Advances in Therapy

, Volume 22, Issue 1, pp 32–43 | Cite as

Comparative efficacy of valsartan and olmesartan in mild-to-moderate hypertension: Results of 24-hour ambulatory blood pressure monitoring

  • Maurizio Destro
  • Rossana Scabrosetti
  • Alessandro Vanasia
  • Amedeo Mugellini
Article

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.

Keywords

valsartan olmesartan hypertension ambulatory blood pressure monitoring 
This is a preview of subscription content, log in to check access.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    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.PubMedCrossRefGoogle Scholar
  2. 2.
    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.PubMedCrossRefGoogle Scholar
  3. 3.
    Warner GT, Jarvis B. Olmesartan medoxomil.Drugs. 2002;62:1345–1353.PubMedCrossRefGoogle Scholar
  4. 4.
    Nussberger J, Koike H. Antagonizing the angiotensin II subtype 1 receptor: a focus on olmesartan medoxomil.Clin Ther. 2004;26(suppl A):A12-A20.PubMedCrossRefGoogle Scholar
  5. 5.
    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.PubMedCrossRefGoogle Scholar
  6. 6.
    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.PubMedGoogle Scholar
  7. 7.
    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.CrossRefGoogle Scholar
  8. 8.
    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.PubMedCrossRefGoogle Scholar
  9. 9.
    Markham A, Goa KL. Valsartan. A review of its pharmacology and therapeutic use in essential hypertension.Drugs. 1997;54:299–311.PubMedCrossRefGoogle Scholar
  10. 10.
    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.PubMedCrossRefGoogle Scholar
  11. 11.
    Oparil S. Comparative antihypertensive efficacy of olmesartan: comparison with other angiotensin II receptor antagonists.J Hum Hypertens. 2002;16(suppl 2):S17-S23.PubMedCrossRefGoogle Scholar
  12. 12.
    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.PubMedCrossRefGoogle Scholar
  13. 13.
    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.PubMedCrossRefGoogle Scholar
  14. 14.
    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.Google Scholar
  15. 15.
    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.Google Scholar
  16. 16.
    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.Google Scholar
  17. 17.
    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.Google Scholar
  18. 18.
    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.Google Scholar
  19. 19.
    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.PubMedCrossRefGoogle Scholar
  20. 20.
    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.Google Scholar
  21. 21.
    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.PubMedCrossRefGoogle Scholar
  22. 22.
    White WB. Blood pressure load and target organ effects in patients with essential hypertension.J Hypertens Suppl. 1991;9:S39-S41.PubMedCrossRefGoogle Scholar
  23. 23.
    Verdecchia P, Schillaci G, Guerrini M, et al. Circadian blood pressure changes and left ventricular hypertrophy in essential hypertension.Circulation. 1991;81:528–536.Google Scholar
  24. 24.
    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.CrossRefGoogle Scholar
  25. 25.
    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.PubMedCrossRefGoogle Scholar

Copyright information

© Health Communications Inc 2005

Authors and Affiliations

  • Maurizio Destro
    • 1
  • Rossana Scabrosetti
    • 1
  • Alessandro Vanasia
    • 2
  • Amedeo Mugellini
    • 2
  1. 1.Divisione di Medicina InternaCentro per la Diagnosi e Cura dell’Ipertensione ArteriosaBroni (PV)Italy
  2. 2.Dipartimento di Medicina Interna eTerapia Medica Centro dell’Ipertensione e Fisiopatologia Cardiovascolare Clinica Medica IIUniversity of PaviaPaviaItaly

Personalised recommendations