MEDAL Study (Multinational Etoricoxib Versus Diclofenac Arthritis Long-Term Study)
The MEDAL program is basically a specifically designed arthritis study programme, conducted across 38 countries, with the primary purpose to assess CV safety.
The study is reportedly the largest and longest controlled clinical assessment of a selective COX-2 inhibitor vs. a traditional NSAID in an arthritis patient population.
In other terms, the MEDAL program was originally designed to provide a precise estimate of the relative cardiovascular event rates with the COX-2 selective inhibitor etoricoxib in comparison to the traditional NSAID diclofenac in patients with osteoarthritis and rheumatoid arthritis.
The MEDAL programme basically consisted of three studies of Arcoxia (60 mg or 90 mg) in patients with osteoarthritis and rheumatoid arthritis. Below, we have given a brief outline of each of these three studies, which were a part of the MEDAL programme.
- MEDAL study: This study was an event-driven CV outcomes study, which included data from more than 23,000 osteoarthritis (OA) and rheumatoid arthritis (RA) patients.
- EDGE: This was a one-year gastrointestinal (GI) tolerability study in 7,111 OA patients, with CV safety designated as a pre-specified secondary endpoint.
- EDGE II: This was a two-and-a-half-year GI tolerability study conducted amongst 4,086 patients, with CV safety designated as a pre-specified secondary endpoint.
The study was based on the primary hypothesis that in the treatment of patients with OA and RA, Arcoxia (60 or 90 mg) would be non-inferior than diclofenac 150 mg, daily based on confirmed thrombotic CV events.
The MEDAL Population
The population or subjects included in the MEDAL study fulfilled one or more of the following inclusion criteria:
- Patients clinically diagnosed with OA or RA and at least 50 years of age
- As per the judgment of the investigator, the patients required chronic therapy, either with traditional NSAIDs or selective COX-2 inhibitors.
- The OA and RA patients enrolled were at a range of various CV risks.
Results and Analysis
A recent news release published the detailed gastrointestinal (GI) results from the MEDAL trial. The report compared Merck’s new COX-2 inhibitor etoricoxib (Arcoxia) with diclofenac. According to this release, fewer uncomplicated upper-GI clinical events were reported with the use of etoricoxib, a benefit that was also seen in patients taking proton pump inhibitors (PPIs) or low-dose aspirin.
The key results of the MEDAL study focused on cardiovascular safety. These results stated the two drugs to be similar with respect to thrombotic events, which was primarily the underlying subject, on which the entire controversy was based.
Meanwhile, experts insist that the gastrointestinal (GI) impact obtained from the MEDAL trial were significant in the light of the finding that the COX-2 inhibitors were developed for the specific purpose of reducing GI side effects associated with traditional NSAIDs.
Another recent research report in context of the MEDAL study indicated that the rates of thrombotic cardiovascular (CV) events in patients with arthritis on etoricoxib are similar to those in patients on diclofenac with the long-term use of these drugs.
As a part of the MEDAL study, 34,701 patients with arthritis, including osteoarthritis and rheumatoid arthritis were randomly assigned to etoricoxib or diclofenac for an average period of 18 months. As a result, thrombotic events were reported in 320 patients in the etoricoxib group and 323 in the diclofenac group.