RESUMO
INTRODUCTION: Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. METHODS AND ANALYSIS: The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5â years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5â mmol/L, glycated haemoglobin <48â mmol/mol, blood pressure <140/90â mmâ Hg for patients without diabetes and <130/80â mmâ Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30â mg/g) after 1â year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1â year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60â months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60â months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia and (4) microalbuminuria (intervention group). ETHICS AND DISSEMINATION: This protocol is approved by the local ethics committee (DK-S-2014007) and The Danish Health and Medicines Authority. Dissemination will occur through presentations at National and International conferences and publications in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02246257.
Assuntos
Artrite Reumatoide/complicações , Doenças Cardiovasculares/prevenção & controle , Hipolipemiantes/administração & dosagem , Projetos de Pesquisa , Sinvastatina/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Albuminúria/prevenção & controle , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Proteína C-Reativa/análise , Dinamarca , Feminino , Hemoglobinas Glicadas/análise , Humanos , Hiperglicemia/prevenção & controle , Hiperlipidemias/prevenção & controle , Hipertensão/prevenção & controle , Lipoproteínas LDL , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Adulto JovemRESUMO
OBJECTIVES: Direct health provider to patient presentation of coronary computed tomography angiography findings may increase adherence to preventive therapy and risk modification. The purpose of this study was to assess the influence of visualization of coronary artery calcification and lifestyle recommendations on cholesterol concentrations and other risk variables in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia. METHODS: We performed a prospective 2-center randomized controlled trial. Patients were randomized 1:1 to intervention or standard follow-up in general practice. The primary end point was change in plasma total cholesterol concentration at 6 months follow-up. RESULTS: We included 189 patients (mean [± standard deviation] age 61 [12] years, 57% were male). Median (range) Agatston score was 166 (70-2054). The reduction in plasma total cholesterol concentrations tended to be higher in the intervention group than in the control group, 51.04 mg/dL versus 45.63 mg/dL (P = .181). In a subgroup including patients continuing statin therapy during follow-up (n = 147), the reduction in plasma total cholesterol concentrations was more pronounced in the intervention group than in the control group, 66.13 mg/dL versus 55.68 mg/dL (P = .027). In the intervention group, there was a higher degree of statin adherence and a higher proportion of patients who stopped smoking and commenced healthier dietary behavior than in the control group. CONCLUSIONS: Visualization of coronary artery calcification and brief recommendations about risk modification after coronary computed tomography angiography in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia may have a favorable influence on plasma total cholesterol concentration, adherence to statin therapy, and risk behavior. Further investigations are needed.