School of Pharmaceutical Science, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
The First Affiliated Hospital, Hunan Provincial Clinical Medical Research Center for Drug Evaluation of Major Chronic Diseases, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
Eur J Clin Pharmacol. 2024 Dec;80(12):1959-1966. doi: 10.1007/s00228-024-03759-6. Epub 2024 Sep 17.
Recent evidence suggests an association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and a higher risk of renal cancer.
We conducted a pharmacovigilance analysis using the US FDA Adverse Event Reporting System (FAERS) to investigate the disproportionate association between SGLT2 inhibitors and renal cancer.
We used AERSMine to mine data from FAERS, covering the period from 2014 Q1 to 2023 Q3. The control group was treated with other glucose-lowering medications (ATC-A10B). Disproportionality analysis results were performed using a proportional reporting ratio (PRR) with a 95% confidence interval (CI) and an information component (IC) with 95% credible interval.
Compared to the control group, the SGLT2 inhibitor group had a higher disproportionate renal cancer reporting frequency (0.92 vs 0.27/1000 reports; PRR 3.38; 95% CI 2.68-4.25; p < 0.001) with an IC of 1.36 (0.60-2.06), comprising dapagliflozin (PRR 4.14; 2.95-5.80; p < 0.001), empagliflozin (PRR 2.74; 1.94-3.89; p < 0.001), and canagliflozin (PRR 3.56; 2.48-5.12; p < 0.001). Consistent results were obtained in the diabetes indication with the primary outcomes only for the SGLT2 inhibitors group (not individual molecule). The results of the sensitivity analysis (excluding hypertension indication or antihypertensive drugs, obesity, smoking, alpha-1 blockers, or anti-renal cancer drugs) were highly consistent with the main outcomes, indicating good robustness of the results. The results from 2004 Q1 to 2023 Q3 were similar to those from 2014 Q1 to 2023 Q3, with the exception of empagliflozin.
There was a disproportionate association between SGLT2 inhibitors and renal cancer, which supports the current meta-analysis results indicating an increased risk of renal cancer associated with SGLT2 inhibitors.
最近的证据表明，钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂与肾癌风险增加之间存在关联。
我们使用美国 FDA 不良事件报告系统（FAERS）进行药物警戒分析，以调查 SGLT2 抑制剂与肾癌之间不成比例的关联。
我们使用 AERSMine 从 FAERS 中挖掘数据，涵盖 2014 年第 1 季度至 2023 年第 3 季度。对照组接受其他降血糖药物（ATC-A10B）治疗。使用比例报告比值（PRR）和信息成分（IC）进行不成比例性分析，置信区间（CI）为 95%，可信区间（IC）为 95%。
与对照组相比，SGLT2 抑制剂组的肾癌报告频率更高（0.92 比 0.27/1000 例报告；PRR 3.38；95%CI 2.68-4.25；p<0.001），IC 为 1.36（0.60-2.06），包括达格列净（PRR 4.14；2.95-5.80；p<0.001）、恩格列净（PRR 2.74；1.94-3.89；p<0.001）和卡格列净（PRR 3.56；2.48-5.12；p<0.001）。仅在 SGLT2 抑制剂组（而不是单个分子）的主要结局中，糖尿病适应症也得到了一致的结果。敏感性分析（排除高血压适应症或抗高血压药物、肥胖、吸烟、α-1 阻滞剂或抗肾癌药物）的结果与主要结局高度一致，表明结果具有良好的稳健性。2004 年第 1 季度至 2023 年第 3 季度的结果与 2014 年第 1 季度至 2023 年第 3 季度的结果相似，除了恩格列净。
SGLT2 抑制剂与肾癌之间存在不成比例的关联，这支持了目前的荟萃分析结果，表明 SGLT2 抑制剂与肾癌风险增加相关。
