Olmesartan Medoxomil in Elderly Patients with Essential or Isolated Systolic Hypertension Efficacy and Safety Data from Clinical Trials

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 I 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, double-blind 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.