Yonsei Med J.  2006 Oct;47(5):614-625. 10.3349/ymj.2006.47.5.614.

Effects on Weight Reduction and Safety of Short-Term Phentermine Administration in Korean Obese People

• Kim KK
• Cho HJ
• Kang HC
• Youn BB
• Lee KR

• KMID: 1381242
• DOI: http://doi.org/10.3349/ymj.2006.47.5.614

Abstract

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.

Keyword

Obesity; phentermine; treatment outcome

MeSH Terms

Weight Loss/*drug effects
Risk Factors
Phentermine/administration & dosage/adverse effects/*therapeutic use
Obesity/*drug therapy
Male
Korea
Humans
Female
Double-Blind Method
Appetite Depressants/administration & dosage/adverse effects/*therapeutic use
Adult

Figure

• 

  Fig. 1 Change from baseline in body weight (A) and waist circumference (B). Data are mean (SE) values for the full intention-to-treat population with the last observations carried forward. p < 0.001 for phentermine vs. placebo in body weight and waist circumference.

• 

  Fig. 2 Proportion of patients who lost ≥ 5% and ≥ 10% of baseline weight at 14th week. ITT, intention-to-treat.

Reference

1. Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999. 341:1097–1105.

2. Stevens J, Nowicki EM. Body mass index and mortality in asian populations: implications for obesity cutpoints. Nutr Rev. 2003. 61:104–107.

3. Banegas JR, Lopez-Garcia E, Gutierrez-Fisac JL, Guallar-Castillon P, Rodriguez-Artalejo F. A simple estimate of mortality attributable to excess weight in the European Union. Eur J Clin Nutr. 2003. 57:201–208.

4. Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005. 293:1861–1867.

5. Oh SW, Shin SA, Yun YH, Yoo T, Huh BY. Cut-off point of BMI and obesity-related comorbidities and mortality in middle-aged Koreans. Obes Res. 2004. 12:2031–2040.

6. Roth JD, Rowland NE. Efficacy of administration of dexfenfluramine and phentermine, alone and in combination, on ingestive behavior and body weight in rats. Psychopharmacology (Berl). 1998. 137:99–106.

7. Weintraub M, Hasday JD, Mushlin AI, Lockwood DH. A double-blind clinical trial in weight control. Use of fenfluramine and phentermine alone and in combination. Arch Intern Med. 1984. 144:1143–1148.

8. Li Z, Maglione M, Tu W, Mojica W, Arterburn D, Shugarman LR, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med. 2005. 142:532–546.

9. Haddock CK, Poston WS, Dill PL, Foreyt JP, Ericsson M. Pharmacotherapy for obesity: a quantitative analysis of four decades of published randomized clinical trials. Int J Obes Relat Metab Disord. 2002. 26:262–273.

10. WHO Global Strategy on Diet, Physical Activity and Health: South-East Asia Regional Consultation meeting report. 2003 March 10-12; New Delhi, India.

11. WHO Regional Office for the Western Pacific. International Association for the Study of Obesity. International Obesity Task Force. The Asia-Pacific perspective: redefining obesity and its treatment. 2000. Melbourne: Health Communications Australia.

12. Brownell KD. The LEARN program for weight management. 2004. 10th ed. Dallas, TX: American Health Publishing Co..

13. National Heart Lung and Blood Institute. NIH Publication Number 00-4084. Obesity Education Initiative. The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. 2000. Bethesda, MD: US Department of Health and Human Services; Public Health Service; National Institutes of Health; National Heart, Lung, and Blood Institute.

14. Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Comparison of continuous and intermittent anorectic therapy in obesity. Br Med J. 1968. 1:352–354.

15. Langlois KJ, Forbes JA, Bell GW, Grant GF Jr. A double-blind clinical evaluation of the safety and efficacy of phentermine hydrochloride (Fastin) in the treatment of exogenous obesity. Curr Ther Res Clin Exp. 1974. 16:289–296.

16. NHLBI. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998. 6:Suppl 2. 51S–209S.

17. Rothman RB, Baumann MH, Dersch CM, Romero DV, Rice KC, Carroll FI, et al. Amphetamine-type central nervous system stimulants release norepinephrine more potently than they release dopamine and serotonin. Synapse. 2001. 39:32–41.

18. Balcioglu A, Wurtman RJ. Effects of phentermine on striatal dopamine and serotonin release in conscious rats: in vivo microdialysis study. Int J Obes Relat Metab Disord. 1998. 22:325–328.

19. Alexander M, Rothman RB, Baumann MH, Endres CJ, Brasic JR, Wong DF. Noradrenergic and dopaminergic effects of (+)-amphetamine-like stimulants in the baboon Papio anubis. Synapse. 2005. 56:94–99.

20. Tao R, Fray A, Aspley S, Brammer R, Heal D, Auerbach S. Effects on serotonin in rat hypothalamus of D-fenfluramine, aminorex, phentermine and fluoxetine. Eur J Pharmacol. 2002. 445:69–81.

21. Adipex-P®. Physicians' desk reference: PDR. 2004. 58th ed. Montvale, NJ: Medical Economics Co., Inc;1341–1342.

22. Bray GA. Eckel RH, editor. Treatment of obesity with drugs in the new millennium. Obesity: mechanisms and clinical management. 2003. Philadelphia: Lippincott Williams & Wilkins;449–475.

23. Kaplan LM. Pharmacological therapies for obesity. Gastroenterol Clin North Am. 2005. 34:91–104.