Table 16

Observational studies comparing adverse events associated with thiazolidinediones to adverse events associated with active controls

Author, Year (Quality)ComparisonSample sizeData source, Population descriptionMain outcomesMain results
Kahler 2007178
(Fair)
TZD vs. SU monotherapy vs. metformin monotherapy vs. metformin + SU vs. no drugs39 721Veterans Health Administration dataAll-cause mortality (15 months)Adjusted odds ratio (95% CI)
SU (reference): 1.00
TZDs: 1.04 (0.75 to 1.46)
Metformin: 0.87 (0.68 to 1.10)
Metformin + SU: 0.92 (0.82 to 1.05)
No drugs: 0.90 (0.74 to 1.09)
Masoudi 2005181
(Good)
TZDs vs. metformin vs. no insulin sensitizer16 417Medicare

Older patients with heart failure
All-cause mortality (1 year)Adjusted hazard ratio (95% CI)
TZDs: 0.87 (0.80 to 0.94)
Metformin: 0.86 (0.78 to 0.97)
SU: 0.99 (0.91 to 1.08)
Insulin: 0.96 (0.88 to 1.05)
TZD+metformin: 0.76 (0.58 to 0.99)
Johannes 2007
(Good)177
TZDs vs. metformin + SU25 140US health insurance claims dataCoronary heart disease events (myocardial infarction or coronary revascularization)Adjusted hazard ratio (95% CI)
TZDs: 1.02 (0.87 to 1.20)
Metformin+SU
(reference): 1.00
McAfee 2007
(Good)182
Rosiglitazone vs. metformin vs. sulfonylurea26 931US health insurance claims data

Patients with type 2 diabetes
Coronary heart disease events (myocardial infarction or coronary revascularization)Adjusted hazard ratio (95% CI)
Rosiglitazone vs. metformin: 1.07 (0.85 to 1.34)
Rosiglitazone vs. SU: 0.82 (0.67 to 1.02)
Rosiglitazone combined with insulin vs. other oral antidiabetics combined with insulin: 0.88 (0.59 to 1.32)
Rosiglitazone therapy vs. all other non-rosiglitazone therapies: 0.93 (0.80 to 1.10)
Karter 2005
(Fair)179
Pioglitazone vs. SU vs. metformin vs. insulin23 440Kaiser Permanente Northern California Diabetes RegistryHospital admission for heart failure (mean 10.2 months)Adjusted hazard ratio (95% CI)
Pioglitazone: 1.28 (0.85 to 1.92)
Insulin: 1.56 (1.00 to 2.45)
Metformin: 0.70 (0.49 to 0.99)
SU (reference): 1.00
Hartung 2005
(Fair)183
TZDs vs. SU vs. metformin vs. metformin + SU vs. insulin vs. insulin + TZD vs. alpha-glucosidase inhibitor1940Oregon Medicaid Claims dataHospital admission for heart failure (within 60 days)Adjusted odds ratio (95% CI)
TZDs: 1.37 (0.98 to 1.92
SU: 0.95 (0.73 to 1.24)
Metformin: 0.97 (0.72 to 1.30)
Metformin+SU: 0.90 (0.60 to 1.34)
Insulin: 1.25 (0.92 to 1.69)
Insulin+TZDs: 1.35 (0.84 to 2.18)
Alpha-glucosidase inhibitor: 0.82 (0.28 to 2.18)
Koro 2007
(Fair)180
TZDs vs. other antidiabetic agents126 971US Integrated Healthcare Information Services databaseCancer incidenceAdjusted odds ratio (95% CI)
TZDs (mono- or combination therapy) compared with other anti-diabetic agents
Breast cancer: 0.89 (0.68 to 1.15)
Colon cancer: 1.03 (0.84 to 1.32)
Prostate cancer: 1.04 (0.83 to 1.31)
Hanefeld 2006
(Poor)176
Pioglitazone vs. glibenclamide500Primary care sites, Germany Patients with type 2 diabetes insufficiently controlled on metformin aloneProgression to insulinPioglitazone: 55/250 (22%)
Glibenclamide: 138/250 (55%)
P<0.001

Abbreviations: CI, confidence interval; SU, sulfonylurea; TZD, thiazolidinedione.

From: Results

Cover of Drug Class Review: Thiazolidinediones
Drug Class Review: Thiazolidinediones: Final Report Update 1 [Internet].
Norris SL, Carson S, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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