Left Ventricular Remodeling Reduced with Olmesartan in ROADMAP

Summary

A prespecified analysis of left ventricular hypertrophy (LVH) as evaluated by electrocardiography from the Olmesartan Medoxomil in Diabetes Mellitus study [ROADMAP] showed that olmesartan significantly reduced LV remodeling in patients with type 2 diabetes mellitus, independent of blood pressure, age, and sex.

  • Hypertensive Disease
  • Diabetes & Endocrinology Clinical Trials
  • Diabetes Mellitus
  • Hypertensive Disease
  • Diabetes & Endocrinology Clinical Trials
  • Endocrinology
  • Diabetes & Metabolic Syndrome
  • Diabetes Mellitus

A prespecified analysis of left ventricular hypertrophy (LVH) as evaluated by electrocardiography (ECG) from the Olmesartan Medoxomil in Diabetes Mellitus study [ROADMAP] showed that olmesartan significantly reduced LV remodeling in patients with type 2 diabetes mellitus (T2DM), independent of blood pressure (BP), age, and sex, according to Roland E. Schmieder, MD, University of Erlangen-Nurnberg, Erlangen, Germany.

The ROADMAP study showed the angiotensin receptor blocker olmesartan 40 mg compared with placebo reduced clinic BP more (by 3.1/1.9 mm Hg), and fewer patients developed microalbuminuria (8.2% and 9.8% respectively) [Haller H et al. N Engl J Med 2011]. Time to onset of microalbuminuria increased by 23% with olmesartan (95% CI, 0.63 to 0.94; p=0.01). Nonfatal cardiovascular (CV) events were reduced with olmesartan, but fatal CV events were higher with the drug (15 vs 3 with placebo; p=0.01), explained by more CV deaths in patients with coronary heart disease in the olmesartan group (11 vs 2 with placebo; p=0.02).

In the present analysis, 1513 patients (777 taking olmesartan, 736 placebo) had interpretable ECGs at baseline and at the last assessment. A significant reduction in the prevalence of Cornell voltage QRS duration product, the primary ECG parameter of LV remodeling and hypertrophy, was found in olmesartan-treated patients with a BP <130/80 mm Hg (RR, 39.2%; p=0.0081) and >130/80 mm Hg (RR, 45.6%; p=0.0406).

The reduction in Cornell voltage QRS duration product was independent of age. The risk reduction was 37.9% (p=0.0347) for patients aged >58 years, and 42.3% for patients ≤58 years (p=0.0121). The reduction was also independent of sex, with the risk reduction in men 46.5% (p=0.0448) and 36.3% in women (p=0.0136).

The significant reduction in LV remodeling in these patients with T2DM was most striking in patients with a longer duration of diabetes, taking antidiabetic medication at baseline, who were obese, and had an HbA1C level that was elevated at baseline or increased during the study. These reductions are summarized in Table 1.

Table 1.

Reduction in Left Ventricular Remodeling With Olmesartan by Patient Characteristic

Cardiac structural adaptation, known to develop early in patients with hypertension and diabetes, was delayed by olmesartan, compared with placebo, as measured by LV remodeling on ECG.

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