Is Angiotensin converting enzyme inhibitor useful for secondary prevention after acute myocardial infarction? An interim report of Japanese Angina and Myocardial infarction Prospective (JAMP) study
To investigate if angiotensin converting enzyme inhibitor (ACEI) is useful for secondary prevention after acute myocardial infarction, a randomized controlled trial was carried out in 43 institutions in of Japan from September 1993. A total of 1, 025 survivors of their first acute myocardial infarct...
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| Published in | Journal of the Japanese Association for Cerebro-cardiovascular Disease Control Vol. 35; no. 1; pp. 8 - 16 |
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| Main Author | |
| Format | Journal Article |
| Language | Japanese |
| Published |
The Japanese Association for Cerebro-cardiovascular Disease Control
31.01.2000
社団法人 日本循環器管理研究協議会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0914-7284 |
| DOI | 10.11381/jjcdp1974.35.8 |
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| Abstract | To investigate if angiotensin converting enzyme inhibitor (ACEI) is useful for secondary prevention after acute myocardial infarction, a randomized controlled trial was carried out in 43 institutions in of Japan from September 1993. A total of 1, 025 survivors of their first acute myocardial infarction who underwent coronary angiographies, consisting of 799 men and 226 women, were included. Mean age was 62.4±10.7 years. Subjects were randomly assigned to 2 groups, 501 who received ACEI (ACEI group) and 524 who received no ACEI (non-ACEI group). There were no statistical differences in the clinical backgrounds, except that smokers were more frequent and patients who underwent percutaneous transluminal coronary angioplasty before discharge were less frequent in the ACEI group. The primary end points were cardiac events, which were defined as sudden death ; fatal or nonfatal recurrent myocardial infarction ; hospitalization because of worsening angina or congestive heart failure ; and coronary revascularization. During the provisional mean follow-up period of 42 months, cardiac events occurred in 105 patients of the ACEI group and 125 of the non-ACEI group. With Kaplan-Meier's analysis, the rate of total cardiac events was 30.1% in the ACEI group and 26.5% in the non-ACEI group. There was no statistical significance between the 2 groups with a log-rank test. The final patient was recruited in December 1995, and it is planned that longterm observation will terminate by the end of 2000. |
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| AbstractList | To investigate if angiotensin converting enzyme inhibitor (ACEI) is useful for secondary prevention after acute myocardial infarction, a randomized controlled trial was carried out in 43 institutions in of Japan from September 1993. A total of 1, 025 survivors of their first acute myocardial infarction who underwent coronary angiographies, consisting of 799 men and 226 women, were included. Mean age was 62.4±10.7 years. Subjects were randomly assigned to 2 groups, 501 who received ACEI (ACEI group) and 524 who received no ACEI (non-ACEI group). There were no statistical differences in the clinical backgrounds, except that smokers were more frequent and patients who underwent percutaneous transluminal coronary angioplasty before discharge were less frequent in the ACEI group. The primary end points were cardiac events, which were defined as sudden death ; fatal or nonfatal recurrent myocardial infarction ; hospitalization because of worsening angina or congestive heart failure ; and coronary revascularization. During the provisional mean follow-up period of 42 months, cardiac events occurred in 105 patients of the ACEI group and 125 of the non-ACEI group. With Kaplan-Meier's analysis, the rate of total cardiac events was 30.1% in the ACEI group and 26.5% in the non-ACEI group. There was no statistical significance between the 2 groups with a log-rank test. The final patient was recruited in December 1995, and it is planned that longterm observation will terminate by the end of 2000. To investigate if angiotensin converting enzyme inhibitor (ACEI) is useful for secondary prevention after acute myocardial infarction, a randomized controlled trial was carried out in 43 institutions in of Japan from September 1993. A total of 1, 025 survivors of their first acute myocardial infarction who underwent coronary angiographies, consisting of 799 men and 226 women, were included. Mean age was 62.4±10.7 years. Subjects were randomly assigned to 2 groups, 501 who received ACEI (ACEI group) and 524 who received no ACEI (non-ACEI group). There were no statistical differences in the clinical backgrounds, except that smokers were more frequent and patients who underwent percutaneous transluminal coronary angioplasty before discharge were less frequent in the ACEI group. The primary end points were cardiac events, which were defined as sudden death ; fatal or nonfatal recurrent myocardial infarction ; hospitalization because of worsening angina or congestive heart failure ; and coronary revascularization.During the provisional mean follow-up period of 42 months, cardiac events occurred in 105 patients of the ACEI group and 125 of the non-ACEI group. With Kaplan-Meier's analysis, the rate of total cardiac events was 30.1% in the ACEI group and 26.5% in the non-ACEI group. There was no statistical significance between the 2 groups with a log-rank test. The final patient was recruited in December 1995, and it is planned that longterm observation will terminate by the end of 2000. 心筋梗塞症 (MI) の二次予防と長期予後の改善にAngiotensin converting enzyme inhibitor (ACEI) が有効か否かを, 高脂血症非合併例, 合併例のそれぞれで明らかにするため, 初MI生存退院例を対象として無作為比較対照試験を行った。全国43施設から登録された1028例中, 1025例が解析可能であった。男性799例, 女性226例で, 平均年齢は62.4±10.7歳であった。高脂血症非合併例は906例でACEI投与群445例と非投与群461例に, 高脂血症合併例は119例で, それぞれ56例と63例とに振り分けられた。薬剤割付け状況は高脂血症合併群, 非合併群ともに均等であった。今回は中間報告として, ACEI投与群501例と非投与群524例で, 登録時の臨床背景解析と1998年12月31日までの予後解析を行った。臨床背景には, ACEI投与群で喫煙者が多く, 経皮的冠動脈形成術施行例が少なかった以外は2群間で差がなかった。観察期間は平均3年7ケ月で, 994例 (97%) での心事故発生率をKaplan-Meier法で求めた。突然死, 心臓死, 非致死的心筋梗塞症, 入院を要する狭心症および心不全, 冠動脈バイパス術または経皮的冠動脈形成術を心事故とした。5年間での心事故発生率は, ACEI非投与群30.1%, 投与群26.5%で, 後者で低い傾向にあるが, 有意差はなかった。本研究は, データセンターを専門管理組織 (Contract Research Organization) に設置し, 欧米と同様のスタイルで行った, 本邦ではじめての多施設共同大規模ランダム化臨床試験で, 2000年12月に最終予後確認を行い, ACEI の二次予防効果の有無を明らかにする予定である。 |
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| References | 8) Swedberg, K et al. Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction : results of the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II). N Engl J Med 1992 ; 327 : 678-684. 9) Chinese Cardiac Study collaborative group. Oral captopril versus placebo among 13634 patients with suspected acute myocardial infarction : interim report from the Chinese Cardiac Study (CCS-1). Lancet 1995 : 345 : 686-687. 6) 深見健一, 他.虚血性心疾患における長期薬物療法の評価と問題点;Japanese Anginaand Myocardial infarction Prospective (JAMP) study. Jpn Circ J 1994 ; 58 (suppl) : 1293-1296. 3) The Trandolapril Cardiac Evaluation (TRACE) study group. A clinical trial of the angiotensin-convertingenzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 1995 ; 333 : 1670-1676. 4) ISIS-4 (Fourth International Study of infarct Survival) collaborative group : ISIS-4 : A randomized factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulfate in 58050 patients with suspected acute myocardial infarction. Lancet 1995 ; 345 : 669-685. 1) Pfeffer, MA et al. Effect of captopril on mortality in patients with left ventricular dysfunction after myocardial infarction : results of the Survival And Ventricular Enlargement (SAVE) trial. N Engl J Med 1992 ; 327 : 669-677. 5) Gruppo Italiano per to Studio della Sopravvivenza nell'Infarto miocardico : GISSI-3 : effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6week mortality and ventricular function after acute myocardial infarction. Lancet 1994 ; 343 : 1115-1122. 7) Kingma, JH et al. Acute intervention with captopril during thrombolysis in patients with first anterior myocardial infarction ; results from the Captopril And Thrombolysis Study (CATS). Eur Heart J 1994 ; 15 : 898-907. 2) The Acute Infarction Ramipril Efficacy (ARIE) study Investigators. Effects of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure Lancet 1993 ; 342 : 821-828. |
| References_xml | – reference: 2) The Acute Infarction Ramipril Efficacy (ARIE) study Investigators. Effects of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure Lancet 1993 ; 342 : 821-828. – reference: 3) The Trandolapril Cardiac Evaluation (TRACE) study group. A clinical trial of the angiotensin-convertingenzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 1995 ; 333 : 1670-1676. – reference: 9) Chinese Cardiac Study collaborative group. Oral captopril versus placebo among 13634 patients with suspected acute myocardial infarction : interim report from the Chinese Cardiac Study (CCS-1). Lancet 1995 : 345 : 686-687. – reference: 8) Swedberg, K et al. Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction : results of the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II). N Engl J Med 1992 ; 327 : 678-684. – reference: 5) Gruppo Italiano per to Studio della Sopravvivenza nell'Infarto miocardico : GISSI-3 : effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6week mortality and ventricular function after acute myocardial infarction. Lancet 1994 ; 343 : 1115-1122. – reference: 7) Kingma, JH et al. Acute intervention with captopril during thrombolysis in patients with first anterior myocardial infarction ; results from the Captopril And Thrombolysis Study (CATS). Eur Heart J 1994 ; 15 : 898-907. – reference: 4) ISIS-4 (Fourth International Study of infarct Survival) collaborative group : ISIS-4 : A randomized factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulfate in 58050 patients with suspected acute myocardial infarction. Lancet 1995 ; 345 : 669-685. – reference: 6) 深見健一, 他.虚血性心疾患における長期薬物療法の評価と問題点;Japanese Anginaand Myocardial infarction Prospective (JAMP) study. Jpn Circ J 1994 ; 58 (suppl) : 1293-1296. – reference: 1) Pfeffer, MA et al. Effect of captopril on mortality in patients with left ventricular dysfunction after myocardial infarction : results of the Survival And Ventricular Enlargement (SAVE) trial. N Engl J Med 1992 ; 327 : 669-677. |
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| SubjectTerms | acute myocardial infarction angiotensin converting enzyme inhibitor long-term prognosis randomized controlled trial アンギオテンシン変換酵素阻害薬 二次予防 心筋梗塞症 無作為比較対照試験 |
| Subtitle | An interim report of Japanese Angina and Myocardial infarction Prospective (JAMP) study |
| Title | Is Angiotensin converting enzyme inhibitor useful for secondary prevention after acute myocardial infarction? |
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