Tags

Type your tag names separated by a space and hit enter

Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Arthritis Rheum. 2012 Jul; 64(7):2387-97.AR

Abstract

OBJECTIVE

To evaluate the efficacy, tolerability, and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia.

METHODS

Patients meeting the American College of Rheumatology criteria for fibromyalgia were randomized to receive esreboxetine at dosages of 4 mg/day (n=277), 8 mg/day (n=284), or 10 mg/day (n=283) or matching placebo (n=278) for 14 weeks. The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Questionnaire (FIQ) total score at week 14. Secondary efficacy measures included scores for the Patient's Global Impression of Change (PGIC) scale, the Global Fatigue Index (GFI), and the 36-item Short-Form health survey (SF-36; physical function scale only) at week 14. The safety profile of esreboxetine was evaluated based on adverse events and other safety measures.

RESULTS

Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score (P≤0.025), the FIQ score (P≤0.023), and the PGIC score (P≤0.007) compared with patients in the placebo group. Additionally, patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo (P=0.001). No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine (any dosage) and those receiving placebo. Adverse events were mostly mild to moderate in severity; insomnia, constipation, dry mouth, nausea, dizziness, hot flush, headache, hyperhidrosis, and palpitations were reported most frequently.

CONCLUSION

Esreboxetine was generally well tolerated and was associated with significant improvements in pain, FIQ, PGIC, and fatigue scores compared with placebo. The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure.

Authors+Show Affiliations

University of Cincinnati College of Medicine, Cincinnati, Ohio 45219, USA. Lesley.Arnold@uc.eduNo 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

22275142

Citation

Arnold, Lesley M., et al. "Safety and Efficacy of Esreboxetine in Patients With Fibromyalgia: a Fourteen-week, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial." Arthritis and Rheumatism, vol. 64, no. 7, 2012, pp. 2387-97.
Arnold LM, Hirsch I, Sanders P, et al. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012;64(7):2387-97.
Arnold, L. M., Hirsch, I., Sanders, P., Ellis, A., & Hughes, B. (2012). Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis and Rheumatism, 64(7), 2387-97. https://doi.org/10.1002/art.34390
Arnold LM, et al. Safety and Efficacy of Esreboxetine in Patients With Fibromyalgia: a Fourteen-week, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial. Arthritis Rheum. 2012;64(7):2387-97. PubMed PMID: 22275142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. AU - Arnold,Lesley M, AU - Hirsch,Ian, AU - Sanders,Paul, AU - Ellis,Amanda, AU - Hughes,Bernadette, PY - 2012/1/26/entrez PY - 2012/1/26/pubmed PY - 2012/9/15/medline SP - 2387 EP - 97 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 64 IS - 7 N2 - OBJECTIVE: To evaluate the efficacy, tolerability, and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia. METHODS: Patients meeting the American College of Rheumatology criteria for fibromyalgia were randomized to receive esreboxetine at dosages of 4 mg/day (n=277), 8 mg/day (n=284), or 10 mg/day (n=283) or matching placebo (n=278) for 14 weeks. The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Questionnaire (FIQ) total score at week 14. Secondary efficacy measures included scores for the Patient's Global Impression of Change (PGIC) scale, the Global Fatigue Index (GFI), and the 36-item Short-Form health survey (SF-36; physical function scale only) at week 14. The safety profile of esreboxetine was evaluated based on adverse events and other safety measures. RESULTS: Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score (P≤0.025), the FIQ score (P≤0.023), and the PGIC score (P≤0.007) compared with patients in the placebo group. Additionally, patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo (P=0.001). No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine (any dosage) and those receiving placebo. Adverse events were mostly mild to moderate in severity; insomnia, constipation, dry mouth, nausea, dizziness, hot flush, headache, hyperhidrosis, and palpitations were reported most frequently. CONCLUSION: Esreboxetine was generally well tolerated and was associated with significant improvements in pain, FIQ, PGIC, and fatigue scores compared with placebo. The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure. SN - 1529-0131 UR - https://www.unboundmedicine.com/medline/citation/22275142/Safety_and_efficacy_of_esreboxetine_in_patients_with_fibromyalgia:_a_fourteen_week_randomized_double_blind_placebo_controlled_multicenter_clinical_trial_ L2 - https://doi.org/10.1002/art.34390 DB - PRIME DP - Unbound Medicine ER -