エプレレノンはMI後の予後を改善する可能性がある（Abstract # 13-LB-15932）

REMINDER：エプレレノンを標準治療に追加投与することによりMI後の心不全リスクが低下する可能性がある
REMINDER: Eplerenone may reduce risk of heart failure after MI when given in addition to standard treatment
薬剤エプレレノンは心筋梗塞（MI）後の心血管死亡および心不全のリスクを3分の1以上減少させるようであるとの研究結果が第62回American College of Cardiology学会で発表された。REMINDER（Reduction of heart failure morbidity in patients with acute ST-elevation myocardial infarction）は、ST上昇MI（STEMI）患者1,012人を対象とした無作為化二重盲検トライアルである。患者は心不全徴候または心不全歴を有さなかった。彼らはエプレレノンまたはプラセボを標準治療に加えて投与された。全体で、エプレレノン内服群はプラセボ内服群よりも予後不良率が38%低かった。追跡期間中央値10.5か月後の心不全、重症不整脈または死亡はエプレレノン投与群患者においてプラセボ投与群患者よりも頻度が低かった（18.4%対29.6%、P <0.0001）。また、1か月後にBNP/NT-proBNP上昇を認めたのはエプレレノン群患者でわずか16%であったのに対し、プラセボ群では25.9%であった（P <0.0002）。今回のスタディ対象患者は低リスク（死亡率0.4%）であり標準治療を受けていた。有害事象は両群で同等であった。
Full Text

The drug eplerenone appears to reduce the risk of cardiovascular mortality and heart failure after a myocardial infarction (MI) by more than one-third, according to research presented today at the American College of Cardiology's 62nd Annual Scientific Session.

The REMINDER (Reduction of heart failure morbidity in patients with acute ST-elevation myocardial infarction) trial was a randomized, double-blind trial of 1,012 patients with ST-elevation MI (STEMI). Patients had no signs or history of heart failure. They were given either eplerenone or placebo in addition to standard therapy. Overall, patients taking eplerenone were 38 percent less likely to have poor outcomes than those given a placebo.

Eplerenone counteracts aldosterone, which can increase blood pressure. The drug is currently approved to treat hypertension and as a treatment for patients who have heart failure several days after an MI.

"This is the first randomized trial to test a mineralocorticoid receptor agonist during the acute phase of heart attack, and the results suggest a clinical benefit," said Gilles Montalescot, M.D., Ph.D., lead investigator of the study and professor of cardiology and head of the Cardiac Care Unit at Pitié-Salpétrière Hospital, Paris.

Clinical trials and registries show that in the 30 days after a first MI, between 8.6 percent and 40 percent of patients will be diagnosed with heart failure.

The primary endpoint of the REMINDER trial included several outcomes:

  • Cardiovascular mortality
  • Rehospitalization or extended initial hospital stay due to heart failure
  • Severe arrhythmias
  • Ejection fraction of 40 percent or lower after one month
  • An elevation of brain natriuretic peptide (BNP) and its associated protein, NT-proBNP, after one month

Patients who had one of these outcomes were considered to have reached the primary endpoint. After a mean follow-up of 10.5 months, patients on eplerenone had one of these outcomes less often than those receiving placebo (18.4 vs. 29.6 percent, P <0.0001). Also, only 16 percent of patients on eplerenone had an elevation of BNP/NT-proBNP after one month, compared with 25.9 percent receiving placebo (P <0.0002). Adverse events rates were similar in both groups.

"Eplerenone has the potential to reduce clinical and subclinical heart failure in STEMI patients," Dr. Montalescot said.

The study population was low-risk (the mortality rate was 0.4 percent) and was receiving standard treatment.

"Despite this, a benefit was observed with eplerenone to prevent adverse outcomes and subclinical heart failure," Dr. Montalescot said. "Confirmation in a higher-risk population with a longer follow-up would be important to support this new strategy."

The ongoing ALBATROSS [Aldosterone Blockade Early After Acute Myocardial Infarction] study is investigating this hypothesis, Dr. Montalescot added.

The study was funded by Pfizer, Inc. Dr. Montalescot indicated no conflict of interest.