Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Original Article
  • Published:

Antihypertensive efficacy and safety of olmesartan medoxomil compared with amlodipine for mild-to-moderate hypertension

Journal of Human Hypertension volume 17, pages 425–432 (2003)Cite this article

Abstract

The antihypertensive efficacy of the angiotensin II receptor blocker olmesartan medoxomil has been shown to compare favourably with that of other antihypertensive agents. This randomized, double-blind study compared the antihypertensive efficacy of the starting dose of olmesartan medoxomil with that of the calcium channel blocker amlodipine besylate (amlodipine) in subjects with mild-to-moderate hypertension. Following a 4-week, single-blind, placebo run-in period, 440 subjects aged ⩾18 years were randomized to the starting dose of olmesartan medoxomil (20 mg/day), amlodipine (5 mg/day), or placebo for 8 weeks. Subjects were evaluated by 24-h ambulatory blood pressure monitoring (ABPM) and by seated cuff blood pressure (BP) measurements at trough. The primary end point was the change from baseline in mean 24-h diastolic blood pressure (DBP) by ABPM at Week 8. Secondary end points included change from baseline in mean 24-h ambulatory systolic blood pressure (SBP) at 8 weeks, change from baseline in mean seated trough cuff DBP and SBP measurements, and response and control rates for DBP <90 and <85 mmHg. Control rates for SBP <140 and <130 mmHg were also calculated. Olmesartan medoxomil and amlodipine produced significantly greater reductions in ambulatory and seated DBP and SBP compared with placebo. Mean reductions in ambulatory and seated BP were similar between the two active agents; however, in the olmesartan medoxomil group, significantly more patients achieved the SBP goal of <130 mmHg and the DBP goal of <85 mmHg. Both drugs were well tolerated at the recommended starting dose. Although amlodipine was associated with a higher incidence of oedema, this did not reach statistical significance. Olmesartan medoxomil is an effective antihypertensive agent, with BP-lowering efficacy at the starting dose similar to that of amlodipine, and is associated with more patients achieving the rigorous BP goals of SBP <130 mmHg and DBP <85 mmHg.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Figure 1
Figure 2
Figure 3

Similar content being viewed by others

References

  1. Birkenhager WH, de Leeuw PW . Non-peptide angiotensin type 1 receptor antagonists in the treatment of hypertension. J Hypertens 1999; 17: 873–881.

    Article  CAS  Google Scholar 

  2. Burnier M, Brunner HR . Comparative antihypertensive effects of angiotensin II receptor antagonists. J Am Soc Nephrol 1999; 10 (Suppl 12): S278–S282.

    CAS  PubMed  Google Scholar 

  3. Neutel J . Safety and efficacy of angiotensin II receptor antagonists. Am J Cardiol 1999; 84: 13K–17K.

    Article  CAS  Google Scholar 

  4. Neutel J . Clinical studies of CS-866, the newest angiotensin II receptor antagonist. Am J Cardiol 2001; 87 (Suppl): 37C–43C.

    Article  CAS  Google Scholar 

  5. Stumpe KO, Ludwig M . Antihypertensive efficacy of olmesartan compared with other antihypertensive drugs. J Hum Hypertens 2002; 16 (Suppl 2): S24–S28.

    Article  CAS  Google Scholar 

  6. Van Mieghem W . A multi-centre, double-blind, efficacy, tolerability and safety study of the oral angiotensin II-antagonist olmesartan medoxomil versus atenolol in patients with mild to moderate essential hypertension. J Hypertens 2001; 19 (Suppl 2): S152.

    Google Scholar 

  7. Oparil S et al. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens 2001; 3: 283–291.

    Article  CAS  Google Scholar 

  8. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med 1997; 157: 2413–2446.

    Article  Google Scholar 

  9. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care 2002; 25: 199–201.

    Article  Google Scholar 

  10. Bakris GL et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis 2000; 36: 646–661.

    Article  CAS  Google Scholar 

  11. Osterloh I . The safety of amlodipine. Am Heart J 1989; 118: 1114–1119.

    Article  CAS  Google Scholar 

  12. Frishman WH et al. Comparison of amlodipine and benazepril monotherapy to amlodipine plus benazepril in patients with systemic hypertension: a randomized, double-blind, placebo-controlled, parallel-group study. The Benazepril/Amlodipine Study Group. J Clin Pharmacol 1995; 35: 1060–1066.

    Article  CAS  Google Scholar 

  13. Ekpo EB, Shah IU, Fernando MU, White AD . Isolated systolic hypertension in the elderly: survey of practitioners' attitude and management. Gerontology 1993; 39: 207–214.

    Article  CAS  Google Scholar 

  14. Frick MH, McGibney D, Tyler HM . A dose–response study of amlodipine in mild to moderate hypertension. J Intern Med 1989; 225: 101–105.

    Article  CAS  Google Scholar 

  15. Pitt B et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet 1997; 349: 747–752.

    Article  CAS  Google Scholar 

  16. Pitt B et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial—the Losartan Heart Failure Survival Study ELITE II. Lancet 2000; 355: 1582–1587.

    Article  CAS  Google Scholar 

  17. Lindholm LH et al, 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: 1004–1010.

    Article  CAS  Google Scholar 

  18. Dahlöf B et al, for the LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995–1003.

    Article  Google Scholar 

  19. Bloom BS . Continuation of initial antihypertensive medication after 1 year of therapy. Clin Ther 1998; 20: 671–681.

    Article  CAS  Google Scholar 

  20. Kloner RA et al, for the Comparison of Candesartan and Amlodipine for Safety, Tolerability and Efficacy (CASTLE) Study Investigators. Comparative effects of candesartan cilexetil and amlodipine in patients with mild systemic hypertension. Am J Cardiol 2001; 87: 727–731.

    Article  CAS  Google Scholar 

  21. Lacourciere Y et al. A comparison of the efficacies and duration of action of the angiotensin II receptor blockers telmisartan and amlodipine. Blood Press Monit 1998; 3: 295–302.

    CAS  PubMed  Google Scholar 

  22. Corea L et al. Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: a comparative study of the efficacy and safety against amlodipine. Clin Pharmacol Ther 1996; 60: 341–346.

    Article  CAS  Google Scholar 

  23. Oparil S et al. Efficacy, tolerability, and effects on quality of life of losartan, alone or with hydrochloro-thiazide, vs amlodipine, alone or with hydrochloro-thiazide, in patients with essential hypertension. Clin Ther 1996; 18: 608–625.

    Article  CAS  Google Scholar 

  24. Hansson L 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. Lancet 1998; 351: 1755–1762.

    Article  CAS  Google Scholar 

  25. Hebert LA et al, for the Modification of Diet in Renal Disease Study Group. Effects of blood pressure control on progressive renal disease in blacks and whites. Hypertension 1997; 30: 428–435.

    Article  CAS  Google Scholar 

  26. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–713.

    Article  Google Scholar 

Download references

Acknowledgements

Sources of research support: Sankyo Pharma Inc.

Author information

Authors and Affiliations

  1. Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City, OK, USA

    S G Chrysant

  2. Orlando Clinical Research Center, Orlando, FL, USA

    T C Marbury

  3. Sankyo Pharma Inc., Parsippany, NJ, USA

    T D Robinson

Authors
  1. S G Chrysant
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. T C Marbury
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. T D Robinson
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to S G Chrysant.

Appendix

Appendix

List of study investigators

James Adelman, MD, Greensboro, NC, USA

Michael Azorr, MD, Portland, OR, USA

Norse Bear, MD, Denver, CO, USA

Frederick Bieberdorf, MD, Austin, TX, USA

Scott Bleser, MD, Bellbrook, OH, USA

Rogelio Cattan, MD, Miami, FL, USA

Deanna Cheung, MD, Long Beach, CA, USA

Steven Chrysant, MD, Oklahoma City, OK, USA

Michael Doyle, MD, Birmingham, MI, USA

James Fulmer, MD, Jacksonville, FL, USA

Thomas Garland, MD, FACC, Lawrenceville, NJ, USA

Gumaro Garza, MD, McAllen, TX, USA

Larry Gilderman, DO, Pembroke Pines, FL, USA

Ronald Gilman, MD, East Providence, RI, USA

Stephen Green, MD, Hampton, VA, USA

William Grossman, MD, Charleston, SC, USA

Frank Hampel, Jr., MD, New Braunfels, TX, USA

Stuart Harris, MD, PhD, Miami, FL, USA

William John Henry III, MD, Greer, SC, USA

Jeffrey Herbst, MD, Portland, OR, USA

James Herron, MD, Chicago, IL, USA

Dean Kereiakes, MD, Cincinnati, OH, USA

Marc Kozinn, MD, Amherst, NY, USA

Andrew Lewin, MD, Los Angeles, CA, USA

Martin Lunde, MD, Arden Hills, MN, USA

Frank Maggiacomo, DO, Cranston, RI, USA

Thomas Marbury, MD, Orlando, FL, USA

David Miller, MD, North Dartmouth, MA, USA

Rafael Montoro, MD, Coral Gables, FL, USA

Joel Neutel, MD, Orange, CA, USA

Alan Niederman, MD, FACC, Ft. Lauderdale, FL, USA

Michael Peveler, MD, Louisville, KY, USA

Paul Ratner, MD, San Antonio, TX, USA

Albert Razetti, MD, DeLand, FL, USA

Dennis Ruff, MD, San Antonio, TX, USA

Stephan Sharp, MD, Nashville, TN, USA

Eugene Spiotta, Jr., MD, Memphis, TN, USA

Gary Andrew Tarshis, MD, Colorado Springs, CO, USA

Melvin Tonkon, MD, Anaheim, CA, USA

Timothy Truitt, MD, Melbourne, FL, USA

Suzanne Weakley, MD, Houston, TX, USA

David Williams, MD, Daytona Beach, FL, USA

Laurence Yellen, MD, San Diego, CA, USA

Rights and permissions

Reprints and permissions

About this article

Cite this article

Chrysant, S., Marbury, T. & Robinson, T. Antihypertensive efficacy and safety of olmesartan medoxomil compared with amlodipine for mild-to-moderate hypertension. J Hum Hypertens 17, 425–432 (2003). https://doi.org/10.1038/sj.jhh.1001577

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.jhh.1001577

Keywords

This article is cited by

Search

Advanced search

Quick links