Combined randomised controlled trial experience of malignancies in studies using insulin glargine.
Combined randomised controlled trial experience of malignancies in studies using insulin glargine.
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DOI：
10.1007/s00125-009-1530-5
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发表时间：
2009-12
期刊：
影响因子：
8.2
通讯作者：
Lagarenne, P.
中科院分区：
文献类型：
--
作者：
Home, P. D.;Lagarenne, P.
最近发表的从人群登记中提取的数据表明，甘精胰岛素治疗与癌症/乳腺癌发生率增加之间可能存在相关性。本研究的目的是使用生产商（赛诺菲-安万特）药物警戒数据库中的数据研究这种可能的关系。我们分析了生产商（赛诺菲-安万特）药物警戒数据库中比较甘精胰岛素与任何对照药物治疗1型或2型糖尿病的所有随机临床试验（RCT; 2-4期）。我们确定了系统器官分类“良性、恶性和未指明肿瘤”下编码的所有严重不良事件。本分析纳入了判定为恶性的治疗后出现的肿瘤。该数据库包括31项研究，12项1型糖尿病研究和19项2型糖尿病研究。20项研究比较了甘精胰岛素与NPH胰岛素，29项为平行组研究，2项为交叉设计。研究通常持续6个月，但试验参考编号4016（n = 1，017）除外，其持续时间为5年。总体而言，10，880人被纳入分析（甘精胰岛素，5，657人;对照药物，5，223人）。甘精胰岛素组和对照药物组分别有45人（0.8%）和46人（0.9%）报告了52例和48例恶性肿瘤病例（RR 0.90，95% CI 0.60-1.36）。皮肤（12人发生16起事件vs 6人发生7起事件，RR 1.85，95% CI 0.69-4.92），结肠和直肠（6人vs 10人，RR 0.55，95% CI 0.20-1.52），乳腺癌（4人vs 6人，RR 0.62，95% CI 0.17-2.18）和胃肠道（6人vs 4人，RR 1.38，95% CI 0.39-4.90）是最常报告的部位。在这31项RCT中，与对照药物组相比，甘精胰岛素与癌症（包括乳腺癌）发生率增加无关。
Recent publications of data extracted from population registries have suggested a possible relationship between treatment with insulin glargine and increased incidence of cancer/breast cancer. The aim of the present study was investigate this possible relationship using data from the manufacturer’s (sanofi-aventis) pharmacovigilance database. We analysed the manufacturer’s (sanofi-aventis) pharmacovigilance database for all randomised clinical trials (RCTs; Phase 2–4) comparing insulin glargine with any comparator in type 1 or type 2 diabetes. We identified all serious adverse events coded under the System Organ Class of ‘neoplasms, benign, malignant and unspecified’. Treatment-emergent neoplasms judged to be malignant were included in this analysis. The database included 31 studies, 12 in type 1 diabetes and 19 in type 2 diabetes. Twenty compared insulin glargine with NPH insulin, 29 were parallel-group studies and two had a crossover design. Studies were generally of 6 months’ duration, except for trial reference number 4016 (n = 1,017), which had a duration of 5 years. Overall, 10,880 people were included in the analysis (insulin glargine, 5,657; comparator, 5,223). Forty-five people (0.8%) vs 46 people (0.9%) reported 52 and 48 cases of malignant cancer in the insulin glargine and comparator groups, respectively (RR 0.90, 95% CI 0.60–1.36). Skin (12 people with 16 events vs six people with seven events, RR 1.85, 95% CI 0.69–4.92), colon and rectum (six vs ten people, RR 0.55, 95% CI 0.20–1.52), breast (four vs six people, RR 0.62, 95% CI 0.17–2.18) and gastrointestinal tract (six vs four people, RR 1.38, 95% CI 0.39–4.90) were the most commonly reported sites. In these 31 RCTs, insulin glargine was not associated with an increased incidence of cancer, including breast cancer, compared with the comparator group.
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