Background: Glucagon-like peptide 1 agonists differ in chemical structure, duration of action and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. Methods: We randomly assigned patients with type 2 diabetes and cardiovascular disease to the addition of once-weekly subcutaneous injection of albiglutide (30 mg to 50 mg) or matching placebo to standard care. We hypothesized that albiglutide would be noninferior to placebo for the primary outcome of first occurrence of cardiovascular death, myocardial infarction, or stroke. If noninferiority was confirmed by an upper limit of the 95% confidence interval for the hazard ratio of less than 1.30, closed-testing for superiority was prespecified. Findings: Overall, 9463 participants were followed for a median of 1.6 years. The primary composite outcome occurred in 338 of 4731 patients (7.1%; 4.6 events per 100 person-years) in the albiglutide group and in 428 of 4732 patients (9.0%; 5.9 events per 100 person-years) in the placebo group (hazard ratio, 0.78; 95% confidence interval [CI ], 0.68 to 0.90), indicating that albiglutide, was superior to placebo (P<0.0001 for noninferiority, P=0.0006 for superiority). The incidence of acute pancreatitis (albiglutide 10 patients and placebo 7 patients), pancreatic cancer (6 and 5), medullary thyroid carcinoma (0 and 0), and other serious adverse events did not differ significantly between the two groups. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. (Funded by GlaxoSmithKline; Harmony Outcomes ClinicalTrials.gov number, NCT02465515.) noninferiority; P = 0.06 for superiority). There seems to be variation in the results of existing trials with GLP-1 receptor agonists, which if correct, might reflect drug structure or duration of action, patients studied, duration of follow-up or other factors.

Objective To compare outcomes in older individuals receiving drug-eluting (DES) and bare metal stents (BMS). Background Comparative effectiveness of DES relative to BMS remains unclear. Methods Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004-2006 using procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke, were compared using estimated cumulative incidence rates with inverse probability weighted estimators and Cox proportional hazards ratios. Results DES were implanted in 217,675 patients and BMS in 45,025. At 30-months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 vs. 10.0/100 pts) and revascularization (23.0 vs. 24.5/100 pts) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, HR=0.75, (95% CI: 0.72 ,0.79), p<0.001) and MI (7.5 vs. 8.9/100 pts, HR=0.77, (95% CI: 0.72,0.81), p<0.001), with minimal difference in revascularization (23.5 vs. 23.4/100 pts; HR=0.91, (95% CI: 0.87,0.96), stroke (3.1 vs. 2.7/100 pts, HR=0.97, (95% CI: 0.88,1.07) or bleeding (3.4 vs. 3.6/100 pts, HR=0.91, (95% CI: 0.84,1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30-months’ follow-up. Conclusion In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months’ follow-up and across all prespecified subgroups.

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