Outcome survey in unselected hypertensive patients with type 2 diabetes mellitus: effects of ace inhibition

Although the benefit of angiotensin converting enzyme (ACE) inhibitors in diabetic nephropathy is well documented in double-blind randomized, controlled clinical trials, it is uncertain whether the benefit extends to unselected patients with diabetes mellitus and arterial hypertension in general practice. In 2504 unselected patients with type 2 diabetes mellitus (mean age 63 ± 10 years) blood pressure, cardiovascular, renal, and metabolic parameters were assessed at baseline and during a treatment period of 1 year with the ACE inhibitor cilazapril by primary care physicians. The average dose of cilazapril was 2.5 mg/day. Outcome measures were blood pressure, serum creatinine, proteinuria (dip stick), HbA1c levels, evaluation of edema, and exertional dyspnea. In the study cohort, systolic blood pressure decreased by 24 ± 17 mm Hg and diastolic blood pressure by 12 ± 11 mm Hg. An increase in serum creatinine (> 0.2 mg/dL) occurred more frequently in patients with than in those without renal involvement (19% v 7%; P< .05). Serum creatinine decreased more frequently in patients with renal involvement than in those without (26% ± 4% v 12% ± 3.8%; P< .05). Overall renal function in patients with diabetic nephropathy (n = 318) improved (2.1 ± 1.6 mg/dL v 1.7 ± 1.4 mg/dL; P< .05). The frequency of proteinuria was lower after 1 year than at baseline (62% ± 9% v 82% ± 8%; P< .05). Metabolic control of diabetes mellitus improved in parallel (median HbA1c 8.0% v 7.0%; P< .01). Scores for edema formation and exertional dyspnea improved as well (P< .01). In this outcome survey of unselected patients with type 2 diabetes mellitus and arterial hypertension, the ACE inhibitor cilazapril effectively lowered blood pressure, which was associated with an improvement in glucose metabolism, cardiac function, and renal function.