. 2011 Jun 20;4:229–243. doi: 10.2147/DMSO.S19197

Table 2.

Main characteristics of the patient sample and program of the considered studies

Author, year	Sample	Type of study	Program
Alberici et al⁷⁷	BL: 51 p. ET: 49 p. BLCPCS: mA 44.1 ± 11.5. F 36. mBMI 24.0 ± 3.4.	Prospective study	Treatment: Topiramate was administered following slow up titration; full dosage of 100 mg/day, bid regimen, reached within 4 weeks. 4 months treatment
Ben-Menachem et al⁷⁵	BL: 49 p. F 28. mA 36.2 ± 11.7. mBW 77.8 ± 16.8. mBMI 26.9 ± 5.9. ET: 38 p. F 22. mA 35.9 ± 11.5. mBW 75.8 ± 14.8. mBMI 26.3 ± 9.3.	Prospective study	Treatment: 1 year. Topiramate added to pre-existing anticonvulsant therapy. Starting dose 25 mg/day, increased biweekly in 25 or 50 mg increments to the best-tolerated dosage providing maximum seizure control mean dosage after 3 months 81 mg/day (21–154 mg/day)
Elfhag et al²⁷	BL: 36 p. ET: 30 p. BLCPCS: F 22. mA 43 ± 12 (20–64). mBMI 40 ± 4 (33–45).	Prospective study	Run in phase: 6 weeks. Clinical trial evaluating the effect of sibutramine on food consumption in laboratory test meals. 2 weeks each of: sibutramine, placebo, and a wash out period (crossover design) Treatment: 26 weeks. Sibutramine (15 mg/day) + monthly dietary advice
Elfhag and Rossner¹⁹	BL: 36 p. F 27. mA 43 ± 12 years (20–64). mBMI 39 ± 4 (30–45). ET: 31 p.	Prospective study	Run in phase: 6 weeks. Sibutramine/placebo and wash out period Treatment: 26 weeks. 15 mg/day sibutramine and dietary advice in monthly group sessions with a dietitian
Elfhag et al³⁵	BLCPCS: 478 p. F 301. mA 42.4 ± 12.2 (16–70). mBMI 42.4 ± 12.2 (26–68).	Retrospective analysis of patients who completed the study	1. Weight Watcher treatment (control) or 2. Sibutramine or 3. Orlistat
Fabricatore et al⁴⁵	BL: 224 P. F 180. mA 43.8 ± 10.2. C 146. OE 76. Sibutramine: 55 p. Lifestyle modification: 55 p. Combined therapy: 60 p. Sibutramine + brief behavioral therapy: 54 p. ET: 185 p.	Prospective study	52 weeks treatment: 1200–1500 kcal/day diet (15% proteins, 30% fats, 55% carbohydrates) + walking + random assignment to: Sibutramine: 8 visits of 10–15 minutes with a primary care provider + pamphlet providing tips for healthy lifestyle + sibutramine 15 mg/day Lifestyle modifications: 30 group behavior modification sessions Combined therapy (a + b) Sibutramine + brief therapy: sibutramine 15 mg/day + 8 sessions of 10–15 minutes behavior therapy sessions
Finer et al²⁹	BL: 928 p. Nondiabetic: 771 p. F 611. C 763. mA 42.4 ± 10.7. mBW 97.5 ± 15.2. mBMI 35.0 ± 4.1. Diabetic: 157 p. mA 51.4 ± 9.6. F 84. C 153. mBW 101.3 ± 17.7. mBMI 35.7 ± 5.4.	Retrospective analysis of patients included in 7 different studies	Run in phase: placebo run-in phase (3 studies); open-label sibutramine run-in phase (2 studies); very low calorie diet (1 study) Treatment: 52 weeks; random assignment to sibutramine (10 mg/day) or placebo (6 studies with fixed dose; 1 study with dose titrated depending on patient’s weight maintenance)
Frey et al⁵⁰	BLCPCS: 110 p. C. F 74. A 42–48. BMI 35.3–35.4. Sibutramine group: 54 p. F 38. mA 46.8 ± 10.5. mBW 99.2 ± 14.1. mBMI 35.1 ± 4.2. Placebo group: 56 p. F 36. mA 49.3 ± 11.0. mBW 104.5 ± 15.2. mBMI 35.5 ± 3.3.	Retrospective study on a part of patients who had completed the program	54 weeks treatment: random assignment to 15 mg/day of sibutramine or placebo + behavior program (16 group sessions) + physical activity + diet (daily energy requirement minus 500 to 1000 kcal/day)
Greenway⁷⁸	SIBUTRAMINE: 83 obese patients with diabetes; 2004 obese patients without diabetes. ORLISTAT: 321 obese patients with diabetes; 2404 obese patients without diabetes. MAZINDOL: 40 obese patients with diabetes; 998 obese patients without diabetes.	Retrospective comparative analysis between a study focusing on diabetic patients and an average of studies in nondiabetic patients for each type of drug	12 weeks sibutramine treatment or 52 weeks orlistat treatment or 12 weeks mazindol treatment
Grudell et a⁴⁷	BL: 181 p. Placebo: 62 p. F 54. mA 41.3 ± 1.4. mBW 95.9 ± 2.1. mBMI 34.5 ± 0.6. Sibutramine 10 mg: 58 p. F 53. mA 42.2 ± 1.4. mBMI 34.8 ± 0.7. Sibutramine 15 mg: 61 p. F 54. mA 44.8 ± 1.3. mBMI 33.9 ± 0.6. ET: 158 p.	Prospective study	12 weeks treatment: behavioral therapy (LEARN manual + 1 group session of 15 minutes each week led by a psychologist) + placebo or sibutramine 10 mg/day or 15 mg/day
Hainer et al²⁴	BL: 80 p. F. mA 43.9 ± 10.6 (18–65). mBMI 36.7 ± 4.8 (30–45). 1st phase: sibutramine 38 p. Placebo 42 p. 2nd phase: 80 p. ET: 67 p.	Prospective study	1st phase: 4 months; random assignment to sibutramine 10 mg/day or placebo 2nd phase: 8 months; sibutramine + 5–6 MJ/day diet (50%–60% carbohydrates; 15%–20% proteins; 25%–30% fat) + physical activity + food diary records
Hansen et al⁴⁶	BL: 605 p. BMI 30–45; 18–65 yr Completers of the 1st phase: 505 p. mA 40.4 ± 10.4. mBW 102.5 ± 15.3. mBMI 36.7 ± 4.1. Enrolled in the 2nd phase: 467 p. 352 sibutramine. 115 placebo. ET: 263 p.	Prospective study	1st phase: 6 months; sibutramine (10 mg/day) and LCD (patient’s estimated daily energy expenditure minus 600 kcal/day. 45%–50% carbohydrates; 30% fats; 15%–20% proteins) 2nd phase: 18 months; random assignment for patients who achieved ≥5% of weight loss to sibutramine 10 mg/day (352 p) or placebo (115 p)
Hauner et al⁵³	BL: 348 p. BMI 30–40; 18–65 yr. Sibutramine: 174 p. F 136. mA 44.5 ± 1.2. mBW 100.2 ± 1.9. mBMI 35.6 ± 0.6. Placebo: 174 p. F 123. mA 47.3 ± 1.3. mBW 105.4 ± 2.0. mBMI 35.7 ± 0.5.	Retrospective analysis of patients included in the study	54 weeks treatment: 20 group sessions and prescription of a diet (500/1000 kcal minus of the daily required energy expenditure) + physical activity + sibutramine or placebo (random assignment) 2 years follow up
Hsiao et al⁵⁴	BL: 131 p. Sibutramine: 87 p. Placebo 44 p. ET: 118 p. BLCPCS: Sibutramine 82 p. F 41. mA 31.7 ± 4.9. mBW Placebo 37 p. F 17. mA 31.1 ± 5.8. mBW 83.8 ± 15.0. mBMI 29.8 ± 3.4.	Prospective study	12 weeks treatment: sibutramine 10 mg/day or placebo
Hsiao et al⁵⁷	BL: 131 p. Sibutramine: 87 p. Placebo 44 p. ET: 118 p. BLCPCS: Sibutramine 82 p. F 41. mA 31.7 ± 4.9. mBW Placebo 37 p. F 17. mA 31.1 ± 5.8. mBW 83.8 ± 15.0. mBMI 29.8 ± 3.4.	Prospective study	12 weeks treatment: sibutramine 10 mg/day or placebo
Klein et al⁷⁶	BL: 26 p. ET: 22 p. F 13. BLCPCS: mA 41.5. mBMI 28.0 ± 6.6. mBW 80.3 ± 19.3.	Prospective study	6 months treatment: topiramate
LLoret-Linares et al³⁷	BL: Sibutramine (3 studies): 115–467 p. F 76%–84%. mA 40.4–43.3. mBMI 32.4–37.9. Orlistat (12 studies): 422–3277 p. F 55%–87%. mA 40–53. mBMI 34.7–37.4. Rimonabant (4 studies): 688–1826 p.	Retrospective comparative analysis between studies considering nondiabetic and diabetic subjects for each type of drug	Sibutramine: 10 or 20 mg once a day for 52 or 104 weeks or Orlistat: 120 mg three times a day for 52/76/104/208 weeks or Rimonabant: 20 mg daily for 52 or 104 weeks. All trials combined pharmacological therapy with a reduced-calorie diet
Malone and Alger-Maye⁴⁰	BL: 30 p. F 26. mA 43.8 ± 9.7. mBW 127 ± 34. mBMI 45.5 ± 11.8. Intervention group: 15 p. F 14. mA 44.9 ± 10.5. BW 130 ± 39. BMI 48.3 ± 14.6. Control group: F 12. mA 42.8 ± 9. BW 124 ± 30. BMI 42.8 ± 8.1. ET: 9 p. Intervention group: 7 p. Control: 2 p.	Prospective study	Patients randomly assigned to the group followed by a community pharmacist (trained and educated for 1 day to support clients during weight loss treatment with orlistat) or to the group not followed by a pharmacist and followed for 26 weeks
Norris et al³⁰	BL: 31 studies. mA 48–66. F 50%. Fluoxetine (6 studies): 296 p (total number). Orlistat (8 studies): 2036 p (total number). Sibutramine (8 studies): 1047 p (total number). Cimetidine 1 study. Diethylpropion (3 studies): 40–58 p (single study). Mazindol (3 studies); 10–64 p (single study). Phentermine (2 studies).	Meta-analysis of studies considering nondiabetic and diabetic subjects for each type of drug	Run-in period: 1–5 weeks in most studies; placebo + dietary counseling Treatment: Fluoxetine: 8 to 52 weeks or Orlistat: 12 to 57 weeks or Sibutramine: 12 to 52 weeks or Cimetidine: 12 weeks Dyethylpropion: 8 to 40 weeks or Mazindol: 6 to 12 weeks or Phentermine: 16 to 26 weeks
Peters et al²⁵	BL: 149 p. F. mA 54 ± 5.78 (45–65). mBW 103.41 ± 20.65 (68.03–175.54). mBMI 40.10 ± 8.01 (30–76). FU: 74 p.	Prospective study	6 months treatment: sibutramine 15 mg/day + 1 hour/month behavior modification seminar + daily exercise
Rissanen et al²⁶	BLCPCS: 220 p. F 178. A 42–49. BW 90.3–101.9. BMI 32.7–36.1.	Retrospective analysis of patients who completed the treatment in two different studies	Run in phase: 4 weeks; hypocaloric diet (30% fat; 500 kcal/day energy deficit) + placebo Treatment: 2 years; random assignment to: 120 mg/day orlistat or placebo + diet
Risser et al⁶³	BL: PAR¹: 22 p. F 90.9%. mA 4 9.9 ± 12. mBMI 39.3 ± 7. Non-PAR: 47 p. F 78.7%. mA 47.1 ± 10. mBMI 37.1 ± 6.12.	Retrospective analysis	1st phase: 8 weeks; 800–1220 kcal/day diet + 24-hour food diary + visits (first 10 weeks: 2–5 days/week) + sibutramine 15 g/daily (flexible doses adjusted depending on patient) 2nd phase: 40 weeks; weight maintenance through well-balanced meals and regular exercise + sibutramine 15 mg/day (flexible doses adjusted depending on patient)
Rodin et al⁴¹	BL: 204 p. Clinic 1: 144 p. F 129. A 18–59. BW 28%–199% overweight. Clinic 2: 60 p. F 60. A 18–54. BW 17%–183% overweight. ET: clinic 1: 33 p. Clinic 2: 56 p.	Prospective study	Clinic 1: 14 weeks (8 weeks treatment): random assignment to 4 groups: behavior modification treatment, diethylpropion 65 mg/day, mazindol 2 mg/day, placebo Clinic 2: 10 weeks; (9 weeks treatment): behavior therapy for all patients + random assignment to two different formulations of mazindol or placebo
Shimizu and Mori⁶⁶ Shimizu et al⁶⁷	BL: 24 p. Trp64Trp: 16 p. Trp64Arg: 8 p. BMI > 35 kg/m². BL: 41 p. F 25. BMI > 35.	Prospective study	12 weeks treatment: mazindol (starting dose 0.5 mg/day. Increments of 0.5 mg/day every 2 weeks up to 1.5 mg/day at week 6 and then continued until week 12)
Tankova et al⁵⁹	BL: 173 p. Diabetic patients: 83 p. Sibutramine group: 44 p. F 27. mA 45.2 ± 5.2. mBMI 33.6 ± 2.2. Control group: 39 p. F 24. mA 44.8 ± 6.1. mBMI 33.9 ± 2.8. Nondiabetic patient: 90 p. Sibutramine group: 49 p. F 32. mA 41.9 ± 5.7. mBMI 34.3 ± 2.6. Control group: 41 p. F 27. mA 44.6 ± 6.0. mBMI 33.9 ± 2.2.	Prospective study	3 months treatment: hypocaloric diet (600 kcal/day deficit on the estimated total daily energy expenditure. <30% fat, 15% protein, 55%–60% carbohydrates) +30 minutes walking/day + random assignment to sibutramine once daily or placebo. First month dosage of sibutramine was 10 mg/day replaced by 15 mg/day in case of no change in body weight
Toplak et al³⁸	BL: 430 p. BMI 30–43; 18–70 yr; BW ≥90, waist circumference ≥88 cm (F) or ≥102 cm (M). Orlistat + 500 kcal/day diet: 215 p. F 168. mA 41.3 ± 11.0. mBW 103.4 ± 11.2. mBMI 37.3 ± 3.4. Orlistat + 1000 kcal/day diet: 215 p. F 166. mA 41.1 ± 12.1. mBW 104.7 ± 12.8. mBMI 37.4 ± 3.6. ET: 264 p.	Prospective study	1 year treatment: orlistat 120 mg 3 times/day + dietary counseling + daily food diary + random assignment to a diet (50% carbohydrates, 30% fat, 20% protein) of 500 or 1000 kcal/day deficit Patients who achieved a 5% weight loss at both months 3 and 6 (295 p) were allowed to continue the study until month 12
Theisen et al⁷⁴	BL: 26 p. F 10. mA 37.4 ± 10.3 (20.7–65.3). M mBMI 28.1 ± 6.4. F mBMI 22.5 ± 3.5. ET: 18 p.	Prospective study	25 weeks treatment with topiramate added to existing anticonvulsant therapy (carbamazepine 12 p; carmanazepine + valproate 3 p; carbamazepine + lamotrigine 3 p; carbamazepine + valproate + lamotrigine 3 p; carbamazepine + valproate + phenobarbital 1 p; carbamazepine + phenobarbital 1 p; carbamazepine + phenytoin 1 p; phenytoin + phenobarbital 1 p; phenytoin + lamotrigine + phenobarbital 1 p)
Ullrich et al³¹	BL: 261 p. F 214. mA 41.4 ± 9.8. mBMI 36.8 ± 4.2. Sibutramine group: 204 p. F 168. mA 41.4 ± 9.7. mBMI 36.6 ± 4.2. Placebo group: 57 p. F 46. mA 41.3 ± 10.0. mBMI 37.1 ± 3.8.	Retrospective analysis of people who completed the study	Run in phase: 4 weeks; hypocaloric diet (600 kcal/day deficit on patient’s estimated basal metabolic rate. ≤30% fat; protein and carbohydrate ad libitum) + placebo (3 times/day with meals) Treatment: 72 weeks; orlistat (120 mg × 3/day). 4-day food diary at weeks −4, −2, 0, 12, 24, 36, 48, 64. Group weight management program sessions (one each 4 weeks)
Van Baak et al⁴⁸	BL: 605 p. BMI 30–45; 17–65 yr. After 6 mo run in phase: 467 p. ET: 261 p. F 214. mA 41.4 ± 9.8. BMI 36.8 ± 4.2.	Prospective study	1st phase: 6 months; sibutramine (10 mg/day) and LCD (patient’s estimated daily energy expenditure minus 600 kcal/day. 45%–50% carbohydrates; 30% fats; 15%–20% proteins) 2nd phase: 18 months; random assignment for patients who achieved ≥5% of weight loss to sibutramine 10 mg/day (352 p) or placebo (115 p). Dietary advice and one meeting with a dietician a month
Vazquez Roque et al⁴⁴	BL: 48 p. Sibutramine 25 p. Placebo 23 p. Overweight: 24 p. mA 36.7 ± 1.7. F 17. C 87.5%. mBW 79.6 ± 1.6. mBMI 27.9 ± 0.3. Obese: 24 p. mA 44.2 ± 2.6. F 13. C 95.8%. mBW 98.2 ± 2.7. mBMI 34.8 ± 0.7. ET: 43 p. Sibutramine 22 p. Placebo 21 p.	Prospective study	12 weeks treatment: LEARN manual (self-help behavioral manual for weight loss) + 10–15 minutes behavior therapy sessions (one every 4 weeks) + random assignment to sibutramine 15 mg/day or placebo
Womble et al⁶⁵	BL: Group 1: 59 p. F 31. M: mA 50.21 ± 7.39; mBMI 39.94 ± 5.99. F: mA 45.72 ± 9.2. mBMI 40.34 ± 8.20. Group 2: 32 p taken from group 1. F 15. ET group 1: 59 p. Group 2: 32 p.	Prospective study	6 months treatment for group 1; 12 months treatment for group 2 For both groups, random assignment to: Fenfluramine + mazindol (6 months; 29 p. 12 months; 18 p) or Fenfluramine + phentermine (6 months; 25 p. 12 months; 11 p) or Caffeine + ephedrine (6 months; 2 p. 12 months, 1 p) or Mazindol (6 months, 3 p. 12 months, 2 p)

Notes:

Cases: patients who had received a prescription for sibutramine in response to priori authorization through their health care insurer (PAR). Controls: subjects who did not receive reimbursement, although they were prescribed, sibutramine (non-PAR).

Abbreviations: BL, sample characteristics at base line; BMI, body mass index (kg/m²); BLCPCS, baseline characteristics of people who completed the study; BW, body weight; C, Caucasians; F, number of female patients; ET, sample characteristics at the end of the program; mA, mean age; mBMI, mean body mass index (kg/m²); mBW, mean body weight; OE, other ethnicity; p, number of patients; yr, years old; LCD, low-calorie diet.