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Effect of selective BET protein inhibitor apabetalone on cardiovascular outcomes in patients with acute coronary syndrome and diabetes: Rationale, design, and baseline characteristics of the BETonMACE trial
- Source :
- American Heart Journal. 217:72-83
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- Background After an acute coronary syndrome (ACS), patients with diabetes remain at high risk for additional cardiovascular events despite use of current therapies. Bromodomain and extra-terminal (BET) proteins are epigenetic modulators of inflammation, thrombogenesis, and lipoprotein metabolism implicated in atherothrombosis. The BETonMACE trial tests the hypothesis that treatment with apabetalone, a selective BET protein inhibitor, will improve cardiovascular outcomes in patients with diabetes after an ACS. Design Patients (n = 2425) with ACS in the preceding 7 to 90 days, with type 2 diabetes and low HDL cholesterol (≤40 mg/dl for men, ≤45 mg/dl for women), receiving intensive or maximum-tolerated therapy with atorvastatin or rosuvastatin, were assigned in double-blind fashion to receive apabetalone 100 mg orally twice daily or matching placebo. Baseline characteristics include female sex (25%), myocardial infarction as index ACS event (74%), coronary revascularization for index ACS (80%), treatment with dual anti-platelet therapy (87%) and renin-angiotensin system inhibitors (91%), median LDL cholesterol 65 mg per deciliter, and median HbA1c 7.3%. The primary efficacy measure is time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or stroke. Assumptions include a primary event rate of 7% per annum in the placebo group and median follow-up of 1.5 years. Patients will be followed until at least 250 primary endpoint events have occurred, providing 80% power to detect a 30% reduction in the primary endpoint with apabetalone. Summary BETonMACE will determine whether the addition of the selective BET protein inhibitor apabetalone to contemporary standard of care for ACS reduces cardiovascular morbidity and mortality in patients with type 2 diabetes. Results are expected in 2019.
- Subjects :
- Male
Acute coronary syndrome
medicine.medical_specialty
medicine.medical_treatment
Atorvastatin
Myocardial Infarction
Type 2 diabetes
030204 cardiovascular system & hematology
Drug Administration Schedule
1117 Public Health and Health Services
Renin-Angiotensin System
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Double-Blind Method
Internal medicine
Diabetes mellitus
medicine
Clinical endpoint
Humans
Rosuvastatin
030212 general & internal medicine
Myocardial infarction
Acute Coronary Syndrome
Renal Insufficiency, Chronic
Rosuvastatin Calcium
1102 Cardiorespiratory Medicine and Haematology
Aged
Quinazolinones
business.industry
Cholesterol, HDL
Proteins
Percutaneous coronary intervention
Cholesterol, LDL
medicine.disease
Stroke
Treatment Outcome
Diabetes Mellitus, Type 2
Cardiovascular System & Hematology
Female
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiology and Cardiovascular Medicine
business
Diabetic Angiopathies
Platelet Aggregation Inhibitors
medicine.drug
Subjects
Details
- ISSN :
- 00028703
- Volume :
- 217
- Database :
- OpenAIRE
- Journal :
- American Heart Journal
- Accession number :
- edsair.doi.dedup.....9cd5056ad11317bbf05de93a9e53aebd