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Read the article and then respond to the following prompts in a word document.Comment on the reliability and sample methods used in the article.Were the sampling methods appropriate for the populations they were trying to assess?Was reliability and validity addressed?If reliability and validity were not expressly addressed, do you believe their study had good reliability and validity? Be sure to address different kinds of validity and reliability.
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O R I G I N A L A RT I C L E
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
Steven P. Marso, M.D., Gilbert H. Daniels, M.D., Kirstine Brown-Frandsen, M.D., Peter Kristensen, M.D.,
E.M.B.A., Johannes F.E. Mann, M.D., Michael A. Nauck, M.D., Steven E. Nissen, M.D., Stuart Pocock, Ph.D.,
Neil R. Poulter, F.Med.Sci., Lasse S. Ravn, M.D., Ph.D., William M. Steinberg, M.D., Mette Stockner, M.D.,
Bernard Zinman, M.D., Richard M. Bergenstal, M.D., and John B. Buse, M.D., Ph.D.et al., for the LEADER
Steering Committee on behalf of the LEADER Trial Investigators*
July 28, 2016
N Engl J Med 2016; 375:311-322
DOI: 10.1056/NEJMoa1603827
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Abstract
B A C KG R O U N D
The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in
patients with type 2 diabetes, remains unknown.
METHODS
In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to
receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first
occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary
hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a
margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for
multiplicity were performed for the prespecified exploratory outcomes.
R E S U LT S
A total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome
occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the
placebo group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97; P
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