Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone

摘要

ObjectiveTo evaluate the efficacy and safety of coadministered lanreotide Autogel (LA; 120?mg/month) and pegvisomant (40–120?mg/week) in acromegaly.DesignThis is a 28-week, multicenter, open-label, single-arm sequential study.MethodsPatients ( n =92) biochemically uncontrolled, on somatostatin analogs (SSAs) or using pegvisomant monotherapy entered a 4-month run-in taking LA (120?mg/month). Patients uncontrolled after the run-in period ( n =57) entered a 28-week coadministration period, receiving LA 120?mg/month plus pegvisomant (60?mg once weekly, adapted every 8 weeks based on IGF1 levels to 40–80?mg once weekly or 40 or 60?mg twice weekly).ResultsIn total, 33 (57.9%) patients had normalized IGF1 following coadministration ( P <0.0001 versus 30% minimum clinically relevant); median pegvisomant dose in normalized patients was 60?mg/week. IGF1 normalized at any time during coadministration in 45 (78.9%) patients ( P 5×upper limit of normal with normalization after withdrawal).ConclusionsIn patients partially controlled by SSAs, LA (120?mg/month) plus pegvisomant normalized IGF1 in 57.9% of patients after 7 months, at a median effective pegvisomant dose of 60?mg/week, and 78.9% at any time. In these patients, results suggest a pegvisomant-sparing effect versus daily pegvisomant monotherapy.