Skip to main content
SpringerLink
Log in

Olmesartan Medoxomil in Elderly Patients with Essential or Isolated Systolic Hypertension

Efficacy and Safety Data from Clinical Trials

  • Original Research Article
  • Published:
Drugs & Aging Aims and scope Submit manuscript

Abstract

Background

The appearance and progression of essential hypertension is associated with increasing age. Older patients also frequently have an abnormally elevated systolic blood pressure (SBP) [≥140 mmHg] without an elevated diastolic blood pressure (DBP) [≤90 mmHg], a phenomenon known as isolated systolic hypertension. Thus, management of hypertension in elderly patients requires agents that can effectively treat isolated systolic hypertension as well as essential hypertension.

Objective

The aim of this analysis was to assess the efficacy and safety of the angiotensin II type 1 receptor antagonist (angiotensin receptor blocker [ARB]) olmesartan medoxomil in elderly patients with either essential hypertension or isolated systolic hypertension.

Methods

Efficacy data were obtained from two studies and safety data from an Integrated Summary of Safety. The efficacy of individually optimized doses of olmesartan medoxomil 20 or 40 mg/day, with or without hydrochlorothiazide, in elderly patients (≥65 years) was assessed in two separate randomized, doubleblind studies. One study assessed DBP changes in 251 patients with essential hypertension (mean seated DBP [seDBP] 100–114 mmHg and mean seated SBP [seSBP] >150 mmHg); the other study evaluated SBP changes in 256 patients with isolated systolic hypertension (mean seSBP >160 mmHg and mean seDBP <90 mmHg). Safety and tolerability were assessed in each study and in an Integrated Summary of Safety, which comprised data from 1646 hypertensive patients aged ≥65 years.

Results

In patients with essential hypertension, 12 weeks of treatment reduced mean seDBP (primary efficacy parameter) by 17.9 mmHg; mean seSBP was also significantly reduced. At study end (week 52), the proportion of diastolic responders (seDBP ≥90 mmHg) was 93%. In patients with isolated systolic hypertension, mean seSBP was reduced by 30.0 mmHg at week 12 (primary efficacy parameter); mean seDBP was only slightly reduced. At study end (week 24), the proportion of systolic responders (seSBP ≥135 mmHg) was 62.5%. Reductions in blood pressure (BP) were maintained throughout treatment in both patient populations. In each study, doubling the olmesartan medoxomil dose from 20 to 40 mg/day or adding hydrochlorothiazide delivered additional BP-lowering efficacy without any tolerability concerns, and the Integrated Summary of Safety also showed that olmesartan medoxomil with or without hydrochlorothiazide was well tolerated. Efficacy and safety results were similar in elderly (65–74 years) and very elderly (≥75 years) patients.

Conclusion

Olmesartan medoxomil provides effective and well tolerated control of hypertension in elderly patients with either essential hypertension or isolated systolic hypertension.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II
Fig. 1
Table III
Table IV
Fig. 2
Table V
Table VI
Table VII

Similar content being viewed by others

References

  1. Lewington S, Clarke R, Qizilbash N, et al. 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(9349): 1903–13

    Article  Google Scholar 

  2. Chobanian AV, Bakris GL, Black HR, et al. 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(19): 2560–72

    Article  CAS  Google Scholar 

  3. Vasan RS, Beiser A, Seshadri S, et al. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA 2002; 287(8): 1003–10

    Article  Google Scholar 

  4. Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and control of hypertension in the United States, 1988–2000. JAMA 2003; 290(2): 199–206

    Article  Google Scholar 

  5. Hyman DJ, Pavlik VN. Characteristics of patients with uncontrolled hypertension in the United States. N Engl J Med 2001; 345(7): 479–86

    Article  CAS  Google Scholar 

  6. Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension. The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007; (25): 1105–87

    Google Scholar 

  7. Franklin SS, Gustin WT, Wong ND, et al. Hemodynamic patterns of age-related changes in blood pressure. The Framingham Heart Study. Circulation 1997; 96(1): 308–15

    Article  CAS  Google Scholar 

  8. Borzecki AM, Wong AT, Hickey EC, et al. Hypertension control: how well are we doing? Arch Intern Med 2003; 163(22): 2705–11

    Article  Google Scholar 

  9. Whitworth JA, World Health Organization International Society of Hypertension Writing Group. 2003 World Health Organization (WHOyinternational Society of Hypertension (ISH) statement on management of hypertension. J Hypertens 2003; 21(11): 1983–92

    Article  Google Scholar 

  10. National Institute for Health and Clinical Excellence (NICE). Clinical guideline 34: Hypertension: management of hypertension in adults in primary care: partial update. June 2006 [online]. Available from URL: http://www.nice.org.uk/CG034guidance [Accessed 2007 Mar 12]

  11. McInnes GT, O’Kane KP, Jonker J, et al. The efficacy and tolerability of candesartan cilexetil in an elderly hypertensive population. J Hum Hypertens 1997; 11 Suppl. 2: S75–80

    PubMed  CAS  Google Scholar 

  12. Conlin PR, Elkins M, Liss C, et al. A study of losartan, alone or with hydrochlorothiazide vs nifedipine GITS in elderly patients with diastolic hypertension. J Hum Hypertens 1998; 12(10): 693–9

    Article  CAS  Google Scholar 

  13. Lacourciere Y. A multicenter, randomized, double-blind study of the antihypertensive efficacy and tolerability of irbesartan in patients aged > or = 65 years with mild to moderate hypertension. Clin Ther 2000; 22(10): 1213–24

    Article  CAS  Google Scholar 

  14. Mogensen CE, Neldam S, Tikkanen I, et al. Randomised controlled trial of dual blockade of renin-angiotensin system in patients with hypertension, microalbuminuria, and non-insulin dependent diabetes: the Candesartan And Lisinopril Microalbuminuria (CALM) study. BMJ 2000; 321(7274): 1440–4

    Article  CAS  Google Scholar 

  15. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For End-point reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359(9311): 995–1003

    Article  CAS  Google Scholar 

  16. Malacco E, Vari N, Capuano V, et al. A randomized, double-blind, active-controlled, parallel-group comparison of val-sartan and amlodipine in the treatment of isolated systolic hypertension in elderly patients: the Val-Syst study. Clin Ther 2003; 25(11): 2765–80

    Article  CAS  Google Scholar 

  17. Punzi HA, Punzi CF. Once-daily eprosartan mesylate in the treatment of elderly patients with isolated systolic hypertension: data from a 13-week double-blind, placebo-controlled, parallel, multicenter study. J Hum Hypertens 2004; 18(9): 655–61

    Article  CAS  Google Scholar 

  18. Mangoni AA, Jackson SH. The implications of a growing evidence base for drug use in elderly patients. Part 2: ACE Inhibitors and angiotensin receptor blockers in heart failure and high cardiovascular risk patients. Br J Clin Pharmacol 2006; 61(5): 502–12

    Article  CAS  Google Scholar 

  19. Thomas GN, Chan P, Tomlinson B. The role of angiotensin II type 1 receptor antagonists in elderly patients with hypertension. Drugs Aging 2006; 23(2): 131–55

    Article  CAS  Google Scholar 

  20. Winkelmayer WC, Zhang Z, Shahinfar S, et al. Efficacy and safety of angiotensin II receptor blockade in elderly patients with diabetes. Diabetes Care 2006; 29(10): 2210–7

    Article  CAS  Google Scholar 

  21. Oparil S, Williams D, Chrysant SG, et al. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens (Greenwich) 2001; 3(5): 283–91, 318

    Article  CAS  Google Scholar 

  22. Brunner HR, Stumpe KO, Januszewicz A. Antihypertensive efficacy of olmesartan medoxomil and candesartan cilexetil assessed by 24-hour ambulatory blood pressure monitoring in patients with essential hypertension. Clin Drug Invest 2003; 23(7): 419–30

    Article  CAS  Google Scholar 

  23. Smith DH, Dubiel R, Jones M. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 2005; 5(1): 41–50

    Article  CAS  Google Scholar 

  24. Brunner H, Arakawa K. Antihypertensive efficacy of olmesartan medoxomil and candesartan cilexetil in achieving 24-hour blood pressure reductions and ambulatory blood pressure goals. Clin Drug Invest 2006; 26(4): 485–93

    Article  Google Scholar 

  25. Mallion JM, Heagerty A, Laeis P. Systolic blood pressure reduction with olmesartan medoxomil versus nitrendipine in elderly patients with isolated systolic hypertension. J Hypertens 2007; 25: 2168–77

    Article  CAS  Google Scholar 

  26. Data on file, Daiichi-Sankyo, 2007

  27. Data on file, Daiichi-Sankyo, 2007

  28. Bowman TS, Sesso HD, Gaziano JM. Effect of age on blood pressure parameters and risk of cardiovascular death in men. Am J Hypertens 2006; 19: 47–52

    Article  Google Scholar 

  29. Brown DW, Giles WH, Greenlund KJ. Blood pressure parameters and risk of fatal stroke, NHANES II mortality study. Am J Hypertens 2007; 20: 338–41

    Article  Google Scholar 

  30. Neal B, MacMahon S, Hapman N. 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(9246): 1955–64

    Article  CAS  Google Scholar 

  31. Brindel P, Hanon O, Dartigues JF, et al. Prevalence, awareness, treatment, and control of hypertension in the elderly: the Three City study. J Hypertens 2006; 24(1): 51–8

    Article  CAS  Google Scholar 

  32. Somes GW, Pahor M, Shorr RI, et al. The role of diastolic blood pressure when treating isolated systolic hypertension. Arch Intern Med 1999; 159(17): 2004–9

    Article  CAS  Google Scholar 

  33. Blacher J, Staessen JA, Girerd X, et al. Pulse pressure not mean pressure determines cardiovascular risk in older hypertensive patients. Arch Intern Med 2000; 160(8): 1085–9

    Article  CAS  Google Scholar 

  34. Vaccarino V, Berger AK, Abramson J, et al. Pulse pressure and risk of cardiovascular events in the systolic hypertension in the elderly program. Am J Cardiol 2001; 88(9): 980–6

    Article  CAS  Google Scholar 

  35. Bremner AD, Baur M, Oddou-Stock P, et al. Valsartan: long-term efficacy and tolerability compared to lisinopril in elderly patients with essential hypertension. Clin Exp Hypertens 1997; 19(8): 1263–85

    Article  CAS  Google Scholar 

  36. Simpson KL, McClellan KJ. Losartan: a review of its use, with special focus on elderly patients. Drugs Aging 2000; 16(3): 227–50

    Article  CAS  Google Scholar 

  37. Mallion JM, Carretta R, Trenkwalder P, et al. Valsartan/hydrochlorothiazide is effective in hypertensive patients inadequately controlled by valsartan monotherapy. Blood Press 2003; Suppl. 1: 36–43

    Google Scholar 

  38. Neutel JM, Bedigian MP. Efficacy of valsartan in patients aged > or = 65 years with systolic hypertension. Clin Ther 2000; 22(8): 961–9

    Article  CAS  Google Scholar 

  39. Schroeder K, Fahey T, Ebrahim S. How can we improve adherence to blood pressure-lowering medication in ambulatory care? Systematic review of randomized controlled trials. Arch Intern Med 2004 Apr 12; 164: 722–32

    Article  Google Scholar 

Download references

Acknowledgements

These studies were sponsored by Daiichi Sankyo GmbH, and the integration of safety data was performed by Daiichi Sankyo GmbH. Professor Mallion and Professor Heagerty have received support from Daiichi Sankyo GmbH for speaking at scientific symposia and Professor Heagerty has acted as a scientific consultant to Daiichi Sankyo GmbH and received lecture fees from Servier, Solvay and Recordati. The authors would like to thank Dr Phil Jones from Wolters Kluwer Health who provided medical writing support on behalf of Daiichi Sankyo GmbH.

Author information

Authors and Affiliations

  1. Division of Cardiovascular and Endocrine Sciences Core Technology, Cardiovascular Research Group, University of Manchester, Manchester, UK

    Anthony M. Heagerty (Professor of Medicine)

  2. CHU Hôpital Nord, Grenoble, France

    Jean-Michel Mallion

Authors
  1. Anthony M. Heagerty
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jean-Michel Mallion
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Heagerty, A.M., Mallion, JM. Olmesartan Medoxomil in Elderly Patients with Essential or Isolated Systolic Hypertension. Drugs Aging 26, 61–76 (2009). https://doi.org/10.2165/0002512-200926010-00005

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/0002512-200926010-00005

Keywords

Search

Navigation