SUPPORT: Addition of olmesartan to therapy did not improve chronic HF outcomes

CHICAGO — When olmesartan was added to treatment with ACE inhibitors or beta-blockers, researchers reported no improved outcomes in patients with chronic HF and hypertension.

Treatment with all three medications in combination was linked with increased risk for all-cause mortality, adverse cardiac events and renal dysfunction, Yasuhiko Sakata, MD, PhD, said at the American Heart Association Scientific Sessions.

The prospective, open-label, blinded-endpoint SUPPORT trial included 1,147 patients aged 20 to 79 years with chronic HF (NYHA Class II to IV) and a history of hypertension. The patients’ mean age was 66 years, 75% were men and the median left ventricular ejection fraction was 54%. All patients were receiving treatment with ACE inhibitors, beta-blockers or both.

Sakata and colleagues randomly assigned each patient to receive the angiotensin receptor blocker olmesartan titrated up to 40 mg per day on top of their existing treatment regimen (n=574) or to a control group that did not receive olmesartan (n=569).

The primary composite endpoint was all-cause mortality, nonfatal acute MI or stroke, and worsening HF that required hospitalization. Secondary endpoints included death due to CV-related issues or HF, acute MI, stroke, development of renal dysfunction, new-onset diabetes or atrial fibrillation and sudden death. Mean follow-up was 4.4 years.

The primary endpoint was observed in 33.2% of patients assigned the olmesartan regimen vs. 29.2% of controls (HR=1.18; 95% CI, 0.96-1.46). More patients assigned olmesartan developed renal dysfunction (16.8% vs. 10.7%; HR=1.638; 95% CI, 1.189-2.257). Subgroup analysis indicated an association between risk for the primary endpoint and the addition of olmesartan to a combination regimen of ACE inhibitors and beta-blockers (HR=1.47; 95% CI, 1.11-1.95). However, the same risk was not observed with the addition of olmesartan to ACE inhibitors or beta-blockers alone. Risk for all-cause mortality and renal dysfunction was also elevated when all three medications were administered in combination, but not when olmesartan was added to treatment with ACE inhibitors or beta-blockers alone, according to data presented.

“The impact of [angiotensin receptor blockers] on top of ACE inhibitors and/or beta-blockers is still controversial,” Sakata, from the department of cardiovascular medicine at Tohoku University Graduate School of Medicine, Sendai, Japan, said. “We believe that our SUPPORT trial has provided new evidence in this field. … Additive use of olmesartan did not improve clinical outcomes but worsened renal function in hypertensive [chronic HF] patients who had been treated with evidence-based medications. In particular, the triple combination with olmesartan, ACE inhibitors and beta-blockers was associated with increased adverse cardiac events.” – by Adam Taliercio

For more information:

Sakata Y. CS.03: Management of Cardiovascular Disease. American Heart Association Scientific Sessions; Nov. 15-19, 2014; Chicago.

Disclosure: Sakata reports no relevant financial disclosures.