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Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival: 10-year follow-up of a 2-year randomised trial.

ABSTRACT: To examine the long-term effects of early low-dose prednisolone use in patients with rheumatoid arthritis (RA) on cardiovascular (CV) morbidity and mortality.Retrieval of data from a 2-year open randomised trial comparing prednisolone 7.5 mg/day in addition to disease-modifying antirheumatic drugs (DMARDs) with DMARD therapy alone. Participants were followed for 10 years since inclusion into the original prednisolone trial or until occurrence of the studied outcomes.Secondary level of care; six participating centres from southern Sweden; both urban and rural populations.Overall, 223 patients with early RA were included. The participants had no history of CV events at baseline and incident cases were identified via the Swedish Hospital Discharge and Cause of Death Registries.Composite CV events, that is, ischaemic coronary and cerebrovascular events, components of the composite CV outcome, and death. Relative HRs from Cox proportional-hazards regression models were calculated.Within 2041 person-years, 17 incident composite CV events occurred in 112 patients (15%) randomised to prednisolone, and 15 events of 111 patients (14%) who were assigned not to receive prednisolone. There were nine deaths (8%) in each group. The age-adjusted relative hazards (HRs; 95% CI) for the first composite CV event, first coronary event and death in the prednisolone group versus the group not treated with prednisolone were 1.8 (0.9 to 3.6), 0.98 (0.4 to 2.6) and 1.6 (0.6 to 4.1), respectively. The risk for the first cerebrovascular event showed a 3.7-fold increased relative hazard (95% CI 1.2 to 11.4) among prednisolone treated patients.In this inception cohort study of low-dose prednisolone use during the first 2 years of RA disease, the incidence of ischaemic coronary artery events was similar in the two treatment groups, whereas the long-term risk of ischaemic cerebrovascular events was higher in the prednisolone group. There was a trend towards reduced survival in the prednisolone group.ISRCTN20612367.

SUBMITTER: Ajeganova S

PROVIDER: S-EPMC3987742 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival: 10-year follow-up of a 2-year randomised trial.

Ajeganova Sofia S Svensson Björn B Hafström Ingiäld I

BMJ open 20140407 4

<h4>Objective</h4>To examine the long-term effects of early low-dose prednisolone use in patients with rheumatoid arthritis (RA) on cardiovascular (CV) morbidity and mortality.<h4>Design</h4>Retrieval of data from a 2-year open randomised trial comparing prednisolone 7.5 mg/day in addition to disease-modifying antirheumatic drugs (DMARDs) with DMARD therapy alone. Participants were followed for 10 years since inclusion into the original prednisolone trial or until occurrence of the studied outco ...[more]

PMID: 24710131

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Project description:ObjectivesTo determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.DesignTwo year randomised controlled trial extended to six years.SettingRheumatology outpatient department in teaching hospital.Participants209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).Main outcome measuresClinical outcomepain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.ResultsParticipants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).ConclusionsOver six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Project description:IntroductionScheduled routine visits in patients with rheumatoid arthritis (RA) may be in a stable period without active disease. Consequently, there is a demand for developing outpatient control procedures which cater to the needs of the individual patient.ObjectiveThis study aims to compare a patient-controlled outpatient follow-up system, Open Outpatient Clinic Programme (OOCP), with traditional scheduled routine follow-up (TSRF) regarding patient satisfaction and disease activity markers in RA patients.MethodIn a 2-year randomized controlled trial, RA patients were allocated to OOCP or TSRF. OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist and had access to nurse-led consultations and a telephone helpline. Appointments for the TSRF group were scheduled according to routine procedures (clinical parameters: DAS-28, C-reactive protein, VAS pain, tender and swollen joint count, HAQ-DI and radiographs; psychological parameters: VAS patient satisfaction and EQ-5D).ResultsOf 282 patients, 239 completed the study (OOCP/TSRF characteristics: age 61.4 ± 10.5/60.9 ± 12.2 years, females 77/74%, ACPA positive 66/65%). At years 1 and 2, OCCP had fewer visits (year 2: 2.6 ± 1.6 vs. 3.5 ± 2; p < 0.0005) but more phone calls (year 2: 0.7 ± 1.4 vs. 0.1 ± 0.3; p < 0.0005) compared to TSRF. OOCP was comparable to TSRF regarding clinical and psychological outcome measures, and no radiographic progression was observed.ConclusionsOOCP was associated with significantly fewer visits but with more phone calls to the nurse and was comparable with TSGentofte University HospitalRF regarding clinical, psychological and radiographic outcomes. Thus, the organization of outpatient care according to OOCP may be applied to strengthen patient-centred care in patients with RA. ClinicalTrials.gov Identifier (July 20, 2020): NCT04476875 Key points • In a patient-controlled outpatient follow-up system, RA patients had significantly fewer visits compared to traditional follow-up. • The patient-controlled follow-up system was comparable with traditional follow-up regarding clinical, psychological and radiographic outcomes. • Organization of outpatient care according to a patient-controlled follow-up system may be applied to strengthen patient-centred care in patients with RA.

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Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival: 10-year follow-up of a 2-year randomised trial.

Publications

Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival: 10-year follow-up of a 2-year randomised trial.

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