Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® ▼ (baricitinib): Kardiovaskulär risk

Patienter med reumatoid artrit (RA) har en ökad kardiovaskulär (CV) risk baserat på deras RA.

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Summary

Cardiovascular risk was evaluated in the BARI phase 3 RA clinical program using the FRS and RRS.1

Framingham Risk Score Results

The FRS represents the likelihood of an individual patient experiencing a CVD event in the next 10 years. It is calculated for men and women aged ≥30 and ≤74 years with no prior history of CVD.1

There were no consistent statistically significant within-group changes from baseline in FRS or statistically significant differences between the BARI 4 mg and placebo groups.1

Reynolds Risk Score Results

The RRS is an alternative to the FRS for characterization of CV risk in non-diabetic men and women aged ≥45 and ≤80 years with no prior history of CVD and/or cerebrovascular events and also represents the likelihood of an individual patient experiencing a CVD event in the next 10 years.1

  • There was a statistically significant within-group decrease in RRS for BARI 4 mg and placebo, with no statistically significant difference between treatment groups in any study, except for one study, RA-BEAM, where there were statistically significantly larger decreases in BARI 4 mg compared to placebo.1
  • Similar findings applied to non-diabetic patients aged 45 to 80 with no prior CVD (regardless of hsCRP status) and the subgroup of non-diabetic patients aged 45 to 80 with no prior CVD and baseline hsCRP ≤20 mg/L, except for RA-BEAM, where there is no significant within-group decrease in RRS for placebo group.1

Information From the Label

Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo.2

  • Elevations in LDL cholesterol decreased to pre- treatment levels in response to statin therapy.2
  • Lipid parameters should be assessed approximately 12 weeks following initiation of baricitinib therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.2
  • The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.2

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

BARI = baricitinib

CV = cardiovascular

CVD = cardiovascular disease

FRS = Framingham Risk Score

hsCRP = high-sensitivity C-reactive protein

PBO = placebo

RA = rheumatoid arthritis

RRS = Reynolds Risk Score

Datum fӧr senaste ӧversyn 2019 M07 15


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