Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial
Autor: | Nina Hannover Bjarnason, Karl Bang Christensen, Pia Bredahl, M. Zemtsovski, Bo Feldt-Rasmussen, Mads Hornum, Michael Perch, Jørn Carlsen, Martin Iversen, Mads J. Andersen, Peter Oturai, Christian H Møller |
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Rok vydání: | 2020 |
Předmět: |
Male
Pulmonary and Respiratory Medicine medicine.medical_specialty medicine.drug_class medicine.medical_treatment Urology Placebo-controlled study Renal function Blood Pressure Calcium channel blocker 030204 cardiovascular system & hematology 030230 surgery Kidney urologic and male genital diseases Placebo 03 medical and health sciences 0302 clinical medicine Double-Blind Method Humans Medicine Lung transplantation Prospective Studies Transplantation Dose-Response Relationship Drug Felodipine business.industry Middle Aged Calcium Channel Blockers Confidence interval Calcineurin Female Surgery Cardiology and Cardiovascular Medicine business Follow-Up Studies Glomerular Filtration Rate Lung Transplantation medicine.drug |
Zdroj: | Hornum, M, Iversen, M, Oturai, P, Andersen, M J, Zemtsovski, M, Bredahl, P, Bjarnason, N H, Christensen, K B, Carlsen, J, Møller, C H, Feldt-Rasmussen, B & Perch, M 2020, ' Felodipine and renal function in lung transplantation : A randomized placebo-controlled trial ', The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, vol. 39, no. 6, pp. 541-550 . https://doi.org/10.1016/j.healun.2020.01.1342 |
ISSN: | 1053-2498 |
DOI: | 10.1016/j.healun.2020.01.1342 |
Popis: | BACKGROUND: Calcium channel blockers may ameliorate the decline in renal function caused by calcineurin inhibitors in lung transplantation (LTX) recipients. We hypothesized that pre-operative and 12-week post-operative treatment with the calcium channel blocker felodipine would reduce the decline in glomerular filtration rate (GFR).METHODS: In this prospective, randomized, double-blind trial, 39 LTX recipients were transplanted and received placebo (n = 19; GFR, 102 ml/min/1.73 m2 [range, 91-113 ml/min/1.73 m2]) or felodipine (n = 20, GFR, 96 ml/min/1.73 m2 [range, 88-104 ml/min/1.73 m2]). Pre-operative treatment was titrated post-operatively to 10 mg or the maximum tolerable dose. The primary end-point was the change in GFR using Cr-51-labeled EDTA from LTX to 12 weeks thereafter, and follow-up was 52 weeks.RESULTS: The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m2 (95% CI: -40 to 22 ml/min/1.73 m2), whereas that of the placebo group was 48 ml/min/1.73 m2 (95% confidence interval [CI]: -56 to 40 ml/min/1.73 m2). Thus, the difference between groups at 12 weeks was 17 ml/min/1.73 m2 (95% CI: 4-29 ml/min/1.73 m2; p = 0.01). Half of the patients were unable to complete the 3-month primary follow-up, and the analysis includes these patients by intention-to-treat. After 52 weeks (40 weeks after termination of treatment), the treatment effect was maintained at 12 ml/min/1.73 m2 (95% CI: 0-24 ml/min/1.73 m2, p = 0.05). The number of days with registered hypotension was significantly higher in the felodipine group than in the placebo group (39 days vs 13 days, rate ratio: 2.9 [95% CI: 1.5-5.3]).CONCLUSIONS: Use of felodipine in select patients was associated with greater preservation in renal function early (90 days) after LTX. The observed benefits were attenuated by 1 year, although trends in better renal function were noted. |
Databáze: | OpenAIRE |
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