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Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.

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Low-dose methotrexate (LD-MTX) use in patients with cardiovascular disease showed increased risks for gastrointestinal, pulmonary, infectious, and hematologic adverse events (AEs). However, renal AEs were decreased, and skin cancer risk was elevated.

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Area of Science:

  • Rheumatology and Pharmacology
  • Cardiovascular Disease Research
  • Clinical Trial Analysis

Background:

  • Low-dose methotrexate (LD-MTX) is a primary treatment for systemic rheumatic diseases, including rheumatoid arthritis.
  • Despite widespread use, robust data on adverse event (AE) rates from placebo-controlled trials are limited.
  • Understanding LD-MTX risks is crucial for patient safety and treatment optimization.

Purpose of the Study:

  • To quantify and compare adverse event (AE) rates and risks between LD-MTX and placebo.
  • To identify specific AE profiles associated with LD-MTX in a high-risk population.
  • To provide evidence-based insights into the safety of LD-MTX.

Main Methods:

  • A double-blind, placebo-controlled, randomized trial (ClinicalTrials.gov: NCT01594333) was conducted in North America.
  • Adult participants with cardiovascular disease and diabetes or metabolic syndrome were randomized to LD-MTX (≤20 mg/wk) or placebo, with all receiving folic acid.
  • Adverse events were assessed through blinded adjudication, comparing risks between groups over a median follow-up of 23 months.

Main Results:

  • Of 4786 participants, 87.0% on LD-MTX and 81.5% on placebo experienced an AE of interest.
  • LD-MTX was associated with elevated risks for gastrointestinal (HR, 1.91), pulmonary (HR, 1.52), infectious (HR, 1.15), and hematologic (HR, 1.15) AEs.
  • Increased skin cancer risk (HR, 2.05) was observed with LD-MTX, while renal AEs were reduced (HR, 0.85).

Conclusions:

  • LD-MTX use in patients without rheumatic disease but with cardiovascular risk factors is linked to increased risks of certain AEs.
  • The study highlights a need for careful monitoring of gastrointestinal, pulmonary, infectious, hematologic, and skin adverse events.
  • Reduced renal AE risk with LD-MTX suggests potential benefits in specific patient populations, warranting further investigation.