The medical community criticized Boehringer Ingelheim Korea’s recent release of high-dose Jardiance 25mg plus metformin combination drug to treat diabetes, for conducting “unethical marketing.”
On Sept. 30, the company rolled out Jardiance Duo (ingredient: empagliflozin/metformin hydrochloride), a combo of high-dose Jardiance and metformin, saying that the variety of the dose of the combo drug would meet the different treatment needs of patients.
However, diabetes experts said the high-dose combo drug did not offer much difference in lowering blood sugar levels, compared to the low-dose one. Boehringer Ingelheim did not provide such information for patients, trying to lure doctors to prescribe the high-dose drug, which is more expensive, they said.
Jardiance is one of the sodium-glucose transport protein 2 (SGLT2) inhibitors, drawing attention as the latest medicine to treat cardiovascular diabetes. Jardiance is actively used in combination with other antidiabetic therapies. Jardiance Duo was authorized as an adjunct therapy for weight loss and exercise to improve glycemic control in adults with type-2 diabetes who are well-suited for co-administration of Jardiance and metformin (one tablet at a time, twice daily).
According to the Ministry of Food and Drug Safety’s approval for Jardiance, the regulator recommends 10mg of Jardiance per day. If a patient tolerates 10mg well and needs additional blood sugar control, however, the dose can be increased to 25mg per day.
Under the regulator’s approval condition, Jardiance 25mg should work stronger to reduce blood glucose more, compared to that in 10mg. However, physicians said Jardiance 25mg was more expensive but did not have a much more significant effect in blood sugar control than Jardiance 10mg.
According to study results revealed on Jardiance’s official webpage, 38 percent of patients treated with Jardiance 10mg had their glycated hemoglobin less than 7 percent, whereas 13 percent of the placebo group did so. In the group of patients treated with Jardiance 25mg, the percentage stood at 39 percent. There was only 1 percentage point difference between the 10mg-dose group and 25mg-dose group in achieving the target blood glucose level.
Jardiance 10mg is priced at 600 won ($0.5) per single tablet, and 5mg combination with metformin (500mg, 850mg, 1,000mg) is 704 won (one tablet 352 won, taken twice a day).
On the other hand, newly released Jardiance Duo 12.5/500mg, 12.5/850mg, 12.5/1000mg are priced at 493 won, 493 won, and 501 won, respectively. As the drug is taken twice a day, the daily drug price is between 986 won and 1,002 won.
“People may think a higher dose of the drug could reduce blood sugar more, but it is not true based on clinical trials on Jardiance and my prescription experiences,” a diabetes specialist said. “As the higher-dose 25mg sells better in Korea, Boehringer Ingelheim seems to have decided to release the higher-dose combo therapy to raise profits.”
U-BIST’s data showed that the outpatient prescriptions of Jardiance 25mg in proportion to Jardiance 10mg prescriptions went up from 40-50 percent in 2017 to 70-80 percent in 2018. The numbers signal that the share of patients taking high-dose Jardiance increased.
Another specialist in diabetes said the new release of the high-dose Jardiance combo “did not seem to be ethical.”
In response to criticism, Boehringer Ingelheim Korea said Jardiance was the only SGLT-2 inhibitor that lowered the risk of cardiovascular death by 38 percent in type-2 diabetic patients accompanying the cardiovascular disease.
European Medicines Agency (EMA) and Korea’s Ministry of Food and Drug Safety authorized the drug, recommending patients start with Jardiance 10mg and increase the dose up to 25mg if necessary, the company noted.
“No pharmaceutical firm has launched a fixed high-dose combination of Jardiance 25mg and metformin other than us,” the company said. “Boehringer Ingelheim Korea released Jardiance Duo 12.5/500mg, 12.5/850mg, and 12.5/1000mg to provide patients with additional treatment options and to give physicians the flexibility in prescriptions.”