Table 3.

Pharmacotherapy

Study	N	Treatment	Length of WM Tx	Results	% Weight Change	Effect Size
Early et al⁶⁰	148 (126 women) 133 eligible for WM 60 at end of trial 55% attrition 48% White 40% Black 9% Hispanic 1.5% Asian 1.5% Other	2-GROUP DESIGN: Sibutramine 15 mg/d + 1 meal replacement & 2 low- calorie meals (~1500 kcal/d) Placebo 3 low-calorie meals (~1500 kcal/d) Both received behavior therapy with self- monitoring, problem solving, social support	9-month WM after 3 months WL with sib. 10 mg/d and low-calorie diet	During WM ^b: Sibutramine −2.5 ± 0.6 kg Placebo +2.9 ± 0.6 kg p < .001 for group difference	During WM ^b: Sibutramine −2.9 ± 0.7% Placebo +3.3 ± 0.7% p <.001 for group difference	.28
Wirth & Krause²⁹	1102 1001 eligible for WM (768 women) 787 at end of trial 21% attrition 99.5% White	3-GROUP DESIGN: Sibutramine ongoing 15mg/d for 44 wks Sibutramine periodic 15mg/d except for weeks 13–18 and 31–36 when placebo was received Placebo All received dietary advice; no formal dietary or behavior therapy	44-week WM after 4 weeks WL with sib. 15 mg/d	During WM: Sib. ongoing −3.8 kg (95% CI, −4.4 to −3.2) Sib. periodic −3.3 kg (95% CI, −3.9 to −2.6) Placebo +0.2 kg (95% CI, −0.6 to 0.94)	During WM: Sib. ongoing Lost an additional 4% Sib. periodic Lost an additional 3.5% Placebo Regained 0.2%	.10
James et al⁶¹	605 467 eligible for WM (390 women) 261 at end of trial 44% attrition 96.5% White	2-GROUP DESIGN: Sibutramine 10mg/d (increased up to 20mg/d if regain) Placebo Both groups received dietary counseling each month or every 2 weeks if desired	18-month WM after 6- month WL with sib. 10 mg/d	Prior to WL Rx to trial end ^a: Sibutramine −8.9 ± 8.1 kg Placebo −4.9 ± 5.9 kg p <.001 for group difference	Sibutramine 43% sustained at least 80% of lost weight. Placebo 16% sustained ≥ 80% of lost weight p <.001 for group difference	.15
Sjostrom et al⁶⁵	688 (567 women) 526 eligible for WM 435 at end of trial 17% attrition Ethnicity not reported	2-GROUP DESIGN: Orlistat 120 mg/TID Placebo Both groups were to follow a weight- maintenance diet; received either orlistat or placebo during WL	1-year WM after 1-year WL with orlistat 120 mg/TID or placebo	During WM: Orlistat in WL orlistat regained 2.4 [SE 0.6] kg less than placebo, p <.001 Placebo in WL orlistat lost 3.6 [SE 0.6] kg versus placebo, p <.001	After 2 years: Continuous orlistat 57.1% maintained a WL > 5% Continuous placebo 37.4% maintained a WL > 5%	.14
Davidson et al⁶²	1187 880 eligible for WM (741 women) 403 at end of trial 54% attrition 81% White 15% Black 4% Hispanic	4-GROUP DESIGN: Orlistat-treated group rerandomized for WM Orlistat 120 mg TID Orlistat 60 mg TID Placebo All followed a WM diet; 4 seminars on strategies for WM; instruction in self-monitoring food intake and activity	1-year WM after 1-year WL with orlistat 120 mg/TID or placebo	During WM ^b: Orlistat 120 mg +3.2 ± 0.45kg Orlistat 60 mg +4.3 ± 0.57kg Placebo +5.6 ± 0.42kg Orlistat 120 mg regained less weight than other groups, p <.001	During WM: Orlistat 120 mg 35.2% of lost weight regained Orlistat 60 mg 51.3% of lost weight regained Placebo 63.4% of lost weight regained	.11
Hill et al⁶³	1313 (605 women) 726 eligible for WM 537 at end of trial 26% attrition 88% White 6% Black 5% Hispanic 1% Other	4-GROUP DESIGN: Orlistat 120 mg TID Orlistat 60 mg TID Orlistat 30mg TID Placebo All followed a WM diet; behavioral & dietary counseling; visits biweekly for 1 mo, monthly until month 5, & bimonthly thereafter.	1-year WM after 1-year WL with a 1000 kcal/d deficit diet	Prior to WL Rx to trial end ^b: Orlistat 120 mg −8.20 ± 0.5% Orlistat 60 mg −6.66 ± 0.5% Orlistat 30 mg −5.94 ± 0.6% Placebo −6.42 ± 0.7%	Percent who regained ≤ 25% of lost weight: Orlistat 120 mg 47.5% Orlistat 60 mg 30.4% Orlistat 30 mg 32.3% Placebo 29.9%	.12
Karhunen et al⁶⁴	96 88 eligible for WM 72 at end of trial (59 women) 18% attrition Ethnicity not reported	2-GROUP DESIGN: Orlistat (O) 120 mg TID Placebo (P) TID Groups were prescribed a WM diet; because of assignment during WL, 4 groups resulted after WL & WM: O+O, O+P, P+O, P+P	1-year WM after 1-year WL with either orlistat 120 mg TID or placebo TID	Weight after WL^a: O+O 82.6 ± 11.4kg O+P 87.7 ± 14.2kg P+O 89.2 ±1 9.0kg P+P 88.2 ± 15.8kg Weight after WM ^a: O+O 85.7 ± 12.4kg O+P 94.0 ± 16.6kg P+O 89.7 ± 19.9kg P+P 91.7 ± 16.0kg	During WM: O+O 24% of lost weight regained O+P 48% of lost weight regained P+O 69% of lost weight regained P+P 37% of lost weight regained	.27

Abbreviations: CI, confidence interval;TID, three times a day; Tx, treatment; WL, weight loss; WM, weight maintenance. ^amean ± standard deviation.

mean ± standard error of the mean.