Nebenwirkungen · Incresync
Incresync 12.5 mg/30 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-124709 · Präparat HOS-095913
A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator-controlled, double-blind clinical studies in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%). In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). Post-marketing, bone fractures have been reported in both male and female patients (see section 4.4).
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