None listed
Conditions
Brief summary
Rheumatoid arthritis (RA) is a chronic disabling autoimmune condition characterized by local and systemic inflammation, joint pain, stiffness and fatigue. RA patients also suffer from so-called ‘extra-articular’ manifestations, affecting several organs and systems such as the skin, eye, lung, heart, kidney, blood vessels, and bone marrow. Patients with RA and cardiovascular risk factors such as high blood pressure and diabetes are known to be at an increased risk of cardiovascular disease. Since cardiovascular disease is known to be an inflammatory condition, RA patients without cardiovascular risk factors may have an additional increased risk of developing cardiovascular disease. However, some evidence suggests that the use of methotrexate (MTX) drug, a traditional anti-inflammatory drug for use in RA patients, may lower the risk of cardiovascular disease. In order to establish whether MTX lowers specific risk factors for CVD in RA patients, any comparison of risk factors such as blood pressure and arterial function between patients receiving and not receiving MTX must take into account other factors that might influence these risk factors and which may be different between groups of patients receiving and not receiving MTX. These factors include the dose and concentration of MTX, levels of exercise, dietary nutrient intake, alcohol intake, and clinical and biological characteristics. The main aim of our study is to examine whether taking MTX drug can improve blood pressure and arterial function in the RA. The novelty of our results will likely translate into a) substantial changes in clinical practice, in particular cardiovascular risk management in RA patients and, possibly, in the general population; b) high-impact research outputs in leading journals in rheumatology, cardiovascular medicine, pharmacology, molecular biology and chemistry; c) invitations to present data at key national and international meetings; and d) ongoing collaborations with the pharmacological industry in relation to the synthesis and further development of MTX analogues.
Interventions
Condition and exposure:
This is an observational study conducted on rheumatoid arthritis (RA) population.
Participants were classified according to methotrexate (MTX) exposure into: currently taking MTX, and not taking MTX for at least 1 year (non-MTX) but they were on other anti-rheumatic medications. A third cohort of RA patient was those who were neither on MTX nor on any other medications. This group included those RA patients who were MTX naive (never treated) as well as those who had been
Condition and exposure: This is an observational study conducted on rheumatoid arthritis (RA) population. Participants were classified according to methotrexate (MTX) exposure into: currently taking MTX, and not taking MTX for at least 1 year (non-MTX) but they were on other anti-rheumatic medications. A third cohort of RA patient was those who were neither on MTX nor on any other medications. This group included those RA patients who were MTX naive (never treated) as well as those who had been exposed to MTX at some stage of their illness. Those started on MTX were considered on therapy until follow-up visit. Duration of observation: The study was taken place between April 2014 and December 2015. All participants were examined at baseline and then followed after 8 months.
Sponsors
Flinders University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients were included if: 1. Aged 18 years or older 2. Diagnosis of RA was made based on 1987 or 2010 American College of Rheumatology diagnostic criteria, and the rheumatologist diagnosis when the first date of fulfilling the diagnostic criteria was considered as RA incidence date
Exclusion criteria
There were no exclusion criteria except if there was one of the following: 1. Sustained atrial fibrillation because arterial function cannot be examined 2. Active cancers as some anticancer drugs (including chemotherapy) induce endothelial dysfunction, which might affect the blood pressure and arterial function 3. Congestive heart failure (left ventricular diastolic dysfunction) 4. Cognitive impairment
Outcome results
None listed