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Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
Arthritis Rheum 2010; 62(1):291-300AR

Abstract

OBJECTIVE

To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS).

METHODS

In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI).

RESULTS

No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea.

CONCLUSION

Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment.

Authors+Show Affiliations

University Hospital Zurich, Zurich, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

20039417

Citation

Distler, Oliver, et al. "Evaluation of the Efficacy and Safety of Terguride in Patients With Fibromyalgia Syndrome: Results of a Twelve-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study." Arthritis and Rheumatism, vol. 62, no. 1, 2010, pp. 291-300.
Distler O, Eich W, Dokoupilova E, et al. Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2010;62(1):291-300.
Distler, O., Eich, W., Dokoupilova, E., Dvorak, Z., Fleck, M., Gaubitz, M., ... Müller-Ladner, U. (2010). Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis and Rheumatism, 62(1), pp. 291-300. doi:10.1002/art.25062.
Distler O, et al. Evaluation of the Efficacy and Safety of Terguride in Patients With Fibromyalgia Syndrome: Results of a Twelve-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study. Arthritis Rheum. 2010;62(1):291-300. PubMed PMID: 20039417.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. AU - Distler,Oliver, AU - Eich,Wolfgang, AU - Dokoupilova,Eva, AU - Dvorak,Zdenek, AU - Fleck,Martin, AU - Gaubitz,Markus, AU - Hechler,Manfred, AU - Jansen,Jan-Peter, AU - Krause,Andreas, AU - Bendszus,Martin, AU - Pache,Lothar, AU - Reiter,Rudolf, AU - Müller-Ladner,Ulf, PY - 2009/12/30/entrez PY - 2009/12/30/pubmed PY - 2010/3/12/medline SP - 291 EP - 300 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 62 IS - 1 N2 - OBJECTIVE: To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS). METHODS: In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI). RESULTS: No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea. CONCLUSION: Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/20039417/Evaluation_of_the_efficacy_and_safety_of_terguride_in_patients_with_fibromyalgia_syndrome:_results_of_a_twelve_week_multicenter_randomized_double_blind_placebo_controlled_parallel_group_study_ L2 - https://doi.org/10.1002/art.25062 DB - PRIME DP - Unbound Medicine ER -