Adverse Effect Differences between Tacrolimus-IR and LCP-Tacrolimus
1Barnes-Jewish Hospital, Saint Louis, MO, 2St. Louis College of Pharmacy, Saint Louis, MO, 3Washington Universidy, Saint Louis, MO, 4Veloxis Pharmaceuticals, Inc, Cary, NC
Meeting: 2019 American Transplant Congress
Abstract number: A261
Keywords: Adverse effects, Immunosuppression, Kidney transplantation
Session Information
Session Name: Poster Session A: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Saturday, June 1, 2019
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Hall C & D
*Purpose: Extended-release tacrolimus (Envarsus XR®, LCP-Tac) was approved in 2015 as conversion from tacrolimus immediate-release (Tac-IR) as part of the maintenance immunosuppression regiment post-kidney transplant. The STRATO trial showed a statistically significant improvement in measured and patient assessment of tremor after conversion from Tac-IR to LCP-Tac. In 2015, our center initiated de novo use of LCP-Tac in place of Tac-IR. The purpose of this study was to evaluate differences in specific adverse effects of tacrolimus between the two formulations.
*Methods: We performed a single center retrospective cohort analysis of adult kidney transplant recipients from 1/2015 to 6/2017 who received either Tac-IR or LCP-Tac and remained on a tacrolimus formulation for the first year. Recipients were separated into two groups. The Tac-IR group either remained on Tac-IR for the first year or were transitioned from Tac-IR to LCP-Tac within the first post-transplant year. The LCP-Tac group received the LCP-Tac formulation for the first post-transplant year. Adverse effects evaluated between the Tac-IR and LCP-Tac groups include tremor, insomnia, alopecia, and development of post-transplant diabetes within the first post-transplant year.
*Results: 503 patients met inclusion criteria, 279 in the Tac-IR group and 224 in the LCP-Tac group. Of the 279 in the Tac-IR, 70 patients converted to LCP-Tac during the first post-transplant year. The LCP-Tac group were older with a higher Class I PRA and Class II PRA at the time of transplant. There were no differences in sex, race, history of diabetes or hypertension, type of induction, or donor type between groups. The differences in tremor, insomnia, and alopecia at 3, 6, and 12 months-post transplant are shown in Table 1. Table 1
| Tac – IR | LCP-Tac | p-value | |
| Tremor | |||
| 3 mo, n (%) | 44 (15.8) | 32 (14.3) | 0.708 |
| 6 mo, n (%) | 54 (19.4) | 23 (10.3) | 0.006 |
| 12 mo, n (%) | 32 (12.2) | 19 (9.8) | 0.455 |
| Insomnia | |||
| 3 mo, n (%) | 15 (5.3) | 10 (4.6) | 0.685 |
| 6 mo, n (%) | 8 (2.9) | 5 (2.2) | 0.781 |
| 12 mo, n (%) | 11 (4.2) | 7 (3.6) | 0.812 |
| Alopecia | |||
| 3 mo, n (%) | 4 (1.4) | 3 (1.3) | >0.999 |
| 6 mo, n (%) | 9 (3.2) | 2 (0.89) | 0.122 |
| 12 mo, n (%) | 4 (1.4) | 0 (0) | 0.140 |
Excluding patients who had diabetes at the time of transplant, 28 (13.2%) and 27 (17.5%) developed post-transplant diabetes within the first year in the Tac-IR and LCP-Tac groups, respectively.
*Conclusions: Of the adverse effects evaluated, LCP-Tac showed significantly less tremor at 6 months post-transplant compared to Tac-IR. Overall, LCP-Tac demonstrated lower incidence of tremor, insomnia and alopecia that may represent a clinically significant benefit of the formulation compared to Tac-IR. No difference in development of post-transplant diabetes was seen between the two formulations.
To cite this abstract in AMA style:
Hagopian J, Carthon C, January S, Gharabagi A, Santos RDelos, Horwedel T. Adverse Effect Differences between Tacrolimus-IR and LCP-Tacrolimus [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/adverse-effect-differences-between-tacrolimus-ir-and-lcp-tacrolimus/. Accessed May 16, 2025.« Back to 2019 American Transplant Congress