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Subgroup and per-protocol analyses from the Hypertension in the Very Elderly Trial

Beckett, Nigela; Peters, Rutha; Leonetti, Gastoneb; Duggan, Joec; Fagard, Robertd; Thijs, Lutd; Narkiewicz, Krzysztofe; McCormack, Terryf; Banya, Winstona; Fletcher, Astridg; Bulpitt, Christophera; on behalf of the HYVET study group

Journal of Hypertension:
doi: 10.1097/HJH.0000000000000195
ORIGINAL PAPERS: Elderly
Abstract

Background: The results of the Hypertension in the Very Elderly Trial showed positive benefits from blood pressure-lowering treatment in those aged 80 and over.

Method: An analysis by the pre-specified subgroups [age, sex, history of cardiovascular disease (CVD) and initial SBP] was performed. The Hypertension in the Very Elderly Trial was a randomized, double-blind, placebo-controlled trial of 3845 participants aged 80 and over with SBPs of 160–199 mmHg and diastolic pressures below 110 mmHg recruited from Europe, China, Australasia and Tunisia. Active treatment was indapamide sustained-release 1.5 mg with the addition of perindopril 2–4 mg as required to reach a target blood pressure of less than 150/80 mmHg.

Results: For total mortality, benefits were consistent: men [hazard ratio 0.82, 95% confidence interval (CI) 0.62–1.11], women (hazard ratio 0.77, 95% CI 0.66–0.99), those aged 80–84.9 (hazard ratio 0.76, 95% CI 0.60–0.96), those aged 85 and over (hazard ratio 0.87, 95% CI 0.64–1.20), those with a history of CVD (hazard ratio 0.76, 95% CI 0.48–1.20) and those without (hazard ratio 0.81, 95% CI 0.65–0.99), and similarly across a range of baseline SBPs. The point estimates for cardiovascular mortality, strokes, heart failure and cardiovascular events were all in favour of benefit. In the per-protocol analysis, strokes were reduced by 34% (P = 0.026), total mortality by 28% (P = 0.001), cardiovascular event by 37% (P < 0.001) and heart failure by 72% (P < 0.001).

Conclusion: In hypertensive patients aged 80 or more, treatment based on indapamide (sustained-release) 1.5 mg showed consistent benefits across pre-specified subgroups including those without established CVD (the majority), supporting the need for treatment even at this advanced age. There were too few aged 90 or over to determine benefit from treatment at extreme age.

Author Information

aImperial College London, Faculty of Medicine, London, UK

bMedical University of Milano, Cardiovascular Rehabilitation and Cardiac Disease Unit, Milan, Italy

cMater Hospital, Dublin, Ireland

dHypertension & Cardiovascular Rehabilitation Unit, Catholic University of Leuven, Belgium

eDepartment Hypertension and Diabetology, Meical University of Gdansk, Poland

fWhitby Group Practice, Whitby

gLondon School of Hygiene and Tropical Medicine, London, UK

*All committee members and investigators are listed in the On-line Supplement.

Correspondence to Dr Nigel Beckett, Department of Medicine, Imperial College London, Du Cane Rd., London W12 0NN, UK.Tel: +44 7957 248886; fax: +44 207 188 2086; e-mail: n.beckett@imperial.ac.uk

Abbreviations: BP, blood pressure; CI, confidence interval; CVD, cardiovascular disease; HR, hazard ratio; HYVET, Hypertension in the Very Elderly Trial; mmHg, millimetres of mercury

Received 21 May, 2013

Revised 27 January, 2014

Accepted 5 March, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins