International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial.
<h4>Background</h4> <p>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...
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| Format: | Journal article |
| Language: | English |
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American Heart Association
2017
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| _version_ | 1826305252844896256 |
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| author | Dos Santos, M Sharma, A Sun, J Pieper, K McMurray, J Holman, R Lopes, R |
| author_facet | Dos Santos, M Sharma, A Sun, J Pieper, K McMurray, J Holman, R Lopes, R |
| author_sort | Dos Santos, M |
| collection | OXFORD |
| description | <h4>Background</h4> <p>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.</p> <h4>Methods and Results</h4> <p>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.</p> <h4>Conclusions</h4> <p>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.</p> |
| first_indexed | 2024-03-07T06:30:06Z |
| format | Journal article |
| id | oxford-uuid:f5b28db6-aae3-47cd-8bb8-f6ac45f9a6d4 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T06:30:06Z |
| publishDate | 2017 |
| publisher | American Heart Association |
| record_format | dspace |
| spelling | oxford-uuid:f5b28db6-aae3-47cd-8bb8-f6ac45f9a6d42022-03-27T12:29:10ZInternational variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:f5b28db6-aae3-47cd-8bb8-f6ac45f9a6d4EnglishSymplectic Elements at OxfordAmerican Heart Association2017Dos Santos, MSharma, ASun, JPieper, KMcMurray, JHolman, RLopes, R <h4>Background</h4> <p>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.</p> <h4>Methods and Results</h4> <p>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.</p> <h4>Conclusions</h4> <p>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.</p> |
| spellingShingle | Dos Santos, M Sharma, A Sun, J Pieper, K McMurray, J Holman, R Lopes, R International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title | International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title_full | International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title_fullStr | International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title_full_unstemmed | International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title_short | International variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the NAVIGATOR Trial. |
| title_sort | international variation in outcomes among people with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance insights from the navigator trial |
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