Table 2.
Characteristics of Randomized Clinical Trials Comparing Lorcaserin, Naltrexone-Bupropion, Phentermine-Topiramate, and Liraglutide vs Placebo for Weight Lossa
| Source/Period | Total Enrolled/mITT/Completers | Cointerventions | Outcomes of Interest Reported | ||||||
|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|||||||
| Intervention | Control | Diet | Exercise | Behavior | Mean Weight Change | Proportion With ≥5% Weight Loss | Proportion With ≥10% Weight Loss | Treatment Withdrawals Due to Adverse Events | |
| Lorcaserin vs Placebo | |||||||||
|
| |||||||||
| O’Neil et al,39 2012 (US)/2007–2010 | 256/251/169 | 252/248/157 | 600-kcal/d deficitb | Moderate, 30 min/d | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Fidler et al,38 2011 (US)/2007–2009 | 1602/1561/917 | 1601/1541/834 | 600-kcal/d deficitb | Moderate, 30 min/d | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Smith et al,40 2010 (US)/2006–2009 | 1595/1538/883 | 1587/1499/676 | 600-kcal/d deficitb | Moderate, 30 min/d | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Naltrexone-Bupropion vs Placebo | |||||||||
|
| |||||||||
| Apovian et al,41 2013 (US)/2007–2009 | 1001/826/538 | 495/456/267 | 500-kcal/d deficit | Nonspecific increase | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Hollander et al,43 2013 (US)/2007–2009 | 333/265/175 | 169/159/100 | 500-kcal/d deficit | Brisk walking, 30 min/d | Yes | ✓ | ✓ | ✓ | |
|
| |||||||||
| Wadden et al,44 2011 (US)/2007–2009 | 591/482/301 | 202/193/106 | Graded energy balancec | Moderate, 180 min/wk, increasing to 360 min/wk | Yes | ✓ | ✓ | ✓ | |
|
| |||||||||
| Greenway et al,42 2010 (US)/2007–2009 | 583/471/296 | 581/511/290 | 500-kcal/d deficitb | Nonspecific increase | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Phentermine-Topiramate vs Placebo | |||||||||
|
| |||||||||
| Allison et al,45 2012 (US)/2007–2009 | 512/498/301 | 514/498/241 | 500-kcal/d deficitb | Nonspecific increase | Yes | ✓ | ✓ | ✓ | |
|
| |||||||||
| Gadde et al,46 2011 (US)/2007–2009 | 995/981/733 | 994/979/616 | 500-kcal/d deficitb | Yes | ✓ | ✓ | ✓ | ✓ | |
|
| |||||||||
| Liraglutide vs Placebo | |||||||||
|
| |||||||||
| Davies et al,47 2015/2011–2013d | 423/412/324 | 212/211/140 | 500-kcal/d deficitb,e | Brisk walking ≥150 min/wk | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Pi-Sunyer et al,48 2015/2011–2013d | 2487/2437/1789 | 1244/1225/801 | 500-kcal/d deficitb,e | Brisk walking ≥150 min/wk | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Astrup et al,49 2012/2007–2009d | 93/72/47 | 98/67/47 | 500-kcal/d deficitb,e | Brisk walking ≥150 min/wk | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Liraglutide vs Orlistat Johnston et al,55 2014 (US)/2007–2009/52 | 93/72/47 | 95/67/45 | 500-kcal/d deficitb,e | Brisk walking ≥150 min/wk | Yes | ✓ | ✓ | ✓ | ✓ |
Abbreviation: mITT, modified intention to treat (last-observation-carried-forward analysis).
All trials were randomized, double-blind, placebo-controlled, multicenter studies. Trials had follow-up through 52 weeks with the exception of the following, which went to 56 weeks: Apovian et al, Hollander et al, Wadden et al, and Greenway et al (all naltrexone-bupropion vs placebo); and Davies et al (liraglutide vs placebo).
Baseline calculated using World Health Organization equations.
Participants: weight ≤249 lb, 1200 kcal/d; weight 250–299 lb, 1500 kcal/d; weight 300–349 lb, 1800 kcal/d; weight ≥350 lb, 2000 kcal/d. Balanced deficit diet: approximately 15%–20% of energy from protein, ≤30% energy from fat, and the remainder from carbohydrate.
International trial.
Thirty percent of energy from fat, 20% from protein, and 50% from carbohydrate.