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2. Cognitive Outcomes of Long-term Benzodiazepine and Related Drug (BDZR) Use in People Living With Mild to Moderate Alzheimer's Disease: Results From NILVAD

Author

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

Published
2020
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7. Antidepressant Use and Orthostatic Hypotension in Older Adults Living with Mild-to-Moderate Alzheimer Disease

Author

Dyer, Adam H, Murphy, Claire, Briggs, Robert, Lawlor, Brian, Kennelly, Sean P, Segurado, Ricardo, Kennelly, Sean, Marcel, G M, Howard, Robert, Pasquier, Florence, Borjesson-Hanson, Anne, Tsolaki, Magda, Lucca, Ugo, Molloy, D William, Coen, Robert, Riepe, Matthias W, Kenny, Rose Anne, Cregg, Fiona, O'Dwyer, Sarah, Walsh, Cathal, Adams, Jessica, Banzi, Rita, Breuilh, Laetitia, Daly, Leslie, Hendrix, Suzanne, Aisen, Paul, Gaynor, Siobhan, Sheikhi, Ali, Taekema, Diana G, Verhey, Frans R, Nemni, Raffaello, Nobili, Flavio, Franceschi, Massimo, Zanetti, Orazio, Konsta, Anastasia, Anastasios, Orologas, Nenopoulou, Styliani, Tsolaki-Tagaraki, Fani, Pakaski, Magdolna, Dereeper, Olivier, Senechal, Olivier, Devendeville, Agnès, Calais, Gauthier, Crawford, Fiona, Mullan, Michael, Aalten, Pauline, Berglund, Maria A, Claassen, Jurgen A, De Heus, Rianne A, De Jong, Daan L K, Godefroy, Olivier, Hutchinson, Siobhan, Ioannou, Aikaterini, Jonsson, Michael, Kent, Annette, Kern, Jurgen, Nemtsas, Petros, Panidou, Minoa-Kalliopi, Abdullah, Laila, Paris, Daniel, Santoso, Angelina M, van Spijker, Gerrita J, Spiliotou, Martha, Thomoglou, Georgia, Wallin, Anders, and Molloy, D. William

Subjects
Male, medicine.medical_specialty, Serotonin reuptake inhibitor, Blood Pressure, Antidepressant, Alzheimer's Disease, Hypotension, Orthostatic, 03 medical and health sciences, Orthostatic vital signs, 0302 clinical medicine, Alzheimer Disease, Internal medicine, Humans, Medicine, Dementia, Orthostatic Hypotension, Risk factor, Aged, Selective-Serotonin Reuptake Inhibitor, 030214 geriatrics, Orthostatic hypotension, business.industry, Falls, Alzheimer's disease, medicine.disease, Selective-serotonin reuptake inhibitor, Antidepressive Agents, Psychiatry and Mental health, Cross-Sectional Studies, Blood pressure, Cohort, Female, Geriatrics and Gerontology, business, circulatory and respiratory physiology
Abstract

Objectives: Antidepressant use is often reported as a risk factor for Orthostatic Hypotension (OH), however this relationship has never been explored in those with mild/moderate Alzheimer Disease (AD), who may represent a particularly vulnerable cohort. Methods: We performed a cross‐sectional analysis of baseline data from the NILVAD study. Participants with mild‐moderate AD were recruited from 23 centres in nine countries. Systolic and Diastolic Blood Pressure (SBP/DBP) was recorded in the seated position and after both 1 and 5 minutes of standing. OH was defined as a drop of ≥20 mmHg SBP/≥10 mmHg DBP. We examined the relationship between antidepressant use, orthostatic BP drop and the presence of OH, controlling for important covariates. Results: Of 509 participants (72.9 ± 8.3 years, 61.9% female), two‐fifths (39.1%; 199/509) were prescribed a regular antidepressant. Antidepressant use was associated with a significantly greater SBP and DBP drop at 5 minutes (β: 1.83, 0.16‐3.50, P = .03 for SBP; β: 1.13, 0.02‐2.25, P

Published
2020

8. Cognitive Outcomes of Long-term Benzodiazepine and Related Drug (BDZR) Use in People Living With Mild to Moderate Alzheimer's Disease: Results From NILVAD

Author

Dyer, Adam H., Dyer, Adam H., Murphy, Claire, Lawlor, Brian, Kennelly, Sean P., Segurado, Ricardo, Kennelly, Sean, Rikkert, Marcel G. M. Olde, Howard, Robert, Pasquier, Florence, Brjesson-Hanson, Anne, Tsolaki, Magda, Lucca, Ugo, Molloy, D. William, Coen, Robert, Riepe, Matthias W., Kalman, Janos, Kenny, Rose Anne, Cregg, Fiona, O'Dwyer, Sarah, Walsh, Cathal, Adams, Jessica, Banzi, Rita, Breuilh, Laetitia, Daly, Leslie, Hendrix, Suzanne, Aisen, Paul, Gaynor, Siobhan, Sheikhi, Ali, Taekema, Diana G., Verhey, Frans R., Nemni, Raffaello, Nobili, Flavio, Franceschi, Massimo, Frisoni, Giovanni, Zanetti, Orazio, Konsta, Anastasia, Anastasios, Orologas, Nenopoulou, Styliani, Tsolaki-Tagaraki, Fani, Pakaski, Magdolna, Dereeper, Olivier, de la Sayette, Vincent, Senechal, Olivier, Lavenu, Isabelle, Devendeville, Agnes, Calais, Gauthier, Crawford, Fiona, Mullan, Michael, Aalten, Pauline, Berglund, Maria A., NILVAD Study Grp, Dyer, Adam H., Dyer, Adam H., Murphy, Claire, Lawlor, Brian, Kennelly, Sean P., Segurado, Ricardo, Kennelly, Sean, Rikkert, Marcel G. M. Olde, Howard, Robert, Pasquier, Florence, Brjesson-Hanson, Anne, Tsolaki, Magda, Lucca, Ugo, Molloy, D. William, Coen, Robert, Riepe, Matthias W., Kalman, Janos, Kenny, Rose Anne, Cregg, Fiona, O'Dwyer, Sarah, Walsh, Cathal, Adams, Jessica, Banzi, Rita, Breuilh, Laetitia, Daly, Leslie, Hendrix, Suzanne, Aisen, Paul, Gaynor, Siobhan, Sheikhi, Ali, Taekema, Diana G., Verhey, Frans R., Nemni, Raffaello, Nobili, Flavio, Franceschi, Massimo, Frisoni, Giovanni, Zanetti, Orazio, Konsta, Anastasia, Anastasios, Orologas, Nenopoulou, Styliani, Tsolaki-Tagaraki, Fani, Pakaski, Magdolna, Dereeper, Olivier, de la Sayette, Vincent, Senechal, Olivier, Lavenu, Isabelle, Devendeville, Agnes, Calais, Gauthier, Crawford, Fiona, Mullan, Michael, Aalten, Pauline, Berglund, Maria A., and NILVAD Study Grp

Abstract

Objective: Benzodiazepines and related drugs (BDZRs) have been associated with an increased risk of Alzheimer's disease (AD) in later life. Despite this, it remains unclear whether ongoing BDZR use may further accelerate cognitive decline in those diagnosed with mild to moderate AD.Design: This study was embedded within NILVAD, a randomized controlled trial of nilvadipine in mild to moderate AD. Cognition was measured at baseline and 18 months using the Alzheimer Disease Assessment Scale, Cognitive Subsection (ADAS-Cog). We assessed predictors of long-term BDZR use and analyzed the effect of ongoing BDZR use on ADAS-Cog scores at 18 months. Additionally, the impact of BDZR use on adverse events, incident delirium, and falls over 18-month follow-up was assessed adjusting for relevant covariates.Setting and Participants: 448 participants with mild to moderate AD recruited from 23 academic centers in 9 European countries.Results: Overall, 14% (62/448) were prescribed an ongoing BDZR for the study duration. Increasing total number of (non-BDZR) medications was associated with a greater likelihood of BDZR prescription (odds ratio 1.16, 95% confidence interval 1.05-1.29). At 18 months, BDZR use was not associated with greater cognitive decline on the ADAS-Cog controlling for baseline ADAS-Cog scores, age, gender, study arm, and other clinical covariates (beta = 1.62, -1.34 to 4.56). However, ongoing BDZR use was associated with a greater likelihood of adverse events [incidence rate ratio (IRR) 1.19, 1.05-1.34], incident delirium (IRR 2.31, 1.45-3.68), and falls (IRR 1.66, 1.02-2.65) over 18 months that persisted after robust adjustment for covariates.Conclusions and Implications: This study found no effect of ongoing BDZR use on ADAS-Cog scores in those with mild to moderate AD over 18 months. However, ongoing use of these medications was associated with an increased risk of adverse events, delirium, and falls. Thus, BDZR use should be avoid

Published
2020

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

Author

Heus, Rianne A. A., Donders, Rogier, Santoso, Angelina M. M., Rikkert, Marcel G. M. Olde, Lawlor, Brian A., Claassen, Jurgen A. H. R., Segurado, Ricardo, Kennelly, Sean, Howard, Robert, Pasquier, Florence, Borjesson-Hanson, Anne, Tsolaki, Magda, Lucca, Ugo, Molloy, D. William, Coen, Robert, Riepe, Matthias W., Kalman, Janos, Kenny, Rose Anne, Cregg, Fiona, O'Dwyer, Sarah, Walsh, Cathal, Adams, Jessica, Banzi, Rita, Breuilh, Laetitia, Daly, Leslie, Hendrix, Suzanne, Aisen, Paul, Gaynor, Siobhan, Sheikhi, Ali, Taekema, Diana G., Verhey, Frans R., Nemni, Raffaello, Nobili, Flavio, Franceschi, Massimo, Zanetti, Orazio, Konsta, Anastasia, Anastasios, Orologas, Nenopoulou, Styliani, Tsolaki-Tagarak, Fani, Pakaski, Magdolna, Dereeper, Olivier, Sayette, Vincent, Senechal, Olivier, Lavenu, Isabelle, Devendeville, Agnes, Calais, Gauthier, Crawford, Fiona, Mullan, Michael, Aalten, Pauline, Berglund, Maria A., Jong, Daan L. K., Godefroy, Olivier, Hutchinso, Siobhan, Loannou, Aikaterini, Jonsson, Michael, Kent, Annette, Kern, Jurgen, Nemtsas, Petros, Panidou, Minoa-Kalliopi, Abdullah, Laila, Paris, Daniel, Spijker, Gerrita J., Spiliotou, Martha, Thomoglou, Georgia, Wallin, Anders, Frisoni, Giovanni, Psychiatrie & Neuropsychologie, MUMC+: MA Med Staf Spec Psychiatrie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Radboud University [Nijmegen], Department of Psychiatry, Institute of Psychiatry, Institute of psychiatry, Troubles cognitifs dégénératifs et vasculaires - U 1171 (TCDV), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), AHEPA University General Hospital [Thessaloniki], Istituto di Ricerce Farmacologiche Mario Negri, IRCCS - Istituto di Ricerche Farmacologiche 'Mario Negri' [Milan, Italy], University of San Diego (USD), Irish Clinical Research Infrastructures Network (ICRIN), Unità operativa di neurologia riabilitativa, Centro IRCCS Santa Maria Nascente', Fondazione Don Carlo Gnocchi, Clinical Neurophysiology Service, Dept of Endocrinological and Metabolic Sciences, University of Ge, Multimedica-Santa Maria, Castellanza, IRCCS San Giovanni di Dio Fatebenefratelli, Laboratoire d'Automatique, de Mécanique et d'Informatique industrielles et Humaines - UMR 8201 (LAMIH), Université de Valenciennes et du Hainaut-Cambrésis (UVHC)-Centre National de la Recherche Scientifique (CNRS), Maastricht University [Maastricht], Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559 (LNFP), Université de Picardie Jules Verne (UPJV), Sahlgrenska Academy at University of Gothenburg [Göteborg], Université de Genève = University of Geneva (UNIGE), Istituto Centro San Giovanni di Dio Fatebenefratelli, and Partenaires INRAE

Subjects
Male, Aging, Alzheimer`s disease Donders Center for Medical Neuroscience [Radboudumc 1], Time Factors, calcium channel blocker, [SDV]Life Sciences [q-bio], Blood Pressure, Calcium channel blocker, ANTIHYPERTENSIVE TREATMENT, Severity of Illness Index, law.invention, Orthostatic vital signs, Hypotension, Orthostatic, Randomized controlled trial, law, Risk Factors, Clinical Studies, Prevalence, Medicine, adverse drug event, Original Research, Aged, 80 and over, CARDIOVASCULAR RISK, DEMENTIA, ASSOCIATION, Middle Aged, Calcium Channel Blockers, Nilvadipine, EUROPEAN-SOCIETY, Europe, Treatment Outcome, Cardiology, antihypertensive agent, Female, Alzheimer's disease, Alzheimer disease, Cardiology and Cardiovascular Medicine, medicine.drug, medicine.medical_specialty, Nifedipine, medicine.drug_class, Posture, CONSENSUS STATEMENT, Risk Assessment, orthostatic hypotension, Double-Blind Method, Internal medicine, MANAGEMENT, Dementia, Humans, In patient, Antihypertensive Agents, Aged, OLDER, HYPERTENSION, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], medicine.disease, COGNITIVE IMPAIRMENT, Treatment, randomized controlled trial, Blood pressure lowering, business
Abstract

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.

Published
2019

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