0000000000287416
AUTHOR
Timo Deutschbein
MON-445 Long-Term Results of an Ongoing Non-Interventional, Real-World Observational Study of Pasireotide SC in Cushing's Disease
Abstract Background: Clinical trials have shown that subcutaneous (sc) pasireotide effectively decreases urinary free cortisol (UFC), improves signs/symptoms and has a favorable safety profile in patients with Cushing’s disease (CD). We describe interim long-term safety and efficacy results of an ongoing multicenter observational study of pasireotide sc in real-world clinical practice for CD (NCT02310269). Methods: This study aims to enroll 100-200 adults with CD for whom surgery has failed or is not an option. Eligible patients could have started pasireotide before (prior use) or at (new use) study entry. Primary endpoint: incidence of pasireotide-related adverse events (AEs) and serious A…
First German Guideline on Diagnostics and Therapy of Clinically Non-Functioning Pituitary Tumors
AbstractAlthough non-functioning pituitary tumors are frequent, diagnostic and therapeutic concepts are not well standardized. We here present the first German multidisciplinary guideline on this topic. The single most important message is to manage the patients by a multidisciplinary team (consisting at least of an endocrinologist, a neurosurgeon, and a (neuro-) radiologist). The initial diagnostic work-up comprises a detailed characterization of both biochemical (focusing on hormonal excess or deficiency states) and morphological aspects (with magnetic resonance imaging of the sellar region). An ophthalmological examination is only needed in presence of symptoms or large tumors affecting …
Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing’s disease: interim results from a long-term real-world evidence study
Abstract Purpose Clinical trials have demonstrated the favorable efficacy/safety profile of pasireotide in patients with Cushing’s disease (CD). We report interim long-term results of an ongoing real-world evidence study of subcutaneous pasireotide in patients with CD. Methods Adults with CD receiving pasireotide, initiated before (prior-use) or at study entry (new-use), were monitored for ≤ 3 years during a multicenter observational study (http://clinicaltrials.gov identifier NCT02310269). Primary objective was to assess long-term safety of pasireotide alone or with other CD therapies. Results At the time of this interim analysis, 127 patients had received pasireotide (new-use, n = 31; pri…