January 22, 2001Archives of Internal Medicine
Toleration of High Doses of Angiotensin-Converting Enzyme Inhibitors in Patients With Chronic Heart Failure
Key result
High-dose lisinopril was well tolerated in patients with chronic heart failure, with withdrawal rates of 27.1% compared to 30.7% in the low-dose group.
Why the study?
Does high-dose lisinopril compared with low-dose lisinopril increase adverse events or discontinuations in patients with chronic heart failure?
Population
3,164 patients with New York Heart Association classes II to IV chronic heart failure and left ventricular…
Comparison
High-dose lisinopril (35.0 or 32.5 mg once daily) vs Low-dose lisinopril (5.0 or 2.5 mg once daily)
Design
RCT, randomized, double-blind
Follow-up
median of 46 months
Authors
Discussion
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Implication
Supports aggressive ACE inhibitor up-titration in chronic heart failure; challenges prior tolerability concerns at target doses.
Study Design
Type
RCT (n=3,164)
Blinding
Double-blind
Multicenter
Yes
Structured PICO
Does high-dose lisinopril compared with low-dose lisinopril increase adverse events or discontinuations in patients with chronic heart failure?
P
Population
3,164 patients with New York Heart Association classes II to IV chronic heart failure and left ventricular ejection fractions of no greater than 0.30
I
Intervention
High-dose lisinopril (35.0 or 32.5 mg once daily)
C
Comparator
Low-dose lisinopril (5.0 or 2.5 mg once daily)
O
Outcome
Occurrence of adverse events and the need for discontinuation and dose reduction during treatment, with a focus on hypotension and renal dysfunctionsafety
Main Result
Absolute Event Rate: 27.1% vs 30.7%
High-dose ACE inhibitor therapy is well tolerated in most patients with chronic heart failure, supporting more aggressive up-titration to target doses.
Cite This Study
Massie et al. (2001) conducted an RCT in Chronic heart failure (n=3,164). High-dose lisinopril vs. Low-dose lisinopril (5.0 or 2.5 mg once daily) was evaluated on Withdrawals. High-dose lisinopril was well tolerated in patients with chronic heart failure, with withdrawal rates of 27.1% compared to 30.7% in the low-dose group.