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Meglumine indometacin is a nonsteroidal anti-inflammatory drug (NSAID). It is a chemically synthesised substance that is authorised as a medicine in the European Union. In the clinical trial data examined here, it appears as a comparator treatment for axial spondyloarthritis.[1]
Meglumine indometacin is a nonsteroidal anti-inflammatory drug (NSAID). It is a chemically synthesised substance, meaning it is made in a laboratory rather than derived from a living organism.[1] The substance is classified as indometacin with ATC code M01AB01.[1] It is authorised as a medicine, and the product name recorded in the trial registry is INDOMETACIN.[1]
Indometacin belongs to the NSAID class of medicines. NSAIDs work by reducing the production of substances in the body called prostaglandins, which are involved in pain, inflammation and fever. The US label for indometacin capsules describes the medicine as a nonsteroidal anti-inflammatory drug.[2] The label also warns that NSAIDs as a class can increase the risk of serious cardiovascular and gastrointestinal events.[2]
Indometacin is taken by mouth. The trial record lists the route of administration as oral.[1] The NHS dm+d browser lists many oral forms, including capsules, modified-release capsules, modified-release tablets, oral solutions and oral suspensions, as well as suppositories.[3] In the European trial, indometacin is given as a 150 mg oral dose.[1]
One European trial, identified as 2024-513213-13-00, includes meglumine indometacin. The trial is a Phase 3 interventional study in axial spondyloarthritis with 100 participants.[1] Its status is Authorised.[1]
In this trial, indometacin is a comparator. The study directly compares NSAIDs with a biosimilar TNF blocker called Remsima in patients with axial spondyloarthritis who have failed NSAID therapy in outpatient care.[1] The NSAID arm includes several medicines: diclofenac, indometacin, ibuprofen, acemetacin, etoricoxib, meloxicam, celecoxib and naproxen.[1]
The primary outcome is the proportion of patients on NSAID versus TNF blocker treatment who achieve low disease activity, defined as ASDAS below 2.1, after 12 weeks of treatment.[1] ASDAS stands for Ankylosing Spondylitis Disease Activity Score, a measure of disease activity in axial spondyloarthritis.
The prescribing information for indometacin capsules carries a boxed warning about serious risks. NSAIDs, including indometacin, can increase the risk of serious cardiovascular thrombotic events such as myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.[2]
NSAIDs can also increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease or gastrointestinal bleeding are at greater risk.[2]
Indometacin capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.[2]
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