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Cardiovascular Safety of Testosterone-Replacement Therapy.

Publication ,  Journal Article
Lincoff, AM; Bhasin, S; Flevaris, P; Mitchell, LM; Basaria, S; Boden, WE; Cunningham, GR; Granger, CB; Khera, M; Thompson, IM; Wang, Q; Li, X ...
Published in: N Engl J Med
July 13, 2023

BACKGROUND: The cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism has not been determined. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, noninferiority trial, we enrolled 5246 men 45 to 80 years of age who had preexisting or a high risk of cardiovascular disease and who reported symptoms of hypogonadism and had two fasting testosterone levels of less than 300 ng per deciliter. Patients were randomly assigned to receive daily transdermal 1.62% testosterone gel (dose adjusted to maintain testosterone levels between 350 and 750 ng per deciliter) or placebo gel. The primary cardiovascular safety end point was the first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis. A secondary cardiovascular end point was the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, assessed in a time-to-event analysis. Noninferiority required an upper limit of less than 1.5 for the 95% confidence interval of the hazard ratio among patients receiving at least one dose of testosterone or placebo. RESULTS: The mean (±SD) duration of treatment was 21.7±14.1 months, and the mean follow-up was 33.0±12.1 months. A primary cardiovascular end-point event occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.78 to 1.17; P<0.001 for noninferiority). Similar findings were observed in sensitivity analyses in which data on events were censored at various times after discontinuation of testosterone or placebo. The incidence of secondary end-point events or of each of the events of the composite primary cardiovascular end point appeared to be similar in the two groups. A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group. CONCLUSIONS: In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 13, 2023

Volume

389

Issue

2

Start / End Page

107 / 117

Location

United States

Related Subject Headings

  • Transdermal Patch
  • Testosterone
  • Stroke
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Hypogonadism
  • Humans
  • Hormone Replacement Therapy
  • General & Internal Medicine
 

Citation

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Lincoff, A. M., Bhasin, S., Flevaris, P., Mitchell, L. M., Basaria, S., Boden, W. E., … TRAVERSE Study Investigators, . (2023). Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med, 389(2), 107–117. https://doi.org/10.1056/NEJMoa2215025
Lincoff, A Michael, Shalender Bhasin, Panagiotis Flevaris, Lisa M. Mitchell, Shehzad Basaria, William E. Boden, Glenn R. Cunningham, et al. “Cardiovascular Safety of Testosterone-Replacement Therapy.N Engl J Med 389, no. 2 (July 13, 2023): 107–17. https://doi.org/10.1056/NEJMoa2215025.
Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jul 13;389(2):107–17.
Lincoff, A. Michael, et al. “Cardiovascular Safety of Testosterone-Replacement Therapy.N Engl J Med, vol. 389, no. 2, July 2023, pp. 107–17. Pubmed, doi:10.1056/NEJMoa2215025.
Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson IM, Wang Q, Wolski K, Davey D, Kalahasti V, Khan N, Miller MG, Snabes MC, Chan A, Dubcenco E, Li X, Yi T, Huang B, Pencina KM, Travison TG, Nissen SE, TRAVERSE Study Investigators. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jul 13;389(2):107–117.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 13, 2023

Volume

389

Issue

2

Start / End Page

107 / 117

Location

United States

Related Subject Headings

  • Transdermal Patch
  • Testosterone
  • Stroke
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Hypogonadism
  • Humans
  • Hormone Replacement Therapy
  • General & Internal Medicine