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Nimesulide-induced hepatotoxicity: A systematic review and meta-analysis.

ABSTRACT: OBJECTIVE:This study aimed to evaluate the risk for hepatotoxicity with nimesulide, a non-steroidal anti-inflammatory drug (NSAID) available in Republic of Korea but withdrawn from the market in several countries. METHODS:A systematic review and meta-analysis were conducted of studies retrieved from PubMed, EMBASE, Cochrane, the Research Information Sharing Service and ClinicalTrials.gov up to September 2017. All studies reporting nimesulide-associated hepatotoxicity in patients as compared with the unexposed or the exposed to other NSAIDs were included. Studies using spontaneous reporting databases were included to estimate reporting odds ratio (ROR) of hepatotoxicity associated with nimesulide exposure. The association between nimesulide use and hepatotoxicity was estimated using relative risk (RR) and ROR with 95% confidence interval (CI). RESULTS:A total of 25 observational studies were eligible for review. In a meta-analysis of five observational studies, nimesulide was significantly associated with hepatotoxicity [RR 2.21, 95% CI 1.72-2.83]. From studies using spontaneous reporting databases (n = 6), rates of reported hepatotoxicity were significantly higher in patients using nimesulide, compared with those treated with other NSAIDs [pooled ROR 3.99, 95% CI 2.86-5.57]. Of a total of 33 patients from case studies and series, the majority (n = 28, 84.8%) were female, and the mean age (± standard deviation) was 56.8 (± 15.6) years. Almost half of the patients on nimesulide (45.5%) either required liver transplantation or died due to fulminant hepatic failure, of whom a third developed hepatotoxicity within less than 15 days of nimesulide administration. CONCLUSIONS:Our study findings support previous reports of an increased risk for hepatotoxicity with nimesulide use and add to existing literature by providing risk estimates for nimesulide-associated hepatotoxicity. As the limited number of studies with primarily observational study designs were included in the analysis, more studies are needed to further describe the effects of dose and length of treatment on the risk for hepatotoxicity.

SUBMITTER: Kwon J

PROVIDER: S-EPMC6345488 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Nimesulide-induced hepatotoxicity: A systematic review and meta-analysis.

Kwon Jeongyoon J Kim Seungyeon S Yoo Hyejin H Lee Euni E

PloS one 20190124 1

<h4>Objective</h4>This study aimed to evaluate the risk for hepatotoxicity with nimesulide, a non-steroidal anti-inflammatory drug (NSAID) available in Republic of Korea but withdrawn from the market in several countries.<h4>Methods</h4>A systematic review and meta-analysis were conducted of studies retrieved from PubMed, EMBASE, Cochrane, the Research Information Sharing Service and ClinicalTrials.gov up to September 2017. All studies reporting nimesulide-associated hepatotoxicity in patients a ...[more]

PMID: 30677025

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Project description:BackgroundGlobally, the human immunodeficiency virus has been recognized as a major public health concern. The direct toxicity of antiretroviral medicines or their active metabolites causes liver cell destruction by different mechanisms, inducing immune-mediated inflammation, oxidative stress, and other mechanisms. On the other hand, the virus itself also produces hepatotoxicity. Therefore, this systematic review and meta-analysis aimed to assess the pooled prevalence of hepatotoxicity among HIV-infected patients in Ethiopia.MethodsPubMed, Science Direct, Cochrane Library, Web of Science, and ResearchGate databases were used to find relevant articles. As well, various professional associations were searched to retrieve grey literature. The Newcastle-Ottawa Quality Assessment Scale was used to assess the quality of recruited studies. The data were extracted using Microsoft Excel, and the meta-analysis was carried out using STATA 14 software. I2 and Cochran's Q test were employed to assess the presence of heterogeneity between studies. A random effect model was used. The funnel plot and Egger's statistics were used to assess publication bias. Moreover, subgroup analysis and sensitivity analysis were also done.ResultsThe pooled prevalence of hepatotoxicity among HIV patients in Ethiopia was 25.45% (95% CI = 20.06-30.84%). There was high heterogeneity, with an I2 value of 93.7%. Subgroup analysis by HAART status showed a higher pooled prevalence of hepatotoxicity among HIV patients taking HAART (23.63%) than among HAART naive patients (7.29%). In subgroup analysis, the pooled prevalence of hepatotoxicity among HIV/Tb co-infected and HIV mono-infected patients was 26.3% and 17.94%, respectively.ConclusionThe current systematic review and meta-analysis showed a high prevalence of hepatotoxicity among HIV-infected patients. Therefore, regular monitoring of hepatotoxicity among HIV-infected patients is required in order to avoid liver damage and other complications. Systematic review registration PROSPERO (2022:CRD42022334704).

Project description:Patients with advanced cancer often undergo myelosuppression after receiving chemotherapy. However, severe myelosuppression results in treatment delay, and some can even be life-threatening. At present, cancer patients undergoing chemotherapy urgently need effective intervention strategies to prevent myelosuppression. Fortunately, ginsenoside Rg3 has shown promise as an anti-myelosuppression agent. Therefore, this study was conducted to evaluate the effectiveness of ginsenoside Rg3 in preventing chemotherapy-induced myelosuppression in cancer patients. The PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Weipu (VIP), and Wanfang databases were searched in this study. A total of 18 trials which reported on 2,222 subjects were identified. All trials concerning the use of ginsenoside Rg3 for the prevention of chemotherapy-induced myelosuppression (the decline of leukocyte, hemoglobin, platelet, and neutrophil counts) were randomized-controlled trials. Dichotomous data were expressed as odds ratio (OR) with their respective 95% confidence intervals (CI). The Cochrane evidence-based medicine systematic evaluation was used to evaluate the methodological quality of the included trials. The Review Manager 5.3 and Stata 12.0 software were used to perform the statistical analyses. The trial sequential analysis (TSA) was used to evaluate information size and prevention benefits. The results revealed obvious ginsenoside Rg3-induced improvement in the leukocyte (OR, 0.46; 95% CI, 0.37-0.55), hemoglobin (OR, 0.64; 95% CI, 0.53-0.77), platelet (OR, 0.60; 95% CI, 0.48-0.75) and neutrophil (OR, 0.62; 95% CI, 0.43-0.90) counts at toxic grades I-IV, and leukocyte (OR, 0.39; 95% CI, 0.28-0.54) counts at toxic grades III-IV. The sensitivity analysis revealed that the results were robust. The Egger's test indicated that there was no publication bias in the results. Overall, this study suggested that ginsenoside Rg3 is beneficial for alleviating the chemotherapy-induced decrease in leukocyte, hemoglobin, platelet, and neutrophil counts. However, the confirmation of the ginsenoside Rg3 can be recommended for myelosuppression patients was limited due to poor methodological quality. Thus, more rigorously designed randomized-controlled trials (RCTs) are required to assess the efficacy of ginsenoside Rg3 for myelosuppression.

Dataset Information

Nimesulide-induced hepatotoxicity: A systematic review and meta-analysis.

Publications

Nimesulide-induced hepatotoxicity: A systematic review and meta-analysis.

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