Study: Tradjenta, other DPP-4 inhibitors linked to bullous pemphigoid

Researchers found that people with type 2 diabetes who are treated with a dipeptidyl peptidase 4 (DPP-4) inhibitor faced a higher risk of developing bullous pemphigoid.

Bullous pemphigoid is a rare skin condition characterized by large blisters filled with fluid. It can be life-threatening, especially for older people with pre-existing conditions.

The study found that patients who started DPP-4 inhibitor treatment faced a 42 percent higher risk of bullous pemphigoid development over the next year compared with new second-generation sulfonylurea patients.

The elevation in risk was equivalent to a bullous pemphigoid incidence rate of 0.42 in users of DPP-4 inhibitors compared to 0.31 for users of sulfonylurea per 1,000 person-years.

Patients aged 65 or older on DPP-inhibitors saw their bullous pemphigoid risk increase by 62%. White patients saw their risk increase by 70%.

Patients who were specifically given Tradjenta saw a 68% increased risk for bullous pemphigoid.

The risks were similar for men and women.

Hemin Lee, MD, MPH of Brigham and Women’s Hospital in Boston said the results weren’t surprising as they are in line with previous results.

The elevated risks found in Tradjenta users, older adults and white people were new findings. Lee said they could be topics to explore in future studies.

Clinicians should increase their awareness on the potential onset of bullous disease in patients initiating DPP-4 inhibitors — especially those with older age, white race, and initiating linagliptin,” Lee said.

The study involved 1,664,880 United States patients from Medicare data and commercial insurance claim databases. All patients were diagnosed with type 2 diabetes and were new DPP-4 or sulfonylurea users. The DPP-4 inhibitors included Onglyza, Januvia, Tradjenta and Nesina. The sulfonylureas included Glynase, Amaryl, Glucotrol and Glucotrol XL.

The researchers wrote that they went through with the study because “despite several recent reports on the elevated risk of bullous pemphigoid in patients with type 2 diabetes treated with dipeptidyl peptidase–4 (DPP-4) inhibitors, evidence on the absolute risk and comparative safety against other antidiabetics is limited.”

The U.S. Food and Drug Administration added a warning to Tradjenta’s label in 2016. The warning said that DPP-4 inhibitors were associated with hospitalization due to bullous pemphigoid. Bullous pemphigoid is a condition which must be treated very quickly because it can lead to infection, sepsis and death.

A University of Miami researcher suggested in March that DPP-4 inhibitors be studied as a possible COVID-19 treatment.

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Nadrich & Cohen, LLP

Nadrich & Cohen, LLP is a California personal injury law firm with offices in Los Angeles, San Francisco, Modesto, Fresno, Tracy and Palm Desert. The firm has been representing victims of dangerous drugs since 1990 and has recovered over $350,000,000 on behalf of clients in that time.