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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.
Ray, KK, Nicholls, SJ, Ginsberg, HD, Johansson, JO, Kalantar-Zadeh, K, Kulikowski, E, Toth, PP, Wong, N, Cummings, JL, Sweeney, M, et al
American heart journal. 2019;:72-83
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Abstract
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.
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High Intensity Resistance Training Methods with and without Protein Supplementation to Fight Cardiometabolic Risk in Middle-Aged Males: A Randomized Controlled Trial.
Kemmler, W, Wittke, A, Bebenek, M, Fröhlich, M, von Stengel, S
BioMed research international. 2016;:9705287
Abstract
Time-effective protocols may potentially increase people's compliance with exercise. The purpose of this paper was to compare the relative effects of 16 weeks of high intensity (resistance) training (HIT) with and without protein supplementation (HIT&P) and HVHIT (high volume/high intensity training) versus a nontraining control group on cardiometabolic risk factors. One hundred and twenty untrained males 30-50 years old were randomly assigned to 3 subgroups: (a) a HIT group; (b) a HIT&P group, and (c) a waiting-control group (phase I) that crossed over to (d) high volume/high intensity training (HVHIT) during the second study phase. HIT was defined as "single set to failure protocol" while HVHIT consistently applied two sets. Protein supplementation provided an overall intake of 1.5 g/kg/body mass. Primary study endpoint was the metabolic syndrome Z-Score (MetS-Z-Score). MetS-Z-Score significantly improved in all exercise groups (p ≤ 0.001) with no significant difference between HIT, HIT&P, and HVHIT (p ≥ 0.829). However, all the exercise groups differed significantly from the CG (p < 0.001) which deteriorated significantly (p = 0.039). In conclusion, all exercise protocols were similarly effective in improving cardiometabolic risk factors. Thus, HIT may be the best choice for people with low time budgets looking to improve their cardiometabolic health.