Postherpetic neuralgia

Three fixed dose parallel-group studies with a similar design show superiority of pregabalin to placebo.53[II], 54 [II], 55[II] The duration of the trial ranged from 8 to 13 weeks, including a one-week titration phase. Stable previous medications (including opioids, antiepileptic, and antidepressant drugs) were permitted and the primary outcome measure was change in pain at the end of the study, with sleep, mood, and quality of life as secondary outcome measures. Allodynia was not systematically assessed. In the first study, the dose was forced titrated to 600 mg/day (with one third remaining on 300 mg/day due to low creatinine clearance). Reduction in mean pain scores rated at baseline and at end point over seven days (primary efficacy measure) was significantly greater in the pregabalin than placebo group (p<0.001; mean treatment difference -1.69 (95 percent CI -2.33, -1.05). Of the secondary outcome measures, sleep and mood improved but quality of life did not (apart from general health perception and, inevitably, bodily pain).53[II] In the second multicenter trial of eight weeks duration, 238 patients were randomized either to receive pregabalin 150 mg day, 300 mg/day, or placebo. Pregabalin was well tolerated at these lower doses. The reduction in daily pain was significantly greater than placebo in both the 150 mg/ day group (mean difference -1.20 (95 percent CI 11.81, -0.58)) and 300 mg/day group (mean difference -1.57 (95 percent CI -2.20, -0.95). Sleep and mood but not quality of life also improved significantly.54[II]

In the third study, 370 patients with PHN were randomized to receive either placebo or three doses of pregabalin: 150, 300, and 600 mg/day, in a 13-week trial (including a one-week titration phase).55[II] Pregabalin showed an increase in effect with increasing dosage. Weekly mean pain scores rated on an 11-point scale improved steadily in all groups and were greatest in the 600 mg/day group. Sleep improved in all active drug groups more than in the placebo group. Patients in the 150 and 600 mg/day group, but not 300 mg/day, reported global improvement more than those receiving placebo.

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