Abstract 12297: Relations between Baseline Physical Activity by Pedometer Counts and Future Cardiovascular Events in the NAVIGATOR Study

Abstract

Few pharmacologic trials of diabetes (DM) or cardiovascular disease (CV) have studied the effects of lifestyle (physical activity, nutrition) on defined clinical events. In NAVIGATOR, 9306 participants with impaired glucose tolerance and either CV or CV risk factors, were randomized, in a double-blind fashion to receive nateglinide, valsartan, both or placebo, in a 2-by-2 factorial design, while all participants were provided with a lifestyle modification program. We report the CV outcomes by baseline daily physical activity as measured by 7-d pedometer [Accusplit] records. Participants were followed for a median of 6.5 years for vital status, with CV outcomes including a composite of death, MI or CVA [DMICVA] or an extended CV outcome [EXTCVD] that included hospitalization for heart failure, revascularization or unstable angina. Mean daily steps (SD) by quartiles were: 1831 (1151), 4652 (659), 7096 (800), and 11240 (2344). By 6.5 years, 639 of 9306 (5.9%) and 1365 of 9306 (13.0%) had experienced DMICVA and EXTCVD events. Every 2,000 average daily steps up to an average of 10,000 daily steps was associated with a reduction of DMICVA by 14.3% (HR 0.857; 0.815-0.902; 95% CI) and EXTCVD 10.3% (HR 0.897; 0.866-0.929) over 6.5 years; (both significant at P<0.001; unadjusted). The observations were very similar and equally significant in an analysis adjusted for age, gender and region of origin, or when adjustment for all of the parameters in the baseline study model, including major conventional cardiovascular risk parameters, where employed. The Kaplan-Meier Curve for the DMICVA outcome by lowest quarter to highest quarter of pedometer steps (unadjusted analysis) is shown. Thus, increased pedometer steps at baseline were related to a reduced risk of DMICVA events outcomes in individuals with cardiometabolic risk, and it was associated with 46% lower risk of DMICVA events in the highest physical activity level (>8600 steps/d) compared to the lowest (<3500 steps/d).