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Blood Pressure Lowering With Nilvadipine in Patients With Mild‐to‐Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension

2019; Wiley; Volume: 8; Issue: 10 Linguagem: Inglês

10.1161/jaha.119.011938

2047-9980

Rianne A.A. de Heus, Rogier Donders, Angelina M.M. Santoso, Marcel G. M. Olde Rikkert, Brian Lawlor, Jurgen A.H.R. Claassen, Ricardo Segurado, Robert Howard, Florence Pasquier, Anne Börjesson‐Hanson, Magda Tsolaki, Ugo Lucca, D. William Molloy, Robert F. Coen, Matthias W. Riepe, János Kálmán, Rose Anne Kenny, Fiona Cregg, Sarah O’Dwyer, Cathal Walsh, Jessica Adams, Rita Banzi, Laëtitia Breuilh, Leslie Daly, Suzanne Hendrix, Paul Aisen, Siobhan Gaynor, Ali Sheikhi, Diana G. Taekema, Frans R.J. Verhey, Raffaello Nemni, Flavio Nobili, M. Franceschi, Giovanni B. Frisoni, Orazio Zanetti, Anastasia Konsta, Anastasios Orologas, Styliani Nenopoulou, Fani Tsolaki-Tagaraki, Magdolna Pákáski, Olivier Dereeper, Vincent de La Sayette, Olivier Sénéchal, Isabelle Lavenu, Agnès Devendeville, Gauthier Calais, Fiona Crawford, Michael Mullan, Pauline Aalten, Maria A. Berglund, Daan L. K. de Jong, Olivier Godefroy, Siobhán Hutchinson, Aikaterini Ioannou, Michael Jonsson, Annette Kent, Jürgen Kern, Petros Nemtsas, Minoa‐Kalliopi Panidou, Laila Abdullah, Daniel Paris, Gerrita J. van Spijker, Martha Spiliotou, Georgia Thomoglou, Anders Wallin, Oliver Gupta,

Cardiovascular Health and Disease Prevention

Background Hypertension is common among patients with Alzheimer disease. Because this group has been excluded from hypertension trials, evidence regarding safety of treatment is lacking. This secondary analysis of a randomized controlled trial assessed whether antihypertensive treatment increases the prevalence of orthostatic hypotension (OH) in patients with Alzheimer disease. Methods and Results Four hundred seventy-seven patients with mild-to-moderate Alzheimer disease were randomized to the calcium-channel blocker nilvadipine 8 mg/day or placebo for 78 weeks. Presence of OH (blood pressure drop ≥20/≥10 mm Hg after 1 minute of standing) and OH-related adverse events (dizziness, syncope, falls, and fractures) was determined at 7 follow-up visits. Mean age of the study population was 72.2±8.2 years and mean Mini-Mental State Examination score was 20.4±3.8. Baseline blood pressure was 137.8±14.0/77.0±8.6 mm Hg. Grade I hypertension was present in 53.4% (n=255). After 13 weeks, blood pressure had fallen by -7.8/-3.9 mm Hg for nilvadipine and by -0.4/-0.8 mm Hg for placebo ( P<0.001). Across the 78-week intervention period, there was no difference between groups in the proportion of patients with OH at a study visit (odds ratio [95% CI]=1.1 [0.8-1.5], P=0.62), nor in the proportion of visits where a patient met criteria for OH, corrected for number of visits (7.7±13.8% versus 7.3±11.6%). OH-related adverse events were not more often reported in the intervention group compared with placebo. Results were similar for those with baseline hypertension. Conclusions This study suggests that initiation of a low dose of antihypertensive treatment does not significantly increase the risk of OH in patients with mild-to-moderate Alzheimer disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02017340.