Effect of beta blocker use and type on hypoglycemia risk among hospitalized insulin requiring patients.
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ABSTRACT:
SUBMITTER: Dungan K
PROVIDER: S-EPMC6882013 | biostudies-literature | 2019 Nov
REPOSITORIES: biostudies-literature
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Effect of beta blocker use and type on hypoglycemia risk among hospitalized insulin requiring patients.
Dungan Kathleen K Merrill Jennifer J Long Clarine C Binkley Philip P
Cardiovascular diabetology 20191127 1
<h4>Background</h4>Although beta blockers could increase the risk of hypoglycemia, the difference between subtypes on hypoglycemia and mortality have not been studied. This study sought to determine the relationship between type of beta blocker and incidence of hypoglycemia and mortality in hospitalized patients.<h4>Methods</h4>We retrospectively identified non-critically ill hospitalized insulin requiring patients who were undergoing bedside glucose monitoring and received either carvedilol or ...[more]
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Project description:ImportanceHypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death.ObjectiveTo determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes.Design, setting, and participantsDouble-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period.InterventionsPatients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment sequence.Main outcomes and measuresThe primary end point was the rate of overall severe or blood glucose-confirmed (<56 mg/dL) symptomatic hypoglycemic episodes during the maintenance period. Secondary end points included the rate of nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period. The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted.ResultsOf the 501 patients randomized (mean age, 45.9 years; 53.7% men), 395 (78.8%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001 for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per 100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%).Conclusions and relevanceAmong patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes.Trial registrationclinicaltrials.gov Identifier: NCT02034513.
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Project description:To assess whether beta-blocker use is associated with cardiovascular events and mortality in patients with heart failure with preserved ejection fraction (HFpEF), this study analyzed the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial data using Cox proportional hazard models. Adjusted HRs for composite cardiovascular events in all patients and in patients without previous MI were significantly higher for those on beta-blockers than for those not on beta-blockers (Hazard ratio [HR] for all patients 1.23, 95% confidence interval [95% CI] 1.02-1.49; HR for patients without previous MI 1.35, 95% CI 1.08-1.70), whereas that for patients with previous MI was not significantly different (HR 1.06, 95% CI 0.74-1.54). Additionally, cardiovascular event risk in propensity score-matched patients without previous MI was significantly higher in those on beta-blockers than in those not on beta-blockers. Risks of all-cause death, major cardiovascular events, and heart failure hospitalization were significantly higher in those on beta-blockers than in those not on beta-blockers. Beta-blocker use in HFpEF patients, particularly those without previous MI, was associated with increased risk of unfavorable cardiovascular events.
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