(HealthDay News) – For patients with diabetic nephropathy, combination treatment with an angiotensin-converting enzyme (ACE) inhibitor and angiotensin-receptor blocker (ARB) has little clinical benefit and is associated with an increased risk of adverse events, according to a study published online Nov. 9 in the New England Journal of Medicine. This research was published to coincide with the annual meeting of the American Society of Nephrology (Kidney Week), held from Nov. 5–10 in Atlanta.
Linda F. Fried, MD, MPH, from the Veterans Affairs Pittsburgh Healthcare System and University of Pittsburgh, and colleagues examined the safety and efficacy of losartan in combination with lisinopril for patients with type 2 diabetes, a urinary albumin-to-creatinine ratio of ≥300, and an estimated glomerular filtration rate (GFR) of 30–89.9ml per minute per 1.73m² of body surface area. A total of 1,448 patients received losartan and were then randomized to receive lisinopril or placebo.
Due to safety concerns, the study was stopped early. The researchers found that over a median follow-up of 2.2 years there were 152 primary end point events (first occurrence of change in the estimated GFR, end-stage renal disease, or death) in the monotherapy group and 132 in the combination-therapy group (P=0.3). No benefit was seen in mortality or cardiovascular events. Compared with monotherapy, combination therapy correlated with increased risk of hyperkalemia and acute kidney injury.
“Use of combination therapy with an ACE inhibitor and an ARB in patients with proteinuric diabetic kidney disease does not provide an overall clinical benefit,” the authors write.
The Investigator-Initiated Studies Program of Merck provided the study drugs. Several authors disclosed financial ties to pharmaceutical companies, including Merck.