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).