Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial
Section snippets
Study design and patients
The trial was an investigator-initiated, randomized, double-blind, placebo-controlled, clinical trial conducted at a national lung transplant center. The program has been described in detail previously.16 Briefly, recipients received induction therapy with anti-thymocyte globulin (1.5 mg/kg daily) for the first 3 days. Azathioprine (1.5 mg/kg) was initiated at admission and cyclosporine (Sandimmun Neoral, Novartis Healthcare AG, Basel, Switzerland) was initiated on the first post-operative day
Results
A total of 41 patients underwent randomization; 2 had their transplant procedure canceled after randomization but were rerandomized and transplanted later, 20 were assigned to receive felodipine, and 19 to receive placebo (Figure 1). As shown in Table 1, the baseline characteristics were similar in the 2 groups except for a higher s-albumin in the felodipine group, a difference that disappeared 1 week after transplantation. The minimum follow-up time was 365 days.
The median daily dose of
Discussion
In this randomized placebo-controlled trial, 12 weeks of intended treatment with the calcium channel blocker felodipine reduced the decline in the GFR at 12 weeks after LTX by 35%. This result was obtained with only 50% patient compliance; only pre-operatively all patients received intended treatment (Figure 2). The pre-operative initiation of the treatment and the peri-operative blood pressure response indicated by the need for more inotropy in the felodipine group during surgery may have been
Disclosure statement
Dr Hornum was supported by an unrestricted grant from the Helen and Ejnar Bjørnow Foundation. Dr Perch reports grants from Roche, non-financial support from Boeringer Ingelheim, personal fees from Novartis, BTG, outside the submitted work. The rest of the authors have no conflicts of interest.
The authors thank the patients who participated in this study. The authors also thank Laboratory Technician Andreas Haltorp and Study Nurse Jytte Grarup and Helle Corinth for their skillful work.
Mads
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