Study Finer

Methods Study design RCT Randomization procedure NR Allocation concealment Unclear Follow-up 12w Participants Country UK Setting Two hospital-based diabetes clinics Number 91 Age 54 Sex 53 Medications 14 diet only 24 insulin BL wt I 84.6, C 82.5 BL BMI I 30.6, C 31.0 BL GHb 9.5 Interventions Drug Sibutramine Dosage 15mg qd Duration 12wDiet 500kcal d deficit Comparison Placebo + diet Outcomes Weight Yes BMI Yes > 5 loss ( ) FBS GHb Yes Cholesterol LDL HDL TG SBP DBP Side effects Notes Funding...

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome HDL

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB l-l3, fixed model l4-26, random model. rho 0.75) Outcome l2 HDL cholesterol Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square l.63 df 4 p Test for overall effect z 3.50 p 0.0005 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours...

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome GHb

Review Pharmacotherapy forweight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB 1-13, fixed model l4-26, random model. rho 0.75) Outcome 06 GHb ControlWeighted Mean Difference (Fixed) Weight Mean(SD) 95 CI ( ) Weighted Mean Difference (Fixed) 95 CI Test for heterogeneity chi-square l38.79 df 6 p Test for overall effect z l0.50 p< 0.0000l -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control Review Pharmacotherapy for weight loss...

Analysis Comparison Drug therapy versus placebo for Sibutramine FT fixed model random model rho Outcome HDL cholesterol

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 23 Drug therapy versus placebo for Sibutramine (FT 1-13, fixed model 14-26, random model. rho 0.75) Outcome 12 HDL cholesterol Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square l.63 df 4 p Test for overall effect z 3.50 p 0.0005 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Random model rho Outcome BMI

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 20 Drug therapy versus placebo for Orlistat (FT+AB l-l3, fixed model 14-26, random model. rho 0.75) Outcome 17 BMI Weighted Mean Difference (Random) Weight Weighted Mean Difference (Random) Total (95 CI) 61 69 Test for heterogeneity chi-square 2.27 df 2 p 0.32 I Test for overalleffect z l.59 p 0.l -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control Review Pharmacotherapy forweight loss in adults with...

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome Total

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB l-l3, fixed model l4-26, random model. rho 0.75) Outcome 10 Total cholesterol ControlWeighted Mean Difference (Fixed) Weight Mean(SD) 95 CI ( ) Weighted Mean Difference (Fixed) 95 CI ControlWeighted Mean Difference (Fixed) Weight Mean(SD) 95 CI ( ) Total (95 CI) 27 Test for heterogeneity chi-square Test for overalleffect z 0.29 p -10.0 -5.0 0 5.0 10.0...

Random model rho Outcome GHb

Review Pharmacotherapy forweight loss in adults with type 2 diabetes mellitus Comparison 23 Drug therapy versus placebo for Sibutramine (FT 1-13, fixed model l4-26, random model. rho 0.75) Outcome 06 GHb ControlWeighted Mean Difference (Fixed) Weight Mean(SD) 95 CI ( ) Weighted Mean Difference (Fixed) 95 CI Test for heterogeneity chi-square l38.79 df 6 p Test for overall effect z l0.50 p< 0.0000l -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control Review Pharmacotherapy for weight loss in...

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome Waist

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB l-l3, fixed model l4-26, random model. rho 0.75) Outcome 18 Waist circumference Treatment Control Weighted Mean Difference (Random) Weight Weighted Mean Difference (Random) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Treatment Control Weighted Mean Difference (Random) Weight Weighted Mean Difference (Random) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Total (95 CI)...

Comparison Drug therapy versus placebo for Fluoxetine FT fixed model random model wks rho

17 0 0 0 0 17 17 0 0 17 0 0 17 17 0 0 17 17 0 0 17 0 17 Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Weighted Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Mean Difference Difference Difference Difference Difference Difference Difference Difference Difference Difference Difference...

Fluoxetine orlistat and sibutramine

Change in weight (kg) and GHb ( ) for full-text studies of fluoxetine, orlistat, and sibutramine are shown in Figure 02 and Figure 03, and the meta-analysis results are presented in Table 13, Table 15, and Table 18. A summary of pooled effects for fluoxetine is found in Table 25, and for orlistat and sibutramine in Table 26. Weight loss ranged from 10.5 kg for sibutramine at 26 weeks follow-up (95 CI, 7.6 - 13.4) (Gokcel 2001) to 1.4 kg for fluoxitine at 8 weeks of follow-up (95 CI, 0.2 to 2.6)...

Participants

Country USA Setting Single, university clinic Number 48 Age 55 Sex I 67 F, C 42 F Medications Insulin BL wt I 106, C 107 BLBMI I 38, C 39.0 BL GHb I 10.5, C 10.2 Kutnowski 1990 Multiple pub Appears to be a different population from Kutnowski 1992 and Daubresse 1996 Kutnowski 1992 Multiple pub Unclear if overlap with Kutnowski 1990 abstract Study design RCT Randomization procedure NR Allocation concealment Unclear Follow-up 8w Study design RCT Randomization procedure NR Allocation concealment...

Types of intervention

Any drug therapy delivered for the primary purpose of losing and or controlling weight was included. Studies that combined pharmacotherapy with other weight loss strategies, including behavioral, educational, lifestyle (diet and exercise), or surgical interventions, were included. Both prescription and over-the-counter medications were included. Drugs that were not approved for weight loss, but which were used for the primary purpose of weight loss were included (i.e., off-label usage of the...

Us Dhhs

Department of Health and Human Services. Cardiac valvulopa-thy associated with exposure to fenfluramine and dexfenfluramine U.S. Department of Health and Human Services Interim Public Health Recommendations. Morbidity and Mortality Weekly Report 1997 46 1061-6. U.S. DHHS 2002 U. S. Department ofHealth and Human Services, CDC, Atlanta GA. National diabetes fact sheet general information and national estimates on diabetes in the United States, 2000. 2002 www.cdc.gov diabetes pubs...

Williamson

Williamson DF, Thompson TJ, Thun M, Flanders D, Pamuk E, Byers T. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care 2000 23 1499-1504. Wing R, Epstein L, Nowalk M, Koeske R, Hagg S. Behavior change, weight loss, and physiological improvements in type II diabetic patients. Journal of Consulting and Clinical Psychology 1985 53(1) 111- Wing RR, Koeske R, Epstein LH, Nowalk MP, Gooding W, Becker D. Long-term effects of modest weight loss in type II...

AbstractsWOS Web of Science

Potentially relevant articles identified from electronic databases and screened for retrieval Articles retrieved for more detailed evaluation. Studies that met inclusion criteria 63 Full text, randomized controlled trials Titles or abstracts excluded as did not fulfill inclusion criteria 7052 Articles excluded as did not fulfill inclusion criteria after review 240 Studies excluded from meta-analysis 32 Lack, of usable data 1 Review Pharmacotherapy forweight loss in adults with type 2 diabetes...

Analysis Comparison Drug therapy versus placebo for Fluoxetine FT fixed model random model wks rho Outcome Percent

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 07 Drug therapy versus placebo for Fluoxetine (FT 1-6, fixed model 7-l2, random model 24-26 wks. rho 0.75) Outcome 08 Percent weight loss ControlWeighted Mean Difference (Random) Weight Mean(SD) 95 CI ( ) Weighted Mean Difference (Random) 95 CI ControlWeighted Mean Difference (Random) Weight Mean(SD) 95 CI ( ) Test for heterogeneity not applicable Test for overall effect z 0.89 p 0.4 -10.0 -5.0 0 5.0 10.0...

Analysis Comparison Drug therapy versus placebo for Fluoxetine FT fixed model random model wks rho Outcome GHb

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 07 Drug therapy versus placebo for Fluoxetine (FT l-6, fixed model 7-l2, random model 24-26 wks. rho 0.75) Outcome 09 GHb Mean Difference (Random) Weight Weighted Mean Difference (Random) Test for heterogeneity chi-square l.58 df 3 p Test for overall effect z 5.09 p< 0.00001 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome DBP

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB l-l3, fixed model l4-26, random model. rho 0.75) Outcome 09 DBP Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square l.79 df 3 p Test for overall effect z 2.05 p 0.04 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Analysis Comparison Drug therapy versus placebo for Orlistat FT fixed model random model rho Outcome Fasting glucose

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison l8 Drug therapy versus placebo for Orlistat (FT l-l3, fixed model 14-26, random model. rho 0.75) Outcome 07 Fasting glucose Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square l3.83 df 7 p Test for overall effect z 7.25 p< 0.0000l -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Analysis Comparison Drug therapy versus placebo for Sibutramine FT fixed model random model rho Outcome with wt loss

Review Pharmacotherapy forweight loss in adults with type 2 diabetes mellitus Comparison 23 Drug therapy versus placebo for Sibutramine (FT 1-13, fixed model 14-26, random model. rho 0.75) Outcome 03 with wt loss > 5 Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square 0.5 df p- -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Analysis Comparison Drug therapy versus placebo for Sibutramine FTAB fixed model random model rho Outcome SBP

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 25 Drug therapy versus placebo for Sibutramine (FT+AB l-l3, fixed model l4-26, random model. rho 0.75) Outcome 08 SBP Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed) 95 CI Finer 2000 Fujioka 2000 Kaukua 2004 McNulty 2003 Redmon 2003 Serrano-Rios 2002 Total (95 CI) -0.20 (3.00) 3.90 (12.60) 4.10 (14.24) -1.50 (14.00) -6.00 (l5.59) -l.l0 (2.48) -0.10 (2.50) 2.40 (14.10) 3.60...

Exclusion criteria

Study populations with binge eating or other eating disorders were excluded from this review. 2. Drugs withdrawn from market in the U.S. were excluded, including fenfluramine, dexfenfluramine, and phenyl-propanolamine. 3. Investigational drugs, defined as those drugs not yet approved for use in the U.S., were excluded (e.g., leptin, beta-2 agonists such as BRL-26830A). 4. Herbal supplements, including ginseng and a number of other herbal supplements that are not regulated by the United States...

Info

Study ID Methods Participants concealment NA Follow- NR BL wt NR BL BMI up Unclear second phase 38.1 BL GHb NR Comparison NA HDL TG Yes SBP Yes 6 Blinding NA DBP Side effects Blinding assessor No BL comparable NA Jadad score NA Risk of bias NA Table G9. Characteristics of included studies Phentermine Medications No insulin BL wt I 85.0, C 84.1 BL BMI NRBLGHb NR LDL HDL TG Yes SBP Yes DBP Yes Side effects Yes 3 pts complained of irritability and insomnia in the first week of RX then subsided...

OMeara

O'Meara S, Glenny A-M, Sheldon T, Melville A, Wilson C. Systematic review of the effectiveness of interventions used in the management of obesity. Journal of Human Nutrition and Dietetics 1998 11 203-6. Padwal 2004 RPadwal, SKLi, DCWLau. Long-term pharmacotherapy for obesity and overweight Long-term pharmacotherapy for obesity and overweight. In The Cochrane Database of Systematic Reviews, Issue 4, 2004. Phelan 2002 Phelan S, Wadden TA. Combining behavioral and pharmacological treatments for...

Random model rho Outcome DBP

Review Pharmacotherapy forweight loss in adults with type 2 diabetes mellitus Comparison 18 Drug therapy versus placebo for Orlistat (FT 1-13, fixed model 14-26, random model. rho 0.75) Outcome 22 DBP Mean Difference (Random) Weight Weighted Mean Difference (Random) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square l7.l4 df Test for overall effect z 2.29 p 0.02 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Random model rho Outcome SBP

Review Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus Comparison 18 Drug therapy versus placebo for Orlistat (FT 1-13, fixed model 14-26, random model. rho-0.75) Outcome 21 SBP Mean Difference (Random) Weight Weighted Mean Difference (Random) N Mean(SD) N Mean(SD) 95 CI ( ) 95 CI Test for heterogeneity chi-square-12.25 df- Test for overall effect z-1.77 p-0.08 -10.0 -5.0 0 5.0 10.0 Favours treatment Favours control

Study Chiasson

Methods Study design RCT Randomization procedure NR Allocation concealment Unclear Follow-up 36w Participants Country Canada Setting NR Number 278 Age 52y Sex NR Medications NR BL wt 100.5 BL BMI 37 Interventions Drug Fluoxetine Dosage 60mg qd Duration 36w Diet Dietary counseling Comparison Placebo Outcomes Weight Yes BMI > 5 loss ( ) FBS Yes GHb Yes Cholesterol LDL HDL TG SBP DBP Side effects Notes Funding NR Abstract full text A LOCF NR ITT NR Attrition NR Blinding Double-blind Blinding...

Corsi Minerva Kolesar

References to studies included in this review Allie EC, Kane MP, Busch RS, Bakst G, Hamilton RA. Orlistat in Obese Patients with Type 2 Diabetes A Retrospective Assessment of Weight Loss and Metabolic Effects. Hospital Pharmacy 2004 39 1 Bach DS, Rissanen AM, Mendel CM, Shepherd G, Weinstein SP, Kelly F, Seaton TB, Patel B, Pekkarinen TA, Armstrong F. Absence of cardiac valve dysfunction in obese patients treated with sibutramine. Obesity Research 1999 7 363-9. Bandisode 1975 published data...

Comparison Drug therapy versus placebo for Fluoxetine FT fixed model random mode wks rho

Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Fixed 95 CI Weighted Mean Difference Random 95 CI Weighted Mean Difference Random 95 CI Weighted Mean Difference Random 95 CI Weighted Mean Difference Random 95 CI Weighted Mean Difference Random 95 CI Weighted Mean Difference Random 95 CI Weighted...