NIH Study Finds Lisinopril, Telmisartan Combination Not Effective In Kidney Disease

To slow the progression of autosomal dominant polycystic kidney disease (ADPKD), a combination of two drugs is not more effective than a single drug, according to a new National Institutes of Health (NIH) study. The NIH announced the results in a press release, stating that another NIH study found that treating blood pressure aggressively did slow the growth of kidney cysts but did not improve kidney function. Results from the two studies in the Halt Progression of Polycystic Kidney Disease (HALT-PKD) Clinical Trials are published in the New England Journal of Medicine (NEJM), November 15 online issue. Investigators will also present the results at the American Society of Nephrology annual meeting.

Study author Michael Flessner, M.D., Ph.D., NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, said, “The HALT-PKD findings show that people with polycystic kidney disease do not need to take both of the drugs studied to slow their rate of kidney cyst growth and decline in kidney function.”

HALT-PKD Trial

The HALT-PKD trial results were reported in a paper titled, “Angiotensin Blockade in Late Autosomal Dominant Polycystic Kidney Disease.” Investigators began the trial with the premise that ADPKD is characterized by the progressive development of kidney cysts and hypertension. While ACE inhibitors are first-line agents to treat hypertension in patients with ADPKD, their superiority over other antihypertensive agents is not proven in clinical trials. The investigators therefore designed a trial to test lisinopril and telmisartan, both FDA-approved drugs. They wanted to know if using the two drugs in combination would shrink kidney cysts and slow the progression of ADPKD.

The placebo-controlled clinical trial assessed the combination of lisinopril (an ACE inhibitor) and telmisartan (an ARB) compared to lisinopril and a placebo. Patients were enrolled from 2006 to 2009 and assigned to either treatment group; 244 patients were assigned to the lisinopril/telmisartan group and 242 people were assigned to the lisinopril/placebo group.

Investigators found no significant differences in the groups in time to death. Both groups experienced the same rate of hospitalizations over the years. No differences were detected in the secondary outcome measures, including symptoms, quality of life, and incidence of pain. In conclusion, study authors state that monotherapy with an ACE inhibitor is sufficient and the addition of an ARB did not confer an additional benefit.