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Clinical pharmacy and clinical trials (including case series)
Cardiovascular risk associated with use of biological therapy with etanercept and adalimumab
  1. J. Gonzalez-Lopez,
  2. E. Vidal Mendoza,
  3. C. Crespo Diz,
  4. M.I. Cadavid Torres,
  5. M.E. Concheiro Nine
  1. 1Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Farmacia, Santiago de Compostela, Spain
  2. 2Facultad de Farmacia, Departamento de Farmacología, Santiago de Compostela, Spain

Abstract

Background Studies (Seriolo et al., 2007; Jamnitski et al., 2010) shows the influence of anti-TNF drugs on lipid profile, causing a variation on cardiovascular risk.

Purpose To study the influence of etanercept and adalimumab in parameters associated with cardiovascular risk (CVR) during the first year of treatment.

Materials and methods Retrospective observational study of 40 patients (15 men and 25 women) treated for 1 year with anti-TNF's. Mean age was 49.5 years (range 12-85). The pathologies treated were: rheumatoid arthritis (60%), ankylosing spondylitis (10%), psoriatic arthritis (7.5%), juvenile idiopathic arthritis (5%) and a final group of 7 patients with a heterogeneous group of rheumatic diseases (17.5%). Variables studied: total cholesterol (TC), triglycerides (TG) and renal function (RF), which analysed every 3 months. The RF was estimated by glomerular filtration rate (GFR) estimate by MDRD4 equation.

Results The mean TC at baseline was 190.5 mg/dL. Twelve months later, TC increased approximately 3% compared to baseline (194.8 mg/dL). Initial TG had a mean value of 93.8 mg/dL, six months later increased to 100.3 mg/dL and finally returned to initial values (91.9 mg/dL). No statistically significant differences between the TC and TG at baseline, 6 and 12 months (p <0.05). The GFR show no significant difference between the baseline and those found at 6 and 12 months. The average GFR was at 91.8 mL/min/1.73 m2. Statins were used by 25% of the patients throughout this study and only one patient was treated with fibrates.

Conclusions Significant differences in lipid profile for the first year of treatment were not found. It would be interesting to study the fractionated cholesterol. RF deterioration is also associated with an increased CVR but no significant changes were observed in this study. Although no significant differences in the parameters were found, clinical implications remain to be established by future investigations.

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