Donepezil, rivastigmine, galantamine and memantine for ...

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28 Clinical effectiveness Comparison: Outcome: Study 01 at 24 weeks Homma 2000 don Rogers 1998a don Subtotal (95% CI) Comparison: Outcome: Study 02 Donepezil: CIBIC responders 01 Donepezil 5 mg Treatment n/N 64/134 39/149 103/283 Test for heterogeneity 2 = 0.50, df = 1, p = 0.48 Test for overall effect z = 5.70, p < 0.00001 02 at 12 weeks Rogers 1998b don Subtotal (95% CI) Test for heterogeneity 2 49/153 49/153 = 0.0, df = 0 Test for overall effect z = 2.79, p = 0.005 02 Donepezil: CIBIC responders 03 Donepezil 10 mg Treatment n/N 01 at 24 weeks Rogers 1998a don Subtotal (95% CI) Test for heterogeneity 2 37/149 37/149 = 0.00, df = 0, p < 0.0001 Test for overall effect z = 3.02, p = 0.003 02 at 12 weeks Rogers 1998b don Subtotal (95% CI) Test for heterogeneity 2 59/155 59/155 = 0.00, df = 0 Test for overall effect z = 3.82, p = 0.0001 statistically significant in three studies. 44,50,51 Two studies showed no overall difference between the study groups. Two of the four trials provided data (mean change and SD) that allowed them to be combined in a meta-analysis (Figure 9). Pooling the data using a Control n/N 17/152 17/152 27/150 27/150 OR (95% CI fixed) Weight % 42.7 42.7 57.3 57.3 OR (95% CI fixed) 2.62 (1.40 to 4.91) 2.62 (1.40 to 4.91) 2.80 (1.65 to 4.75) 2.80 (1.65 to 4.75) Total (95% CI) Test for heterogeneity 2 96/304 44/302 100.0 2.72 (1.82 to 4.08) = 0.02, df = 1, p = 0.88 Test for overall effect z = 4.87, p < 0.00001 FIGURE 8 CIBIC-plus responders with donepezil 10 mg 25/129 17/152 42/281 27/150 27/150 30.1 28.1 58.1 41.9 41.9 0.1 0.2 1 5 10 Favours control Favours treatment 3.80 (2.19 to 6.61) 2.82 (1.51 to 5.25) 3.33 (2.20 to 5.03) 2.15 (1.25 to 3.67) 2.15 (1.25 to 3.67) Total (95% CI) Test for heterogeneity 2 152/436 69/431 100.0 2.83 (2.04 to 3.93) = 2.12, df = 2, p = 0.35 Test for overall effect z = 6.25, p < 0.00001 FIGURE 7 CIBIC-plus responders with donepezil 5 mg Control n/N OR (95% CI fixed) Weight % 0.1 0.2 1 5 10 Favours control Favours treatment OR (95% CI fixed) fixed-effect model showed no overall improvement on the CDR with 5 mg/day donepezil compared with placebo [WMD –0.22 (95% CI: –0.46 to 0.03)]. There was, however, statistically significant heterogeneity ( 2 test for heterogeneity 6.27, df = 1, p = 0.012). No difference was noted using a random-effects model.
TABLE 9 CDR-SB for donepezil © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 1 Homma et al., 2000 44 Mean change ± SE from baseline (NB: protocol compatible population) Donepezil 5 mg/day (n = 116) Placebo (n = 112 ) p-Value versus placebo –0.10 ± 0.12 0.75 ± 0.15 p = 0.001 Burns et al., 199950 Least-squares mean change from baseline ± SE Numbers estimated from figures 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 274) p-Value versus placebo (n = 271) (n = 273) 0.06 ± 0.11 –0.06 ± 0.11 0.37 ± 0.06 1. p = 0.0344 2. p = 0.0033 Rogers et al., 199851 Mean change from baseline ± SEM 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 153) p-Value versus placebo (n = 154) (n = 151) –0.01 ± 0.14 –0.02 ± 0.14 0.58 ± 0.14 1. p = 0.0008 2. p = 0.0007 Rogers et al., 199852 Least-squares mean ± SEM change from baseline 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 150) p-Value versus placebo (n = 156) (n = 154) –0.10 ± 0.11 –0.31 ± 0.11 –0.14 ± 0.11 1. p = 0.32 Rogers et al., 199653 Adjusted mean (min., max.) change from baseline 1. Donepezil 2. Donepezil 3. Donepezil 4. Placebo p-Value versus placebo 1 mg/day 3 mg/day 5 mg/day (n = 40) (n = 42) (n = 40) (n = 39) 0.18 (–2.0, 5.0) 0.23 (–3.0, 6.0) –0.11 (–2.0, 3.0) 0.10 (–2.0, 3.0) Not reported Rogers et al., 199653 Mean change from baseline 1. Donepezil 2. Donepezil 3. Donepezil 4. Placebo p-Value versus placebo 1 mg/day 3 mg/day 5 mg/day (n = 40) (n = 42) (n = 40) (n = 39) 0.10 0.04 –0.15 0.04 Not reported Comparison: Outcome: Study 04 Donepezil: CDR change from baseline 02 Donepezil 5 mg Treatment n Mean (SD) Control n 01 at 24 weeks Rogers 1998a don Subtotal (95% CI) Test for heterogeneity 2 154 –0.01 (1.70) 153 154 153 = 0.0, df = 0 Test for overall effect z = 3.04, p = 0.002 02 at 12 weeks Rogers 1998b don Subtotal (95% CI) Test for heterogeneity 2 156 –0.10 (1.40) 150 156 150 = 0.0, df = 0 Test for overall effect z = 0.25, p = 0.8 0.58 (1.70) 40.5 40.5 –0.14 (1.40) 59.5 59.5 –0.59 (–0.97 to –0.21) –0.59 (–0.97 to –0.21) 0.04 (–0.27 to 0.35) 0.04 (–0.27 to 0.35) Total (95% CI) Test for heterogeneity 2 310 303 100.0 –0.22 (–0.46 to 0.03) = 6.27, df = 1, p = 0.012 Test for overall effect z = 1.74, p = 0.08 FIGURE 9 CDR change from baseline with donepezil 5 mg Mean (SD) WMD (95% CI fixed) Weight % –10 –5 0 5 10 Favours treatment Favours control WMD (95% CI fixed) 29
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
Page 7 and 8: List of abbreviations .............
Page 9 and 10: AChEI acetylcholinesterase inhibito
Page 11 and 12: Epidemiology and background Alzheim
Page 13: Galantamine Five published economic
Page 17 and 18: Description of underlying health pr
Page 19 and 20: TABLE 1 Estimated prevalence of AD
Page 21 and 22: as one component of their care. A n
Page 23 and 24: The a priori methods used for syste
Page 25: Data synthesis Data were synthesise
Page 28 and 29: 14 Clinical effectiveness TABLE 3 C
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Page 38 and 39: 24 Clinical effectiveness donepezil
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Page 54 and 55: 40 Clinical effectiveness statistic
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Page 62 and 63: 48 Clinical effectiveness differenc
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78 Clinical effectiveness donepezil
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80 Evidence from systematic reviews
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82 Economic analysis TABLE 48 Chara
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88 Economic analysis The AD2000 stu
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96 Economic analysis one another. W
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98 Economic analysis outcomes: (1)
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100 Economic analysis respond to ga
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102 Economic analysis donepezil, ri
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104 Economic analysis of this study
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106 Economic analysis independent,
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108 Economic analysis classificatio
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114 Economic analysis Livingston an
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118 Economic analysis Neumann and c
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120 Economic analysis The model str
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122 Economic analysis CEA, given th
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124 Economic analysis TABLE 70 Key
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126 Economic analysis TABLE 73 Prof
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128 Economic analysis Probability o
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130 Economic analysis Results are s
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132 Economic analysis 4. The model
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134 Economic analysis perspective e
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136 Economic analysis indicating th
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Ongoing research, with relevance to
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The increasing numbers of the very
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146 Discussion and conclusions dose
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148 Discussion and conclusions effo
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150 Discussion and conclusions Stre
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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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This version of HTA monograph volum
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