Author, year | Source population, study period | Study design, population, age | Diabetes Type 2 population definition | Study endpoint ascertainment (Number of cases) | Case validation | Exposure assessment | Exposure recency | Exposure Group(s) (n) vs. reference group (n) |
---|---|---|---|---|---|---|---|---|
A: Comparison(s) Contributing to Meta-analysis | ||||||||
B: Other Reported Comparison(s) | ||||||||
Studies included in the meta-analysis (n = 12) | ||||||||
Chou [33] | Taiwan Longitudinal Health Insurance Database 1998-2006 | Cohort N = 7725 < 110 years | ICD-9 code 250.xx in the study period with prescriptions for glitazones | Incident outpatient and emergency department diagnoses of nonfatal HF (ICD-9: 428 and diuretic use) (N = 356) | None | Prevalent and new users Dispensed prescriptions | Current, continuous use of more than 120 days in last 180 days after index date of cohort inclusion | A: Rosiglitazone (n = 6048) vs. pioglitazone (n = 1677); as add-on treatment to other medications |
Graham [34] | Medicare, USA 2006-2009 | Cohort N = 227571 ≥ 65 years | First prescriptions for glitazones | Hospitalization for HF (ICD-9: 402.x1; 404.x3; 428) (N = 3307) | External; PPV: range, 85%-96% | New users Dispensed prescriptions | Current, continuous use including 7 days gap | A: Rosiglitazone (n = 67593) vs. pioglitazone (n = 159978) |
Horsdal [35] | Danish National Registries, Denmark 1996-2004 | Cohort N = 8494 Patients hospitalized for AMI receiving monotherapy with OHA | Subjects were classified as with T1DM and excluded if they were younger than 30 years at the time of their first related prescription or diagnosis and had never received a prescription for an oral glucose-lowering drug. Subjects with T2DM were those with codes for diabetes mellitus who had not received pharmacotherapy, or had received prescriptions for oral glucose-lowering drugs, or were older than 30 years when they had their first diagnostic code or prescription. | Hospital admission for HF (ICD-10: I11.0, I13.0, I13.2, I25.5, I42.0, I42.7, I42.8, I42.9, I50.0, I50.1, I50.9) within 1 year of AMI (N = NR) | None | Prevalent and new users Dispensed prescriptions | At least one prescription of study drug within 90 days before hospitalization | A: Metformin monotherapy (n = 396) vs. SU monotherapy (n = 2382) |
Hsiao [36] | Taiwan Longitudinal Health Insurance Database 2001-2005 | Cohort N = 473483 Age, NR | Subjects with their first ambulatory visit with ICD-9-CM code 250.xx who were prescribed oral blood glucose lowering agents at least three times. Subjects were excluded if they had T1DM (ICD-9-CM codes 250.x1) or if they had been prescribed insulin only during the study period. | Hospitalization for HF (ICD-9: 428, 402.01, 402.11, 402.91; 404) (N = 2530) | None | New users Dispensed prescriptions | Current, continuous use during study period | A: Pioglitazone monotherapy (n = 495) or rosiglitazone monotherapy (n = 2093) vs. metformin-based therapy (n = 46444) and vs. SU-based therapy (n = 97651) B: Pioglitazone + SU + metformin (n = 9510) vs. Rosiglitazone + SU + metformin (n = 39962) Pioglitazone + metformin (n = 774) vs. Rosiglitazone + metformin (n = 2408) Pioglitazone + SU (n = 1231) vs. Rosiglitazone + SU (n = 5141) |
Juurlink [37] | Ontario diabetes database, Canada 2002-2008 | Cohort N = 39736 ≥ 66 years | First prescription for a glitazone. | Hospitalization for HF (ICD-10: I50) (N = 1330) | External; PPV ≈ 90% | New users Dispensed prescriptions | Current use, if refill occurred < 1.5 times the days’ supply of the preceding glitazone claim | A: Pioglitazone (n = 16951) vs. rosiglitazone (n = 22785) |
Karter, [38] | Kaiser Permanente, diabetes registry, USA 1999-2001 | Cohort N = 23440 Age, mean (SD): 58.9 (12.3) years | Diagnosis of T2DM in the Kaiser Permanente Northern California Diabetes Registry, initiation of diabetes treatment, and at least one refill of the initial drug. | Incident; excluded within 5 years prior to baseline outpatient, emergency or hospital discharge diagnoses of CHF Hospitalization for CHF (ICD-9: 428; 401.91, 402.01, 402.11, 402.91; 404.01, 404.03, 404.11, 404.13, 404.93, 425.1, 425.4, 425.5, 425.7) (N = 320) | External, PPV = 97% | New users Dispensed prescriptions | Current, continuous use during study period | A: Pioglitazone (n = 3556) or metformin (n = 11937) vs. SU (n = 5921) as single index therapy but with other maintenance therapy |
Koro [39] | GPRD, United Kingdom 1987-2001 | Nested case–control N = 9089 ≥ 30 years | The cohort follow-up started with the earliest diagnosis of T2DM in the electronic medical record. | First ever diagnosis of CHF according to GPs recorded OXMIS/Read codes (N = 1301) | External | Prevalent and new users Prescriptions issued | Current use in last 3 months before index date (case date or matched date for controls) | A: Metformin (152 cases; 915 controls) or metformin + SU (177 cases, 817 controls) vs. SU (591 cases, 3547 controls) |
Loebstein [40] | Maccabi Healthcare Services, Israel 2000-2007 | Cohort N = 15436 Age, mean (SD): 59.1 (11.4) years | Subjects in the Maccabi diabetes registry with prescriptions for rosiglitazone or metformin for at least 6 months. | Hospitalization for HF (wrong code reported as ICD-9 150) (N = NR) | None | Prevalent and new users Dispensed prescriptions | Current, continuous use within study period with gaps not longer than 3 months | A: Rosiglitazone monotherapy (n = 745) or in combination with metformin (n = 2753) vs. metformin monotherapy (n = 11938) (Formulary restriction for rosiglitazone only if not adequate control after SU, metformin, or both) |
McAlister [41] | Saskatchewan Health beneficiaries, Canada 1991-1996 | Cohort N = 5631 ≥ 30 years | New prescription for an oral blood glucose-lowering drug. The authors describe the study population as subjects with recent onset of diabetes. | Incident during prior 3 years Hospitalization for CHF or physician visit with HF diagnosis (ICD-9: 428) (N = 981) | External | New users Dispensed prescriptions | At least one prescription for an OHA | A: SU (glyburide, chlorpropamide or tolbutamide) monotherapy (n = 4162) vs. metformin monotherapy (n = 1469) |
Tzoulaki, [42] | GPRD, United Kingdom 1990-2005 | Cohort N = 91521 35-90 years | One episode of care associated with a clinical or referral event for diabetes and prescriptions for oral blood glucose-lowering treatment. | First ever diagnosis of CHF according to Read codes (N = 6900) | External; confirmed 83% of the CHF diagnoses | Prevalent and new users Prescriptions issued | Current, continuous intervals of use within the study period | A: First-generation SU monotherapy (n = 6053) or second-generation SU monotherapy (n = 58095) or rosiglitazone monotherapy (n = 8442) and combination therapy (n = 9640) or pioglitazone including monotherapy and combination therapy (n = 3816) vs. metformin (n = 68181) B: Glibenclamide or gliclazide or glimepiride or glipizide or gliquidone vs. metformin (n = 68181) |
Wertz [43] | HealthCore Integrated Research Database, USA 2001-2005 | Cohort N = 36628 ≥ 18 years | First prescription for glitazones. | Hospitalizations for AHF (ED visits included) (ICD-9: 402.01, 402.11, 402.91; 404.01, 404.03, 404.11, 404.13, 404.91, 404.93) (N = 508) | None | New users Dispensed prescriptions | Current use, if refill occurred < 1.5 times the days’ supply of the preceding claim for TZD | A: Rosiglitazone (n = 14469) vs. pioglitazone (n = 14469) |
Winkelmayer [44] | Medicare, New Jersey, USA 1999-2005 | Cohort N = 28361 > 65 years | First prescription for a glitazone, regardless of previous treatment with other diabetes drug. | Hospitalization for CHF (ICD-9: 428) (N = 1259) | External PPV = 94% | New users Dispensed prescriptions | Current, continuous use until 60 days after the supply date of their most recently filled prescription duration or until switching to other TZD | A: Rosiglitazone (n = 14101) vs. pioglitazone (n = 14260) |
Studies reviewed but not included in the meta-analysis (n = 8) | ||||||||
Delea [45] | Pharmetrics integrated outcomes database USA 1997-2001 | Cohort N = 33544 ≥ 18 years | Subjects with one or more claims with ICD-9 codes 250.x0 or 250.x2 and one or more prescriptions for oral blood glucose-lowering drugs (first prescription in the case of glitazones). | First ever inpatient or outpatient claim for CHF (ICD-9-CM: 402.11, 402.91, 428, 428.0, 428.1, 428.9) (N = 423) | None | New users Dispensed prescriptions | Current, continuous use with permitted gaps of 90 days after the last refill | A: NA B: Troglitazone or rosiglitazone or pioglitazone (n = 5441) vs. other OHA or vs. non-TZD noninsulin OHA or vs. no use of TZD (n = 28103) |
Habib [46] | Henry Ford, USA 2000-2006 | Cohort N = 19171 > 18 years | Subjects with one or more claims with ICD-9 code 250.xx and one or more prescriptions for oral blood glucose-lowering drugs. | Hospitalization for CHF (codes not reported) (N = 2725) All-cause mortality | None | Prevalent and new users Dispensed prescriptions | Days’ supply of medication dispensed in a 6-month period divided by the number of days | A: NA B: Rosiglitazone, pioglitazone, or rosiglitazone + pioglitazone(n = 4580) vs. other OHA or vs. nonuse of TZD (n = 14591) |
Hartung, [47] | Medicaid USA 1999-2001 | Case–control N = 1940 ≥ 18 years | Subjects were eligible as cases or controls if they had one or more records with ICD-9 code 250.xx as primary diagnosis and one or more prescriptions for oral blood glucose-lowering drugs. | Hospitalization for HF (DRG 127.xx) (N = 288) (Controls: hospitalizations for other conditions) | None | Prevalent and new users Dispensed prescriptions | Current, at least use of one prescription within 60 days before index hospitalization for cases and controls | A: NA B: TZD (n = 275) vs. nonuse of TZD (n = 1665) B: TZD (n = 275) vs. nonuse of TZD (n = 1665) |
Horsdal [48] | Danish National Registries, Denmark 1996-2004 | Cohort N = 3930 Patients aged ≥ 30 years hospitalized for AMI | At least one prescription for a sulfonylurea in the 90 days before hospitalization for myocardial infarction. | Hospital admission for HF within 1 year of AMI (ICD 10: I11.0, I13.0, I13.2, I25.5, I42.0, I42.6-I42.9, I50.0, I50.1, I50.9) (N = 329) | External | Prevalent and new users Dispensed prescriptions | Use of at least one prescription of study drug within 90 days before the index hospitalization for AMI | A: NA B: Gliclazide (n = 216) or glimepiride (n = 906) or glipizide (n = 616) or glibenclamide (n = 1238) vs. tolbutamide (n = 472) |
Hsiao [49] | Taiwan Longitudinal Health Insurance 2001-2005 | Cohort N = 8139 Patients hospitalized for CHF and prescribed either TZD or SU monotherapy | At least one code for T2DM (ICD-9 code 250.xx [sic]). Subjects were excluded if they had T1DM (mechanism for identification not explained) or if they only had prescriptions for insulin during the study period (description not clear). | Hospital readmission for HF (ICD-9: 428, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.92) (N = 2536) | None | Prevalent and new users Dispensed prescriptions | Cumulative use (DDD) since index hospitalization | A: NA B: TZD (n = 7023) vs. SU (n = 204) |
Lipscombe [50] | Ontario Health Care Database, Canada 2002-2006 | Nested case–control N = 159026 ≥ 66 years | Subjects registered in the Ontario Diabetes Database were followed since their last prescription for an oral hypoglycemic agent. | Hospitalization for CHF or emergency visit (ICD 10: I50) (N = 12491) | External | Prevalent and new users Dispensed prescriptions | Current, use in last 14 days before index date (admission date and corresponding date for matched controls) | A: NA B: Rosiglitazone or pioglitazone monotherapy or combination (n = 1692) vs. other OHA monotherapy or combination (n = 87253) |
Rajagopalan [51] | Pharmetrics integrated outcomes database USA 1999-2002 | Cohort N = 3336 ≥ 18 years | Subjects with one or more claims with ICD-9 code 250.x0 or 250.x2 and/or “evidence of use of antidiabetic medications who began receiving pioglitazone or insulin” during the study period. | First ever, ≥ 1 provider or facility claim with diagnosis of CHF or ≥ 1 inpatient claim with CHF diagnosis (n = NR) | None | New users Dispensed prescriptions | Continuous use for ≥ 90 days of the index therapy | A: NA B: Pioglitazone (n = 1668) vs. insulin as monotherapy or with metformin or SU (n = 1668) |
Toprani [52] | USA Veterans Administration 1999-2004 | Cohort N = 3956 (only males) | Subjects with one more records with ICD-9 code 250.xx and one or more prescriptions for thiazolidinediones. | First ever, at least one inpatient or outpatient visit with a recorded diagnosis of CHF (ICD-9: 428) (N = 1157) | None | Prevalent and new users Dispensed prescriptions | Users of at least 2 OHAs | A: NA B: TZD vs. non-TZD OHAs (n = not provided) |