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document
Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival : 10-year follow-up of a 2-year randomised trial . OBJECTIVE To examine the long-term effects of early low-dose prednisolone use in patients with rheumatoid arthritis ( RA ) on cardiovascular ( CV ) morbidity and mortality . DESIGN 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 . SETTING Secondary level of care ; six participating centres from southern Sweden ; both urban and rural populations . PARTICIPANTS 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 . OUTCOMES 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 . RESULTS 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 . CONCLUSIONS 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 . TRIAL REGISTRATION NUMBER ISRCTN20612367 .
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Intervention_Pharmacological
Low-dose prednisolone treatment
64909
Intervention_Pharmacological
prednisolone
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Intervention_Pharmacological
prednisolone
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Intervention_Pharmacological
disease-modifying antirheumatic drugs ( DMARDs )
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Intervention_Pharmacological
prednisolone
64913
Intervention_Pharmacological
prednisolone
64914
Intervention_Pharmacological
prednisolone
64915
Intervention_Pharmacological
prednisolone
64916
Intervention_Pharmacological
prednisolone
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Intervention_Pharmacological
prednisolone
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Intervention_Pharmacological
prednisolone
64919
Intervention_Pharmacological
prednisolone
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Intervention_Pharmacological
prednisolone
64921
Outcome_Physical
late cardiovascular outcome
64922
Outcome_Mortality
survival
64923
Outcome_Physical
long-term effects
64924
Outcome_Physical
cardiovascular ( CV ) morbidity
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Outcome_Mortality
mortality
64926
Outcome_Physical
CV events
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Outcome_Physical
Composite CV events
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Outcome_Mortality
death
64929
Outcome_Physical
composite CV events
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Outcome_Mortality
deaths
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Outcome_Physical
composite CV event , first coronary event
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Outcome_Mortality
death
64933
Outcome_Physical
risk for the first cerebrovascular event
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Outcome_Physical
incidence of ischaemic coronary artery events
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Outcome_Physical
long-term risk of ischaemic cerebrovascular events
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Outcome_Mortality
reduced survival
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Participant_Condition
early rheumatoid arthritis
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Participant_Condition
rheumatoid arthritis ( RA ) on cardiovascular ( CV ) morbidity and mortality
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Participant_Sample-size
six
64940
Participant_Sample-size
223
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Participant_Condition
had no history of CV events at baseline