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Acute Pain | Chronic Pain | General

Pregabalin in neuropathic pain - 2010 update

 

Clinical bottom line

Pregabalin has been studies in large, long duration studies, and in four neuropathic pain conditions, including fibromyalgia. It has useful levels of efficacy in all the conditions, with NNTs of 3-5 in neuropathic pain, and around 9 in fibromyalgia.


References

There are three reviews of pregabalin that provide information that is useful, but for the purposes of this 2010 update on efficacy, the Cochrane review is that from which data have been taken.

Moore et al.Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076.
Straube et al. Pregabalin in fibromyalgia--responder analysis from individual patient data. BMC Musculoskelet Disord. 2010 Jul 5;11:150..
Straube et al. Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports. Rheumatology (Oxford). 2010 49:706-715.

Study

Results

The trials in chronic pain were predominantly of long duration (typically 12 weeks, apart from occasional shorter studies, though these were about 8 weeks; sensitivity analyses reported that limiting analysis to studies of 8 weeks or longer made no appreciable difference to efficacy. Responders were identified in most trials, and as best can be judged these were probably using the last observation carried forward method. A variety of daily doses were used, 150 mg, 300 mg, 450 mg (in fibromyalgia) , and 600 mg, usually with a degree of titration up to the maximum daily dose.

Results tabulated below are the main efficacy findings

Postherpetic neuralgia

  Number of Percent with outcome    
Outcome
- daily dose
Trials Patients Pregabalin Placebo Relative benefit
or risk
(95% CI)
NNT
(95%CI)
At least 30% pain relief
150 mg
1
180
39
17
2.3 (1.4 to 3.8)
4.6 (2.9 to 11)
300 mg
2
369
49
24
2.1 (1.5 to 2.7)
4.0 (2.9 to 6.5)
600 mg
3
537
62
24
2.5 (2.0 to 3.2)
2.7 (2.2 to 3.4)
At least 50% pain relief
150 mg
3
527
25
11
2.3 (1.6 to 3.4
6.9 (4.8 to 13)
300 mg
4
713
32
13
2.5 (1.9 to 3.4)
5.1 (3.9 to 7.4)
600 mg
4
732
41
15
2.7 (2.1 to 3.5)
3.9 (3.1 to 5.1)
PGIC much or very much improved
150 mg
2
342
27
15
1.8 (1.2 to 2.8)
8.4 (4.9 to 30)
300 mg
2
348
32
15
2.2 (1.4 to 3.3)
5.8 (3.9 to 12)
600 mg
1
183
37
16
2.3 (1.3 to 3.9)
4.9 (3.0 to 12)
Lack of efficacy discontinuation
150 mg
3
527
8
13
0.6 (0.3 to 1.0)
300 mg
4
713
4
11
0.4 (0.2 to 0.7)
-15 (-9 to -34)
600 mg
4
732
3
11
0.3 (0.1 to 0.5)
-13 (-9 to -24)

 

Note that a negative NNT for lack of efficacy discontinuation means that this occurs less often with pregabalin than with placebo.

 

Painful diabetic neuropathy

Number of
Percent with outcome
Outcome
- daily dose
Trials
Patients
Pregabalin
Placebo
Relative benefit
or risk
(95% CI)
NNT
(95%CI)
At least 30% pain relief
150 mg
300 mg
2
482
59
45
1.3 (1.1 to 1.6)
6.8 (4.3 to 17)
600 mg
3
819
63
43
1.5 (1.3 to 1.7)
5.1 (3.8 to 7.8)
At least 50% pain relief
150 mg
2
359
27
23
1.1 (0.8 to 1.6)
not calculated
300 mg
4
823
40
26
1.5 (1.2 to 1.8)
7.5 (5.1 to 14)
600 mg
6
1360
45
25
1.7 (1.5 to 2.0)
5.0 (4.0 to 6.6)
PGIC much or vey much improved
150 mg
1
195
45
34
1.4 (0.96 to 2.0)
not calculated
300 mg
2
359
48
30
1.6 (1.2 to 2.1)
5.6 (3.6 to 13)
600 mg
4
875
56
33
1.8 (1.5 to 2.1)
4.2 (3.3 to 5.8)
Lack of efficacy discontinuation
150 mg
2
359
4
7
0.7 (0.3 to 1.5)
300 mg
2
341
3
8
0.4 (0.2 to 1.0)
600 mg
4
869
4
11
0.3 (0.2 to 0.5)
-14 (-9 to -31)

 

Central neuropathic pain

Number of
Percent with outcome
Outcome
- daily dose
Trials
Patients
Pregabalin
Placebo
Relative benefit
or risk
(95% CI)
NNT
(95%CI)
At least 30% pain relief
600 mg
1
136
42
13
3.1 (1.6 to 6.1)
3.5 (2.3 to 7.0)
At least 50% pain relief
600 mg
2
176
25
7
3.6 (1.5 to 8.4)
5.6 (3.5 to 14)
Lack of efficacy discontinuation
600 mg
2
177
6
24
0.3 (0.1 to 0.6)
-5.4 (-3.5 to -12)

 

Fibromyalgia

 
Number of
Percent with outcome
Outcome
- daily dose
Trials
Patients
Pregabalin
Placebo
Relative benefit
or risk
(95% CI)
NNT
(95%CI)
At least 30% pain relief
150 mg
1
263
31
27
1.1 (0.8 to 1.7)
300 mg
4
1374
39
28
1.4 (1.2 to 1.6)
9.2 (6.3 to 17)
450 mg
4
1376
43
28
1.5 (1.3 to 1.8)
6.6 (5.0 to 9.8)
600 mg
3
1122
39
28
1.4 (1.2 to 1.6)
9.1 (6.1 to 18)
At least 50% pain relief
150 mg
1
263
13
13
1.0 (0.5 to 1.9)
300 mg
4
1374
21
14
1.5 (1.2 to 1.9)
14 (9.0 to 33)
450 mg
4
1376
25
14
1.7 (1.4 to 2.1)
9.8 (7.0 to 16)
600 mg
3
1122
24
15
1.6 (1.3 to 2.1)
11 (7.1 to 21)
PGIC much or very much improved
150 mg
1
263
32
27
1.2 (0.8 to 1.8)
300 mg
4
1374
36
28
1.5 (1.2 to 1.9)
11 (7.3 to 26)
450 mg
4
1376
42
28
1.5 (1.3 to 1.8)
6.8 (5.1 to 10)
600 mg
3
1122
41
28
1.5 (1.2 to 1.7)
7.7 (5.4 to 13)
PGIC very much improved
150 mg
300 mg
4
1352
17
11
1.7 (1.2 to 2.9)
16 (9.9 to 37)
450 mg
4
1354
19
11
1.8 (1.4 to 2.4)
11 (7.9 to 20)
600 mg
3
1095
12
7
1.7 (1.1 to 2.4)
21 (12 to 83)
Lack of efficacy discontinuation
150 mg
1
263
9
14
0.7 (0.3 to 1.3)
300 mg
4
1374
4
10
0.4 (0.3 to 0.7)
-18 (-12 to -34)
450 mg
4
1376
3
10
0.3 (0.2 to 0.5)
-15 (-11 to -25)
600 mg
3
1122
2
9
0.3 (0.2 to 0.5)
-15 (-11 to -26)

 

Efficacy figures

The figures show the NNTs for the four clinical conditions, for 300 mg and 600 mg daily using at least 30% and at least 50% pain intensity reduction

Pregabalin 300 mg daily, at least 30% pain reduction

Pregabalin 300 mg daily, at least 50% pain reduction

Pregabalin 600 mg daily, at least 30% pain reduction

Pregabalin 600 mg daily, at least 50% pain reduction


Adverse events

Adverse events of somnolence, dizziness, and adverse event discontinuations were also reported for the four clinical conditions. Typically they were dose dependent, and typical event rates and NNTs were as follows:

Somnolence

Somnolence tended to occur in 15--20% of patients on pregabalin 300-600 mg daily, with rates of about 5% with placebo, with NNH values of 6-8. The exception was central neuropathic pain with much higher rates and with an NNH of 4.

Dizziness

Dizziness tended to occur in 25--45% of patients on pregabalin 300-600 mg daily, with rates of about 10% with placebo, with NNH values of about 4.

Adverse event withdrawal

Adverse event withdrawal tended to occur in 15--30% of patients on pregabalin 300-600 mg daily, with rates of about 5-10% with placebo, with NNH values of about 10.

Serious adverse events

Serious adverse events were no more frequent with pregabalin than placebo.

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