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Should Gabapentin Be Dose Adjusted: What Are the Clinical Consequences?

机译:加巴喷丁的剂量应调整:临床后果是什么?

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Objective: To review the clinical necessity of renal dose adjustment of gabapentin.Data Sources: Medical literature (1966-February 2006, week 2) was accessed through MEDLINE, EMBASE, Pre-MEDLINE, International Pharmaceutical Abstracts, and the manufacturer's package insert. Search terms included gabapentin, side effects/adverse effects, overdose, toxicity, and renal impairment. Literature references were consulted for relevant information.Study Selection and Data Extraction: All studies from the data sources that were published in English were evaluated. Case reports, case series, and clinical trials with primarily adult populations were included in the review to determine the clinical necessity of dosage adjustment, including morbidity and mortality associated with dose adjustment failure. Case reports of gabapentin overdose were evaluated for clinically significant outcomes. All reports were examined for clinical relevance and adequate information to address the issue of major clinical consequences of failure to dose adjust gabapentin in specific patient populations, including renally impaired and elderly patients.Data Synthesis: The package insert suggests dose adjustment of gabapentin in patients with decreased renal function, yet published information regarding clinical consequences of gabapentin in patients is limited. Although gabapentin possesses a favorable safety profile and is generally well tolerated, there have been cases reporting serious adverse effects. While clinical studies and the majority of case reports demonstrate minimal adverse effects, there is some concern that select patients may experience serious outcomes if the drug is not dose adjusted.Conclusions: The recommendation for dosage adjustment is suitably based upon the pharmacokinetic properties of gabapentin, yet healthcare practitioners should determine the need for gabapentin dosage adjustment in specific patients. There should be continued emphasis on recommending renal dose adjustments, with the most concern applied to the elderly and patients with significant renal impairment/end-stage renal disease.
机译:目的:探讨加巴喷丁肾剂量调整的临床必要性。数据来源:医学文献(1966-2006年2月,第2周)通过MEDLINE,EMBASE,Pre-MEDLINE,International Pharmaceutical Abstracts和制造商的包装说明书获得。搜索词包括加巴喷丁,副作用/不良反应,用药过量,毒性和肾功能不全。相关信息参考了文献参考。研究选择和数据提取:对所有以英语发表的数据来源的研究进行了评估。回顾中包括病例报告,病例系列和主要针对成人人群的临床试验,以确定剂量调整的临床必要性,包括与剂量调整失败相关的发病率和死亡率。对加巴喷丁过量的病例报告进行了临床意义重大的评估。审查了所有报告的临床相关性和足够的信息,以解决未能在特定患者人群(包括肾功能不全和老年患者)中调整加巴喷丁剂量的主要临床后果问题。肾功能下降,但有关加巴喷丁对患者临床后果的公开信息有限。尽管加巴喷丁具有良好的安全性,并且通常具有良好的耐受性,但仍有一些病例报告了严重的不良反应。尽管临床研究和大多数病例报告均显示出不良反应极小,但仍存在一些担忧,即如果不调整药物剂量,则部分患者可能会出现严重的结局。结论:剂量调整的建议宜根据加巴喷丁的药代动力学特性,然而,医疗保健从业人员应确定特定患者需要调整加巴喷丁的剂量。应继续强调建议调整肾脏剂量,最关注的是老年人和患有严重肾功能不全/终末期肾脏疾病的患者。

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