But a large portion of the meeting was spent discussing whether patients in the trial were on optimal ACE inhibitor doses and whether the same benefits might have been achieved by increasing the dose of the ACE inhibitor.
What was missing in the study was a protocol-driven effort to ensure that investigators pushed ACE inhibitor doses to the best level possible, according to the agency.
Generic captopril is cheapest ACE inhibitor.
enalapril Available in generic and trade formulations.
Clinicians should add candesartan to the medical regimen in nonallergic CHF patients with an ejection fraction of 40% or lower who are already on an optimal dose of an ACE inhibitor.
The approval of the angiotensin receptor blocker (ARB)--to reduce cardiovascular death and heart failure hospitalizations in patients with heart failure (NYHA II-IV and an ejection fraction of 40% or less)--now includes this statement: "Atacand also has an added effect on these outcomes when used with an ACE inhibitor.
" The first ARB approved for use with an ACE inhibitor for treating heart failure.
The Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM)-Added trial involved 2,548 patients with symptomatic CHF and a left ventricular ejection fraction of 40% or less who were being treated with an ACE inhibitor.
They were randomized to a target dose of 32 mg once daffy of candesartan or placebo and followed for a median of 41 months.
There were no identifiable patient subgroups that benefited from the ACE inhibitor.
CHARM-Added was for patients with an ejection fraction of 40% or less who were on an ACE inhibitor.
CHARM-Preserved enrolled patients with CHF who had an ejection fraction greater than 40%, a common condition often called diastolic dysfunction.
The purpose of the panel meeting, the FDA agenda stated, was to assess "whether CHARM-Added provides compelling evidence that candesartan should, under some circumstances, be recommended for use in patients on an ACE inhibitor.