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Antipsychotic Drugs and Risk of Hip Fracture in People Aged 60 and Older in Norway † ‡§¶ Marit S

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Antipsychotic Drugs and Risk of Hip Fracture in People Aged 60 and Older in Norway † ‡§¶ Marit S Antipsychotic Drugs and Risk of Hip Fracture in People Aged 60 and Older in Norway † ‡§¶ Marit S. Bakken, MD, PhD,* Jan Schjøtt, MD, PhD, Anders Engeland, MSc, PhD,*** ‡†† ‡‡ Lars B. Engesæter, MD, PhD, and Sabine Ruths, MD, PhD* of sustaining a hip fracture during exposure than during nonexposure. Although confounding by indication, comor- OBJECTIVES: To examine associations between exposure bidity, or other drugs used cannot be excluded, this associ- to various subgroups of antipsychotic drugs and risk of ation is relevant for clinical practice because hip fracture hip fracture in older adults. and antipsychotic drug use are prevalent in vulnerable DESIGN: Nationwide cohort study. older individuals. Clinical studies examining mechanisms or causality of the observed association between antipsy- SETTING: Norway, 2005–2010. chotic drug use and excess risk of hip fracture are needed. PARTICIPANTS: Everyone living in Norway born before J Am Geriatr Soc 64:1203–1209, 2016. 1945 (N = 906,422). MEASUREMENTS: Information was obtained on all pre- Key words: antipsychotics; hip fractures; aged; pharma- scriptions of antipsychotic drugs dispensed from 2004 to coepidemiology; population registers 2010 (Norwegian Prescription Database) and data on all primary hip fractures from 2005 to 2010 (Norwegian Hip Fracture Registry). Incidence rates of hip fracture during person-time exposed and unexposed to antipsychotic drugs were compared by calculating the standardized incidence ratio (SIR). RESULTS: Thirty-nine thousand nine hundred thirty-eight ip fractures are highly prevalent in older people, with (4.4%) participants experienced a primary hip fracture. Himplications for morbidity and mortality.1,2 Numer- Greater risk of hip fracture was associated with exposure ous factors (e.g., medical conditions, drug use, lifestyle) = to any antipsychotic (SIR 2.1, 95% confidence interval affect the risk of hip fracture. Most hip fractures result = – = (CI) 1.9 2.1), first-generation antipsychotics (SIR 2.0, from a combination of low bone mineral density and a = – 95% CI 1.8 2.2), second-generation antipsychotics fall,3 and low bone mineral density and falls are both mul- = = – (SIR 2.2, 95% CI 1.9 2.4), prolactin-sparing antipsy- tifactorial in origin. Use of psychotropic drugs (antidepres- = = – chotics (SIR 2.4, 95% CI 1.8 3.1) and prolactin-ele- sant, anxiolytic, hypnotic, antipsychotic drugs) is an = = – vating antipsychotics (SIR 2.0, 95% CI 1.9 2.2). independent, and potentially modifiable, risk factor for CONCLUSION: In people aged 60 and older in Norway, falls in older people.4 Their effects on bone metabolism those who took an antipsychotic drug had twice the risk differ; whereas antidepressants with serotonergic properties – negatively affect bone metabolism,5 7 there is no evidence From the *Department of Global Public Health and Primary Care, Faculty that anxiolytics or hypnotics do, and the results are con- † 8,9 of Medicine and Dentistry, University of Bergen; Kavli Research Centre flicting regarding antipsychotics. for Geriatrics and Dementia, Haraldsplass Deaconess Hospital; ‡ Schizophrenia and other psychotic disorders and Department of Clinical Science, Faculty of Medicine and Dentistry, § symptoms are the main indications for treatment with University of Bergen; Section of Clinical Pharmacology, Laboratory of ¶ 10 Clinical Biochemistry; Regional Medicines Information and antipsychotic drugs, often involving long-term drug 11 Pharmacovigilance Centre, Haukeland University Hospital, Bergen; treatment. Off-label prescribing is widespread, especially **Department of Pharmacoepidemiology, Norwegian Institute of Public †† for behavioral and psychiatric symptoms of dementia in Health, Oslo; Norwegian Arthroplasty Registry, Department of nursing home residents such as agitation and restless- Orthopaedics and Department of Clinical Medicine, Haukeland University – ‡‡ 12 14 Hospital; and Research Unit for General Practice, Uni Research Health, ness. Treatment effects are limited in these conditions, 12 Bergen, Norway. severe adverse effects are common, and antipsychotic Address correspondence to Marit S. Bakken, Department of Global Public drugs can be withdrawn from most residents without 14 Health and Primary Care, University of Bergen, PB 7804, N-5018 Bergen, adversely affecting their behavior. Antipsychotics are Norway. E-mail: [email protected] prescribed to 4% to 10% of community-dwelling people 15,16 DOI: 10.1111/jgs.14162 aged 70 and older and 20% to 50% of nursing home JAGS 64:1203–1209, 2016 © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society 0002-8614/16/$15.00 1204 BAKKEN ET AL. JUNE 2016–VOL. 64, NO. 6 JAGS – residents worldwide.17 20 Whereas prescription rates of medication dispensed to people staying in the hospital antipsychotics for community-dwelling people are stable, (~12,000 at any time) and in nursing homes (~40,000 at they are declining in nursing homes; prescription rates in any time). Norway are in the lowest parts of the range.16,21 The Norwegian Hip Fracture Registry, starting from Observational studies have shown associations January 2005, contains national data (injury, fracture, sur- between antipsychotic drug use and hip fracture; which gery) on people who undergo surgery for hip fracture at subgroup is associated with the greatest excess risk is all 55 hospitals in Norway performing such surgery.33 For unclear,8,13,22,23 as are the mechanisms involved. the purpose of this study, the date of first (primary) hip It is thought that antipsychotic drugs have their fracture registered for the period January 2005 until antipsychotic effect by occupying dopaminergic receptors December 2010 was extracted. Even though hip fractures in the brain, although a contribution from serotonergic occurring during a hospital or nursing home stay are effects cannot be excluded.24 All antipsychotics have pro- included in the Norwegian Hip Fracture Registry, these lactin-elevating potential, primarily associated with groups could not be identified in the dataset. dopaminergic D2 receptor occupancy in the pituitary and The Central Population Registry contains demographic the drugs’ ability to penetrate the blood–brain barrier.25 information on the entire population of Norway. The data First-generation antipsychotics (FGAs) have high affinity extracted for this study comprise birth year, sex and date for dopaminergic receptors, whereas dopaminergic affinity of death or emigration if applicable. varies among second-generation antipsychotics (SGAs). The variables selected from these three registries were The latter also show variable binding to serotonergic (5- linked using the unique 11-digit personal identity number hydroxytryptamine; 5-HT), adrenergic, histaminergic, and assigned after 1960 to everyone living in Norway. muscarinic receptors.26 Serotonin levels and serotonergic neurotransmission may influence prolactin secretion.27 Study Population Thus, SGAs could be associated with greater prolactin secretion, although antidopaminergic activity varies within The study population included everyone born before 1945 this subgroup of antipsychotics. and living in Norway on January 1, 2005. All individuals Antipsychotic drugs probably affect bone tissue indi- in this cohort were followed until the day of any first hip rectly through prolactin-induced hypogonadism. Recent fracture, emigration or death, or the end of the study per- studies suggest that they may also directly affect bone iod on December 31, 2010. – homeostasis.8,9,27 30 An example is risperidone, which is thought to affect bone formation and resorption through 31 Medications Studied its ability to block 5-HT2B and a1-adrenoceptors. The following medications were included in this study: ATC code N05A, antipsychotics: Aims of the Study N05AA, phenothiazines with aliphatic side-chain (chlor- The aim of the study was to examine associations between promazine, levomepromazine) exposure to various subgroups of antipsychotic drugs and N05AB, phenothiazines with piperazine structure (dixyra- the risk of hip fracture in older people. The subgroups zine, fluphenazine, perphenazine, prochlorperazine, triflu- were FGAs or SGAs and prolactin-sparing or prolactin-ele- operazine) vating antipsychotics. If associations were found, the goal N05AC, phenothiazines with piperidine structure (thiori- was to estimate the attributable risk of hip fracture. dazine, pipotiazine) N05AD, butyrophenone derivatives (haloperidol, melper- METHODS one) N05AE, indole derivatives (sertindole, ziprasidone) This was a nationwide study based on merged data from N05AF, thioxanthene derivatives (flupenthixol, chlorproth- the Norwegian Prescription Database,32 the Norwegian ixene, zuclopenthixol) Hip Fracture Registry,33 and the Central Population Regis- N05AG, diphenylbutylpiperidine derivatives (pimozide, try.34 The study lasted from January 1, 2005, to December penfluridol) 31, 2010. N05AH, diazepines, oxazepines, thiazepines, oxepines (clozapine, olanzapine, quetiapine) Data Sources N05AL, benzamides (sulpiride, tiapride amisulpride) N05AX, others (risperidone, aripiprazole) The Norwegian Prescription Database, starting from Jan- uary 2004, contains detailed information on all prescrip- Although lithium is classified as N05A in the ATC sys- tion drugs purchased at all pharmacies in Norway.32 The tem (N05AN01), its main indication as a mood stabilizer data extracted for this study comprise all prescriptions of differs from that of all other N05A drugs, and it was antipsychotics
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