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Similar cardiovascular outcomes in patients with diabetes and established or high risk for coronary vascular disease treated with dulaglutide with and without baseline metformin
G. Ferrannini, H. Gerstein, HM. Colhoun, GR. Dagenais, R. Diaz, L. Dyal, M. Lakshmanan, L. Mellbin, J. Probstfield, MC. Riddle, JE. Shaw, A. Avezum, JN. Basile, WC. Cushman, P. Jansky, M. Keltai, F. Lanas, LA. Leiter, P. Lopez-Jaramillo, P. Pais,...
Language English Country Great Britain
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 1996 to 1 year ago
Open Access Digital Library
from 1996-01-01
- MeSH
- Diabetes Mellitus, Type 2 * complications drug therapy epidemiology MeSH
- Glucagon-Like Peptides analogs & derivatives MeSH
- Hypoglycemic Agents therapeutic use MeSH
- Immunoglobulin Fc Fragments MeSH
- Cardiovascular Diseases * epidemiology prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Metformin * therapeutic use MeSH
- Vascular Diseases * MeSH
- Glucagon-Like Peptide-1 Receptor MeSH
- Recombinant Fusion Proteins MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
OBJECTIVE: Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial. RESEARCH DESIGN AND METHODS: Patients in REWIND (n = 9901; women: 46.3%; mean age: 66.2 years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69%). They were randomized (1:1) to sc. dulaglutide (1.5 mg/weekly) or placebo in addition to standard of care. The primary outcome was the first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes. Key secondary outcomes included a microvascular composite endpoint, all-cause death, and heart failure. The effect of dulaglutide in patients with and without baseline metformin was evaluated by a Cox regression hazard model with baseline metformin, dulaglutide assignment, and their interaction as independent variables. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by a Cox regression model with adjustments for factors differing at baseline between people with vs. without metformin, identified using the backward selection. RESULTS: Compared to patients with metformin at baseline (n = 8037; 81%), those without metformin (n = 1864; 19%) were older and slightly less obese and had higher proportions of women, prior CV events, heart failure, and renal disease. The primary outcome occurred in 976 (12%) participants with baseline metformin and in 281 (15%) without. There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81-1.05) vs. 0.78 (CI 0.61-0.99); interaction P = 0.18]. Findings for key secondary outcomes were similar in patients with and without baseline metformin. CONCLUSION: This analysis suggests that the cardioprotective effect of dulaglutide is unaffected by the baseline use of metformin therapy.
Baker Heart and Diabetes Institute 75 Commercial Rd Melbourne VIC 3004 Australia
Department of Medicine K2 Karolinska Institutet Solnavägen 1 Stockholm SE171 77 Sweden
Department of Medicine University of Cape Town Observatory Cape Town 7925 South Africa
Division of Cardiology Medical University of South Carolina 171 Ashley Ave Charleston SC 29425 USA
Eli Lilly and Company 893 Delaware St Indianapolis IN 46225 USA
Institute of Genetics and Molecular Medicine University of Edinburgh Crewe Road Edinburgh EH4 2XU UK
References provided by Crossref.org
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- $a Similar cardiovascular outcomes in patients with diabetes and established or high risk for coronary vascular disease treated with dulaglutide with and without baseline metformin / $c G. Ferrannini, H. Gerstein, HM. Colhoun, GR. Dagenais, R. Diaz, L. Dyal, M. Lakshmanan, L. Mellbin, J. Probstfield, MC. Riddle, JE. Shaw, A. Avezum, JN. Basile, WC. Cushman, P. Jansky, M. Keltai, F. Lanas, LA. Leiter, P. Lopez-Jaramillo, P. Pais, V. Pīrāgs, N. Pogosova, PJ. Raubenheimer, WH. Sheu, L. Rydén
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- $a OBJECTIVE: Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial. RESEARCH DESIGN AND METHODS: Patients in REWIND (n = 9901; women: 46.3%; mean age: 66.2 years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69%). They were randomized (1:1) to sc. dulaglutide (1.5 mg/weekly) or placebo in addition to standard of care. The primary outcome was the first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes. Key secondary outcomes included a microvascular composite endpoint, all-cause death, and heart failure. The effect of dulaglutide in patients with and without baseline metformin was evaluated by a Cox regression hazard model with baseline metformin, dulaglutide assignment, and their interaction as independent variables. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by a Cox regression model with adjustments for factors differing at baseline between people with vs. without metformin, identified using the backward selection. RESULTS: Compared to patients with metformin at baseline (n = 8037; 81%), those without metformin (n = 1864; 19%) were older and slightly less obese and had higher proportions of women, prior CV events, heart failure, and renal disease. The primary outcome occurred in 976 (12%) participants with baseline metformin and in 281 (15%) without. There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81-1.05) vs. 0.78 (CI 0.61-0.99); interaction P = 0.18]. Findings for key secondary outcomes were similar in patients with and without baseline metformin. CONCLUSION: This analysis suggests that the cardioprotective effect of dulaglutide is unaffected by the baseline use of metformin therapy.
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