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Abstract

Several reasons account for the delayed development of fixed combination antihypertensive drugs in Japan. First, specialists have not wanted to lose their flexibility in combining individual antihypertensive drugs. Second, officials of the Ministry of Health and Welfare, Japan, have hesitated to approve combinations of a given pair of drugs from the many drugs available within the same category. Third, concrete guidelines for the clinical evaluation of fixed combination antihypertensive drugs have never been implemented. However, an opinion survey and the results of prospective postmarketing surveillance on antihypertensive drugs indicate that the efficacy and advantages of combination therapy for hypertension are well recognized by Japanese physicians. A negative balance of the National Health Insurance budget, which requires the improved cost-effectiveness of drug treatment, and new guidelines for the evaluation of antihypertensive drugs, which will be implemented in conjunction with the International Conference on Harmonization guidelines, may promote the development of fixed combination products in the near future.

Keywords

Fixed combination antihypertensive drugs Japan Cardiovascular disease

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Outlook for the Development of Fixed Combination Antihypertensive Agents in Japan

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