Nebenwirkungen · Xigduo
Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-128367 · Präparat HOS-096549
In the DECLARE study, the numbers of patients with events suggestive of volume depletion were balanced between treatment groups: 213 (2.5%) and 207 (2.4%) in the dapagliflozin and placebo groups, respectively. Serious adverse events were reported in 81 (0.9%) and 70 (0.8%) in the dapagliflozin and placebo group, respectively. Events were generally balanced between treatment groups across subgroups of age, diuretic use, blood pressure and ACE-I/ARB use. In patients with eGFR < 60 mL/min/1.73 m2 at baseline, there were 19 events of serious adverse events suggestive of volume depletion in the dapagliflozin group and 13 events in the placebo group.
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 2026-03-13T13:14:00Z · SHA-256 5e4e22027f26f36b3af00f1144f882799bae35ea23b1602e05670ab58107afc7 · Passage abdff48d476f43f89c01bb90c43f154d4f971eb2e92727c0cfc1e7b0df1b510d · Zeichen 13165–13817 im Abschnitt