Effect of treatment with losartan on cardiovascular autonomic and large sensory nerve fiber function in individuals with diabetes mellitus: a 1-year randomized, controlled trial.

This study evaluated the effect of losartan, an angiotensin II receptor antagonist, on cardiovascular autonomic function and large sensory nerve fiber function in individuals with diabetes mellitus. In a double-blind placebo-controlled trial, individuals were randomly assigned to treatment with a daily oral dose of 50-mg losartan (n=24) or placebo (n=20) for 12 months. Tests of cardiovascular autonomic function (i.e., RR-variation during deep breathing and the Valsalva maneuver) and of large sensory nerve fiber function (i.e., vibratory thresholds) were measured at baseline and at 12 months. No significant difference at baseline was found for duration of diabetes, glycemic control, blood pressure, or body mass index (BMI) between the two groups. After 12 months, the decline in RR-variation that occurs over time appeared to be less for those taking losartan. There was, however, no statistically significant change in the results for any of the tests of cardiovascular autonomic function or vibratory thresholds between the groups. Multivariate analyses in the losartan study group revealed an independent association of duration of diabetes, change in (reduced) systolic blood pressure (SBP), and improved vibratory thresholds. This association was particularly noted for women. Pharmacologic agents may affect cardiovascular autonomic function by favorable or detrimental changes in the electrophysiology of the heart. The results of this study indicate that, although losartan may have slowed the normal decline in RR-variation, it did not result in any significant improvement in cardiovascular autonomic nerve fiber function. An association of vibratory thresholds and SBP was observed.

RCT Entities:   Population Interventions Outcomes