
Results: Of the 1,015 patients enrolled, 916 (90.2%) returned for safety evaluation and 907 (89.4%) for efficacy assessment. In all, 555 (61.2%) of 907 patients had lost 5% or more of body weight. Mean weight loss was 5.0kg (SD 4.0). A total of 437 adverse events (AEs) were reported from 298 patients (32.5%). The most prevalent
adverse event was insomnia (9.0%), followed by dry mouth (8.6%), tachycardia (5.7%), headache (3.7%), dizziness (3.3%), palpitation (2.9%), constipation (2.4%), anxiety (2.0%), tremor (1.9%) and nausea (1.6%). Nineteen patients (4.4%) discontinued taking phendimetrazine as a direct result of AEs. No serious AEs were reported. During the 12 weeks of treatment, phendimetrazine was continued by 57.4% and discontinued by 42.6%. Women, young age, high education, combined therapy, good compliance, new user, and occurrence of AE were associated with good efficacy (P<0.05).
Conclusions: The adverse events of phendimetrazine were common, even though phendimetrazine was quite effective for weight loss and well tolerated.
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KEYWORD
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Phendimetrazine, Safety, Efficacy, Postmarketing surveillance
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