[総説］わが国の降圧薬の大規模臨床試験について : 施行上の問題点

概要

論文の詳細を見る
Many large scale clinical trials which were almost exclusively carried out in the western countries have revealed reductions in morbidity and mortality of cardiovascular diseases by pharmacological antihypertensive treatment. Japanese people, however, have different characteristics in cardiovascular morbidity from those in the western countries. The results of these studies are not necessarily applicable to Japanese people. Moreover, the large scale clinical trials are limited in Japan. The Japanese Trial on the Efficacy of Antihypertensive Treatment in the Elderly (JATE) was the first large scale double blind trial using an inactive placebo in Japan. The aim was to evaluate effects of antihypertensive treatment with Ca antagonists on cardiovascular events in 2,000 elderly patients with mild hypertension. However, the study failed because of enrollment of only 329 patients over 3.5 years. On the other hand, open trials or postmarketing surveillance comparatively succeeded in enrolling large number of patients. After discontinuing the JATE study, we sent a questionnaire to 1,433 physicians who had participated in the study to survey their attitudes to the JATE study and large scale clinical trials. Seven hundred and seventy eight physicians returned the questionnaire (response rate: 54.3%). Reasons for poor enrollment of patients (% agree): use of inactive placebo 40, difficulty in obtaining informed consent 37, lack of participant's benefit 36, low trust of the general public in administration of pharmaceutical affairs 26, few patients meeting eligibility criteria 26, too busy to obtain informed consent 23. Reasons for difficulty in obtaining informed consent (% agree): lack of recognition of importance of large scale clinical trials in general public and mass media 50, use of inactive placebo 30. Necessity of performing the trials in Japan: yes 99%, no 1%. Circumstances in which large scale clinical trials could be successfully performed (% agree): sufficient recognition of importance of the trials in general public 78, sufficient support by government 62, presence of coordinators in the institutes participated 58, presence of participant's benefit 54, presence of physician's benefit 24. These results point out that physicians, government, general public, mass media and pharmaceutical companies should sufficiently recognize the importance and necessity of large scale clinical trials in Japan. This should become a national consensus. Furthermore, effective systems for performing successful trials should be constructed.
琉球医学会,Ryukyu Medical Associationの論文

著者

瀧下修一
琉球大学医学部第三内科

[総説］わが国の降圧薬の大規模臨床試験について : 施行上の問題点

スポンサーリンク

概要

著者

関連論文

スポンサーリンク