Comparative study to evaluate efficacy and safety of azilsartan and telmisartan in patients with grade I-II essential hypertension

Authors

  • Deepak S. Bhosle Department of Pharmacology, MGM Medical College and Hospital, Aurangabad, Maharashtra, India
  • Sameer Khan Department of Pharmacology, MGM Medical College and Hospital, Aurangabad, Maharashtra, India
  • Mohd Faheem Mubeen Department of Pharmacology, MGM Medical College and Hospital, Aurangabad, Maharashtra, India
  • Zubair Quazi Department of Pharmacology, MGM Medical College and Hospital, Aurangabad, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20175697

Keywords:

Angiotensin receptor blockers, Azilsartan, Blood pressure, Clinical trials, Efficacy studies, Safety, Telmisartan

Abstract

Background: Objectives of the study was to study the effect of Azilsartan 40mg once daily versus Telmisartan 40mg once daily in patients with Grade I-II essential hypertension.

Methods: A prospective study was conducted at MGM Medical college and Hospital which included 80 patients in each group with Grade I–II essential hypertension. The sex, age, presenting illness, and family history of the patients were recorded. Investigations such as blood sugar, urine analysis, kidney function test, lipid profile, and ECG were performed before starting the treatment. Any adverse effects during the treatment were noted. Blood pressure was recorded at baseline and during follow-up. One group received Azilsartan 40mg once daily and another group Telmisartan 40mg once daily. Patients were followed-up every week for 5 weeks.

Results: Patients receiving Azilsartan 40mg and Telmisartan 40mg showed a significant fall (P <0.05) in systolic (SBP) at the end of fifth week, when compared to baseline and diastolic blood pressure (DBP) significant fall at fourth and fifth week. The difference in fall in SBP and DBP was insignificant between the groups, after first, second and third week (P >0.05). Adverse effects such as Nasopharyngitis, Upper respiratory tract inflammation, Gastroenteritis, headache, dizziness, and fatigue were reported with both drugs.

Conclusions: Reduction of blood pressure with Azilsartan and Telmisartan was similar, but fall in blood pressure from baseline was highly significant in both groups.

References

Hoffman BB. Therapy of Hypertension. In: Brunton LL, Lazo JS, Parker KL, editors. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 11thed. New York: McGraw-Hill Co.; 2006:845-850.

Boos CJ, Beevers GD, Lip GY. Assessment of platelet activation indices using the adviatm 120 amongst ‘high-risk’ patients with hypertension. Ann Med. 2007;39:72-8.

Whitworth JA. World Health Organization, International Society of Hypertension Writing Group. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003;21:1983-92.

Hansson L, Zanchetti A, Carruthers SG, Dahlof 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) randomised trial. HOT Study Group. Lancet. 1998;351:1755-62.

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.

Zaiken K, Cheng JW. Azilsartan medoxomil: a new Angiotensin receptor blocker. Clin Ther. 2011;33:1577-89.

Kajiya T, Christopher HO, Wang J, Vilardi R, Kurtz TW. Molecular and cellular effects of azilsartan: a new generation angiotensin II receptor blocker. J Hypertens. 2011;29:2476-83.

Rakugi H, Enya K, Sugiura K, Ikeda Y. Comparison of the efficacy and safety of azilsartan with that of candesartan cilexetil in Japanese patients with grade I-II essential hypertension: a randomized, double-blind clinical study. Hypertens Res. 2012;35:552-8.

Rakugi H, Kario K, Enya K, Igeta M, Ikeda Y. Effect of azilsartan versus candesartan on nocturnal blood pressure variation in Japanese patients with essential hypertension. Blood Pressure. 2013;22:22-8.

Rothwell PM, Howard SC, Dolan E, O’Brien E, Dobson JE. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010;375:895-905.

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: The JNC 7 report. JAMA. 2003;289:2560-72.

Carretero OA, Oparil S. Essential hypertension. Part I: Defi nition and etiology. Circulation. 2000;101:329-35.

Abegunde DO, Mathers CD, Adam T, Ortegon M, Strong K. The burden and costs of chronic diseases in low-income and middle-income countries. Lancet. 2007;370:1929-38.

Neal B, MacMahon S, Chapman N. Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects of ace inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: Results of prospectively designed overviews of randomised trials. Blood pressure lowering treatment trialists’ collaboration. Lancet. 2000;356:1955-64.

Ogden LG, He J, Lydick E, Whelton PK. Long-term absolute benefi t of lowering blood pressure in hypertensive patients according to the JNC vi risk stratifi cation. Hypertension. 2000;35:539-43.

Kassler-Taub K, Littlejohn T, Elliott W, Ruddy T, Adler E. Comparative efficacy of two angiotensin II receptor antagonists, irbesartan and losartan, in mild-to-moderate hypertension. Ame J of Hyp. 1998 Apr;11(4):445-53.

Hedner T, Oparil S. A comparison of angiotensin antagonists Valsartan and Losartan in the treatment of essential hypertension. Am J Hypertens. 1992;12:414-7.

Millan JH, Siche JP. ABPM comparison of the hypertensive profile of the selective angiotensin-2 receptor antagonists telmisartan and losartan in patients of mild to moderate hypertension. J Hum Hypertens. 1999;13:657-64.

Diament M, Idema RN. The use of Fourier analysis in the calculation of trough and peak ratio from ambulatory blood pressure measurement J Hum Hypertens. 1998;12:61-7.

Andersen OK, Neldam S. The antihypertensive effects and tolarebility of Candesartan Cilexetil. A new angiotensin-2 receptor antagonist, in comparison with losartan. Blood Press. 1998;7:53-50.

Oparil S, Guthrie R, Lewin AJ, Marbury T, Reilly K, Triscari J, et al. Irbesartan/Losartan Study Investigators. An elective-titration study of the comparative effectiveness of two angiotensin II-receptor blockers, irbesartan and losartan. Clinical therapeutics. 1998 May;20(3):398-409.

Ram CV. Angiotensin receptor blockers: Current status and future prospects. Am J Med. 2008;12:656-63.

Furukawa Y, Kishimoto S, Nishikawa K, inventors. Takeda Chemical Industries, Ltd, Osaka, Japan, assignee. US Patent. Hypotensive imidazole-5-acetic acid derivatives. 1982 October 20;355:040.

Furukawa Y, Kishimoto S, Nishikawa K, inventors. Takeda Chemical Industries, Ltd., Osaka, Japan, assignee. US Patent 4. Hypotensive imidazole derivatives. 1982 July 20;340:598.

Duncia JV, Chiu AT, Carini DJ, Gregory GB, Johnson AL, Price WA, et al. The discovery of potent nonpeptide angiotensin II receptor antagonists: a new class of potent antihypertensives. Journal of medicinal chemistry. 1990 May;33(5):1312-29.

Takeda Pharmaceuticals North America. Edarbi prescribing information. 2011.

Kohara Y, Imamiya E, Kubo K, Wada T, Inada Y, Naka T. A new class of angiotensin II receptor antagonists with a novel acidic bioisostere. Bioorganic Medicinal Chemistry Letters. 1995;5(17):1903-8.

Kohara Y, Kubo K, Imamiya E, Wada T, Inada Y, Naka T. Synthesis and angiotensin II receptor antagonistic activities of benzimidazole derivatives bearing acidic heterocycles as novel tetrazole bioisosteres. J Med Chem. 1996;39(26):5228-35.

Rakugi H, Enya K, Sugiura K, Ikeda Y. Comparison of the efficacy and safety of azilsartan with that of candesartan cilexetil in Japanese patients with grade I-II essential hypertension: a randomized, double-blind clinical study. Hypertens Res.; 2012.

Naka T, Kubo K. A new class of diacidic nonpeptide angiotensin II receptor antagonists: candesartan cilexetil. Curr Pharm Des. 1999;5(6):453-72.

Baker WL, White WB. Azilsartan medoxomil: A new angiotensin II receptor antagonist for treatment of hypertension. Ann Pharmacother. 2011;45(12):1506-15.

Ojima M, Igata H, Tanaka M, Sakamoto H, Kuroita T, Kohara Y, et al. In vitro antagonistic properties of a new angiotensin type 1 receptor blocker, azilsartan, in receptor binding and function studies. Journal of Pharmacology and Experimental Therapeutics. 2011 Mar 1;336(3):801-8.

Kusumoto K, Igata H, Ojima M, Tsuboi A, Imanishi M, Yamaguchi F, et al. Antihypertensive, insulin-sensitising and renoprotective effects of a novel, potent and long-acting angiotensin II type 1 receptor blocker, azilsartan medoxomil, in rat and dog models. European J of Phar. 2011 Nov 1;669(1):84-93.

Zannad F, Fay R. Blood pressure-lowering efficacy of olmesartan relative to other angiotensin II receptor antagonists: an overview of randomized controlled studies. Fundam Clin Pharmacol. 2007;21(2):181-90.

Sica D, White WB, Weber MA, Bakris GL, Perez A, Cao C, et al. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring. The Journal of Clinical Hypertension. 2011 Jul 1;13(7):467-72.

White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, et al. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011;57(3):413-20.

Bakris GL, Sica D, Weber M, White WB, Roberts A, Perez A, et al. The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure. The Journal of Clinical Hypertension. 2011 Feb 1;13(2):81-8.

Downloads

Published

2017-12-23

How to Cite

Bhosle, D. S., Khan, S., Mubeen, M. F., & Quazi, Z. (2017). Comparative study to evaluate efficacy and safety of azilsartan and telmisartan in patients with grade I-II essential hypertension. International Journal of Basic & Clinical Pharmacology, 7(1), 184–190. https://doi.org/10.18203/2319-2003.ijbcp20175697

Issue

Section

Original Research Articles