Neuralgias and Neuropathies - unfolding of Pregabalin

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Abstract from Headache. 2005 Jan;45(1):95

NEURALGIAS AND NEUROPATHIES.

Rosenstock J, Tuchman M, LaMoreaux L, Sharma U.

Pregabalin for the treatment of painful diabetic peripheral neuropathy: a

double-blind, placebo-controlled trial. Pain. 2004;110:628-638.

A randomized, double-blind, placebo-controlled, parallel-group, multicenter,

8-week trial (with subsequent open-label phase) evaluated the effectiveness of

pregabalin in alleviating pain associated with diabetic peripheral neuropathy

(DPN).

For enrollment, patients must have had at baseline: 1- to 5-year history of DPN

pain; pain score >/= 40 mm (Short-Form McGill Pain Questionnaire [sF-MPQ] visual

analogue scale); average daily pain score of >/= 4 (11-point numerical pain

rating scale [0 = no pain, 10 = worst possible pain]).

One hundred forty-six (146) patients were randomized to receive placebo

(Formula: see text) or pregabalin 300 mg/day (Formula: see text). Primary

efficacy measure was endpoint mean pain score from daily patient diaries

(11-point numerical pain rating scale). Secondary measures included SF-MPQ

scores; sleep interference scores; Patient and Clinical Global Impression of

Change (PGIC and CGIC); Short Form-36 (SF-36) Health Survey scores; and Profile

of Mood States (POMS) scores.

Safety assessment included incidence and intensity of adverse events, physical

and neurological examinations, and laboratory evaluations. Pregabalin produced

significant improvements versus placebo for mean pain scores [Formula: see

text], mean sleep interference scores [Formula: see text], total SF-MPQ score

[Formula: see text], SF-36 Bodily Pain subscale [Formula: see text], PGIC

[Formula: see text], and Total Mood Disturbance and Tension-Anxiety components

of POMS [Formula: see text].

Pain relief and improved sleep began during week 1 and remained significant

throughout the study [Formula: see text]. Pregabalin was well tolerated despite

a greater incidence of dizziness and somnolence than placebo. Most adverse

events were mild to moderate and did not result in withdrawal.

Pregabalin was safe and effective in decreasing pain associated with DPN, and

also improved mood, sleep disturbance, and quality of life.

Comment: Pregabalin is a new compound related to gabapentin, but long acting, so

presumably QD in dosing. Because gabapentin works in migraine prevention (Mathew

NT, Rapoport A, Saper J, Magnus L, Bernstein P, Klapper J, Ramadan N, Stacey B,

Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache.

2001;41:119-128.), and because we use gabapentin for neuralgias, the unfolding

of the utility of pregabalin is quite important.- J. Tepper, MD

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