Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database

Naganuma, Misa; Motooka, Yumi; Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Fukuda, Akiho; Nakao, Shin-ichi; Shimada, Kazuyo; Hirade, Kouseki; Mōri, Takayuki; Yoshimura, Tomoaki; Kato, Takeshi; Nakamura, Mitsuhiro

doi:10.1177/2050312118772475

Cited by 11 publications

(6 citation statements)

References 42 publications

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“…Hematologic and non-hematologic AE rates showed no significant difference in each regimen except patients in the ESHAP group had more renal impairment than the ICE group. This finding supported the database of the Japanese Adverse Drug Event Report that showed a higher risk of renal impairment of cisplatin compared with carboplatin and another platinum-based compound (reporting odds ratio 2.7, 95% CI 2.5–3.0) [ 18 ].…”

Section: Discussionsupporting

confidence: 84%

Efficacy of ESHAP versus ICE plus dexamethasone (DICE) as salvage chemotherapy for relapsed or refractory diffuse large B-cell lymphoma

Boonlerd,

Tantiworawit,

Norasetthada

et al. 2023

Annals of Medicine

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Objectives To compare the efficacy and side effects of salvage chemotherapy between etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP) and ifosfamide, carboplatin and etoposide plus dexamethasone (DICE) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Methods Medical records of patients with relapsed or refractory DLBCL receiving second-line ESHAP or DICE chemotherapy with or without rituximab from January 2007 to November 2022 were retrospectively reviewed. The primary objective was progression-free survival (PFS). The secondary objectives were overall survival (OS), overall response rate (ORR) and adverse events (AEs). Results Seventy patients were enrolled including 21 patients who received ESHAP and 49 patients who received the DICE regimen. Six patients (28.6%) and 19 patients (38.8%) in the ESHAP and DICE groups underwent ASCT, respectively. The ORR was 47.6% for ESHAP and 53.1% for DICE ( p = .67). The two-year PFS was 14.3% for ESHAP and 26.5% for DICE ( p = .33) with median PFS of 5 months and 14 months, respectively (hazard ratio 0.74; 95% CI 0.39–1.36, p = .330). The two-year OS was 14.3% for ESHAP and 26.5% for DICE ( p = .37) with median OS of 8 months and 19 months, respectively. Patients in ESHAP group have more all-grade renal impairment than DICE group (23.8% vs. 6.1%, p = .047). Discussion and conclusions Efficacy between ESHAP and DICE regimens as salvage chemotherapy for relapsed or refractory DLBCL was not significantly different in terms of two-year PFS, two-year OS and ORR. DICE regimen had less renal AE than ESHAP.

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Section: Discussionsupporting

confidence: 84%

Efficacy of ESHAP versus ICE plus dexamethasone (DICE) as salvage chemotherapy for relapsed or refractory diffuse large B-cell lymphoma

Boonlerd,

Tantiworawit,

Norasetthada

et al. 2023

Annals of Medicine

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“…Recently, the Weibull distribution is used to detect the signals for adverse events by utilizing time-to-events date. [14][15][16][17] Thus, we evaluated the time-to-onset of ganciclovir-induced adverse events using Weibull distribution parameters. The results of both scale parameter α and shape parameter β of total adverse events in JADER suggested that ganciclovir-induced adverse reactions including cytopenia, leukopenia and liver damage develop early in most cases (the early failure type) ( Table 2).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Expression Time of Ganciclovir-Induced Adverse Events Using JADER and FAERS

Ando

Taguchi

Enoki

et al. 2019

Biological & Pharmaceutical Bulletin

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Investigation of the occurrence time of adverse drug reactions helps to prevent the development and aggravation of adverse reactions, but the expression time of ganciclovir-induced adverse events has not been elucidated. In this study, using databases of spontaneous adverse event reports, the Japanese Adverse Drug Event Report database (JADER) and the U.S. Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS), the incidence of adverse reactions due to ganciclovir and their expression time were analyzed. As a result of calculation of the reporting odds ratio (ROR) and 95% confidence interval for individual main adverse reactions of ganciclovir (cytopenia, leukopenia, thrombocytopenia, liver damage, and acute renal failure), a signal was detected for all adverse reactions in both databases, except for liver damage in JADER. Furthermore, the Weibull distribution was performed for the analysis of onset time of each ganciclovir-induced adverse event. The results of Weibull parameter α and β values of each adverse event in both JADER and FAERS suggested that most adverse events occurred within 30 d and classified into the early failure type, except that thrombocytopenia and acute renal failure in JADER classified into the random failure type. Based on these findings, it concluded that the paying attention to signs of each ganciclovirinduced adverse event is required from the early phase after ganciclovir administration. However, in FAERS, development after a long-term course also accounted for 11%, suggesting that long-term periodic monitoring of adverse reactions would be also required.

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“…Disease names were defined using the Medical Dictionary for Regulatory Activities (MedDRA/J) version 24.0. According to a previous report [ 10 ], the following six preferred term was used for searching CDDP-associated acute kidney injury: “acute kidney injury,” “renal impairment,” “renal failure,” “renal disorder,” “renal function test abnormal,” and “renal tubular disorder.” Effect of 5-HT 3 RAs on CDDP-associated acute kidney injury was evaluated using the reporting odds ratio (ROR). To calculate the ROR, CDDP-associated acute kidney injury and all other reported adverse events associated with CDDP were defined as “cases” and “non-cases,” respectively.…”

Section: Methodsmentioning

confidence: 99%

“…Disease names were defined using the Medical Dictionary for Regulatory Activities (MedDRA/J) version 24.0. According to a previous report [10], the following six preferred term was used for searching CDDP-associated acute kidney injury: "acute kidney injury, " "renal impairment, " "renal failure, " "renal disorder, " "renal function test abnormal, " and "renal tubular disorder. " Effect of Takemura et al Journal of Pharmaceutical Health Care and Sciences (2022) 8: 215-HT 3 RAs on CDDP-associated acute kidney injury was evaluated using the reporting odds ratio (ROR).…”

Section: Analyses On the Effect Of 5-ht 3 Ras On Cddp-associated Acut...mentioning

confidence: 99%

Concomitant palonosetron ameliorates cisplatin-induced nephrotoxicity, nausea, and vomiting: a retrospective cohort study and pharmacovigilance analysis

Takemura

Ikemura

Kondo

et al. 2022

J Pharm Health Care Sci

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Background Cisplatin (CDDP)-induced nephrotoxicity is the most important complication of CDDP treatment. 5-Hydroxytryptamine type 3 receptor antagonists (5-HT3RAs) are widely used to prevent chemotherapy-induced nausea and vomiting (CINV). However, in patients with the triple antiemetic (neurokinin-1 receptor antagonist, 5-HT3RA, and dexamethasone) therapy, the advantage of palonosetron in comparison with other 5-HT3RAs on CDDP-induced nephrotoxicity and CINV remains unclear. In the present study, we investigated the effect of palonosetron on CDDP-induced nephrotoxicity and CINV in patients with the triple antiemetic therapy by a retrospective cohort study and a pharmacovigilance analysis. Methods We retrospectively analyzed the effect of 5-HT3RAs on the development of nephrotoxicity and CINV in 110 patients who received CDDP, fluorouracil, and triple antiemetic therapy for the treatment of esophageal cancer. Moreover, the effect of 5-HT3RAs on CDDP-induced nephrotoxicity was validated in patients with the triple antiemetic therapy using the Japanese Adverse Drug Event Report (JADER) database. Results In a retrospective study, the incidence of nephrotoxicity (≥ grade 1) in patients receiving palonosetron (18%) was significantly lower than that in patients receiving ramosetron (another 5-HT3RA) (36%, p = 0.044). Moreover, severe nephrotoxicity ≥ grade 3 was observed in one patient treated with ramosetron, whereas hematological toxicity was comparable between the two groups (p = 0.553). Furthermore, the incidence rate of CINV within 120 h following CDDP administration in patients treated with palonosetron (18%) was significantly lower than that in patients receiving ramosetron (39%, p = 0.026). JADER database analyses revealed that the reporting odds ratio of palonosetron for CDDP-induced acute kidney injury was 0.282 (95% confidence interval: 0.169–0.472). Conclusions The findings of the present study suggested a greater potential of palonosetron against CDDP-induced nephrotoxicity and CINV than other 5-HT3RAs in patients with the triple antiemetic therapy.

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Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database

Cited by 11 publications

References 42 publications

Efficacy of ESHAP versus ICE plus dexamethasone (DICE) as salvage chemotherapy for relapsed or refractory diffuse large B-cell lymphoma

Efficacy of ESHAP versus ICE plus dexamethasone (DICE) as salvage chemotherapy for relapsed or refractory diffuse large B-cell lymphoma

Evaluation of the Expression Time of Ganciclovir-Induced Adverse Events Using JADER and FAERS

Concomitant palonosetron ameliorates cisplatin-induced nephrotoxicity, nausea, and vomiting: a retrospective cohort study and pharmacovigilance analysis

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