Evaluation of efficacy and safety of oral olmesartan + chlorthalidone combination in the management of hypertension in Indian patients

Vijay Bramhabhatt, Manoj Kumar Jha, Arif A. Faruqui

Abstract


Background: Hypertension is a major health problem in India. Being a multifactorial condition often requires the administration of multiple drugs. Despite improvements in the management of hypertension and the availability of effective antihypertensive agents, only 50% of these individuals achieve BP control. The present study was undertaken to evaluate the efficacy and safety of, fixed dose combination of olmesartan 40 mg + chlorthalidone 12.5 mg, in the management of hypertension uncontrolled with olmesartan monotherapy.

Methods: 110 patients were enrolled in this Post-Marketing Surveillance (PMS) study. Patients were prescribed to take fixed dose combination for 60 days.

Results: There was significant decrease (P <0.0001) in Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP) from the baseline to 15th, 30th and 60th days of the treatment. At the end of the study period of 60 days 95.4% & 90.9% patients of age group >60 years and <60 years achieved the Joint National Committee (JNC VIII) recommended goal respectively. (<150/90 for elder patients aged above 60 year and 140/90 for those aged less than 60 years).

Conclusion: Thus fixed dose combination therapy of olmesartan & chlorthalidone has been shown to be excellent in efficacy and tolerability & gives another option for the optimal management of hypertension.

 


Keywords


Diastolic, Systolic, Blood pressure, Hypertension, Fixed dose combination, Target goal, Uncontrolled hypertension

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References


American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2010;33(Suppl 1):11-61.

Ong KL, Cheung BM, Man YB, Lau CP, Lam KS. Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004. Hypertension. 2007;49:69-75.

Rajeev Gupta, Soneil Guptha. Strategies for initial management of hypertension. Indian J Med Res. 2010 Nov;132:531-42.

NICE. Clinical Guidelines, No. 127. In: NICE, eds. National Clinical Guideline Centre (UK). London: Royal College of Physicians (UK); August 2011.

Davis TM, Millns H, Stratton IM, Holman RR, Turner RC. Risk factors for stroke in type 2 diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS). Arch Intern Med. 1999;159:1097-103.

Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851-60.

Devabhaktuni M, Bangalore S. Fixed combination of amlodipine and atorvastatin in cardiovascular risk management: patient perspectives. Vasc Health Risk Manag. 2009;5:377-87.

Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903-13.

Hansson L, Zanchetti A, Carruthers SG, Dahlöf B, Elmfeldt D, Julius S, et al. Effects of intensive blood pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomized trial. Lancet. 1998;351:1755-62.

Sandozi T, Emani VK. Survey of prescription pattern of anti-hypertensive drugs in hypertensives & hypertension associated diabetics. Int J Pharma Bio Sci. 2010;1(4):P23-6.

Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden hypertension: analysis of worldwide data. Lancet. 2005;365:217-23.

Mancia G, De Backer G, Dominiczak A. Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European society of hypertension (European society of hypertension) and of the European Society of Cardiology (ESC). J Hypertens. 2007;25(6):1105-87.

Oparil S, Ripley E. Candesartan cilexetil enhances blood pressure reduction severe (state 3, JNC-VI) hypertensive patients inadequately controlled with HCTZ. Am J Hypertens. 1998;11(4 part 1):121A.

Larochelle P, Flack JM, Marbury TC, Sareli P, Krieger EM, Reeves RA. Irbesartan Multicenter Investigators: Effects and tolerability of irbesartan versus enalapril in patients with severe hypertension. Am J Cardiol. 1997;80:1613-5.

Norris K, Neutel JM. Emerging Insights in the first-step use of antihypertensive combination therapy. J Clin Hypertens (Greenwich). 2007;9(12 Suppl 5):5-14.

Sanjay Kalra, Bharti Kalra, Navneet Agrawal. Combination therapy in hypertension: an update. Diabetol Metab Syndr. 2010;2:44.

Mancia G, Laurent S, Agabiti-Rosei E. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27(11):2121-58.

Degli Esposti L, Valpiani G. Pharmacoeconomic burden of undertreating hypertension. Pharmacoeconomics. 2004;22(14):907-28.

Paramore LC, Halpern MT, Lapuerta P, Hurley JS, Frost FJ, Fairchild DG, et al. Impact of poorly controlled hypertension on healthcare resource utilization and cost. Am J Manag Care. 2001;7(4):389-98.

Gupta R. Trends in hypertension epidemiology in India. J Hum Hypertens. 2004;18:73-8.

Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665.

Alleman Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with uncontrolled hypertension with previous monotherapy: the Exforge in previous failure after single therapy (EX-fast) study. J Clin Hypertens. 2008;10:185-94.

Pool JL, Glazer R, Weinberger M, Alvarado M, Huang J, Graff. A. Comparison of valsartan/hydrochlorothiazide combination therapy at doses up to 320/25 versus monotherapy: a double blind placebo controlled study followed by long-term combination therapy in hypertensive adults. Clin Ther. 2007;29:61-73.