New Analysis Finds Significant Increased Risk Of Bladder Cancer For SGLT2 Inhibitors With Empagliflozin
For years there has been a lingering concern over whether Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors, a relatively new class of diabetes drugs, are associated with the development of bladder cancer.
The most recent medical journal article we have seen regarding this drug safety issue singles out the SGLT2 inhibitors which contain the active ingredient empagliflozin, which are listed below:
- Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2014
- Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2015
- Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2015
- Synjardy XR (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2016
This article, "SGLT2 inhibitors and risk of cancer in type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials", was published in the October 2017 edition of Diabetologia (after first being made available online in July 2017). It presents the findings of medical researchers who conducted a systematic literature review to identify randomized controlled trials that reported cancer events in Type-2 diabetes patients treated with SGLT2 inhibitors for at least 24 weeks.
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From the Abstract for this Diabetologia medical journal article:
Aims/hypothesis: The association between sodium–glucose cotransporter 2 (SGLT2) inhibitors and the risk of cancer in individuals with type 2 diabetes remains uncertain. This study aimed to evaluate the risk of cancer associated with SGLT2 inhibitor treatment of type 2 diabetes.
Results: In total, 580 incidences of cancer among 34,569 individuals were identified from 46 independent RCTs with a mean trial duration of 61 weeks. When compared with comparators (placebo or other active glucose-lowering treatments), SGLT2 inhibitors were not significantly associated with an increased risk of overall cancer (OR 1.14 [95% CI 0.96, 1.36]). For pre-specified cancer types, the risk of bladder cancer might be increased with SGLT2 inhibitors (OR 3.87 [95% CI 1.48, 10.08]), especially [Jardiance (empagliflozin)] (OR 4.49 [95% CI 1.21, 16.73]). Interestingly, [Invokana (canagliflozin)] might be protective against gastrointestinal cancers (OR 0.15 [95% CI 0.04, 0.60). [Emphasis added.]
Conclusions/interpretation: Current evidence from short-term RCTs did not indicate a significantly increased risk of overall cancer among individuals with type 2 diabetes using SGLT2 inhibitors. Given the short-term trial durations and uncertainty of evidence, future long-term prospective studies and post-marketing surveillance studies are warranted.
When considering the bladder cancer findings from this recent medical journal article, it is important keep in mind that:
- Patients with diabetes already have increased risk for bladder cancer.
- Increased urinalysis related to the increased risk of UTIs and genital infections with SGLT2 inhibitor use could increase detection of bladder cancer.
These two so-called "confounding factors" must be taken into account when considering whether or not there is potential link between bladder cancer and empagliflozin-containing diabetes drugs such as Jardiance, Glyxambi, and Synjardy.
Of course, we will continue to monitor this drug safety issue and report significant developments.
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