Background The management of anaemia and secondary hyperparathyroidism (SHPT) in haemodialysis patients with chronic kidney disease means a significant consumption of drugs with high economic and health consequences. Purpose To evaluate the potential economic impact of the different erythropoiesis stimulating agents (ESA) and active vitamin D analogues in haemodialysis patients in terms of cost minimisation. Materials and methods Retrospective observational study, in adult haemodialysis patients treated with ESA and active vitamin D analogues between January 2011 and February 2012. The sources of drug use data included drug acquisition costs and the prescribed monthly dose (PMD) defined as the average maintenance dose. Therapeutic equivalence was assumed in compliance with KDOQI and KDIGO quality criteria guidelines (haemoglobin, parathyroid hormone, calcium-phosphorus product). Statistical analysis was done using SPSS. The comparisons of averages were done using Student’s T test with a CI95% p < 0.05. Results 473 patients were included, 59% of them men. The total cost of the medicines dispensed was 1,207,225 €. For anaemia 328 patients were treated with epoetin: average PMD of 58,427 ± 38,989 IU and a total cost of 535,907 €; 145 patients were treated with darbepoetin: average PMD of 272 ± 213 mcg and a total cost of 222.214 €. The conversion ratio epoetin/darbepoetin was 214 IU:mcg, the PMDs cost 169 ± 113 € and 192 ± 150 €, respectively, and no significant differences were found (p = 0.07). To manage SHPT, 220 patients were treated with alfacalcidol: average PMD of 12.6 mcg and a cost of 16.965 €; 130 patients were treated with paricalcitol: average PMD of 24.3 mcg and a cost of 71.739 €. The conversion ratio alfacalcidol/paricalcitol was 1:2 mcg, and the PMDs cost 12.4 ± 6.8 € and 81.5 ± 33.8 €, respectively, reaching statistical significance (p < 0.001). Using alfacalcidol instead of paricalcitol could save 61,711 €. Conclusions Alfacalcidol seems to be the best cost alternative, even with a conversion ratio higher than the one recommended by the manufacturer (1:3 mcg). Epoetin and darbepoetin generate similar costs. This data supports the therapeutic positioning of these medicines in our field. No conflict of interest.
BackgroundInfliximab is a monoclonal antibody approved for the treatment of inflammatory diseases. The best approach in adjusting the dose of infliximab because of the high interindividual variability in serum concentrations is with a Bayesian approach.PurposeOur aim was to estimate the precision and accuracy of five pharmacokinetic models (PopPKmodel) in patients with inflammatory bowel disease.Material and methodsAn observational retrospective study was designed. Patients with ulcerative colitis or Crohn’s disease treated with infliximab during 2014 were included. Trough blood samples for determining infliximab were drawn. Five PopPKmodels were implemented in NONMEM: PopPK in ulcerative colitis and Crohn’s disease. The Infliximab concentrations were estimated from five models at the sample times, through the empirical Bayesian of estimates (EBEs) of the pharmacokinetic parameters. To validate these models, bias of estimated concentrations were calculated as the mean residual predictive error (MRPE) and the precision was calculated as the root mean square predictive error (RMSPE) in our population.ResultsTwo hundred and seventy-three serum infliximab concentrations from 160 patients (54% males and 46% females) were included. The mean age was 36 years (CI 95%: 31 to 41), weight 73.1 kg (CI 95%: 71.1 to 75.2) and 3.92 mg/dL (CI 95%: 3.86 to 3.98) baseline serum albumin concentration. 62.5% of patients were diagnosed with Crohn’s disease and 36.3% for ulcerative colitis. The mean trough serum concentration of infliximab was 4.1 mg/L (CI 95%: 3.6 to 4.6). 68.1% of patients were treated with infliximab and 31.9% with biosimilar. Bias of estimated concentrations (MRPE) and precision (RMSPE):Abstract 4CPS-165 Table 1 Accuracy (mean, CI 95% ) Precision (mean, CI 95% ) Model 1 36.8 (92–18.3) 468 (65–1001) Model 2 54. 1 (142.5–34.2) 752 (137–1642) Model 3 442 (1213–328) 6558 (1345–14462) Model 4 17 (51–15) 285 (66–637) Model 5 73 (197–50) 1054 (197–2305) ConclusionIn our study, neither PopPKmodels overestimate infliximab concentrations in the population, although Model 4 was better, (i.e. closer to zero) in terms of bias and accuracy.Reference and/or Acknowledgements1. Fasanmade, et al. 2009: Model 1;2. Fasanmade, et al. 2011: Model 2; Buurman y col, 2015: Model 3; Dotan y col, 2014: Model 4 and Brandse y col, 2017: Model 5.No conflict of interest
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