Boehringer Ingelheim has reported a positive safety profile of oral Jardiance (empagliflozin) for the treatment of adults with type 2 diabetes.
The firm carried out an analysis of pooled safety data from 15 randomised Phase I-III clinical trials and four extension studies conducted with 10mg and 25mg of Jardiance in more than 12,500 patients.
Available for use in the US and Europe, empagliflozin is a once-daily, highly selective inhibitor of sodium glucose cotransporter 2 (SGLT2), leading to excretion of excess blood sugar and salt from the body.
According to the data, Jardiance was well-tolerated, without an imbalance in lower limb amputations or bone fractures when compared to placebo.
The EMPA-REG OUTCOME trial has indicated a 38% decrease in risk of cardiovascular death with Jardiance and standard-of-care combination in patients who had established cardiovascular disease.
The overall safety profile during the trial was found to be consistent with data from previous empagliflozin studies and existing label information.
In the pooled data analysis, the incidences of adverse events, severe adverse events, serious adverse events and adverse events leading to discontinuation of therapy with Jardiance were found to be lower when compared to placebo.
Additionally, the analysis showed that the incidences of events related to amputations and bone fractures were similar in the case of both empagliflozin and placebo.
The incidence of urinary tract infection events was also found to be the same, while the genital infection events were frequent with Jardiance.