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| |  Pregabalin Results in Pain Relief in Fibromyalgia Patients: Presented at EULAR By Jill Stein PARIS -- June 13, 2008 -- Pregabalin improves important symptom domains in patients with fibromyalgia, according to a large global trial presented here at EULAR 2008, the Annual Congress of the European League Against Rheumatism. The study is the first to assess the safety and efficacy of pregabalin for the management of pain and other key symptom domains in fibromyalgia patients outside the United States. Lynne Pauer, MS, Pfizer Global Research and Development, Pfizer Inc., New London, Connecticut, and colleagues randomised 747 patients to pregabalin BID at total daily doses of 300, 450, or 600 mg or placebo for 14 weeks (a 2-week dosage escalation phase followed by a 12-week fixed-dosage phase). The study, presented on June 12, was conducted in Denmark, France, Germany, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland, the United Kingdom, Canada, Mexico, India, the Republic of Korea, Australia, and Venezuela. The primary efficacy measure was the endpoint mean pain score (MPS), using an 11-point daily pain diary numerical rating scale, where a score of 0 indicated a complete absence of pain and 10 denoted the worst pain possible. All patients had widespread pain for at least 3 months and a pain Visual Analog Scale (VAS) score of 40 mm or greater (0-100 mm) but did not achieve a reduction of at least 30% in VAS score during a 1-week placebo run-in. Additional efficacy parameters included endpoint scores on the Patient Global Impression of Change (PGIC) scale (1 = very much improved, 7 = very much worse), Medical Outcome Study (MOS) Sleep Disturbance subscale, and the Fibromyalgia Impact Questionnaire (FIQ). At enrolment, the MPS was 6.7. Differences compared with placebo in MPS change from baseline to endpoint were -0.34 for the 300-mg dose (P = .168), 0.54 for the 450-mg dose (P = .0164), and -0.23 for the 600-mg dose (P = .234). Patients in all the pregabalin cohorts had a statistically significant improvement starting in the first week and lasting through the sixth week. The 450-mg group maintained efficacy through week 14. On the PGIC scale, 67% of the 300-mg group (P = .054), 73% of the 450-mg group (P = .002), and 69% of the 600-mg group (P = .023) reported at least minimal improvement compared with 56% of placebo patients. At enrolment, patients had moderate to severe sleep disturbances, with a mean score of 60 on the MOS Sleep Disturbance subscale. All dose groups demonstrated statistically significant improvements compared with placebo. Pregabalin 450 mg was associated with a significant reduction in FIQ total score at endpoint (P = .0012). The 5 most common adverse effects for all pregabalin dosages were dizziness (41%), sleepiness (17%), weight gain (13%), dry mouth (9%), and peripheral oedema (9%). The safety profile was in line with what has been reported in earlier fibromyalgia trials. Overall, these results show that the 450-mg/day dosage demonstrated consistent efficacy for relief of fibromyalgia-associated pain, global impression of change, function, and sleep disturbance, the researchers concluded. The results are comparable to those previously published in US trials and demonstrate the efficacy of pregabalin for reduction of pain and improvement of overall status, function, and sleep in fibromyalgia patients worldwide. Funding for the study was provided by Pfizer Inc.
[Presentation title: Pregabalin for Management of Fibromyalgia (FM): A 14-Week, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial (Study A0081100). Abstract THU382]
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