Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): A 6-month, double-blind, placebo-controlled trial with pregabalin
Abstract
This was a multicenter, double-blind (DB), placebo-controlled, randomized discontinuation trial to evaluate the efficacy of pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain. The trial included a 6-week open-label (OL) pregabalin-treatment period followed by 26-week DB treatment with placebo or pregabalin. Adults with FM and 40-mm score on 100-mm pain visual analog scale (VAS) were eligible. During OL weeks 1-3, patients received escalating dosages of pregabalin to determine their optimal dosages. During OL weeks 4-6, patients received their optimal fixed dosages (300, 450, 600mg/d). To be randomized, patients must have had 50% decrease in pain VAS and a self-rating of "much" or "very much" improved on Patient Global Impression of Change (PGIC) at the end of OL. Double-blind treatment was with placebo or the patient's optimal fixed dosage of pregabalin. Primary outcome was time to loss of therapeutic response (LTR), defined as <30% reduction in pain (from OL baseline) or worsening of FM. A total of 1051 patients entered OL; 287 were randomized to placebo, 279 to pregabalin. Time to LTR was longer for pregabalin versus placebo (P<.0001). Kaplan-Meier estimates of time-to-event showed half the placebo group had LTR by Day 19; half the pregabalin group still had not lost response by trial end. At the end of DB, 174 (61%) placebo patients met LTR criteria versus 90 (32%) pregabalin patients. Pregabalin was well tolerated, though 178 (17%) discontinued duri…
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Thirty-eight percent of PGB-treated subjects compared to 19% of placebo patients remained on study drug and maintained a therapeutic response to week 26 of the study.
“Thirty-eight percent of the PGB-treated subjects compared to 19% of placebo patients remained on study drug and maintained a therapeutic response to week 26 of the study.”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [18]
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- Authors
- Crofford, L. J., Mease, P. J., Simpson, S. L., Young, J. P., Martin, S. A., Haig, G. M., & Sharma, U.
- Affiliations
- University of Kentucky HealthCare (US)
- Pfizer (United States) (US)
- Corresponding author
- Crofford, Leslie J.
- Venue
- Pain
- Published
- 2008-06
- Volume
- 136
- Issue
- 3
- Pages
- 419-431
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W2124677225
- Cited by
- 236
- References
- 4
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 4 · 2022: 6 · 2021: 5 · 2020: 3 · 2019: 1 · 2018: 3 · 2017: 8 · 2016: 6 · 2015: 12 · 2014: 10 · 2013: 21 · 2012: 26
- FWCI
- 29.20
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- fibromyalgia, pregabalin, relapse, analgesia, monotherapy, treatment discontinuation, adverse events
- MeSH terms
- Pregabalin, Analgesics, Clinical Protocols, Clinical Trials as Topic, Double-Blind Method, Female, Fibromyalgia, gamma-Aminobutyric Acid, Humans, Longitudinal Studies, Male, Middle Aged, Placebo Effect, Treatment Outcome, Outcome Assessment, Health Care, Adrenergic Uptake Inhibitors
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