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Olmesartan Medoxomil in Elderly Patients with Essential or Isolated Systolic Hypertension

Efficacy and Safety Data from Clinical Trials

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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.

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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.

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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

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  1. Anthony M. Heagerty
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  2. Jean-Michel Mallion
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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

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