Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries

항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교

  • Wang, So Young (Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety) ;
  • Shon, Soo Jung (Drug Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Um, Jung Yoon (Drug Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Lim, Hwa Kyung (Drug Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Lim, Sook (Drug Evaluation Department, National Institute of Food and Drug Safety Evaluation) ;
  • Kang, Seung Ho (Department of Applied Statistics, Yonsei University) ;
  • Lee, Sun Hee (Drug Evaluation Department, National Institute of Food and Drug Safety Evaluation)
  • 왕소영 (식품의약품안전처 의약품안전국) ;
  • 손수정 (식품의약품안전평가원 의약품심사부) ;
  • 엄정윤 (식품의약품안전평가원 의약품심사부) ;
  • 임화경 (식품의약품안전평가원 의약품심사부) ;
  • 임숙 (식품의약품안전평가원 의약품심사부) ;
  • 강승호 (연세대학교 응용통계학과) ;
  • 이선희 (식품의약품안전평가원 의약품심사부)
  • Received : 2013.07.31
  • Accepted : 2013.09.06
  • Published : 2013.09.30
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Abstract

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

Keywords

References

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