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KMID : 0941820130230030239
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Korean Journal of Clinical Pharmacy
2013 Volume.23 No. 3 p.239 ~ p.247
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Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries
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Wang So-Young
Shon Soo-Jung
Um Jung-Yoon
Lim Hwa-Kyung
Lim Sook
Kang Seung-Ho
Lee Sun-Hee
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Abstract
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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 coadministration, 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.
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KEYWORD
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Antihypertensive drug, Triple combination therapies, Initial therapy, Add-on/switch therapy, Substitutional/replacement therapy
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