ANTIDEPRESSANT MEDICATION & RISK OF DEMENTIA

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1 ANTIDEPRESSANT MEDICATION & RISK OF DEMENTIA A Nationwide Cohort Study in Taiwan / Speaker: Chee-Kin Then / Advisor: Prof. Shing-Chuan Shen / Unit: Graduate Institute of Medical Sciences / Date:

2 Dementia A clinical syndrome characterized by cognitive impairment, which including difficulties in thinking, memory, language and emotion 02

3 Mixed dementia Alzheimer s disease Vascular dementia Dementia with Lewy bodies Frontotemporal dementia 03

4 In Taiwan, the age-adjusted prevalence of all-cause dementia, was 8.04% Sun Y. et al. A Nationwide Survey of Mild Cognitive Impairment and Dementia, Including Very Mild Dementia, in Taiwan. PloS one. Jun ;9(6) 04

5 Younger onset depression is a risk factor of late life dementia They are comorbidity, share common risk factors or similar pattern of neuronal injury Depression can act as symptom or consequence of dementia Bennett S, Thomas AJ. Depression and dementia: cause, consequence or coincidence? Maturitas. Oct 2014;79(2):

6 1 Study by using Taiwan s NHIRD illustrated populations with dementia have higher ratio in taking antidepressants 2 Causes severe neurological side effects, which reflects antidepressants would interfere neurotransmitter systems 3 Cytotoxicity, damage normal cells which include osteoblasts, osteoclasts, hepatocytes, etc Madhusoodanan S, et al. Extrapyramidal symptoms associated with antidepressants--a review of the literature and an analysis of spontaneous reports. Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists. Aug 2010;22(3): Hodge JM, et al. Selective serotonin reuptake inhibitors inhibit human osteoclast and osteoblast formation and function. Biological psychiatry. Jul ;74(1): Hsiao FY, et al. Dose-responsive effect of psychotropic drug use and subsequent dementia: a nationwide propensity score matched case-control study in Taiwan. Journal of the American Medical Directors Association. Jul 2014;15(7):

7 Antidepressant medication would increase the risk of dementia TCAs & TeCAs SSRIs SARIs MAOIs SNRIs 07

8 In Taiwan, the prevalence of antidepressants use 3.21% 4.63% Year 2000 Year 2009 Wu CS, Shau WY, Chan HY, Lee YC, Lai YJ, Lai MS. Utilization of antidepressants in Taiwan: a nationwide population-based survey from 2000 to Pharmacoepidemiology and drug safety. Sep 2012;21(9):

9 Study Design 9 years 4 years Outcome: Dementia years Antidepressant(+/-) Risk factors: Stroke Depression Diabetes Mellitus Hypertension Hyperlipidemia With 1:4 age-, sex- and date-matched schema: 5819 cases and controls were enrolled 09

10 Table 1. Comparison of demographic characteristics and risk factors between cases and controls Study (n=5,819) Control (n=23,276) P value n (%) n (%) Age group (years) * ,510 (25.95%) 6,051 (26.00%) ,606 (44.78%) 10,407 (44.71%) 65 1,703 (29.27%) 6,818 (29.29%) Sex (male) * 2,508 (43.10%) 10,032 (43.10%) 0 Insurance amount (NT$) * < , (14.14%) 2,955 (17.18%) 20,000-39, (21.64%) 4,580 (26.62%) <20,000 2,712 (64.22%) 9,670 (56.20%) Region *.003 North 2,565 (44.31%) 10,312 (44.51%) Center 1,414 (24.43%) 5,740 (24.77%) South 1,639 (28.31%) 6,622 (28.58%) East 171 (2.95%) 495 (2.14%) Urbanicity * < (most urbanized) 1,744 (33.23%) 7,439 (35.12%) 2 1,748 (33.31%) 6,672 (31.50%) (15.68%) 3,621 (17.09%) 4(least urbanized) 933 (17.78%) 3,450 (16.29%) Risk factors * Stroke 357 (6.14%) 610 (2.62%) <.001 Depression 969 (16.65%) 434 (1.86%) <.001 Diabetes Mellitus 721 (12.39%) 2,103 (9.04%) <.001 Hypertension 1,128 (19.38%) 3,903 (16.77%) <.001 Hyperlipidemia 775 (13.32%) 2,514 (10.80%) <.001 *Chi-square test. Subjects for all levels do not sum up to original cases due to missing values. Note: NT = New Taiwan. 10

11 Table 2 Logistic regressions of factors associated with the treated incidence of dementia Event, n Rate (95%CI), per 100 person Age group (years) * 44 13/7, [ ] /13, [ ] 65 years 383/8, [ ] Sex Female 269/16, [ ] Male 192/12, [ ] Insurance amount (NT$) 40,000 21/3, [ ] 20,000-39,999 50/5, [ ] < NT$20, /12, [ ] Region North 178/12, [ ] Center 130/7, [ ] South 137/8, [ ] East 11/ [ ] Urbanicity 1 (most urbanized) 109/9, [ ] 2 125/8, [ ] 3 70/4, (least urbanized) [ ] 104/4, [ ] With Depression (n=1,403) 2.05 [ ] [ ] 1.02 [ ] 4.05 [ ] 5.64 [ ] 1.10 [ ] 1.03 [ ] 2.02 [ ] 0.75 [ ] 1.02 [ ] 1.30 [ ] Crude OR [95%CI] Without Depression (n=27,692) 2.96 [ ] [ ] 0.96 [ ] 1.42 [ ] 3.09 [ ] 1.35 [ ] 1.21 [ ] 1.11 [ ] 1.34 [ ] 1.40 [ ] 2.15 [ ] Total (n=29,095) 2.92 [ ] [ ] 0.94 [ ] 1.54 [ ] 3.27 [ ] 1.32 [ ] 1.20 [ ] 1.20 [ ] 1.25 [ ] 1.33 [ ] 2.02 [ ] With Depression (n=1,403) 1.78 [ ] [ ] 0.96 [ ] 3.75 [ ] 5.27 [ ] 1.21 [ ] 1.10 [ ] 1.74 [ ] 0.72 [ ] 1.12 [ ] 1.31 [ ] Adjusted OR [95%CI] Without Depression (n=27,692) 2.70 [ ] [ ] 0.93 [ ] 1.42 [ ] 2.85 [ ] 1.33 [ ] 1.15 [ ] 1.04 [ ] 1.33 [ ] 1.42 [ ] 1.96 [ ] Total (n=29,095) 2.64 [ ] *** [ ] 0.91 [ ] 1.54 [ ] 3.00 *** [ ] 1.31 [ ] 1.14 [ ] 1.13 [ ] 1.25 [ ] 1.36 [-1.84] 1.86 *** [ ] 12

12 With Depression (n=1,403) Risk factors Stroke [Without] [With] 2.18 [ ] Diabetes Mellitus [Without] [With] 2.20 [ ] Hypertension [Without] [With] 2.24 [ ] Hyperlipidemia [Without] [With] 1.78 [ ] Antidepressants Usage [Without] [With] 2.07 *** [ ] *Multivariate analysis adjusted for stroke, diabetes mellitus, hypertension and hyperlipidemia. Adjusted OR [95%CI] Without Depression (n=27,692) 2.60 [ ] 1.87 [ ] 2.82 [ ] 1.25 [ ] 2.58 *** [ ] Total (n=29,095) 2.70 [ ] 1.90 [ ] 2.75 [ ] 1.32 [ ] 2.66 *** ] 13

13 DISEASE-FREE DURATIONS 14

14 Disease-Free Probability Figure 1 Kaplan-Meier failure curve of study and control group patients who developed dementia Nonuser controls: 266/23,276 (Rate: 1.14%) 0.95 Antidepressant user cases: 195/5,819 (Rate: 3.35%) Log Rank test: p< Time (days) The median follow-duration for cases and nonuser were 6.76 & 8.92 years. 15

15 13 ANTIDEPRESSANTS TCAs and TeCAs SSRIs MAOIs SARIs SNRIs 16

16 Table 3 Risk of dementia as use of antidepressants (Reference=Control) Exposed to Study and control (n=29,095) Crude OR [95%CI] Adjusted OR [95%CI] n (%) Control 23,276 Selective serotonin reuptake inhibitors (SSRIs) Fluoxetine (Prozac) 825 (14.18%) 0.95 [ ] 0.97 [ ] Citalopram (Celexa) 299 (5.14%) 2.99 [ ] 2.85 [ ] Escitalopram (Lexapro, Cipralex) 101 (1.74%) 2.65 [ ] 2.27 [ ] Fluvoxamine (Luvox) 179 (3.08%) 3.00 [ ] 2.81 [ ] Sertraline (Zoloft, Lustral) 538 (9.25%) 2.65 [ ] 2.53 [ ] Paroxetine (Paxil, Seroxat) 429 (7.37%) 3.79 [ ] 3.33 [ ] Selective norepinephrine reuptake inhibitors (SNRIs) Venlafaxine (Effexor) 384 (6.60%) 3.03 [ ] 2.85 [ ] Tricyclic antidepressants (TCAs) Amitriptyline (Elavil, Endep) 333 (5.72%) 3.80 [ ] 3.14 [ ] Imipramine (Tofranil) 1,065 (18.30%) 3.03 [ ] 2.14 [ ] Doxepin (Adapin, Sinequan) 185 (3.18%) 2.40 [ ] 2.12 [ ] Tetracyclic antidepressants (TeCAs) Mirtazapine (Remeron) 223 (3.83%) 4.06 [ ] 3.66 [ ] Monoamine oxidase inhibitors (MAOIs) Moclobemide (Aurorix, Manerix) 155 (2.66%) 3.48 [ ] 2.95 [ ] Serotonin antagonist and reuptake inhibitors (SARIs) *Multivariate Trazodone (Desyrel) analysis adjusted for stroke, depression, 1,103 diabetes mellitus, (18.96%) hypertension, 4.02 [ ] and hyperlipidemia [ ] 17

17 17

18 DOSAGE- DEPENDENT 19

19 Table 4. Logistic regressions on the risk of dementia associated with antidepressants by cumulative DDDs Event, n Antidepressants cddds Rate (95%CI), per 100 person With Depression (n=1,403) Crude OR [95%CI] Without Depression (n=27,692) Total (n=29,095) With Depression (n=1,403) Adjusted OR [95%CI] Without Depression (n=27,692) Total (n=29,095) No use 266/23, [ ] <90 137/4, [ ] /1, [ ] >180 28/ [ ] 1.54 [ ] 1.59 [ ] 2.37 [ ] 2.94 [ ] 2.41 [ ] 3.50 [ ] 2.95 [ ] 2.62 [ ] 3.92 [ ] 1.76 [ ] 2.22 [ ] 3.16 *** [ ] 2.54 *** [ ] 2.42 *** [ ] 3.15 *** [ ] 2.44 [ ] *** 2.43 [ ] *** 3.29 [ ] *** cddds, cumulative defined daily doses; OR, odds ratio; CI, confidence interval. *Adjusted by stroke, depression, diabetes mellitus, hypertension, and hyperlipidemia. 20

20 Dementia Risk Odds for dementia of 13 antidepressants were significantly different CONCLUSION Antidepressants medications are associated with 3 Controls dementia in 2.58 a manner 2.66 independent of depression. Cases Both depression & non-depression antidepressant user cases had higher incidence of dementia With Depression (n=1,403) Without Depression (n=27,692) Total (n=29,095) With Depression (n=1,403) Antidepressants cddds No use Adjusted OR [95%I] Without Depression (n=27,692) Total (n=29,095) < Dose-dependent [ ] [ ] risk of [ ] dementia with antidepressants use [ ] [ ] [ ] > [ ] 3.15 [ ] 3.29 [ ] 21

21 Discussion 1 Dementia may be an Iatrogenic result of taking antidepressant medication, besides of pathogenic consequence of depression. 22

22 Discussion 2 Fluoxetine is least dementia-associated antidepressant. Fluoxetine can rescue the effect after exposure to inescapable shock Fluoxetine can enhance hippocampal neurogenesis in long term depression Malberg JE, Duman RS. Cell proliferation in adult hippocampus is decreased by inescapable stress: reversal by fluoxetine treatment. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. Sep 2003;28(9): Chen H, Pandey GN, Dwivedi Y. Hippocampal cell proliferation regulation by repeated stress and antidepressants. Neuroreport. Jun ;17(9):

23 Cell Viability (Compared to Control) *** AKA *** *** *** AKA Antidepressant-induced cell * * *** * death of astrocyte AKA-3 AKA *** ** * *** *** AKA-5 AKA-6 AKA (um) (um) * ** ** AKA-9 *** *** AKA-10 * *** ** ** ** * * * AKA-8 AKA (um) 24

24 Counts AKA-1-induced ROS generation of astrocyte Control H 2 O 2 (AKA-1) 2.5mM DCF fluorescence intensity (% of control) C H 2 O 2 AKA-1 (um) Sertraline (mm) (AKA-1) 5mM AKA-1 combined with amyloid beta Increased cytotoxicity in astrocyte (AKA-1) 7.5mM (AKA-1) 10mM Fluorescence intensity (DCF) 25

25 CONCLUSION Antidepressants medications are associated with dementia in a manner independent of depression. 26

26 The End 27

27 Flowchart of subjects selection National Health Insurance Research Database (NHIRD) In Random sample of NHI insured in (N=1,000,000) Cases (n=8553) were selected with taking any of 13 antidepressants, complied with two conditions: (1) interval between two continuous antidepressant -prescribed visits should be less than 30 days; (2) the first and last antidepressant-prescribed visits should more than 30 days apart. Controls (n=51,755) were matched to cases according to the age, sex, and index date, complied with one condition: (1) No any history of taking antidepressants Exclude (1) Patients who had been taking more than one type of antidepressant in (n=853) (2) Diagnosed dementia before taking antidepressant, pseudo-prescribed and (n=3,043) (3) Aged over 80 in 2015 (n=66,608) (4) Patients with undetermined gender (n=12,633) Study group Antidepressant long term users (n=5819) Control group Non antidepressant users (n=23,276) Follow-up until

28 Table 1. Comparison of Demographic Characteristics and Risk Factors Between Cases and Controls. Study (N=5819) Control (N=23,276) N (%) N (%) P Value Age, mean (SD) a (14.97) (14.99).942 Sex (male) a 2508 (43.10%) 10,032 (43.10%) 0 Insurance amount (NT$) b,c < , (14.14%) 2955 (17.18%) 20,000-39, (21.64%) 4580 (26.62%) <20, (64.22%) 9670 (56.20%) Region b,c.916 Northern 2565 (44.31%) 10,312 (44.51%) Central 1414 (24.43%) 5740 (24.77%) Southern 1639 (28.31%) 6622 (28.58%) Eastern 171 (2.95%) 495 (2.14%) Urbanicity b,c (most urbanized) 1744 (33.23%) 7439 (35.12%) (33.31%) 6672 (31.50%) (15.68%) 3621 (17.09%) 4 (least urbanized) 933 (17.78%) 3450 (16.29%) Risk factors b Stroke 357 (6.14%) 610 (2.62%) <.001 Depression 969 (16.65%) 434 (1.86%) <.001 Diabetes Mellitus 721 (12.39%) 2103 (9.04%) <.001 Hypertension 1128 (19.38%) 3903 (16.77%) <.001 Hyperlipidemia 775 (13.32%) 2514 (10.80%).040 Insomnia 1145 (19.68%) 1876 (8.06%) <.001 Anxiety 1378 (23.68%) 2005 (8.61%) <.001 CCI Score b < (89.21%) 21,666 (93.08%) (6.22%) 1023 (4.40%) (4.57%) 587 (2.52%) Antidepressant cddd, mean (SD) (181.90) Antidepressant cddd < (71.37%) (17.53%) > (11.10%) a T test. b Chi-square test. c Subjects for all levels do not sum up to original cases due to missing values. 29

29 Table 2: Risk Factors Examination for Dementia using Cox Proportional Hazards Regression Model. Event, n Rate (95% CI), per 100 persons Univariate HR [95% CI] Multivariate HR [95% CI] P Value Age (years) 1.13 [ ] 1.12 [ ]** <.001 Sex.806 Female 210/16, [ ] Male 146/12, [ ] 0.93 [ ] 0.97 [ ] Insurance amount (NT$) < ,000 17/ [ ] 20,000-39,999 38/ [ ] 1.45 [ ] 1.41 [ ] <20, /12, [ ] 3.09 [ ] 2.63 [ ]** Region.515 Northern 138/12, [ ] Central 100/ [ ] 1.30 [ ] 1.22 [ ] Southern 105/ [ ] 1.18 [ ] 1.12 [ ] Eastern 9/ [ ] 1.28 [ ] 1.15 [ ] Urbanicity (most urbanized) 81/ [ ] 2 103/ [-1.48] 1.39 [ ] 1.37 [ ]* 3 55/ [ ] 1.41 [-1.98] 1.44 [ ]* 4 (least urbanized) 73/ [ ] 1.90 [ ] 1.65 [ ]** CCI Score /28, [ ] 2 12/ [ ] 3.78 [ ] 1.51 [ ]* 3 4/ [ ] 5.03 [ ] 1.53 [ ]* Depression.011 [Without] 316/27, [ ] [With] 40/ [ ] 2.85 [ ] 1.59 [ ]* Antidepressant Usage <.001 [Without] 200/23, [ ] [With] 156/ [ ] 5.03 [ ] 3.89 [ ]** Depression*Antidepressant.193 Antidepressant effect (Depression=N) 5.08 [ ] 4.05 [ ] Antidepressant effect (Depression=Y) 2.27 [ ] 2.42 [ ] *:p<0.05, **: p<

30 Table 3: Risk of Dementia with the Use of Antidepressants from Different Classes (Reference=Control). Exposed to Study (N=5819) N (%) Univariate HR [95% CI] Multivariate HR [95% CI] Selective serotonin reuptake inhibitors (SSRIs) 2371 (40.75%) 4.10 [ ] 3.66 [ ]** Selective norepinephrine reuptake inhibitors (SNRI) 384 (6.60%) 5.35 [ ] 4.73 [ ]** Tricyclic antidepressants (TCAs) 1583 (27.20%) 4.64 [ ] 3.26 [ ]** Tetracyclic antidepressants (TeCA) 223 (4.00%) 8.29 [ ] 6.62 [ ]** Monoamine oxidase inhibitors (MAOI) 155 (2.66%) 6.72 [ ] 4.94 [ ]** Serotonin antagonist and reuptake inhibitors (SARI) 1103 (18.96%) 6.56 [ ] 4.48 [ ]** *:p<0.05, **: p<0.01. SSRIs include Fluoxetine, Citalopram, Escitalopram, Fluvoxamine, Sertraline, Paroxetine; SNRI includes Venlafaxine; TCAs include Amitriptyline, Imipramine, Doxepin; TeCA includes Mirtazapine; MAOI includes Moclobemide; SARI includes Trazodone. 31

31 Table 4: Examination of the Risk Factors of Dementia in terms of the Antidepressant cddd and its Side Effects using Cox Proportional Hazards Regression. Event, n Rate (95% CI), per 100 persons Univariate HR [95% CI] Multivariate HR [95% CI] P for trend Antidepressant cddd <.001 No use 200/23, [ ] <90 108/ [ ] 4.89 [ ] 3.74 [ ]** / [ ] 4.45 [ ] 3.73 [ ]** >180 24/ [ ] 6.69 [ ] 5.22 [ ]** Side effects of antidepressant medications Sedation a / [ ] 1+ 30/ [ ] 1.64 [-2.71] 1.56 [ ] 3+ 31/ [ ] 1.34 [ ] 1.04 [ ] 4+ 57/ [ ] 1.86 [ ] 1.47 [ ] Side effects of antidepressant medications Anticholinergic a / [ ] 1+ 25/ [ ] 1.57 [ ] 1.60 [ ]* 3+ 31/ [ ] 0.99 [ ] 0.84 [ ] 4+ 9/ [ ] 1.05 [ ] 0.93 [ ] *:p<0.05, **: p<0.01. a Scale: 0 = none; 1+ = slight; 2+ = low; 3+ = moderate; 4+ = high. About the potency of sedative property of antidepressants, 0 for Fluoxetine, Citalopram, Escitalopram, and Sertraline; 1+ for Fluvoxamine, Paroxetine, and Venlafaxine; 3+ for Imipramine and Doxepin; 4+ for Amitriptyline, Mirtazapine, and Trazodone. About the potency of anticholinergic property of antidepressants, 0 for Fluoxetine, Citalopram, Escitalopram, Sertraline, Fluvoxamine, Trazodone, and Venlafaxine; 1+ for Paroxetine and Mirtazapine; 2+ for Imipramine and Doxepin; 4+ for Amitriptyline. 32

32 Table 5: Assessment of Risk Factors for Dementia using Cox Proportional Hazards Regression Model. Risk Factor Univariate HR [95% CI] Multivariate HR [95% CI] Stroke 6.22 [ ] 2.55 [ ]** Diabetes Mellitus 3.51 [ ] 1.58 [ ]** Hypertension 4.06 [ ] 2.27 [ ]** Hyperlipidemia 2.85 [ ] 1.27 [ ] Depression 2.85 [ ] 1.59 [ ]* Insomnia 2.94 [ ] 1.64 [ ]** Anxiety 2.69 [ ] 1.49 [ ]** CCI Score (2 vs. 1) 3.78 [ ] 1.51 [ ]* CCI Score ( 3 vs. 1) 5.03 [ ] 1.53 [ ]* *:p<0.05, **: p<

33 Table 6: Subgroup Analysis of Cox Proportional Hazard Regressions of Antidepressant Associated with the Incidence of Dementia. Subgroup Univariate HR [95% CI] Multivariate HR [95% CI] Age group [ ] 2.47 [ ] [ ] 8.34 [ ]** [ ] 3.84 [ ]** Gender [Female] 4.80 [ ] 3.59 [ ]** [Male] 5.37 [ ] 4.45 [ ]** Stroke [Without] 4.81 [ ] 4.08 [ ]** [With] 3.09 [ ] 2.90 [ ]** Diabetes Mellitus [Without] 4.73 [ ] 3.90 [ ]** [With] 4.71 [ ] 3.91 [ ]** Hypertension [Without] 4.97 [ ] 4.09 [ ]** [With] 4.52 [ ] 3.65 [ ]** Hyperlipidemia [Without] 4.94 [ ] 4.04 [ ]** [With] 4.54 [ ] 3.51 [ ]** Depression [Without] 5.12 [ ] 4.07 [ ]** [With] 2.19 [ ] 2.54 [ ]* Insomnia [Without] 4.45 [ ] 3.55 [ ]** [With] 4.50 [ ] 4.96 [ ]** Anxiety [Without] 4.70 [ ] 3.92 [ ]** [With] 3.76 [ ] 3.67 [ ]** CCI score [ ] 4.07 [ ]** [ ] 2.99 [ ]** *:p<0.05, **: p< [ ] 3.79 [ ]** 34

34 Kaplan-Meier estimates of study and control group patients who developed dementia 35

35 Fig 3. Forest Plot of Factors Associated with the Incidence of Dementia. 36

36 S1 Fig. The plot of log(-log(survival function)) versus log of survival time. 37

37 S2 Fig. Kaplan-Meier Estimates of Study and Control Group Patients Who Developed Dementia after 5 years of index date. 38

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