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Abstract

Evaluation of the rationality of some FDCs: Focus on antihypertensive drug

Author(s): Jayanti Panda1, P Tiwari1, R Uppal2
1 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar-160 062, Punjab, India 2 Department of Pharmacology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India

Correspondence Address:
P Tiwari Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar-160 062, Punjab India E-mail: [email protected]


The use of fixed-dose combinations is a widespread clinical practice in the treatment of various cardiovascular disorders. These fixed-dose combinations are valuable only when they have been developed based on sound rational pharmacokinetic and pharmacodynamic criteria, and when claims for their benefits have been supported by evidence-based data and well-designed clinical studies. However, a look at the available fixed-dose combinations reveals that there are combinations which do not meet these basic criteria, and hence their clinical benefit is debatable. In this context, several stakeholders have put forward their views on the rationality of some of the fixed-dose combinations. The situation has become more complicated as there are very limited reports to assess and describe the rationality of fixed-dose combinations on an individual basis. In the present study, a thorough evaluation of 44 fixed-dose combinations used in various cardiovascular disorders using comprehensive criteria has been completed. This evaluation has demonstrated that a large number of fixed-dose combinations are rational, based on the criteria used. Finally, there seems to be enough reason to re-investigate six of them, which did not match the criteria as well as others. These six combinations could be the subject of study by the clinicians and/or pharmaceutical companies to assess their clinical benefit.



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