The main objective was to determine the prevalence of real drug–drug interactions (DDIs) of immunosuppressants in transplant patients. We conducted a prospective, observational 1‐year study at a tertiary hospital, including all transplanted patients. We evaluated data from monitoring blood concentrations of immunosuppressive drugs and adverse drug events (ADEs) caused by DDIs. The DDIs were classified as C, D, or X according to their Lexi‐Interact rating (C = monitor therapy, D = consider therapy modification, X = avoid combination). The clinical importance of real DDIs was expressed in terms of patient outcomes. The causality of DDIs was determined using Drug Interaction Probability Scale. The data were analyzed using Statistical Package for Social Sciences v. 25.0. A total of 309 transplant patients were included. Their mean age was 52.0 ± 14.7 years (18–79) and 69.9% were male. The prevalence of real DDIs was 21.7%. Immunosuppressive drugs administered with antifungal azoles and tacrolimus (TAC) with nifedipine have a great clinical impact. Real DDIs caused ADEs in 22 patients. The most common clinical outcome was nephrotoxicity (1.6%; n = 5), followed by hypertension (1.3%; n = 4). Suggestions for avoiding category D and X DDIs included: changing the immunosuppressant dosage, using paracetamol instead of non‐steroidal anti‐inflammatory drugs, and interrupting atorvastatin. The number of drugs prescribed and having been prescribed TAC was associated with an increased risk of real DDIs. There are many potential DDIs described in the literature but only a small percentage proved to be real DDIs, based on the patients´ outcomes.
The variables studied were sex, age, ECOG stage, treatment duration, reason for discontinuation and percentage of dead patients at the end of the study.Data were collected through the electronical clinical record and the onco-haematological prescription program. Statistical analysis was performed with SPSS v.22.0. The Kaplan-Meier method was used to calculate OS and PFS. Results A total of 30 patients were analysed (100% women). The median age was 58 (range, 48 to 66) years. The 66,7% of patients (N=20) had ECOG 0-1 and the 33,3% (N=10) had ECOG 2.The median number of cycles received were 8 (range, 3 to 16) and the median treatment duration was 6 (range, 3 to 12) months.The reasons for the treatment discontinuation were: 53,3% progression (N=16), 6,7% toxicity (N=2) and 10% death (N=3).At the end of the study, the 30% of patients (N=9) continued with the treatment and the 48,3% (N=14) had died.The median OS obtained was 16,80 months (95% CI 7,64 to 25,96) and the median PFS was 10,27 months (95 CI% 5,34 to 15,35).In the study TDM4450g/BO21976, the median of PFS and OS were 9,4 and 30,9 months, respectively. In the pivotal trial TDM4370g/BO21977, the median PFS was 14,2 months and the OS could not be estimated. Conclusion and RelevanceThe median PFS in patients with HER2-positive MBC treated with T-DM1 reported in our study was similar than the pivotal trials. However, the median OS was substantially lower than the study TDM4450g. This difference could be mainly due to the sample size. Moreover, patients included in the previous study had a better functional status (100% ECOG 0-1) than our patients at the start of the treatment.
Aim: The main objective of this study was to determine the prevalence of real DDIs between immunosuppressants and other drugs in transplant patients. Methods: We conducted a prospective, observational 1-year study at a tertiary hospital, including all transplanted patients. We evaluated data from monitoring blood concentrations of immunosuppressive drugs and adverse drug events (ADEs) caused by DDIs. The DDIs were classified as C, D, or X according to their Lexi-Interact rating (C = monitor therapy, D = consider therapy modification, X = avoid combination). The clinical importance of real DDIs was expressed in terms of patient outcomes. The data were analyzed using Statistical Package for Social Sciences (SPSS) package v. 25.0 (IBM Corp., Armonk, NY, USA). Results: A total of 309 transplant patients were included. Their mean age was 52.0 ± 14.7 years (18–79) and 69.9% were male. The prevalence of real DDIs was 21.7%. Immunosuppressive drugs administered with anti-fungal azoles and tacrolimus (TAC) with nifedipine have a great clinical impact. Real DDIs caused ADEs in 22 patients. The most common clinical outcome was nephrotoxicity (1.6%; n=5), followed by hypertension (1.3%; n=4). Suggestions for avoiding category D and X DDIs included: changing the immunosuppressant dosage, using paracetamol instead of non-steroidal anti-inflammatory drugs, and interrupting atorvastatin. The number of drugs prescribed and having been prescribed TAC was associated with an increased risk of real DDIs. Conclusion: There are many potential DDIs described in the literature but only a small percentage proved to be real DDIs, based on the patients´ outcomes.
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