Donepezil, rivastigmine, galantamine and memantine for ...

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22 Clinical effectiveness TABLE 6 MMSE for donepezil AD2000 2004 43 Change from baseline Numbers estimated from figure Donepezil 5 mg/day or 10 mg/day (n = 154) Placebo (n = 160) p-Value versus placebo –1.5 –1.75 Not reported a Gauthier et al., 2002 41 Standardised MMSE least-squares mean change from baseline Numbers estimated from figure Donepezil 10 mg/day (n = 91) Placebo (n = 100) p-Value versus placebo 1.5 –0.56 0.0002 Holmes et al., 200449 Mean change from baseline ± SEM Donepezil 10 mg/day (n = 41) Placebo (n = 55) p-Value versus placebo –0.1 (0.6) –1.8 (0.5) p = 0.02 Mohs et al., 200146 Adjusted mean change from baseline Numbers estimated from figure Donepezil 10 mg/day (n = 207) Placebo (n = 208) p-Value versus placebo 0.6 (n = 207) –0.6 (n = 208) p < 0.001 Nunez et al., 200348 Least-squares mean change from baseline Numbers estimated from figure Donepezil 10 mg/day (n = 99) Placebo (n = 103) p-Value versus placebo 1.7 0.5 p < 0.05 Winblad et al., 200147 Wimo et al., 2003 56 Least-squares mean change from baseline ± SE Numbers estimated from figure Donepezil 10 mg/day (n = 142) Placebo (n = 144) p-Value versus placebo –0.46 ± 0.34 (n = 135) –2.18 ± 0.29 (n = 137) p < 0.001 Rogers et al., 199851 Mean change from baseline ± SE 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 154) p-Value versus placebo (n = 153) (n = 150) 0.24 ± 0.29 0.39 ± 0.29 –0.97 ± 0.28 1. p = 0.0007 2. p = 0.0002 Rogers et al., 199852 Least-squares mean change from baseline ± SEM 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 150) p-Value versus placebo (n = 156 ) (n = 156) 1.0 ± 0.25 1.3 ± 0.24 0.04 ± 0.25 1. p < 0.004 2. p < 0.001 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) 0.6 (–4.0, 7.0) 0.9 (–7.0, 5.0) 2.0 (–1.0, 7.0) p < 0.05 relative to 1 mg 1.2 (–6.0, 8.0) Not reported Rogers et al., 199653 Mean change from baseline Numbers estimated from figure 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) 0.66 0.80 2.00 1.37 Not reported a p-Values were reported for the overall treatment effect (p < 0.0001) rather than for the difference between groups at this particular time point (60 weeks).
Comparison: Outcome: Study 03 Donepezil: MMSE change from baseline 01 Donepezil 5 mg Treatment n Mean (SD) Control n 01 at 24 weeks Rogers 1998a don Subtotal (95% CI) Test for heterogeneity 2 153 –0.24 (3.30) 154 153 154 = 0.0, df = 0 Test for overall effect z = 3.21, p = 0.001 02 at 12 weeks Rogers 1998b don Subtotal (95% CI) Test for heterogeneity 2 156 1.00 (3.10) 150 156 150 = 0.0, df = 0 Test for overall effect z = 2.71, p = 0.007 Although both groups showed a decline in MMSE, this decline was seen to be greater in the placebo group. One other trial 49 that had a 12-week prerandomisation open-label treatment period demonstrated a mean change from randomisation at 24 weeks of –0.1 (SEM 0.6) in the 10 mg donepezil group and –1.8 (SEM 0.5) in the Mean (SD) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 1 WMD (95% CI fixed) Weight % –0.97 (3.30) 47.0 47.0 0.04 (3.10) 53.0 53.0 WMD (95% CI fixed) 1.21 (0.47 to 1.95) 1.21 (0.47 to 1.95) 0.96 (0.27 to 1.65) 0.96 (0.27 to 1.65) Total (95% CI) Test for heterogeneity 2 309 304 100.0 1.08 (0.57 to 1.58) = 0.23, df = 1, p = 0.63 Test for overall effect z = 4.17, p = 0.00003 FIGURE 3 MMSE change from baseline with donepezil 5 mg Comparison: Outcome: Study 03 Donepezil: MMSE change from baseline 01 Donepezil 10 mg Treatment n Mean (SD) Control n 01 at 24 weeks Rogers 1998a don Subtotal (95% CI) Test for heterogeneity 2 150 0.39 (3.60) 154 150 154 = 0.0, df = 0 Test for overall effect z = 3.34, p = 0.0008 02 at 12 weeks Rogers 1998b don Subtotal (95% CI) Test for heterogeneity 2 156 1.30 (3.00) 150 156 150 = 0.0, df = 0 Test for overall effect z = 3.61, p = 0.0003 –10 –5 0 5 10 Favours control Favours treatment –0.97 (3.50) 42.3 42.3 0.04 (3.10) 57.7 57.7 1.36 (0.56 to 2.16) 1.36 (0.56 to 2.16) 1.26 (0.58 to 1.94) 1.26 (0.58 to 1.94) Total (95% CI) Test for heterogeneity 2 306 304 100.0 1.30 (0.78 to 1.82) = 0.03, df = 1, p = 0.85 Test for overall effect z = 4.91, p < 0.00001 FIGURE 4 MMSE change from baseline with donepezil 10 mg Mean (SD) WMD (95% CI fixed) Weight % –10 –5 0 5 10 Favours control Favours treatment WMD (95% CI fixed) placebo groups. This was statistically significant at p = 0.02. One unpublished trial 55 reported mean change in MMSE score over 24 weeks. The participants in this study were those with mild AD; the mean MMSE at baseline was 24.1 (SEM 0.18) in the 23
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
Page 30 and 31: 16 Clinical effectiveness TABLE 3 C
Page 32 and 33: 18 Clinical effectiveness particula
Page 34 and 35: 20 Clinical effectiveness Compariso
Page 38 and 39: 24 Clinical effectiveness donepezil
Page 46 and 47: 32 Clinical effectiveness DAD The D
Page 48 and 49: 34 Clinical effectiveness clinical
Page 50 and 51: 36 Clinical effectiveness TABLE 10
Page 54 and 55: 40 Clinical effectiveness statistic
Page 60 and 61: 46 Clinical effectiveness Summary:
Page 62 and 63: 48 Clinical effectiveness differenc
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72 Clinical effectiveness by the pa
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74 Clinical effectiveness TABLE 42
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76 Clinical effectiveness TABLE 46
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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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84 TABLE 49 Economic analysis Outli
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86 Economic analysis The UK study r
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88 Economic analysis The AD2000 stu
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90 Economic analysis term). Where w
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92 Economic analysis published econ
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94 Economic analysis Fenn and Gray
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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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110 Economic analysis survey studie
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112 Economic analysis vascular deme
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114 Economic analysis Livingston an
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116 Economic analysis sensitive to
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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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376 Health Technology Assessment Pr
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378 Health Technology Assessment Pr
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