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International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial.

Publication ,  Journal Article
Harumi Higuchi Dos Santos, M; Sharma, A; Sun, J-L; Pieper, K; McMurray, JJV; Holman, RR; Lopes, RD
Published in: J Am Heart Assoc
January 13, 2017

BACKGROUND: Regional differences in risk of diabetes mellitus and cardiovascular outcomes in people with impaired glucose tolerance are poorly characterized. Our objective was to evaluate regional variation in risk of new-onset diabetes mellitus, cardiovascular outcomes, and treatment effects in participants from the NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) trial. METHODS AND RESULTS: NAVIGATOR randomized people with impaired glucose tolerance and cardiovascular risk factors or with established cardiovascular disease to valsartan (or placebo) and to nateglinide (or placebo) with a median 5-year follow-up. Data from the 9306 participants were categorized by 5 regions: Asia (n=552); Europe (n=4909); Latin America (n=1406); North America (n=2146); and Australia, New Zealand, and South Africa (n=293). Analyzed outcomes included new-onset diabetes mellitus; cardiovascular death; a composite cardiovascular outcome of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; and treatment effects of valsartan and nateglinide. Respective unadjusted 5-year risks for new-onset diabetes mellitus, cardiovascular death, and the composite cardiovascular outcome were 33%, 0.4%, and 4% for Asia; 34%, 2%, and 6% for Europe; 37%, 4%, and 8% for Latin America; 38%, 2%, and 6% for North America; and 32%, 4%, and 8% for Australia, New Zealand, and South Africa. After adjustment, compared with North America, European participants had a lower risk of new-onset diabetes mellitus (hazard ratio 0.86, 95% CI 0.78-0.94; P=0.001), whereas Latin American participants had a higher risk of cardiovascular death (hazard ratio 2.68, 95% CI 1.82-3.96; P<0.0001) and the composite cardiovascular outcome (hazard ratio 1.48, 95% CI 1.15-1.92; P=0.003). No differential interactions between treatment and geographic location were identified. CONCLUSIONS: Major regional differences regarding the risk of new-onset diabetes mellitus and cardiovascular outcomes in NAVIGATOR participants were identified. These differences should be taken into account when planning global trials. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00097786.

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Published In

J Am Heart Assoc

DOI

EISSN

2047-9980

Publication Date

January 13, 2017

Volume

6

Issue

1

Location

England

Related Subject Headings

  • Valsartan
  • Stroke
  • South Africa
  • Risk Factors
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Phenylalanine
  • Outcome Assessment, Health Care
  • North America
  • New Zealand
 

Citation

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Harumi Higuchi Dos Santos, M., Sharma, A., Sun, J.-L., Pieper, K., McMurray, J. J. V., Holman, R. R., & Lopes, R. D. (2017). International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc, 6(1). https://doi.org/10.1161/JAHA.116.003892
Harumi Higuchi Dos Santos, Marilia, Abhinav Sharma, Jie-Lena Sun, Karen Pieper, John J. V. McMurray, Rury R. Holman, and Renato D. Lopes. “International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial.J Am Heart Assoc 6, no. 1 (January 13, 2017). https://doi.org/10.1161/JAHA.116.003892.
Harumi Higuchi Dos Santos M, Sharma A, Sun J-L, Pieper K, McMurray JJV, Holman RR, et al. International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc. 2017 Jan 13;6(1).
Harumi Higuchi Dos Santos, Marilia, et al. “International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial.J Am Heart Assoc, vol. 6, no. 1, Jan. 2017. Pubmed, doi:10.1161/JAHA.116.003892.
Harumi Higuchi Dos Santos M, Sharma A, Sun J-L, Pieper K, McMurray JJV, Holman RR, Lopes RD. International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc. 2017 Jan 13;6(1).
Journal cover image

Published In

J Am Heart Assoc

DOI

EISSN

2047-9980

Publication Date

January 13, 2017

Volume

6

Issue

1

Location

England

Related Subject Headings

  • Valsartan
  • Stroke
  • South Africa
  • Risk Factors
  • Randomized Controlled Trials as Topic
  • Proportional Hazards Models
  • Phenylalanine
  • Outcome Assessment, Health Care
  • North America
  • New Zealand