Table 2.
Studies included in systematic review for long-term pharmacotherapy of obesity. Attrition for each study was calculated from the total number of participants who were randomized to treatments. Results for weight change are reported from intention to treat analyses, generally with the last observation carried forward. Some results reported in the studies (e.g. for follow-up intervals other than 1 year) are not included in the table.
| Drug | Study | Subjects (sites for trial) | Groups (number randomized) | Lifestyle intervention | Attrition (%) | Drug change in weight at 1y (kg) | Placebo change in weight at 1y (kg) | Drug change in weight relative to baseline weight at 1y (%) | Placebo change in weight relative to baseline weight at 1y (%) | Drug percent losing ≥5% of baseline weight at 1y (%) | Placebo percent losing ≥5% of baseline weight at 1y (%) | Drug percent losing ≥10% of baseline weight at 1y (%) | Placebo percent losing ≥10% of baseline weight at 1y (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orlistat | Hollander et al9 |
Adults (49% female) with type 2 diabetes and BMI 28–40 kg/m2who were clinically stable on oral sulfonylureas only and treatment compliance of 70% during placebo run- in. Those with recurrent nephrolithiasis or symptomatic cholelithiasis were excluded (USA) |
Orlistat 120mg TID (n=163); Placebo TID (n=159) |
500 kcal/day caloric reduction |
21 | −6.2 | −4.3 | −6.2 | −4.3 | 48.8 | 22.6 | 17.9 | 8.8 |
| Orlistat | Sjostrom et al10 |
Adults (83% female) with BMI 28–47 kg/m2 and treatment compliance of 75% during placebo run- in. Those with uncontrolled hypertension and drug-treated diabetes were excluded (Europe) |
Orlistat 120mg TID (n=345); Placebo TID (n=343) |
600–900 kcal/day caloric reduction |
21 | −10.3 | −6.1 | −10.2 | −6.1 | 68.5 | 49.2 | 38.8 | 17.7 |
| Orlistat | Davidson et al11 |
Adults (84% female) with BMI 30–43 kg/m2 and treatment compliance of 75% during placebo run- in. Those with drug- treated diabetes were excluded (USA) |
Orlistat 120mg TID (n=668); Placebo TID (n=224) |
500–900 kcal/day caloric reduction; behavior modification program involving exercise counseling, food diary |
34 | −8.8 | −5.8 | −8.8 | −5.8 | 65.7 | 43.6 | 38.9 | 24.8 |
| Orlistat | Finer et al12 |
Adults (88% female) with BMI 30 – 43 kg/m2 and treatment compliance of 70% during placebo run- in. Those with diabetes or uncontrolled hypertension (UK) |
Orlistat 120mg TID (n=114); Placebo TID (n=114) |
600–900 kcal/day caloric reduction |
39 | −3.3 | −1.3 | −8.5 | −5.4 | 35 | 21 | 28 | 17 |
| Orlistat | Hauptman et al13 |
Adults (78% female) with BMI 30–44 kg/m2 and treatment compliance of 75% during placebo run- in. Those with uncontrolled hypertension were excluded (USA) |
Orlistat 60mg TID (n=213); Orlistat 120mg TID (n=210); Placebo TID (n=212) |
1200–1500 kcal/day diet; exercise; food diary; educational video |
33 | For 60mg: −7.1 For 120mg: −7.9 |
−4.1 | For 60mg: −7.1 For 120mg: −7.9 |
−4.2 | For 60mg: 48.8 For 120mg: 50.5 |
30.7 | For 60mg: 24.4 For 120mg: 28.6 |
11.3 |
| Orlistat | Lindgarde et al14 |
Adults (64% female) with BMI 28–38 kg m2) with type 2 diabetes treated only with metformin or sulfonylurea, hypercholesterolem ia and/or hypertension who completed a placebo run-in (Sweden) |
Orlistat 120mg TID (n=190); Placebo TID (n=186) |
600–900 kcal/day caloric reduction; exercise; self-help weight control educational package |
14 | −5.6 | −4.3 | −5.9 | −4.6 | 54.2 | 40.9 | 19.2 | 14.6 |
| Orlistat | Rossner et al15 |
Adults (82% female) with BMI 28–43 kg/m2 and treatment compliance of 75% during placebo run- in. Those with uncontrolled hypertension, drug- treated diabetes mellitus, or history or presence of symptomatic cholelithiasis were excluded (Europe) |
Orlistat 60mg TID (n=242); Orlistat 120mg TID (n=244); Placebo TID (n=243) |
600 kcal/day caloric reduction; food diaries, counseling by dietitian |
28 | For 60mg: −8.5 For 120mg: −9.4 |
−6.4 | For 60mg: −8.6 For 120mg: − 9.7 |
−6.6 | For 60mg: N/A For 120mg: N/A |
N/A | For 60mg: 31.2 For 120mg: 38.3 |
18.8 |
| Orlistat | Broom et al16 |
Adults (78% female) with BMI ≥28 kg/m2 and untreated hypertension, impaired glucose tolerance, or dyslipidemia who were eligible after a 2-week placebo run-in. If compliance with medication was <60%, subjects were withdrawn (UK) |
Orlistat 120mg TID (n=265); Placebo TID (n=266) |
600–900 kcal/day caloric reduction; food diary |
35 | −5.8 | −2.3 | −5.8 | −2.3 | 55.6 | 24.3 | 19.7 | 11 |
| Orlistat | Hanefield and Sachse17 |
Adults (51% female) with BMI ≥28 kg/m2 with diabetes and HA1C 6.5–11% treated with diet alone or sulfonylurea who were eligible after a 4-week placebo run-in. Those with uncontrolled hypertension were excluded. If compliance with medication was <75%, subjects were withdrawn (Germany) |
Orlistat 120mg TID (n=195); Placebo TID (n=188) |
600 kcal/day caloric reduction, diet diary |
31 | −5.3 | −3.4 | −5.4 | −3.6 | 51.3 | 31.6 | N/A | N/A |
| Orlistat | Miles et al19 |
Adults (48% female) with BMI 28 – 43 kg/m2 and type 2 diabetes with HA1C 7.5–12% receiving oral hypoglycemic who were eligible after a 2-week screening phase. Those with poorly controlled hypertension or treated with insulin, thiazolidinediones, or alpha- glucosidase inhibitors were excluded (USA and Canada) |
Orlistat 120mg TID (n=255); Placebo TID (n=261) |
600 kcal/day caloric reduction and exercise counseling |
40 | −4.7 | −1.8 | −4.6 | −1.7 | 39.0 | 15.7 | 14.1 | 3.9 |
| Orlistat | Krempf et al18 |
Adults (86% female) with BMI ≥28 kg/m2 without diabetes or other significant medical condition who were eligible after a 2- week placebo run- in (France) |
Orlistat 120mg TID (n=346); Placebo TID (n=350) |
20% energy reduced diet, increased by 10% if weight stable; food diary |
≤39* | −6.3 | −3.3 | −6.3 | −3.6 | 65.9 | 46.4 | 32.9 | 24.5 |
| Orlistat | Torgerson et al20 |
Adults (55% female) age 30–60y with BMI ≥30 kg/m2. Patients were required to have nondiabetic glucose tolerance. Those with ongoing and active cardiovascular or gastrointestinal disease were excluded (Sweden) |
Orlistat 120mg TID (n=1650); Placebo TID (n=1655) |
800 kcal/day caloric reduction; lifestyle intervention program |
16 | −10.6 | −6.2 | N/A | N/A | 72.8 | 45.1 | 41 | 20.8 |
| Orlistat | Berne et al21 |
Adults (45% female) age 30–75y with BMI 28–40 kg/m2 and type 2 diabetes and HA1C 6.5–10% treated only with metformin or sulfonylurea who were eligible after a 2-week diet run-in (Sweden) |
Orlistat 120mg TID (n=111); Placebo TID (n=109) 1 subject unclear allocation |
600 kcal/day caloric reduction; diet and exercise counseling; self- management educational package |
14 | N/A | N/A | −5.0 | −1.8 | 45.9 | 11 | 13.5 | 2.8 |
| Orlistat | Swinburn et al22 |
Adults (57% female) age 40–70y with BMI 30–50 kg/m2 and type 2 diabetes treated only with oral agents and HA1C 6.5–10%, hypercholesterolem ia and/or hypertension who completed a placebo run-in. Those with uncontrolled hypertension were excluded (Australia and New Zealand) |
Orlistat 120mg TID (n=170); Placebo TID (n=169) |
Reduced fat diet and exercise counseling |
21 | −4.7 | −0.9 | N/A | N/A | N/A | N/A | N/A | N/A |
| Orlistat | Derosa et al23 |
Adults (49% female) with BMI ≥30 kg/m2 with type 2 diabetes and HA1C >8.0% (Italy) |
Orlistat 120mg TID (n=126); Placebo TID (n=128) |
600 kcal/day caloric reduction, behavior modification program, exercise counseling |
8 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Lorcaserin | Smith et al31 |
Adults (83% female) with BMI 30–45 kg/m2 or 27– 29.9 kg/m2 with an obesity-related comorbid condition. Those with cardiac valvulopathy, type 2 diabetes, and uncontrolled hypertension were excluded (USA) |
Lorcaserin 10mg BID (n=1595; Placebo BID (n=1587) |
600 kcal/day caloric reduction; Standardize d nutritional and exercise counseling |
50 | −5.8 | −2.2 | −5.8 | −2.2 | 47.5 | 20.3 | 22.6 | 7.7 |
| Lorcaserin | Fidler et al32 |
Adults (80% female) with BMI 30–45 kg/m2 or 27– 29.9 kg/m2 with an obesity-related comorbid condition. Those with type 2 diabetes, and uncontrolled hypertension or dyslipidemia were excluded (USA) |
Lorcaserin 10mg qD (n=801) Lorcaserin 10mg BID (n=1602); Placebo (n=1601) |
600 kcal/day caloric reduction and exercise counseling, diet diary |
45 | For 10mg qD: −4.7 For 10mg BID: −5.8 |
−2.9 | For 10mg qD: −4.7 For 10mg BID: −5.8 |
−2.8 | For 10mg qD: 40.2 For 10mg BID: 47.2 |
25.0 | For 10mg qD: 17.4 For 10mg BID: 22.6 |
9.7 |
| Lorcaserin | O'Neil et al30 |
Adults (54% female) with BMI 27–45 kg/m2 and type 2 diabetes treated with metformin or sulfonylurea and HA1C 7–10%. Those with severe cardiovascular disorders were excluded (USA) |
Lorcaserin 10mg qD (n=95); Lorcaserin 10mg BID (n=256); Placebo (n=252) |
600 kcal/day caloric reduction; nutritional and exercise counseling |
34 | For 10mg qD: −5 For 10mg BID: −4.7 |
−1.6 | For 10mg qD: −5 For 10mg BID: −4.5 |
−1.5 | For 10mg qD: 44.7 For 10mg BID: 37.5 |
16.1 | For 10mg qD: 18.1 For 10mg BID: 16.3 |
4.4 |
| Phentermine / Topiramate ER |
Allison et al.33 |
Adults (83% female) with BMI ≥35 kg/m2 with fasting glucose ≤110mg/dl, triglycerides ≤200 mg/dl with ≤1 lipid- lowering medications, BP ≤140/90 mm Hg with ≤2 antihypertensive medications. (USA) |
Phentermine/ topiramate ER 3.75/23mg (starting dose) (n=241); Phentermine/ topiramate- ER 15/92mg (top dose) (n=512), Placebo (n=514) |
Self-help weight control manual, 500 kcal/day caloric reduction, monthly progress reviews |
40 | N/A | N/A | For 3.75/23mg :−5.1 For 15/92mg: −10.9 |
−1.6 | For 3.75/23m g: 44.9 For 15/92mg: 66.7 |
17.3 | For 3.75/23mg: 18.8 For 15/92mg: 47.2 |
7.4 |
| Phentermine / Topiramate ER |
Gadde et al34 |
Adults (70% female) with BMI 27–45 kg/m2 and 2 or more weight- related comorbidities. No lower BMI limit for participants with type 2 diabetes (16% of cohort). Those with uncontrolled diabetes, hypertension, or hypertriglyceridemi a, or who used antidiabetic drugs other than metformin were excluded (USA) |
Phentermine/ topiramate ER 7.5/46mg (recommend er dose) (n=498) Phentermine/ topiramate- ER 15/92mg (top dose) (n=995) Placebo (n=994) |
Standardize d lifestyle counseling, 500 kcal/day caloric reduction |
31 | For 7.5/46mg : −8.1 For 15/92mg: −10.2 |
−1.4 | For 7.5/46mg: −7.8 For 15/92mg:- −9.8 |
−1.2 | For 7.5/46mg: 62; For 15/92mg: 70 |
21 | For 7.5/46mg: 37 For 15/92mg: 48 |
7 |
HA1C: Hemoglobin A1C; N/A: Not available.
*
Attrition available only at 18mos.