Yu-Chi Su, Yu-Chen Su, Edward Chia-Cheng Lai, Yu-Ching Lin
{"title":"巴氯芬和替扎尼定对骨关节炎和关节置换术的风险：一项目标试验模拟研究。","authors":"Yu-Chi Su, Yu-Chen Su, Edward Chia-Cheng Lai, Yu-Ching Lin","doi":"10.1007/s40261-025-01448-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Preclinical studies have shown that baclofen may reduce the risk of osteoarthritis through its anti-inflammatory effect.</p><p><strong>Objective: </strong>We aimed to clarify this association by comparing the risks of osteoarthritis and joint replacement surgery in patients receiving baclofen and tizanidine.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted on the global TriNetX platform (October 31, 2024). New users of baclofen and tizanidine aged ≥40 years were included in the baclofen and tizanidine group, respectively. The propensity score matching method was used. The primary outcomes were osteoarthritis and joint replacement surgery. The secondary outcomes included all-cause mortality, a composite outcome of osteoarthritis and all-cause mortality, and a composite outcome of joint replacement surgery and all-cause mortality. Cause specific hazard ratios (HRs) with 95% confidence intervals (CIs) of the outcomes were calculated with Cox regression using the TriNetX platform.</p><p><strong>Results: </strong>Two well-balanced groups containing 68,210 patients each were generated by propensity score matching (age: 57.8 years; female: 55.6% in both groups). Baclofen users had a significantly lower risk of developing osteoarthritis than tizanidine users (HR: 0.965, 95% CI: 0.941 to 0.989). A similar relationship was observed for joint replacement surgery (HR: 0.847, 95% CI: 0.750 to 0.956). However, the composite outcome of osteoarthritis or death had a HR of 1.129 (95% CI: 1.109 to 1.150), and the HR of joint replacement surgery or death was 1.509 (95% CI: 1.463 to 1.556). The HR of death was 1.577 (95% CI: 1.527 to 1.629), suggesting a higher risk of mortality in the baclofen group.</p><p><strong>Conclusion: </strong>The surviving baclofen users had a lower risk of osteoarthritis and joint replacement surgery compared to surviving tizanidine users. However, baclofen users exhibited a higher risk of mortality than tizanidine users. Future studies are necessary to clarify the impact of baclofen on osteoarthritis and joint replacement surgery while accounting for mortality.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Risk of Osteoarthritis and Arthroplasty Between Baclofen and Tizanidine: A Target Trial Emulation Study.\",\"authors\":\"Yu-Chi Su, Yu-Chen Su, Edward Chia-Cheng Lai, Yu-Ching Lin\",\"doi\":\"10.1007/s40261-025-01448-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Preclinical studies have shown that baclofen may reduce the risk of osteoarthritis through its anti-inflammatory effect.</p><p><strong>Objective: </strong>We aimed to clarify this association by comparing the risks of osteoarthritis and joint replacement surgery in patients receiving baclofen and tizanidine.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted on the global TriNetX platform (October 31, 2024). New users of baclofen and tizanidine aged ≥40 years were included in the baclofen and tizanidine group, respectively. The propensity score matching method was used. The primary outcomes were osteoarthritis and joint replacement surgery. The secondary outcomes included all-cause mortality, a composite outcome of osteoarthritis and all-cause mortality, and a composite outcome of joint replacement surgery and all-cause mortality. Cause specific hazard ratios (HRs) with 95% confidence intervals (CIs) of the outcomes were calculated with Cox regression using the TriNetX platform.</p><p><strong>Results: </strong>Two well-balanced groups containing 68,210 patients each were generated by propensity score matching (age: 57.8 years; female: 55.6% in both groups). Baclofen users had a significantly lower risk of developing osteoarthritis than tizanidine users (HR: 0.965, 95% CI: 0.941 to 0.989). A similar relationship was observed for joint replacement surgery (HR: 0.847, 95% CI: 0.750 to 0.956). However, the composite outcome of osteoarthritis or death had a HR of 1.129 (95% CI: 1.109 to 1.150), and the HR of joint replacement surgery or death was 1.509 (95% CI: 1.463 to 1.556). The HR of death was 1.577 (95% CI: 1.527 to 1.629), suggesting a higher risk of mortality in the baclofen group.</p><p><strong>Conclusion: </strong>The surviving baclofen users had a lower risk of osteoarthritis and joint replacement surgery compared to surviving tizanidine users. However, baclofen users exhibited a higher risk of mortality than tizanidine users. 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Risk of Osteoarthritis and Arthroplasty Between Baclofen and Tizanidine: A Target Trial Emulation Study.
Background: Preclinical studies have shown that baclofen may reduce the risk of osteoarthritis through its anti-inflammatory effect.
Objective: We aimed to clarify this association by comparing the risks of osteoarthritis and joint replacement surgery in patients receiving baclofen and tizanidine.
Methods: This retrospective cohort study was conducted on the global TriNetX platform (October 31, 2024). New users of baclofen and tizanidine aged ≥40 years were included in the baclofen and tizanidine group, respectively. The propensity score matching method was used. The primary outcomes were osteoarthritis and joint replacement surgery. The secondary outcomes included all-cause mortality, a composite outcome of osteoarthritis and all-cause mortality, and a composite outcome of joint replacement surgery and all-cause mortality. Cause specific hazard ratios (HRs) with 95% confidence intervals (CIs) of the outcomes were calculated with Cox regression using the TriNetX platform.
Results: Two well-balanced groups containing 68,210 patients each were generated by propensity score matching (age: 57.8 years; female: 55.6% in both groups). Baclofen users had a significantly lower risk of developing osteoarthritis than tizanidine users (HR: 0.965, 95% CI: 0.941 to 0.989). A similar relationship was observed for joint replacement surgery (HR: 0.847, 95% CI: 0.750 to 0.956). However, the composite outcome of osteoarthritis or death had a HR of 1.129 (95% CI: 1.109 to 1.150), and the HR of joint replacement surgery or death was 1.509 (95% CI: 1.463 to 1.556). The HR of death was 1.577 (95% CI: 1.527 to 1.629), suggesting a higher risk of mortality in the baclofen group.
Conclusion: The surviving baclofen users had a lower risk of osteoarthritis and joint replacement surgery compared to surviving tizanidine users. However, baclofen users exhibited a higher risk of mortality than tizanidine users. Future studies are necessary to clarify the impact of baclofen on osteoarthritis and joint replacement surgery while accounting for mortality.
期刊介绍：
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
-Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs.
-Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice.
-Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed.
-Studies focusing on the application of drug delivery technology in healthcare.
-Short communications and case study reports that meet the above criteria will also be considered.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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