title: Efficacy of sibutramine, orlistat and combination therapy on short-term weight management in obese patients.
abstract: OBJECTIVE
  To compare changes in anthropometric measures [body mass index (BMI), body weight] of obese patients treated with diet and exercise alone or additionally sibutramine, orlistat or the combination of both drugs, respectively. To describe encountered adverse effects.
  
  
  METHODS
  Short-term (12 weeks), randomized, open-labeled trial. A total of 86 patients (18.6% male, age 41.1 +/- 8.7 years, BMI: 36.11 +/- 4.34 kg/m(2)) were randomized to (1) sibutramine group (10 mg/d, n = 22), or (2) orlistat group (3 x 120 mg/d, n = 25), or (3) combination group (10 mg sibutramine/d + 3 x 120 mg orlistat/d, n = 20), or (4) diet group (n = 19). The primary outcome parameter was a decrease in BMI. Additionally patient-reported adverse effects were reported.
  
  
  RESULTS
  The four interventional groups displayed decreases in BMI as follows: (1) -4.41 +/- 1.26 kg/m(2); (2) -3.64 +/- 0.97 kg/m(2); (3) -5.12 +/- 1.44 kg/m(2) and (4) -2.52 +/- 1.36 kg/m(2); with the diet group showing the significantly lowest decrease in BMI compared to the orlistat (P = 0.004), sibutramine (P < 0.001) or the combination groups (P < 0.001), respectively. Decreases in BMI did not statistically differed between the sibutramine group and the combination therapy group (P = 0.072). However, both treatment groups were significantly more efficient in decreasing BMI than the orlistat group (P < 0.001). In addition to well-known side effects, such as gastrointestinal disturbances, headache and dry mouth, newly described adverse effects were self-reported hypermenorrhea (13.6%, n = 3) with sibutramine and forgetfulness with orlistat (24%, n = 6).
  
  
  CONCLUSIONS
  In our study pharmacotherapy showed significant better results in the short-term management of obesity than dietary regimens alone. Sibutramine and sibutramine in combination with orlistat seemed to be equally effective in terms of weight reduction compared to orlistat monotherapy. Attention should be paid to the possibility of adverse effects.
authors.affiliation: Haydarpasa Numune Training and Research Hospital, 5th Department of Internal Medicine, Istanbul, Turkey.
authors.forename: Ayca
authors.initials: A
authors.lastname: Kaya
authors.forename: Neslihan
authors.initials: N
authors.lastname: Aydin
authors.forename: Pinar
authors.initials: P
authors.lastname: Topsever
authors.forename: Müge
authors.initials: M
authors.lastname: Filiz
authors.forename: Ali
authors.initials: A
authors.lastname: Oztürk
authors.forename: Arslan
authors.initials: A
authors.lastname: Dağar
authors.forename: Ebru
authors.initials: E
authors.lastname: Kilinç
authors.forename: Cem
authors.initials: C
authors.lastname: Ekmekcioglu
mesh_terms: D000328:Adult; D015992:Body Mass Index; D003503:Cyclobutanes / Q000008:administration & dosage*; D004038:Diet, Reducing / Q000379:methods / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007783:Lactones / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology; D000077403:Orlistat; D011446:Prospective Studies; D013997:Time Factors; D015431:Weight Loss / Q000187:drug effects* / Q000502:physiology
chemical_list: D003503:Cyclobutanes; D007783:Lactones; D000077403:Orlistat; C058254:sibutramine