pregabalin efficacy in peripheral neuropathic pain results from the first 15 months of an ongoing...
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Pregabalin Efficacy in Peripheral Neuropathic Pain
Results from the first 15 months of an ongoing open-label study in patients with treatment-refractory pain: Peripheral neuropathic pain analysis.
Refractory Pain Study – Peripheral Neuropathic Pain Analysis: Inclusion Criteria
• Patients with DPN or PHN who had previously taken part in placebo-controlled, double-blind pregabalin trials
• Refractory to:–Gabapentin ≥1800 mg/day AND–Tricyclic antidepressant ≥75 mg/day AND–≥1 3rd line agent (e.g. AED, narcotic, SSNRI, NSAID)
• Refractoriness defined as inadequate pain relief for 2 weeks and/or intolerable side-effects on each of the above–SF-MPQ pain VAS score ≥40 mm–Allowed to continue all pain medications–No inferential testing performed
Adapted from D'Urso De Cruz et al. Diabetes 2005; 54 (Suppl. 1): A139 (abstract).
Refractory Pain Study – Peripheral Neuropathic Pain Analysis: Design Overview
Treatment period 1
Drug holiday 1
Treatment period 2
Drug holiday 2
Treatment period 3
Drug holiday 3
Treatment period 4
Drug holiday 4
Treatment period 5
3 months 3-28 days 3 months 3-28 days 3 months 3-28 days 3 months 3-28 days 3 months
Relapse
Not at all = 1
A little worse =2
√ Moderately worse =3
√ Much worse =4
√ Very much worse =5
Relapse
“How much has your pain worsened since discontinuing study medication?”
Relapse RelapseRelapse
Treatment period = 3-month open-label treatment period with pregabalin 150-600 mg/dayDrug holiday = pregabalin drug holiday. Only 4 patients did not relapse during drug holidays.
Adapted from D'Urso De Cruz et al. Diabetes 2005; 54 (Suppl. 1): A139 (abstract).
Refractory Pain Study – Pain Reported on Pregabalin Treatment* and During Drug Holidays
DH = pregabalin drug holiday. Only 4 patients did not relapse during drug holidays.*15-month open-label pregabalin treatment analysis
Adapted from D'Urso De Cruz et al. Diabetes 2005; 54 (Suppl. 1): A139 (abstract).
Refractory Pain Study – Peripheral Neuropathic Pain Analysis: Distribution of Pain Severity at Baseline and 15 Months
No/Mild Pain: 0-39; Moderate Pain: 40-69; Severe Pain: ≥70 on SF-MPQ pain VAS15-month analysis (LOCF). Only 4 patients did NOT relapse during drug holidays.
Adapted from D'Urso De Cruz et al. Diabetes 2005; 54 (Suppl. 1): A139 (abstract).