Background Numerous drugs prolong the QTc interval on the ECG and potentially increase the risk of cardiac arrhythmia. This risk is clinically relevant in patients with additional risk factors. Objective The objective was to develop and validate a risk model to predict QTc interval prolongation of eligible ECGs. Setting Spaarne Gasthuis (Haarlem/Hoofddorp, The Netherlands). Method A dataset was created from ECGs recorded in patients using one or more QTc prolonging drugs, in the period January 2013 and October 2016. In the development set, independent risk factors for QTc interval prolongation were determined using binary logistic regression. Risk scores were assigned based on the beta coefficient. In the risk-score validation set, the area under the ROC-curve, sensitivity and specificity were calculated. Main outcome measure QTc interval prolongation, defined as a QTc interval > 500 ms. Results In the development set 12,949 ECGs were included and in the risk-score validation set 6391 ECGs. The proportion of ECGs with a prolonged QTc interval in patients with no risk factors in the risk-score validation set was 2.7%, while in patients with a high risk score the proportion was 26.1%. The area under the ROC curve was 0.71 (95% CI 0.68-0.73). The sensitivity and specificity were 0.81 and 0.48, respectively. Conclusion A risk model was developed and validated for the prediction of QTc interval prolongation. This risk model can be implemented in a clinical decision support system, supporting the management of the risks involved with QTc interval prolonging drugs.
Product Information -Australia (CCDS200821) 3 IMBRUVICA (210413) API haematological toxicities. If ≥ Grade 3 elevations in liver function tests occur, with or without a rise in bilirubin, therapy should be withheld.Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose. If the toxicity reoccurs, the dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue IMBRUVICA.Recommended dose modifications are described below. Toxicity occurrence MCL dose modification after recovery CLL/SLL/WM dose modification after recovery First restart at 560 mg daily restart at 420 mg daily Second restart at 420 mg daily restart at 280 mg daily Third restart at 280 mg daily restart 140 mg daily Fourth discontinue IMBRUVICA Product Information -Australia (CCDS200821) 4 IMBRUVICA (210413) API Product Information -Australia (CCDS200821) 11 IMBRUVICA (210413) API98 months) with 70% and 52% of patients receiving treatment for more than 2 years and 4 years, respectively. The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively. The overall known safety profile of IMBRUVICA-exposed patients remained consistent, other than an increasing prevalence of hypertension, with no new safety concerns identified. The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 6% (year 1-2), 8% (year 2-3), 9% (year 3-4) and 9% (year 4-5). The incidence for the 5-year period was 11%.
Introduction Dose adjustments in patients with renal or hepatic dysfunction using anticancer drugs are indicated according to guidelines. However, implementation depends on awareness of prescribing physicians. We implemented a Clinical Decision Support System (CDSS), recommending dose adjustments upon electronic prescriptions based on renal and hepatic function. The alert provides a dose adjustment proposal and recent laboratory results. Our objective was to determine the frequency of dose adjustments before and after implementation of this CDSS. Methods We included all first orders for patients ≥18 years treated with parenteral antineoplastic agents, for whom dosage adjustment is necessary based on renal or hepatic function between February 2018 and January 2019. This study was performed at the department of Clinical Oncology and Hematology of the Amsterdam University Medical Center. We implemented the CDSS August first. All prescriptions were prescribed according to common practice. We analyzed the orders where a dose reduction based on renal or hepatic function was indicated. Results We included 73 orders before implementation and 99 orders after implementation. Before implementation 21% of doses were reduced in line with the guidelines versus 34% after implementation (p = 0.048). For hepatic dysfunction the proportion changed from 11% to 46% p = 0.011, while there was no effect for renal dysfunction (24% vs. 26% p = 0.75). Conclusion Dosages are more frequently adjusted in concordance with guidelines in patients with hepatic dysfunction who are treated with parenteral antineoplastic agents after implementation of a CDSS. The change was not seen in patients with renal dysfunction.
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