Abstract
The aim of this prospective, randomized, open-label, blinded endpoint (PROBE) study was to compare the antihypertensive efficacy of 2 angiotensin II (AII) receptor antagonists with different pharmacologic profiles, valsartan and olmesartan, in patients with mild-to-moderate essential hypertension. After an initial 2-week washout period, 114 patients (64 men, 50 women; aged 35–70 years) were randomly assigned to receive valsartan 160 mg or olmesartan 20 mg once daily for 8 weeks. After the washout period and after 2 and 8 weeks of treatment, 24-hour ambulatory blood pressure monitoring (ABPM) was performed using a noninvasive device, and casual blood pressure (BP) and heart rate were measured. Both olmesartan and valsartan had a clear-cut antihypertensive effect. However, significantly earlier and more pronounced antihypertensive activity was achieved with valsartan than with olmesartan, as demonstrated by (1) significantly lower 24-hour, daytime, and nighttime ABPM values after 2 weeks with valsartan (P < .01); (2) significantly lower percentage of abnormal BP readings with valsartan; (3) significantly higher trough-peak ratio and smoothness index with valsartan, suggesting a more prolonged and homogeneous antihypertensive effect; and (4) lower 24-hour postdose clinic systolic and diastolic BP values versus olmesartan. These findings show that pharmacodynamic and pharmacokinetic differences between All receptor antagonists, at clinically comparable dosages, may be associated with differences in anti hypertensive efficacy.
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Parving HH, Lehnert H, Brochner-Mortensen J, et al, for the Irbesartan in patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes.N Engl J Med. 2001;345:870–878.
Dahlof B, Devereux RB, Kjeldsen SE, for the LIFE Study Group. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention for Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.Lancet. 2002;359:995–1003.
Warner GT, Jarvis B. Olmesartan medoxomil.Drugs. 2002;62:1345–1353.
Nussberger J, Koike H. Antagonizing the angiotensin II subtype 1 receptor: a focus on olmesartan medoxomil.Clin Ther. 2004;26(suppl A):A12-A20.
Wehling M. Can the pharmacokinetic characteristics of olmesartan medoxomil contribute to the improvement of blood pressure control?Clin Ther. 2004;26(suppl A):A21-A27.
Criscione L, de Gasparo M, Buhlmayer P, Whitebread S, Ramjoue HP, Wood J. Pharmacological profile of valsartan: a potent, orally active, nonpeptide antagonist of the angiotensin II AT1-receptor subtype.Br J Pharmacol. 1993;110:761–771.
Criscione L, Bradley WA, Buhlmayer P, et al. Valsartan: preclinical and clinical profile of an antihypertensive angiotensin II antagonist.Cardiovasc Drug Rev. 1995;3:230–250.
Muller P, Flesch G, De Gasparo M, et al. Pharmacokinetics and pharmacodynamic effects of the angiotensin II antagonist valsartan at steady state in healthy, normotensive subjects.Eur J Clin Pharmacol. 1997;52:441–449.
Markham A, Goa KL. Valsartan. A review of its pharmacology and therapeutic use in essential hypertension.Drugs. 1997;54:299–311.
Waldmeier F, Flesch G, Muller P, et al. Pharmacokinetics, disposition and biotransformation of [14C]-radiolabelled valsartan in healthy male volunteers after a single oral dose.Xenobiotica. 1997;27:59–71.
Oparil S. Comparative antihypertensive efficacy of olmesartan: comparison with other angiotensin II receptor antagonists.J Hum Hypertens. 2002;16(suppl 2):S17-S23.
Verdecchia P, Angeli F. Assessment of the optimal daily dose of valsartan in patients with hypertension, heart failure, or both.Clin Ther. 2004;26:460–472.
Malacco E, Santonastaso M, Vari NA, et al. Blood pressure reduction and tolerability of valsartan in comparison with lisinopril study. Comparison of valsartan 160 mg with lisinopril 20 mg, given as monotherapy or in combination with a diuretic, for the treatment of hypertension: the blood pressure reduction and tolerability of valsartan in comparison with lisinopril (PREVAIL) study.Clin Ther. 2004;26:855–865.
Groppelli A, Omboni S, Ravogli A, et al. Validation of the Spacelabs 90202 and 90207 devices for ambulatory blood pressure monitoring by comparison with intra-arterial resting and ambulatory measurements.J Hypertens. 1991;9(suppl 3):S334-S355.
US Food and Drug Administration.Proposed Guidelines for the Clinical Evaluation of Antihypertensive Drugs. Rockville, Md: US Department of Health and Human Services, Division of Cardio-Renal Drug Products; 1988.
Mancia G, Frattola A, Groppelli A, et al. Blood pressure reduction and end-organ damage in hypertension.J Hypertens. 1994;12(suppl 8):S35-S42.
Zanchetti A, on behalf of the Italian Nifedipine GITS Study Group. Trough:peak ratio of the blood pressure response to dihydropyridine calcium antagonists.J Hypertens. 1994; 12(suppl 8):S97-S106.
Parati G, Rizzoni D, Omboni S, et al. “Smoothness index” but not T/P ratio estimates balanced 24-h blood pressure control and predicts regression of organ damage by antihypertensive treatment.J Hypertens. 1997;15(suppl 4):S7-S8.
Mancia G, Omboni S, Ravogli A, Parati G, Zanchetti A. Ambulatory blood pressure monitoring in the evaluation of antihypertensive treatment: additional information from a large data base.Blood Press. 1995;4:148–156.
The SAMPLE study group. Ambulatory blood pressure is superior to clinic blood pressure in predicting treatment-induced regression of left ventricular hypertrophy.Circulation. 1997;95: 1464–1470.
Julius S, Kjeldsen SE, Weber M, et al, for the VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial.Lancet. 2004;363:2022–2031.
White WB. Blood pressure load and target organ effects in patients with essential hypertension.J Hypertens Suppl. 1991;9:S39-S41.
Verdecchia P, Schillaci G, Guerrini M, et al. Circadian blood pressure changes and left ventricular hypertrophy in essential hypertension.Circulation. 1991;81:528–536.
Chon J, Tognoni G, for the Valsartan Heart Failure Trial Investigators. A randomised trial of the angiotensin-receptor blocker valsartan in chronic heart failure.N Engl J Med. 2001;345:1667–1675.
Pfeffer MA, McMurray JJ, Velasquez EJ, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular disfunction.N Engl J Med. 2003;349:1893–1906.
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Destro, M., Scabrosetti, R., Vanasia, A. et al. Comparative efficacy of valsartan and olmesartan in mild-to-moderate hypertension: Results of 24-hour ambulatory blood pressure monitoring. Adv Therapy 22, 32–43 (2005). https://doi.org/10.1007/BF02850182
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DOI: https://doi.org/10.1007/BF02850182