Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial.
Age Factors
Aged
Aged, 80 and over
Aging
/ drug effects
Cardiovascular Diseases
/ epidemiology
Diabetes Mellitus, Type 2
/ drug therapy
Drug Therapy, Combination
Female
Glucagon-Like Peptides
/ analogs & derivatives
Hospitalization
/ statistics & numerical data
Humans
Hypoglycemia
/ chemically induced
Hypoglycemic Agents
/ administration & dosage
Immunoglobulin Fc Fragments
/ therapeutic use
Male
Middle Aged
Recombinant Fusion Proteins
/ therapeutic use
Severity of Illness Index
Treatment Outcome
cardiovascular
dulaglutide
older
Journal
The Journal of clinical endocrinology and metabolism
ISSN: 1945-7197
Titre abrégé: J Clin Endocrinol Metab
Pays: United States
ID NLM: 0375362
Informations de publication
Date de publication:
23 04 2021
23 04 2021
Historique:
received:
09
11
2020
pubmed:
5
2
2021
medline:
28
9
2021
entrez:
4
2
2021
Statut:
ppublish
Résumé
Dulaglutide reduced major adverse cardiovascular events (MACE) in the Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial. Its efficacy and safety in older vs younger patients have not been explicitly analyzed. This work aimed to assess efficacy and safety of dulaglutide vs placebo in REWIND by age subgroups (≥ 65 and < 65 years). A post hoc subgroup analysis of REWIND was conducted at 371 sites in 24 countries. Participants included type 2 diabetes patients aged 50 years or older with established cardiovascular (CV) disease or multiple CV risk factors, and a wide range of glycemic control. Patients were randomly assigned (1:1) to dulaglutide 1.5 mg or placebo as an add-on to country-specific standard of care. Main outcomes measures included MACE (first occurrence of the composite of nonfatal myocardial infarction, nonfatal stroke, or death from CV or unknown causes). There were 5256 randomly assigned patients who were 65 years or older (mean = 71.0), and 4645 were younger than 65 years (mean = 60.7). Baseline characteristics were similar in randomized treatment groups. Dulaglutide treatment showed a similar reduction in the incidence (11% vs 13%) of MACE in older vs younger patients. The rate of permanent study drug discontinuation, incidence of all-cause mortality, hospitalizations for heart failure, severe hypoglycemia, severe renal or urinary events, and serious gastrointestinal events were similar between randomized treatment groups within each age subgroup. The incidence rate of serious cardiac conduction disorders was numerically higher in the dulaglutide group compared to placebo within each age subgroup but the difference was not statistically significant. Dulaglutide had similar efficacy and safety in REWIND in patients65 years and older and those younger than 65 years.
Identifiants
pubmed: 33537745
pii: 6127538
doi: 10.1210/clinem/dgab065
pmc: PMC8063250
doi:
Substances chimiques
Hypoglycemic Agents
0
Immunoglobulin Fc Fragments
0
Recombinant Fusion Proteins
0
Glucagon-Like Peptides
62340-29-8
dulaglutide
WTT295HSY5
Banques de données
ClinicalTrials.gov
['NCT01394952']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1345-1351Commentaires et corrections
Type : CommentIn
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society.
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