SHS_543044 BROF CNOV 14063

Non-interventional study for the generation of long term safety and efficacy data of pasireotide in s.c. in patients with Cushing disease (Post-Authorization Safety Study)

This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

Inclusion Criteria:

Male or female patients aged 18 years or older with a diagnosis of Cushing disease for whom surgery has failed or for whom surgery is not an option
Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry

Exclusion Criteria:

Patients with ectopic ACTH-dependent Cushing syndrome
Patients with adrenal Cushing syndrome
Patients with Pseudo Cushing syndrome
Neurosciences, All Other
Kevin Yuen, M.D.
xLauren Lennox
  • Swedish Medical Center