Expert opinion on drug safety
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Expert Opin Drug Saf · May 2020
Meta Analysis Comparative StudyRisk of adverse events in lymphoma patients treated with brentuximab vedotin: a systematic review and meta-analysis.
Objectives: To assess the risk of adverse events (AEs) associated with brentuximab vedotin in lymphoma patients. Methods: Articles were retrieved from PubMed, Cochrane, and Clinicaltrials Databases to identify randomized controlled trials (RCTs) comparing brentuximab vedotin with non-brentuximab vedotin in lymphoma patients. Results: A total of 2225 patients from 4 RCTs were included. ⋯ The brentuximab vedotin group significantly increased the risk of all-grade peripheral sensory neuropathy (RR 2.29, 95% CI: 1.23-4.26), pyrexia (RR 1.23, 95% CI: 1.05-1.44), nausea (RR 1.51, 95% CI: 1.05-2.18), vomiting (RR 1.54, 95% CI: 1.08-2.19), diarrhea (RR 1.69, 95% CI: 1.44-1.98), and alopecia (RR 1.18, 95% CI: 1.00-1.39), respectively. The brentuximab vedotin group significantly increased the risk of high-grade sensory neuropathy (RR 4.79, 95% CI: 1.46-15.75), neutropenia (RR 1.48, 95% CI: 1.01-2.18), nausea (RR 2.65, 95% CI: 1.37-5.12), vomiting (RR 2.2, 95% CI: 1.17-4.12), and diarrhea (RR 1.85, 95% CI: 1.21-2.85). Conclusion: Brentuximab vedotin increased the risk of certain AEs in lymphoma patients.
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Expert Opin Drug Saf · May 2018
Review Meta AnalysisThe tolerability and safety profile of patiromer: a novel polymer-based potassium binder for the treatment of hyperkalemia.
Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. ⋯ Patiromer effectively reduces serum potassium, and gastrointestinal adverse events (AEs) are the most common patiromer-associated AEs. Effective management of HK with patiromer may allow use of RAASI at optimal doses as recommended by treatment guidelines. Future research should examine the potential for potassium binders, including patiromer, to extend use of RAASI in appropriate patient populations.
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Expert Opin Drug Saf · Jan 2017
Review Meta Analysis Comparative StudyRisk of arterial and venous occlusive events in chronic myeloid leukemia patients treated with new generation BCR-ABL tyrosine kinase inhibitors: a systematic review and meta-analysis.
A previous meta-analysis demonstrated that 3 of the new-generation BCR-ABL tyrosine kinase inhibitors (TKIs) (dasatinib, nilotinib and ponatinib) are associated with an increased risk of vascular occlusive events in patients with Ph+ chronic myeloid leukemia compared with imatinib. This meta-analysis of randomized controlled trials aims at assessing these risks separately. ⋯ Vascular occlusive events associated with new-generation BCR-ABL TKIs are driven by arterial occlusive events.
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Expert Opin Drug Saf · Aug 2016
Review Meta AnalysisDrug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis.
Roflumilast is the only phosphodiesterase 4 inhibitor approved for the treatment of COPD patients with chronic cough and sputum, and a history of exacerbations, but the compliance to treatment is reduced by poorly tolerated adverse events (AEs). ⋯ The safety profile of roflumilast administered in combination with further drugs for the treatment of COPD should be investigated through specifically designed RCTs, and the post-marketing surveillance might help to characterize the real risk of very SAEs. Roflumilast may provide more benefit than harm in patients at high risk of severe exacerbations, and the therapy discontinuation may be reduced by a correct education of patients on the generally transient and mild-to-moderate nature of gastrointestinal AEs induced by this drug.
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Expert Opin Drug Saf · Oct 2015
Review Meta AnalysisRisk of elevated transaminases in cancer patients treated with immune checkpoint inhibitors: a meta-analysis.
This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. ⋯ Our study has shown that the use of immune checkpoint inhibitors has a causal relationship to an increased risk of high-grade elevated ALT and AST. Clinicians using these agents should be attentive of this risk.