FOLLOW
UP STUDY OF PATIENTS RANDOMLY ALLOCATED RAMIPRIL OR PLACEBO FOR HEART FAILURE AFTER ACUTE
MYOCARDIAL INFARCTION: AIRE Extension (AIREX) Study.
The original acute infarction
ramipril efficacy (AIRE) study (1993) reported a 6% reduction in mortality after 15 months
in patients with clinical heart failure (HF) after acute myocardial infarction when the
angiotensin converting enzyme (ACE) inhibitor ramipril [Altace] was compared with placebo.
This
follow-up study reports results after 5 years.
Conclusion: The benefits of ramipril were large and sustained over many years.
STUDY
Randomized, placebo-controlled trial entered over 600 patients with acute myocardial
infarction (AMI).
All had clinical evidence of HF usually sufficient to justify diuretic or vasodilator
therapy . (Transient or persisting left ventricular failure on chest radiograph,
auscultatory evidence of pulmonary edema, or a third heart sound plus persistent
tachycardia.)
Randomized to: 1) ramipril target 5 mg twice a day; or 2) placebo for 12 months.
RESULTS
Over an average of 5 years, death from all causes occurred in 39% of placebo patients
and 28% of ramipril patientsabsolute reduction in mortality of 11% . (114 additional
survivors per 1000 patients treated)
DISCUSSION
"We estimate that treatment of nine patients with ramipril for an average of 1 year
will result in one additional survivor in 5 years." (NNT after 5 years = 9)
Eight major survival studies investigating the effects of 5 different ACE inhibitors
have collectively randomized more than 100 000 patients who have had an AMI. These
investigations represent one of the most comprehensive evaluations of a medical treatment
strategy ever done.
There continues to be a variety of opinions as to whether, when, and for how long
individual patients should receive treatment.
"We have shown that administration of ramipril to patients with clinically defined
heart failure after AMI produces a benefit which is large in magnitude, statistically
robust, and sustained over 5 years, and is therefore clinically important."
"We recommend that once a clinician has decided to treat an individual patient with
an ACE inhibitor after AMI, therapy should be continued indefinitely, unless intolerance
develops."
CONCLUSION Administration of ramipril to patients with clinically defined heart
failure after acute myocardial infarction resulted in a survival benefit that is not only
large in magnitude, but also sustained over many years.
Lancet May 24, 1997; 349: 1493-97 Original investigation from the AIREX Study Group
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