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. 2008 May 16;66(2):266–275. doi: 10.1111/j.1365-2125.2008.03200.x

Table 2.

Main results in pregabalin trials

Efficacy % with
Subgroup Number of patients Relative benefit (95% CI) NNT (95% CI) Placebo Pregabalin
At least 50% pain relief
All 2430 2.4 (2.0, 2.8) 5.2 (4.5, 6.4) 14 33
PEE 1342 2.3 (1.6, 2.9) 6.3 (4.9, 8.7) 15 31
NEE 1088 2.4 (1.8, 3.3) 4.4 (3.6, 5.6)a 13 36
150 mg 538 1.6 (1.0, 2.5) 14 (7.3, 150) 13 20
300 mg 697 2.4 (1.7, 3.5) 6.1 (4.4, 9.5)b 13 30
600 mg 1195 2.6 (3.0, 3.3) 3.8 (3.2, 4.7)c 16 42
Patient global impression of change
All 1724 2.0 (1.6, 2.3) 4.7 (3.9, 6.0) 22 43
PEE 1018 2.1 (1.7, 2.6) 4.3 (3.4, 5.8) 22 45
NEE 706 1.8 (1.3, 2.4) 5.3 (3.8, 9.1) 22 41
150 mg 416 1.5 (1.0, 2.2) 11 (5.5, 350) 20 29
300 mg 549 2.1 (1.5, 2.9) 4.8 (3.5, 7.7)d 20 41
600 mg 759 2.1 (1.6, 2.7) 3.7 (2.9, 5.1)e 25 52
Lack of efficacy withdrawal
All 2174 0.36 (0.27, 0.49) −12 (−19, −9.0) 14 6
PEE 1085 0.33 (0.20, 0.54) −18 (−45, −11) 10 4
NEE 1089 0.38 (0.27, 0.53) −8.4 (−14, −6.0)f 20 8
150 mg 538 0.55 (0.32, 0.95) −23 (71, −10) 12 8
300 mg 568 0.39 (0.22, 0.72) −20 (−750, −9.9) 11 5
600 mg 1068 0.28 (0.19, 0.42) −8.4 (−14, −6.1)g 18 6
Harm
with
Subgroup Number of patients Relative risk (95% CI) NNH (95% CI) Placebo Pregabalin
Adverse event withdrawal
All 2431 2.2 (1.6, 2.9) 14 (10, 20) 6 14
PEE 1343 2.2 (1.5, 3.2) 16 (11, 30) 6 12
NEE 1089 2.1 (1.4, 3.3) 12 (8.3, 23) 7 16
150 mg 538 1.0 (0.52, 1.9) 960 (20, −21) 8 8
300 mg 697 1.7 (1.0, 3.1) 21 (11, 150) 6 10
600 mg 1197 3.0 (2.0, 4.5) 8.3 (6.3, 12)h 7 19
Somnolence
All 2432 4.4 (3.2, 6.1) 6.7 (5.8, 8.1) 5 20
PEE 1343 4.4 (2.9, 6.7) 5.6 (4.7, 7.0) 5 23
NEE 1089 4.4 (2.6, 7.6) 8.6 (6.6, 12)i 5 16
150 mg 538 2.0 (1.0, 4.1) 16 (9.0, 73) 6 12
300 mg 697 4.9 (2.6, 9.2) 5.8 (4.6, 7.9)j 4 22
600 mg 1197 5.4 (3.4, 8.7) 5.7 (4.7, 7.2)k 5 22
Dizziness
All 2432 3.2 (2.5, 4.1) 5.1 (4.4, 6.0) 9 29
PEE 1343 2.9 (2.2, 3.9) 4.9 (4.1, 6.2) 11 31
NEE 1089 4.0 (2.6, 6.3) 5.2 (4.3, 6.6) 6 26
150 mg 538 1.6 (0.96, 2.8) 14 (7.8, 95) 9 16
300 mg 697 2.9 (1.9, 4.3) 5.0 (3.9, 7.0)l 11 31
600 mg 1197 4.5 (3.1, 6.6) 4.0 (3.4, 4.8)m 8 33

NNT, number needed to treat. NNH, number needed to harm. 150 mg, 300 mg and 600 mg refer to the maximum daily doses of pregabalin allowed in the trials. For patient global impression of change after pregabalin treatment we display the results for subjects reporting ‘much or very much’ improvement, and the 600 mg subgroup contains data from one trial group [29] that used 450 mg as the maximum allowed daily dose of pregabalin. Lack of efficacy withdrawals also includes those described as ‘treatment failure’. Significant differences between treatment groups are labelled in the figure as follows: a) P = 0.044 for the comparison PEE vs. NEE, b) P = 0.040 for 150 mg vs. 300 mg, c) P < 0.00006 for 150 mg vs. 600 mg, d) P = 0.052 for 150 mg vs. 300 mg. e) P < 0.0027 for 150 mg vs. 600 mg. f) P = 0.036 for PEE vs. NEE. g) P = 0.039 for 150 mg vs. 600 mg. h) P < 0.00014 for 150 mg vs. 600 mg. i) P = 0.014 for PEE vs. NEE. j) P = 0.0014 for 150 mg vs. 300 mg. k) P < 0.00032 for 150 mg vs. 600 mg. l) P < 0.0019 for 150 mg vs. 300 mg. m) P < 0.00006 for 150 mg vs. 600 mg.