Nafrialdi Nafrialdi
Department Of Pharmacology And Therapeutics, University Of Indonesia Medical School/ Dr. Cipto Mangunkusumo Hospital, Jakarta.

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Journal : Paediatrica Indonesiana

Plasma digoxin levels and ejection fraction in pediatric heart failure Nafrialdi Nafrialdi; Sake Juli Martina; Mulyadi Djer; Melva Louisa
Paediatrica Indonesiana Vol 55 No 6 (2015): November 2015
Publisher : Indonesian Pediatric Society

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (107.029 KB) | DOI: 10.14238/pi55.6.2015.322-7

Abstract

Background Digoxin has long been prescribed in children with heart failure, but its efficacy has not been evaluated. A previous study at the Department of Child Health, Dr. Cipto Mangunkusumo Hospital revealed that plasma digoxin levels, following a maintenance dose of 15 μg/kg/d, were sub-therapeutic. Regarding its narrow margin of safety, the trend is to use digoxin in even lower dose. Thus, the drug’s impact on cardiac performance need to be evaluated. Objective To evaluate whether a lower maintenance dose of digoxin (10 μg/kg/d) is sufficient to achieve a therapeutic level and to assess for possible correlations between plasma digoxin level and left ventricular ejection fraction (LVEF) as well as fractional shortening (LVFS). Methods A cross-sectional study was conducted on 20 pediatric heart failure patients at the Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Jakarta, from January to May 2012. Plasma digoxin levels were measured by ELISA method after one month or more of treatment; LVEF and LVFS were measured by echocardiography. Correlations between plasma digoxin level and LVEF or LVFS were analyzed by Spearman’s correlation test. The LVEF before and after digoxin treatment were compared by paired T-test. Results Thirteen out of 20 patients had plasma digoxin levels within therapeutic range (0.5-1.5 ng/mL; 95%CI 0.599 to 0.898) and 7 had sub-therapeutic levels (<0.5 ng/ mL; 95%CI 0.252 to 0.417). No significant correlations were observed between plasma digoxin level and LVEF (r=-0.085; P=0.722) or LVFS (r=-0.105; P=0.659). There was a significant increase in LVEF before [42.18 (SD 14.15)%] and after digoxin treatment [57.52 (SD 11.09)%], (P < 0.0001). Conclusion Most patients in this study have plasma digoxin levels within therapeutic range. There are no significant correlations between plasma digoxin level at the time point of measurement and LVEF or LVFS. However, an increase of LVEF is observed in every individual patients following digoxin treatment.
Comparative efficacy, safety, and cost of iron chelation monotherapy vs. combination therapy in pediatric beta-thalassemia major: a single-center retrospective study Dewi Sharon Simorangkir; Nafrialdi Nafrialdi; Pustika Amalia Wahidiyat; Vivian Soetikno
Paediatrica Indonesiana Vol 62 No 2 (2022): March 2022
Publisher : Indonesian Pediatric Society

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14238/pi62.2.2022.91-7

Abstract

Background Iron chelation therapy is used to maintain iron balance in β-thalassemia major patients who undergo repeated blood transfusions. Objective To compare the efficacy, safety, and cost of iron chelation combination regimens [deferiprone (DFP) + deferoxamine (DFO) or DFP + deferasirox (DFX])] vs. high-dose DFP monotherapy (≥ 90 mg/kg/day) in pediatric β-thalassemia major patients. Methods This cross-sectional, retrospective study was done at Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Retrospective data was obtained from electronic medical records of pediatric b-thalassemia major patients with serum ferritin of ≥ 2,500 ng/mL and/or transferrin saturation of ≥ 60%, who received either combination or monotherapy iron chelation agents. Outcome effectiveness was determined by the reduction of serum ferritin level of at least 80%. Safety was analyzed descriptively. A pharmacoeconomic analysis was performed based on clinical outcomes consisting of effectiveness and direct medical costs. Results At the end of the study, serum ferritin was reduced in 34.7% of the combination therapy group and 27.5% of the monotherapy group, however there was no significant difference between the two treatments (P=0.391). Nine (19.5%) patients on combination therapy and 17 (21.2%) patients on monotherapy had adverse drug reaction (ADR), with the most frequently reported ADR was elevated transaminase enzyme levels. Cost minimization analysis revealed that monotherapy for 6 months was IDR 13,556,592.64 less expensive than combination therapy (IDR 44,498,732.07); whereas monotherapy for 12 months was IDR 20,162,836.10 less expensive than combination therapy (IDR 78,877,661.12). Conclusion Combination regimens are as effective as monotherapy regimens in reducing serum ferritin in pediatric β-thalassemia major patients. There is no differences of ADR between combination or monotherapy. The average cost per patient is less expensive with monotherapy compared to combination therapy.