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Adverse Effects of Low-Dose Methotrexate

医学 安慰剂 不利影响 内科学 危险系数 类风湿性关节炎 甲氨蝶呤 相对风险 体质指数 随机对照试验 外科 置信区间 病理 替代医学
作者
Daniel H. Solomon,Robert J. Glynn,Elizabeth W. Karlson,Fengxin Lu,Cassandra Corrigan,J Colls,Chang Xu,Jean MacFadyen,Medha Barbhaiya,Nancy Berliner,Paul F. Dellaripa,Brendan M. Everett,Aruna D. Pradhan,Sarah P. Hammond,Meredith Murray,Deepak A. Rao,Susan Ritter,Anna E. Rutherford,Jeffrey A. Sparks,Jackie Stratton,Dong Hyun Suh,Sara K. Tedeschi,Kathleen M M Vanni,Nina P. Paynter,Paul M. Ridker
出处
期刊:Annals of Internal Medicine [American College of Physicians]
卷期号:172 (6): 369-369 被引量:120
标识
DOI:10.7326/m19-3369
摘要

Background: Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred. Objective: To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo. Design: Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333) Setting: North America. Participants: Adults with known cardiovascular disease and diabetes or metabolic syndrome. Intervention: Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week. Measurements: Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication. Results: After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]). Limitation: The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period. Conclusion: Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased. Primary Funding Source: National Institutes of Health.
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