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Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes.
Conclusions: EXSCEL-observed HRs for MACE and ACM remained robust after right censoring or application of literature-derived risk reductions, but the exenatide versus placebo MACE effect size and statistical significance were increased by IPTW. Effects of open-label drop-in cardioprotective medications need to be considered carefully when designing, conducting, and analyzing cardiovascular outcome trials of glucose-lowering agents under the premise of glycemic equipoise. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01144338. PMID: 32098501 [PubMed - as supplied by publisher]
Source: Circulation - February 25, 2020 Category: Cardiology Authors: Bethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Öhman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR Tags: Circulation Source Type: research

Metformin Use and Clinical Outcomes among Patients with Diabetes with or without Heart Failure or Kidney Dysfunction: Observations from the SAVOR-TIMI 53 Trial.
CONCLUSIONS: In a cohort of 12,156 patients with T2DM and high CV risk, metformin use was associated with lower rates of all-cause mortality, including after adjustment for clinical variables and biomarkers, but not lower rates of the composite endpoint of CV death, MI, or ischemic stroke. This association was most apparent in patients without prior HF or moderate to severe CKD. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov Unique Identifier: NCT01107886. PMID: 31362530 [PubMed - as supplied by publisher]
Source: Circulation - July 30, 2019 Category: Cardiology Authors: Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM, SAVOR-TIMI 53 Steering Committee and Investigators Tags: Circulation Source Type: research