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Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin.
Clin J Pain. 2012 Sep; 28(7):609-14.CJ

Abstract

OBJECTIVE

To determine the incidence and duration of response of clinically meaningful improvements with pregabalin across several key symptoms of fibromyalgia (FM).

METHODS

This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled, randomized, withdrawal study, originally designed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change (PGIC) criteria. Responder criteria for Fibromyalgia Impact Questionnaire total score (≥16-point change), Medical Outcomes Study Sleep Scale Sleep Disturbance subscale (≥15.8-point change), and the 36-item Short-Form Health Survey Vitality scale (≥10-point change) were used to evaluate the incidence and duration of improvements in function, sleep, and fatigue for pregabalin versus placebo among pain and PGIC responders. A composite responder index consisting of pain, PGIC, function, and sleep endpoints was used to explore multidimensional response.

RESULTS

Approximately 80% of patients meeting pain and PGIC improvement criteria at randomization had clinically meaningful improvement in fatigue, sleep, or function. Higher proportions of patients in the pregabalin group maintained a clinically meaningful response, and pregabalin-treated patients had a significantly longer time to loss of therapeutic response compared with the placebo group. Composite responder Kaplan-Meier analysis, performed with patients demonstrating clinically meaningful improvements in pain, PGIC, function, and sleep at randomization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients.

DISCUSSION

The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM (ClinicalTrials.gov registry ID: NCT00151489).

Authors+Show Affiliations

Pfizer Global Research and Development, New London, CT, USA. lynne.pauer@pfizer.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22688598

Citation

Pauer, Lynne, et al. "Long-term Maintenance of Response Across Multiple Fibromyalgia Symptom Domains in a Randomized Withdrawal Study of Pregabalin." The Clinical Journal of Pain, vol. 28, no. 7, 2012, pp. 609-14.
Pauer L, Atkinson G, Murphy TK, et al. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012;28(7):609-14.
Pauer, L., Atkinson, G., Murphy, T. K., Petersel, D., & Zeiher, B. (2012). Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. The Clinical Journal of Pain, 28(7), 609-14. https://doi.org/10.1097/AJP.0b013e31823dd315
Pauer L, et al. Long-term Maintenance of Response Across Multiple Fibromyalgia Symptom Domains in a Randomized Withdrawal Study of Pregabalin. Clin J Pain. 2012;28(7):609-14. PubMed PMID: 22688598.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. AU - Pauer,Lynne, AU - Atkinson,Gary, AU - Murphy,T Kevin, AU - Petersel,Danielle, AU - Zeiher,Bernhardt, PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2013/1/17/medline SP - 609 EP - 14 JF - The Clinical journal of pain JO - Clin J Pain VL - 28 IS - 7 N2 - OBJECTIVE: To determine the incidence and duration of response of clinically meaningful improvements with pregabalin across several key symptoms of fibromyalgia (FM). METHODS: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled, randomized, withdrawal study, originally designed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change (PGIC) criteria. Responder criteria for Fibromyalgia Impact Questionnaire total score (≥16-point change), Medical Outcomes Study Sleep Scale Sleep Disturbance subscale (≥15.8-point change), and the 36-item Short-Form Health Survey Vitality scale (≥10-point change) were used to evaluate the incidence and duration of improvements in function, sleep, and fatigue for pregabalin versus placebo among pain and PGIC responders. A composite responder index consisting of pain, PGIC, function, and sleep endpoints was used to explore multidimensional response. RESULTS: Approximately 80% of patients meeting pain and PGIC improvement criteria at randomization had clinically meaningful improvement in fatigue, sleep, or function. Higher proportions of patients in the pregabalin group maintained a clinically meaningful response, and pregabalin-treated patients had a significantly longer time to loss of therapeutic response compared with the placebo group. Composite responder Kaplan-Meier analysis, performed with patients demonstrating clinically meaningful improvements in pain, PGIC, function, and sleep at randomization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients. DISCUSSION: The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM (ClinicalTrials.gov registry ID: NCT00151489). SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/22688598/Long_term_maintenance_of_response_across_multiple_fibromyalgia_symptom_domains_in_a_randomized_withdrawal_study_of_pregabalin_ L2 - https://doi.org/10.1097/AJP.0b013e31823dd315 DB - PRIME DP - Unbound Medicine ER -