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

ABSTRACT:

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

SUBMITTER: Solomon DH 

PROVIDER: S-EPMC7229518 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature