Pregabalin Efficacy in Peripheral Neuropathic Pain Results from the first 15 months of an ongoing open-label study in patients with treatment-

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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 months3-28 days3 months3-28 days3 months3-28 days3 months3-28 days3 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 Treatment period = 3-month open- label treatment period with pregabalin mg/day Drug 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 VAS 15-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).