Assessment of rational use of fixed dose combinations in hypertension in a tertiary care teaching hospital in north India

Rohini Gupta, Apoorva Malhotra, Pavan Malhotra


Background: Fixed-dose combination (FDC) agents could be considered as an effective therapy in chronic illnesses like hypertension, which have multifactorial etiology. At present, many FDCs have come into the market without being assessed for their efficacy, safety and rationality by the drug regulatory authorities. The objective of the present study was to assess the rational use of fixed dose drug combinations in hypertension.

Methods: It was a cross-sectional observational study conducted in the cardiology outpatient department of ASCOMS and H, Sidhra, Jammu, Jammu and Kashmir from February 2016 to July 2016. In the study 92 prescriptions of hypertensive patients who were on anti-hypertensive fixed-dose drug combinations (FDCs) were recruited after thoroughly evaluated for inclusion and exclusion criteria. Data obtained includes the demographic profile of the patients, pattern of the prescribed FDCs in hypertension, evaluation of the rationality of the FDCs based upon the comprehensive seven-point criteria developed by Panda et al.

Results: In the present study, about sixteen different anti-hypertensive FDCs were observed in the prescriptions of 92 patients during six-month period. It was observed that about 93.75% of FDCs were dual drug combinations. Among the dual drug combinations, most commonly used combination was Olmesartan (ARB; Angiotensin receptor blocker) + Amlodipinine (Calcium channel blocker) in 17.4% of patients. It was also observed that among the 16 different anti-hypertensive fixed dose combinations analysed, 12 FDCs (75%) were found to be rational and 4 FDCs (25%) were found to be irrational.

Conclusions: In the present study it was found that 75% of the FDCs prescribed were rational and 25% were irrational. Therefore, before marketing the FDCs proper assessment of their efficacy, safety and rationality should be done.


Fixed-dose drug combinations, Hypertension, Irrational, Rational

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Office of Combination Products. Food and Drug Administration, USA. Available at: roducts/Guidance RegulatoryInformation/ucm109108.htm. Accessed on 2017 Mar 15.

Prakash S. Irrational combinations: No consideration for patient safety. Indian J Pharmacol. 2007;39(5):217.

Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007 Aug 1;120(8):713-9.

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo Jr JL, et al. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertens. 2003 Dec 1;42(6):1206-52.

Nash DT. Rationale for combination therapy in hypertension management: focus on angiotensin receptor blockers and thiazide diuretics. Southern Med J. 2007 Apr 1;100(4):386-93.

Neethu J, Shah DR, Vitus A, Jaffar J, Evaluation of rationality of fixed-dose combination (FDC) of antihypertensive drug in a Multi-speciality tertiary care hospital in south India. Asian J Med Health Res. 2016;1(7):1-15.

Yasmin R, Shakeel S, Iffat W, Sana MF. Fixed dose combination: understanding of imminent pharmacist. Int J Pharma. 2014;4(1):52-5.

Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br J Clin Pharmacol. 2008 May 1;65(5):795-6.

Avijit C. Fixed dose combinations in therapy. Express Pharm India. 2007. Available at:

Sreedhar D, Janodia MD, Ligade VS, Mohapatra S, Ganguly R, Udupa N. Fixed dose combinations: Rational or irrational?. Current Sci. 2008 Sep 10;95(5):581-3.

Goswami N, Gandhi A, Patel P, Dikshit R. An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors. Perspect Clin Res. 2013 Apr;4(2):130.

WHO drug information. Geneva: WHO. 2003;(17). Available at: http://

Sreedhar D, Subramanian G, Udupa N. Combination drugs: Are they rational. Curr Sci. 2006 Aug 25;91:406.

Schellack N, Malan L. An overview of fixed-dose combinations of antihypertensive drugs in South Africa. South African Fam Pract. 2014 Jul 4;56(4):206-11.

Md. Sarwar S, Md. Hossain D. Fixed dose combination and disease management. Int Res J Pharma. 2013;3(11):17-2.

Rathnakar UP, Shenoy A, Ullal SD, Sudhakar P, Shastry R, Shoeb A. Prescribing patterns of fixed dose combinations in hypertension, diabetes mellitus and dyslipedimia among patients attending a cardiology clinic in a tertiary care teaching hospital in India. Int J Comprehen Pharma. 2011;2(6):1-3.

Stanton T, Reid JL. Fixed dose combination therapy in the treatment of hypertension. J Hum Hypertens. 2002 Feb 7;16(2):75.

Jayanti P, Tiwari P, Uppal R. Evaluation of the rationality of some FDCs: Focus on antihypertensive drug. Indian J Pharmaceut Sci. 2006;68(5):649-52.

Connor J, Rafter N, Rodgers A. Do fixed-dose combination pills or unit-of-use packaging improve adherence? A systematic review. Bull World Health Organization. 2004;82(12):935-9.

Pan F, Chernew ME, Fendrick AM. Impact of fixed-dose combination drugs on adherence to prescription medications. J General Internal Med. 2008 May 1;23(5):611-4.

Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. Br Med J. 2003 Jun 26;326(7404):1419.

Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents. Am J Health Syst Pharm. 2007;64(12):1279-83.

Pharmacotherapy C, Public Health Research Working Group. Combination pharmacotherapy for cardiovascular disease. Ann Internal Med. 2005 Oct 18;143(8):593-9.

Benson SC, Pershadsingh HA, Ho CI, Chittiboyina A, Desai P, Pravenec M, et al. Identification of telmisartan as a unique angiotensin II receptor antagonist with selective PPARγ–modulating activity. Hypertens. 2004 May 1;43(5):993-1002.