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Sedative Load of Drugs and Adverse Outcomes Faculty of Health Sciences Is in Kuopio

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Sedative Load of Drugs and Adverse Outcomes Faculty of Health Sciences Is in Kuopio Sirpa Hartikainen Professor of Geriatric Pharmacotherapy, MD Kuopio Research Center of Geriatric Care School of Pharmacy, University of Eastern Finland Sedative load of drugs and adverse outcomes Faculty of Health Sciences is in Kuopio - 2400 undergraduate students 1 - 60 doctoral degrees every year 5 . 4 UEF - 100 professors 2 . 2 0 1 3 The city of Kuopio with about 120 000 inhabitants Esityksen nimi / Tekijä 15.4.2013 3 Esityksen nimi / Tekijä 15.4.2013 4 Kuopio Research Centre of Geriatric Care (GerHo) http://www.uef.fi/gerho ) 5 SEDATION •objectively measured decrease in psychomotor functioning including memory and attention •subjective feelings of drowsiness and sleepiness •subjective and objective do not necessarily correlate with each other. •The sedative effects of drugs may be pronounced among older people due to age- related changes in body, in CNS and in pharmacokinetics and - dynamics Esityksen nimi / Tekijä 15.4.2013 6 Pharmacological mechanisms •GABA-A complex (Benzodiazepines and barbiturates) Subtypes of GABA-A receptor also mediate other effects like muscle relaxation. •Histamine H1 receptors in the CNS (antihistamines) Sedative effects of histamine antagonism may be explained with the fact that histamine regulates the sleep-wake cycle •Opioids: μ-opioid receptors which also mediate sedation •A potential source of sedative effect is antagonism or agonism of α1- and α2-adrenergic receptors in the CNS Esityksen nimi / Tekijä 15.4.2013 7 Several models of assessing sedative load of drugs •Sedative Load Model •Sloan Model •Drug Burden Index •CNS Drug Model 15.4.2013 8 Comparison of the different methods to calculate cumulative effect of taking multiple drugs with sedative properties and ratings proposed to drug classes. Sedative Load Sloane Drug Burden CNS Drug Drug class Model Model Index Model Conventional rating: 2 rating: 3 included included antipsychotics Atypical rating: 1 rating: 3 included included antipsychotics TCAs, non-selective rating: 2 rating: 3 included included MAO inhibitors SSRIs rating: 1 rating: 3 included included Second generation rating: 1 rating: 3 included included antidepressants (mianserin rating 2) Benzodiazepines rating: 2 rating: 6 included included Other anxiolytics rating: 2 rating: 3 included not included and hypnotics Esityksen nimi / Tekijä 15.4.2013 9 Reference : Taipale H 2012 Comparison of the different methods to calculate cumulative effect of taking multiple drugs with sedative properties and ratings proposed to drug classes. Sedative Load Sloane Drug Burden CNS Drug Drug class Model Model Index Model Opioids rating: 1 rating: 3 included included Antiepileptics rating: 1 rating: 3 included not included Antiemetics rating: 1 rating: 3 included not included (metoclopramide, scopolamine) Antispasmodics rating: 1 no included not included with psychotropics Centrally acting rating: 1 no included not included muscle relaxants Anticholinergic rating: 1 rating: 3 included not included anti-parkinson drugs Indomethacin (with rating: 1 rating: 3 not included not included ethylmorphine) Esityksen nimi / Tekijä 15.4.2013 10 Sedative load model •reviewing the summary of product characteristics for all drugs available in Finland from 1998 to 2001 and updated 2008. •a comprehensive classification of all drugs on market and to include also drugs for somatic disorders. • All drugs were classified into 1 of 4 groups – (1) primary sedatives (score 2) – (2) drugs with sedation as a prominent side effect or preparations with a sedating component (score 1) – (3) drugs with sedation as a potential adverse effect (score 0) – (4) drugs with no known sedation. (score 0) Esityksen nimi / Tekijä 15.4.2013 11 The classification was based on consensus between a psychogeriatrician, a geriatrician, and a physician specialized in pharmacoepidemiology. According to the model, sedative load was calculated by summing the sedative rating for each drug in a person’s medication regimen according to the following formula: Esityksen nimi / Tekijä 15.4.2013 12 GeMS-study •Population is 1000 randomly sampled inhabitants of Kuopio, aged 75 years or older. •Randomization into intervention (500 persons) and control group (500 persons) •Intervention group: Comprehensive Geriatric Assessment (CGA) by a geriatrician, a nurse and a physiotherapist •Interventions: physical exercise counselling and gym, examination by dentist, nutritional counselling if needed, new diagnoses, assessment of medication … Esityksen nimi / Tekijä 15.4.2013 13 Population People aged ≥75 years living in Kuopio N=5615 (1 January, 2004) Random sample n=1000 (1 November, 2003) Intervention group, n=500 Comparison group, n=500 Not examined Refused n=162 Died n=55 Moved n=2 Baseline 2004 Intervention group, n=404 Comparison group, n=377 Loss to follow-up Refused n=11 Died n=52 No contact n=1 1. Follow-up 2005 Intervention group, n=371 Comparison group, n=346 Loss to follow-up Refused n=4 Died n=55 Moved n=1 2. Follow-up 2006 Intervention group, n=339 Comparison group, n=318 Loss to follow-up Refused n=2 Died n=46 3. Follow-up 2007 Intervention group, n=315 Comparison group, n=294 Esityksen nimi / Tekijä 15.4.2013 14 Characteristics of the study participants according to sedative load groups in the baseline of the GeMS Study. All Sedative Sedative Sedative p- % (n) load 0 load 1-2 load ≥3 valuea % (n) % (n) % (n) Women 69 (486) 66 (324) 80 (118) 76 (44) 0.002 Education ≤6 y 51 (346) 50 (240) 50 (72) 63 (34) 0.173 Loneliness <0.001 Often 4 (32) 3 (13) 8 (11) 14 (8) Sometimes 32 (225) 28 (138) 41 (60) 47 (27) Never 63 (441) 69 (343) 52 (76) 39 (22) Esityksen nimi / Tekijä 15.4.2013 15 Age, comorbidity and number drugs in the study participants according to sedative load groups in the baseline of the GeMS Study. All Sedative Sedative Sedative p- valuea load 0 load 1-2 load ≥3 Mean value Mean value Mean value Mean value ±SD ±SD ±SD ±SD Mean age 81.3 (4.6) 80.8 (4.4) 82.4 (4.7) 82.5 (5.6) <0.001 FCI mean 2.6 (1.7) 2.5 (1.7) 2.9 (1.8) 3.4 (1.7) <0.001 Mean number of 4.9 (3.2) 4.1 (2.7) 6.4 (3.1) 8.6 (3.6) <0.001 drugs a Continuous variables were tested with analysis of variance, and are presented Esityksen nimi / Tekijä 15.4.2013 16 as means (±SD), comparison between sedative load groups 0, 1-2 and ≥3. FCI=Functional Comorbidity Index score. Cognitive functioning, an self-rated health of the study participants according to sedative load groups in the baseline of the GeMS Study. All Sedative Sedative Sedative p- valuea % (n) load 0 load 1-2 load ≥3 % (n) % (n) % (n) Poor self-rated 15 (103) 10 (51) 24 (35) 30 (17) <0.001 health MMSE <25 25 (170) 20 (99) 30 (44) 47 (27) <0.001 Dementia 16 (109) 12 (61) 20 (30) 31 (18) <0.001 diagnosis GDS ≥5 8 (55) 5 (25) 12 (18) 21 (12) <0.001 Geriatric depression scale Esityksen nimi / Tekijä 15.4.2013 17 Physical functioning of the study participants according to sedative load groups in the baseline of the GeMS Study. Physical All Sedative Sedative Sedative p- valuea functioning % (n) load 0 load 1-2 load ≥3 % (n) % (n) % (n) Poor IADL, 36 (252) 30 (146) 46 (67) 67 (39) <0.001 score ≤6 Physical <0.001 activity Inactive 36 (245) 31 (150) 44 (62) 60 (33) Moderate or 64 (429) 69 (328) 56 (79) 40 (22) active Unable to walk 46 (324) 46 (229) 47 (69) 45 (26) 0.963 independently 400m Esityksen nimi / Tekijä 15.4.2013 18 Sedative load and associations with phycical performance, balance, muscle strenght and mobility Esityksen nimi15.4.2013 / Tekijä19 Timed up and go Muscle strenght (TUG) Balance ASSOCIATION WITH MUSCLE STRENGHT Grip strenght (kg) Knee extension (Newtons) Esityksen nimi / Tekijä 15.4.2013 20 Taipale HT. J Gerontol A Biol Sci Med Sci 66: 1384-1392, 2011. ASSOCIATIONS WITH MUSCLE STRENGHT Five time chair stand 10 m walking speed (m/s) (time in seconds) Taipale HT. J Gerontol A Biol Sci Med Sci 66: 1384-1392, Esityksen nimi / Tekijä 15.4.2013 21 2011 ASSOCIATIONS WITH BALANCE AND MOBILITY TUG (Timed Up and Go) Berg’s Balance Test (time in seconds) max 56 points The present study population consisted of 158 community-dwelling, dentate, non-smoking older people who participated in an oral clinical examination (110 women and 48 men, with a mean age of 79.3 and SD being 3.7 years). Esityksen nimi / Tekijä 15.4.2013 22 Taipale HT et al. J Clin Psychopharmacol 32: 218-224, 2012. LONGITUDINAL STUDY ON SEDATIVE LOAD •Baseline 2004 to the final examination in 2007, the sample decreased from 700 persons to 581 persons. •Among survivors the prevalence of sedative load at least 1 increased during the study years, from 29% to 36%. Esityksen nimi / Tekijä 15.4.2013 23 Sedative use during years 2004 to 2007 in the GeMS Study population, home-dwelling (n=700) at the baseline. 2004 2005 2006 2007 n=700 n=656 n=621 n=581 % n % n % n % n Users with sedative 29.3 205 30.0 197 33.7 209 36.1 210 load >1 1-2 21.0 147 22.1 145 24.3 151 24.4 142 ≥3 8.3 58 7.9 52 9.3 58 11.7 68 Women users 33.3 162 33.7 155 37.4 162 38.8 158 Men users 20.1 43 21.4 42 25.0 47 29.9 52 Age groups with sedative load >1 75-79 22.8 79 21.6 72 26.5 86 29.7 92 80-84 34.0 73 36.4 72 39.5 73 39.9 69 ≥85 38.1 53 42.4 53 44.6 50 50.0 49 15.
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