Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Rosuvastatin
- Conditions
- Carotid Artery Plaque
- Sponsor
- Diakonhjemmet Hospital
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Carotid artery cholesterol plaque regression and stabilization
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk of developing cardiovascular disease. The reason(s) for this have not been well investigated, but there is a general understanding that systemic inflammation plays a part in the increased cardiovascular morbidity and mortality. In spite of the increased risk in these patients, they have not been included as a high risk patient group in cardiovascular prevention guidelines.
The investigators have carried out a cardiovascular study of RA and AS patients, as well as patients with arthritis for the first time. The investigators have demonstrated cholesterol plaques in the carotid artery in some of these patients. Plaques in the carotid artery represent a risk for development of cerebral stroke and are significantly associated with myocardial infarction. These plaques, which are asymptomatic and do not cause haemodynamically significant narrowing, diameter reduction (i.e. operation is not indicated), are vascular atheromatous disease. Therefore, according to prevailing cardiovascular guidelines (SCORE 2007), these patients shall have secondary prevention with a lipid lowering agent with the LDL-cholesterol goal of 1.8 mmol/L and HDL-cholesterol > 1.0 mmol/L for men and > 1.1 mmol/L for women.
Statins are cholesterol-lowering drugs, and have been shown to reduce the risk of cardiovascular disease significantly. In addition, reduction in the size of coronary plaques has been induced by statins, when the LDL has been reduced to 1.6-1.8 mmol/l. Plaques in the carotid or coronary arteries have not previously been treated and characterized in patients with RA, AS and other inflammatory forms of arthritis.
The aim of this study is to treat patients with cholesterol plaques in the carotid artery with cholesterol-lowering medication, in the form of Rosuvastatin for 18 months, and characterize the effects on the plaques in the carotid and coronary arteries. In addition, the investigators want to clarify the connection between plaques in the carotid and coronary arteries in patients with RA, AS and other inflammatory forms of arthritis.
Investigators
Anne Grete Semb
Leader of the Preventive Cardio-Rheuma clinic
Diakonhjemmet Hospital
Eligibility Criteria
Inclusion Criteria
- •Women and men with RA, AS and other inflammatory forms of arthritis, aged 35-80 years.
- •Cholesterol plaques demonstrated in carotid artery by ultrasound.
- •Informed consent.
Exclusion Criteria
- •Concomitant statin treatment
- •Arterial fibrillation or others with chronic irregular heart rhythm (because of CT).
- •Contraindication to statin treatment.
- •Hypersensitivity to statins
- •Liver disease with ASAT/ALAT ≥ twice the upper normal limit
- •Previous statin-induced myopathy or severe hypersensitivity reactions to other statins
- •Raised creatinine (because of contrast medium)
- •Pregnancy or breast feeding
- •Fertile women who do not use contraceptives
- •Cyclosporine treatment
Arms & Interventions
Rosuvastatin intervention
Patients \> 70 years will be given Rosuvastatin of 5 mg a day, uptitering the dose until the LDL level of 1.6-1.8 mmol/l has been reached. Patient \<70 years, strat on Rosuvastatin 20 mg a day, uptitered to 40 mg a day, with the LDL of 1.6-1.8 mmol/l. -1.8 mmol/l. The objective is that all the participants should have reached a LDL level of 1.6-1.8 mmol/l 3 months after the start of the study. The participants will remain on Rosuvastatin medication for a total of 18 months.
Intervention: Rosuvastatin
Outcomes
Primary Outcomes
Carotid artery cholesterol plaque regression and stabilization
Time Frame: 18 months
Reduction of plaque area and change of the plaque morphology to less vulnerable for rupture after 18 months with 40 mg Rosuvastatin daily.
Secondary Outcomes
- Carotid artery cholesterol plaque regression and stabilization(18 months)
- Disease activity and health measures, lipoprotein components and inflammatory biomarkers(18 months)