Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies
Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies
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DOI：
10.2147/vhrm.s16925
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发表时间：
2011-01-01
影响因子：
2.9
通讯作者：
Kothny, Wolfgang
中科院分区：
文献类型：
--
作者：
Schweizer, Anja;Dejager, Sylvie;Kothny, Wolfgang
目的：从单个研究中分析药物的安全性可能导致难以解释的结果。因此，本文的目的是基于大型II期和III期临床试验汇总数据库，评估维格列汀的一般安全性和耐受性，包括最常见不良事件（ae）的发生率。方法：安全性数据来自38项研究，持续时间为12周至104周。维格列汀（50mg bid, N = 6116）的AE谱相对于一组比较药（安慰剂和活性比较药，N = 6210）进行评估。计算所有ae、严重ae、ae所致停药和死亡的绝对发生率。结果：在接受维格列汀治疗的患者（分别为69.1%、8.9%、5.7%和0.4%）和接受比较药物治疗的患者（分别为69.0%、9.0%、6.4%和0.4%）中，报告的总体ae、sae、因ae而停药和死亡的频率相似，而在接受维格列汀治疗的患者中，药物相关ae的频率较低（15.7%比比较药物治疗的21.7%）。除了与使用磺脲类药物相关的比较组低血糖、震颤和多汗症的发生率增加外，维格列汀和比较药物之间最常见的特异性不良事件的发生率也相似。结论：目前的汇总分析显示，维格列汀在临床试验中总体耐受性良好，持续时间长达20年。这些数据进一步强调了来自大型安全性数据库的汇总分析与来自单个研究的安全性和耐受性评估的价值。
Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials.Methods: Safety data were pooled from 38 studies of >12 to >104 weeks' duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of-comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths.Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drugrelated AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas.Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies.