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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

  1. Randomized, placebo-controlled trial entered over 600 patients with acute myocardial infarction (AMI).
  2. 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.)
  3. Randomized to: 1) ramipril — target 5 mg twice a day; or 2) placebo for 12 months.

RESULTS

  1. Over an average of 5 years, death from all causes occurred in 39% of placebo patients and 28% of ramipril patients—absolute reduction in mortality of 11% . (114 additional survivors per 1000 patients treated)

DISCUSSION

  1. "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)
  2. 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.
  3. There continues to be a variety of opinions as to whether, when, and for how long individual patients should receive treatment.
  4. "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."
  5. "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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