Comparative effectiveness of canagliflozin, SGLT2 inhibitors and non‐SGLT2 inhibitors on the risk of hospitalization for heart failure and amputation in patients with type 2 diabetes mellitus: A real‐world meta‐analysis of 4 observational databases (OBSERVE‐4D)

Autor: Frank J. DeFalco, Martijn J. Schuemie, John B. Buse, Paul E. Stang, Zhong Yuan, Patrick B. Ryan, Norman Rosenthal, Jesse A. Berlin
Rok vydání: 2018
Předmět:
Adult
Male
medicine.medical_specialty
Adolescent
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
030209 endocrinology & metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
Amputation
Surgical
Young Adult
03 medical and health sciences
0302 clinical medicine
Endocrinology
Risk Factors
Internal medicine
Diabetes mellitus
Internal Medicine
medicine
Humans
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Aged
Retrospective Studies
Aged
80 and over
Heart Failure
business.industry
Type 2 Diabetes Mellitus
Middle Aged
medicine.disease
Diabetic Foot
3. Good health
Hospitalization
Observational Studies as Topic
Treatment Outcome
Databases as Topic
Diabetes Mellitus
Type 2
Amputation
Meta-analysis
Heart failure
Female
Observational study
business
Diabetic Angiopathies
medicine.drug
Zdroj: Diabetes, Obesity and Metabolism. 20:2585-2597
ISSN: 1463-1326
1462-8902
Popis: Sodium glucose co-transporter 2 inhibitors (SGLT2i) are indicated for treatment of type 2 diabetes mellitus (T2DM); some SGLT2i have reported cardiovascular benefit, and some have reported risk of below-knee lower extremity (BKLE) amputation. This study examined the real-world comparative effectiveness within the SGLT2i class and compared with non-SGLT2i antihyperglycaemic agents.Data from 4 large US administrative claims databases were used to characterize risk and provide population-level estimates of canagliflozin's effects on hospitalization for heart failure (HHF) and BKLE amputation vs other SGLT2i and non-SGLT2i in T2DM patients. Comparative analyses using a propensity score-adjusted new-user cohort design examined relative hazards of outcomes across all new users and a subpopulation with established cardiovascular disease.Across the 4 databases (142 800 new users of canagliflozin, 110 897 new users of other SGLT2i, 460 885 new users of non-SGLT2i), the meta-analytic hazard ratio estimate for HHF with canagliflozin vs non-SGLT2i was 0.39 (95% CI, 0.26-0.60) in the on-treatment analysis. The estimate for BKLE amputation with canagliflozin vs non-SGLT2i was 0.75 (95% CI, 0.40-1.41) in the on-treatment analysis and 1.01 (95% CI, 0.93-1.10) in the intent-to-treat analysis. Effects in the subpopulation with established cardiovascular disease were similar for both outcomes. No consistent differences were observed between canagliflozin and other SGLT2i.In this large comprehensive analysis, canagliflozin and other SGLT2i demonstrated HHF benefits consistent with clinical trial data, but showed no increased risk of BKLE amputation vs non-SGLT2i. HHF and BKLE amputation results were similar in the subpopulation with established cardiovascular disease. This study helps further characterize the potential benefits and harms of SGLT2i in routine clinical practice to complement evidence from clinical trials and prior observational studies.
Databáze: OpenAIRE
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