Donepezil, rivastigmine, galantamine and memantine for ...

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16 Clinical effectiveness TABLE 3 Characteristics of included studies for donepezil (cont’d) Study Methods Participants Outcomes Nunez et al., 2003 48 Rogers et al., 1998 51 Rogers et al., 1998 52 Rogers et al., 1996 53 Design: RCT, multicentre Interventions: 1. 10 mg/day donepezil 2. placebo Number of centres: not stated Duration of treatment: 12 weeks Sponsor: not reported Design: RCT, double-blind, multicentre Interventions: 1. 5 mg/day donepezil 2. 10 mg/day donepezil (blinded forced titration phase – 5 mg was given for the first 7 days) 3. placebo Number of centres: 20 Duration of treatment: 24 weeks Sponsor: Eisai (USA) and Eisai (Japan) Design: RCT, double-blind, multicentre Interventions: 1. 5 mg/day donepezil 2. 10 mg/day donepezil (blinded forced titration phase – 5 mg was given for the first 7 days) 3. placebo Number of centres: 23 Duration of treatment: 12 weeks Sponsor: Eisai (USA) and Eisai (Japan) Design: multicentre, double-blind, parallel group RCT Interventions: 1. 1 mg donepezil 2. 3 mg donepezil 3. 5 mg donepezil 4. placebo Number of centres: not reported, but 10 members of the donepezil study group are listed, all at different locations Duration of treatment: 12 weeks Sponsor: Eisai (USA) and Eisai (Japan) Inclusion criteria: mild to moderate (MMSE 10–26) possible or probable AD (NINCDS-ADRDA, DSM-IV). Patients entered an open-label donepezil phase before randomisation; those showing ‘no apparent clinical benefit’ were then randomised to study groups. Numbers: 202 randomised 1. 99 to 10 mg/day donepezil 2. 103 to placebo Mean age ± SD: 1. 74.1 ± 7.6 2. 71.4 ± 9.3 Inclusion criteria: ≥ 50 years old; probable AD by NINCDS-ADRDA criteria, DSM-III-R categories of 290.00 or 290.10; MMSE 10–26; CDR of 1 or 2 Numbers: 473 randomised 1. 154 to 5 mg/day 2. 157 to 10 mg/day 3. 162 to placebo Mean age ± SE (range): 1. 72.9 ± 0.6 (51–86) 2. 74.6 ± 0.6* (53–94) 3. 72.6 ± 0.6 (56–88) * p = 0.03 Inclusion criteria: ≥ 50 years; probable AD by NINCDS-ADRDA criteria, DSM-III-R categories of 290.00 or 290.10; MMSE 10–26; CDR of 1 or 2 Numbers: 468 randomised 1. 157 to 5 mg/day 2. 158 to 10 mg/day 3. 153 to placebo Mean age ± SE (range): 1. 73.8 ± 0.67 (50–94) 2. 73.4 ± 0.65 (50–92) 3. 74.0 ± 0.65 (52–93) Inclusion criteria: 55–85 years; mild to moderately severe AD (DSM-III-R and NINCDS criteria); MMSE 10–26; CDR 1 or 2 Numbers: 161 randomised 1. 42 to 1 mg donepezil 2. 40 to 3 mg donepezil 3. 39 to 5 mg donepezil 4. 40 to placebo Mean age (range): 1. 72.6 (55–85) 2. 71.0 (54–85) 3. 72.9 (55–85) 4. 70.6 (56–84) Primary outcomes: ● MMSE ● ADAS-cog ● DAD ● NPI Primary outcomes: ● ADAS-cog ● CIBIC-plus Secondary outcomes: ● MMSE ● CDR-SB ● Patient-rated QoL ● Adverse events Primary outcomes: ● ADAS-cog ● CIBIC-plus Secondary outcomes: ● MMSE ● CDR-SB ● Patient-rated QoL ● Adverse events Primary outcomes: ● ADAS-cog. ● CGIC Secondary outcomes: ● ADL ● MMSE ● CDR-SB ● QoL-P, QoL-C ● Adverse events continued
TABLE 3 Characteristics of included studies for donepezil (cont’d) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 1 Study Methods Participants Outcomes Seltzer et al., 2004 55 Winblad et al., 2001; 47 Wimo et al., 2003 56 Design: RCT, double-blind, multicentre Interventions: 1. donepezil 5 mg/day for 6 weeks and then 10 mg/day 2. placebo Number of centres: 17 Duration of treatment: 24 weeks Sponsor: Pfizer and Eisai Design: RCT, double-blind, multicentre Interventions: 1. donepezil 5 mg/day for 28 days and then 10 mg/day 2. placebo Number of centres: 28 Duration of treatment: 52 weeks Sponsor: Pfizer Pharmaceuticals Group, Pfizer TABLE 4 Quality assessment table for donepezil Study Randomisation Concealment of allocation Inclusion criteria: 50–90 years; [Commercial/academic confidential information removed]; MMSE 21–26 Numbers: 153 patients randomised 1. 96 to donepezil 10 mg/day 2. 57 to placebo Mean age ± SD (range): [Commercial/academic confidential information removed] Inclusion criteria: possible or probable AD on DSM-IV and NINCDS- ADRDA; MMSE 10–26 Numbers: 286 patients randomised 1. 142 to donepezil 5 mg/day 2. 144 to placebo Mean age ± SE (range): 1. 72.1 ± 8.6 (49–86) 2. 72.9 ± 8.0 (51–88) Baseline characteristics Primary outcomes: ● Modified ADAS-cog. Secondary outcomes: ● CDR-SB ● MMSE ● Computerised Memory Battery ● [Commercial/academic confidential information removed] ● Apathy Scale ● PGA ● Compliance ● Adverse events Primary outcomes: ● Gottfries-Bråne–Steen (GBS) scale. Secondary outcomes: ● MMSE ● PDS ● NPI ● GDS Wimo et al.: 56 IADL scale; Physical Self-maintenance Scale (PSMS) AD200043 Ad Un Rep Ad Par Ad Ad In In Ad Burns et al., 1999 50 Un Un Rep Ad Par Par Par Ad In Ad Gauthier et al., 2002 41 Un Un Rep Par Un Un Un In In Par Greenberg et al., 2000 54 Ad Ad Rep Ad Ad Ad Ad Ad In Ad Holmes et al., 2004 49 Ad Ad Rep Ad Un Ad Ad Ad In Ad Homma et al., 2000 44 Un Un Rep Ad Un Par Par Ad In Par Krishnan et al., 2003 45 Ad Un Rep Ad Un Ad Ad In In Par Mohs et al., 2001 46 Un Un Rep Ad Ad Par Par Par In Ad Nunez et al., 2003 48 Un Un Rep Ad Un Par Par In In Un Rogers et al., 1998 51 Ad Un Rep Ad Par Par Par Ad In Par Rogers et al., 1998 52 Un Un Rep Ad Ad Par Par Ad In Ad Rogers et al., 1996 53 Un Un Rep Ad Un Par Par Par In Ad [Commercial/academic confidential information relating to Seltzer et al. 55 removed] Winblad et al., 2001 47,56 Ad Un Rep Ad Un Par Par Ad In Ad Ad, adequate; In, inadequate; Par, partial; Rep, reported; Un, unknown. Eligibility Blinding of assessors Care provider blinding Patient blinding Reporting outcomes ITT analysis Withdrawals explained 17
Page 1 and 2: Health Technology Assessment 2006;
Page 3 and 4: The clinical and cost-effectiveness
Page 5 and 6: Objectives: To provide an update re
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Page 9 and 10: AChEI acetylcholinesterase inhibito
Page 11 and 12: Epidemiology and background Alzheim
Page 13: Galantamine Five published economic
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Ongoing research, with relevance to
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148 Discussion and conclusions effo
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1. Clegg A, Bryant J, Nicholson T,
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placebo-controlled study of donepez
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94. Brooks E, Deal L. The effect of
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of memantine in patients with moder
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