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Maintenance of effect of duloxetine in Chinese patients with pain due to osteoarthritis: 13-week open-label extension data.
Wang, Guochun; Bi, Liqi; Li, Xiangpei; Li, Zhijun; Zhao, Dongbao; Chen, Jinwei; He, Dongyi; Wang, Chia-Ning; Wu, Tao; Dueñas, Héctor; Skljarevski, Vladimir; Yue, Li.
Afiliação
  • Wang G; Rheumatology Department, China-Japan Friendship Hospital, Beijing, China.
  • Bi L; Rheumatology Department, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China.
  • Li X; Rheumatology Department, Anhui Provincial Hospital, Hefei, Anhui, China.
  • Li Z; Rheumatology Department, Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
  • Zhao D; Rheumatology Department, Shanghai Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Chen J; Rheumatology Department, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
  • He D; Rheumatology Department, Shanghai Guanghua Hospital, Shanghai, China.
  • Wang CN; Asian-Pacific Statistical Sciences, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.
  • Wu T; Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, Shanghai, China.
  • Dueñas H; Corporate Affairs Manager, Latin America Caribbean and Mexico, Eli Lilly de Mexico, Mexico City, Mexico.
  • Skljarevski V; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Yue L; Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, 19F, Centre T1, HKRI Taikoo, No. 288, Shimen No.1 Road, Shanghai, 200021, China. yueli97021@126.com.
BMC Musculoskelet Disord ; 20(1): 174, 2019 Apr 22.
Article em En | MEDLINE | ID: mdl-31010413
ABSTRACT

BACKGROUND:

The objectives of this study were to assess the maintenance of effect of duloxetine 60 mg once-daily (QD) in Chinese patients with chronic pain due to osteoarthritis (OA) of the knee or hip and to provide additional long-term safety data.

METHODS:

This was an open-label, extension phase of a randomized, double-blind, placebo-controlled clinical trial. Eligible patients were outpatients who met the American College of Rheumatology clinical and radiographic criteria for OA with a rating ≥4 on Brief Pain Inventory (BPI) 24-h average pain. After completing the 13-week placebo-controlled phase, patients originally assigned to placebo were titrated to duloxetine 60 mg QD (PLA_DLX), whereas patients originally assigned to duloxetine 60 mg QD remained on the same dose of duloxetine (DLX_DLX) for another 13 weeks. The maintenance effect of duloxetine 60 mg QD during the extension phase was evaluated by a 1-sided 97.5% confidence interval (CI) of the baseline-to-endpoint change in the extension phase for patients who took duloxetine and reported ≥30% reduction in BPI average pain at the end of placebo-controlled phase (placebo-controlled phase duloxetine responders). Other BPI severity and interference items, as well as safety and tolerability, were assessed.

RESULTS:

Of 342 patients entering the extension phase, 162 (97.6%) DLX_DLX-treated patients and 157 (89.2%) PLA_DLX-treated patients completed this phase. Most patients (76.0%) were female. Mean age was 60.6 years. Mean BPI average pain was 5.5 at baseline of the placebo-controlled phase. Among 113 placebo-controlled phase duloxetine responders, mean change in BPI average pain during the extension phase was - 0.59 (from 2.47 to 1.88); the upper bound of the 1-sided 97.5% CI was - 0.31 and less than the pre-specified non-inferiority margin of a 1.5-point increase (p < 0.001). Significant within-group improvements in all BPI items were observed for both PLA_DLX and DLX_DLX groups during the extension phase (all p < 0.01). No deaths or suicide-related events occurred. Seven (4.0%) PLA_DLX-treated patients and no DLX_DLX-treated patients discontinued due to an adverse event.

CONCLUSION:

The analgesic effect of duloxetine 60 mg QD among treatment responders was maintained for the entire duration of the extension phase. Duloxetine 60 mg QD was well tolerated during the extension phase. TRIAL REGISTRATION ClinicalTrials.gov identification number NCT01931475 . Registered 29 August 2013.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Osteoartrite do Quadril / Artralgia / Osteoartrite do Joelho / Dor Crônica / Cloridrato de Duloxetina / Analgésicos Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Prognostic_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Osteoartrite do Quadril / Artralgia / Osteoartrite do Joelho / Dor Crônica / Cloridrato de Duloxetina / Analgésicos Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Prognostic_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article