Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial

Background The SUSTAIN 6 trial demonstrated that once-weekly semaglutide (0.5 and 1.0 mg) significantly reduced major adverse cardiovascular (CV) events (MACE) vs placebo in subjects with type 2 diabetes (T2D) and high CV risk. The effects of gender, age and baseline CV risk on outcomes are importan...

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Veröffentlicht in:	Cardiovascular diabetology Jg. 18; H. 1; S. 73 - 12
Hauptverfasser:	Leiter, Lawrence A., Bain, Stephen C., Hramiak, Irene, Jódar, Esteban, Madsbad, Sten, Gondolf, Theis, Hansen, Thomas, Holst, Ingrid, Lingvay, Ildiko
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	London BioMed Central 06.06.2019 Springer Nature B.V BMC
Schlagworte:	Age Age Factors Aged Angina pectoris Angiology Antidiabetics Baseline cardiovascular risk Blood pressure Body weight Cardiology Cardiovascular disease Cardiovascular diseases Cardiovascular Diseases - diagnosis Cardiovascular Diseases - mortality Cardiovascular Diseases - prevention & control Cardiovascular events Cerebral infarction Cholesterol Clinical medicine Clinical Trials, Phase III as Topic Coronary artery Coronary artery disease Demography Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - diagnosis Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - mortality Drug Administration Schedule Epidermal growth factor receptors Female Gender Gender differences Glucagon Glucagon-like peptide 1 Glucagon-Like Peptides - administration & dosage Glucagon-Like Peptides - adverse effects Health risk assessment Heart attacks Heart diseases Heart failure Heart surgery Hospitalization Humans Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Incretins - administration & dosage Incretins - adverse effects Ischemia Kidney diseases Male Medicine Medicine & Public Health Middle Aged Myocardial infarction Original Investigation Patients Protective Factors Randomized Controlled Trials as Topic Risk Assessment Risk Factors Semaglutide Sex Factors Smoking Stenosis Stroke Systematic review Time Factors Treatment Outcome Type 2 diabetes Type 2 diabetes Cardiovascular events Semaglutide Baseline cardiovascular risk Gender Cardiovascular outcome trial Age SUSTAIN 6
ISSN:	1475-2840, 1475-2840
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Zusammenfassung:	Background The SUSTAIN 6 trial demonstrated that once-weekly semaglutide (0.5 and 1.0 mg) significantly reduced major adverse cardiovascular (CV) events (MACE) vs placebo in subjects with type 2 diabetes (T2D) and high CV risk. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. Methods Subjects were grouped according to gender, age (50–65 years and > 65 years), and CV risk profile at baseline (prior myocardial infarction [MI] or stroke vs no prior MI or stroke, and established CV disease [CVD] vs CV risk factors alone, including subjects with chronic kidney disease). Time to MACE and its individual components (CV death, nonfatal MI, nonfatal stroke), hospitalization for unstable angina or heart failure, and revascularization (coronary and peripheral) were analyzed for all subgroups. Additional analyses were performed for gender and age to investigate change from baseline in HbA 1c and body weight, as well as tolerability. Results A total of 3297 subjects were included. The majority of subjects (60.7%) were male; 43% were > 65 years of age; 41.5% had a history of MI or stroke; and 76.8% had established CVD. Compared with placebo, semaglutide reduced the risk of the first occurrence of MACE and each MACE component consistently across all subgroups (gender, age, and baseline CV risk profile). Revascularizations, HbA 1c and body weight were also reduced consistently across all subgroups compared with placebo. Gastrointestinal adverse events in all treatment groups were more common among women than men, but rates of premature treatment discontinuation were similar for both genders. Conclusions In this post hoc analysis of SUSTAIN 6, once-weekly semaglutide vs placebo reduced the risk of MACE in all subjects included in the trial, regardless of gender, age, or baseline CV risk profile. Trial registry Clinicaltrials.gov, Identifying number: NCT01720446, Date of registration: October 29, 2012
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
ISSN:	1475-2840 1475-2840
DOI:	10.1186/s12933-019-0871-8