Nebenwirkungen · Trajenta
Trajenta 5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6
HOS-124338 · Präparat HOS-095839
Linagliptin cardiovascular and renal safety study (CARMELINA) The CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease (see section 5.1). The study included 3 494 patients treated with linagliptin (5 mg) and 3 485 patients treated with placebo. Both treatments were added to standard of care targeting regional standards for HbA1c and CV risk factors. The overall incidence of adverse events and serious adverse events in patients receiving linagliptin was similar to that in patients receiving placebo. Safety data from this study was in line with previous known safety profile of linagliptin.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-25T11:01:00Z · SHA-256 73424c1e020c37b48d67477dc8a70669c6b089aa10dc47a6d26b62d35baf79b5 · Passage f39ba734b5772c7e7adf3693caecf8ba8e63b208bda3a5f5aac2b0b9c78aefbd · Zeichen 4106–4868 im Abschnitt