Aim: To assess the efficacy and safety of pasireotide long-acting release (PAS-LAR) alone or in combination with pegvisomant by switching patients with acromegaly who were well controlled with long-acting somatostatin analogues (LA-SSAs) and pegvisomant to PAS-LAR with or without pegvisomant. Methods: Sixty-one patients with acromegaly were enrolled in a prospective open-label study. We included patients with an insulin-like growth factor I (IGF-I) ≤1.2 × upper limit of normal (ULN) during treatment with LA-SSAs and pegvisomant. At baseline, the pegvisomant dose was reduced by 50% up to 12 weeks. When IGF-I remained ≤1.2 × ULN after 12 weeks, patients were switched to PAS-LAR 60 mg monotherapy. When IGF-I was >1.2 × ULN, patients were switched to PAS-LAR 60 mg, and they continued with the 50% reduced pegvisomant dose. Results: At baseline, mean IGF-I was 0.97 × ULN, and the median pegvisomant dose was 80 mg/wk. At 12 weeks, mean IGF-I increased to 1.59 × ULN, and IGF-I levels ≤1.2 ULN were observed in 24.6% of participants. At 24 weeks, IGF-I levels were reduced into the reference range in 73.8% of patients. Between baseline and 24 weeks, the pegvisomant dose was reduced by 66.1%. PAS-LAR was well tolerated, but hyperglycemia was the most frequent adverse event. The frequency of diabetes increased from 32.8% at baseline to 68.9% at 24 weeks. Conclusions: Switching to PAS-LAR, either as monotherapy or combination with pegvisomant, can control IGF-I levels in most patients. PAS-LAR demonstrated a pegvisomant-sparing effect of 66% compared with the combination with LA-SSAs. Hyperglycemia was the most important safety issue.
Aim: To assess the efficacy and safety of pasireotide long-acting release (PAS-LAR) alone or in combination with pegvisomant by switching patients with acromegaly who were well controlled with long-acting somatostatin analogues (LA-SSAs) and pegvisomant to PAS-LAR with or without pegvisomant. Methods: Sixty-one patients with acromegaly were enrolled in a prospective open-label study. We included patients with an insulin-like growth factor I (IGF-I) ≤1.2 × upper limit of normal (ULN) during treatment with LA-SSAs and pegvisomant. At baseline, the pegvisomant dose was reduced by 50% up to 12 weeks. When IGF-I remained ≤1.2 × ULN after 12 weeks, patients were switched to PAS-LAR 60 mg monotherapy. When IGF-I was >1.2 × ULN, patients were switched to PAS-LAR 60 mg, and they continued with the 50% reduced pegvisomant dose. Results: At baseline, mean IGF-I was 0.97 × ULN, and the median pegvisomant dose was 80 mg/wk. At 12 weeks, mean IGF-I increased to 1.59 × ULN, and IGF-I levels ≤1.2 ULN were observed in 24.6% of participants. At 24 weeks, IGF-I levels were reduced into the reference range in 73.8% of patients. Between baseline and 24 weeks, the pegvisomant dose was reduced by 66.1%. PAS-LAR was well tolerated, but hyperglycemia was the most frequent adverse event. The frequency of diabetes increased from 32.8% at baseline to 68.9% at 24 weeks. Conclusions: Switching to PAS-LAR, either as monotherapy or combination with pegvisomant, can control IGF-I levels in most patients. PAS-LAR demonstrated a pegvisomant-sparing effect of 66% compared with the combination with LA-SSAs. Hyperglycemia was the most important safety issue.
Authors: Andrea Giustina; Garni Barkhoudarian; Albert Beckers; Anat Ben-Shlomo; Nienke Biermasz; Beverly Biller; Cesar Boguszewski; Marek Bolanowski; Jens Bollerslev; Vivien Bonert; Marcello D Bronstein; Michael Buchfelder; Felipe Casanueva; Philippe Chanson; David Clemmons; Maria Fleseriu; Anna Maria Formenti; Pamela Freda; Monica Gadelha; Eliza Geer; Mark Gurnell; Anthony P Heaney; Ken K Y Ho; Adriana G Ioachimescu; Steven Lamberts; Edward Laws; Marco Losa; Pietro Maffei; Adam Mamelak; Moises Mercado; Mark Molitch; Pietro Mortini; Alberto M Pereira; Stephan Petersenn; Kalmon Post; Manuel Puig-Domingo; Roberto Salvatori; Susan L Samson; Ilan Shimon; Christian Strasburger; Brooke Swearingen; Peter Trainer; Mary L Vance; John Wass; Margaret E Wierman; Kevin C J Yuen; Maria Chiara Zatelli; Shlomo Melmed Journal: Rev Endocr Metab Disord Date: 2020-09-10 Impact factor: 6.514
Authors: Eva C Coopmans; Nour El-Sayed; Jan Frystyk; Nils E Magnusson; Jens O L Jørgensen; Aart-Jan van der Lely; Joop A M J L Janssen; Ammar Muhammad; Sebastian J C M M Neggers Journal: Endocrine Date: 2020-04-24 Impact factor: 3.633
Authors: Annamaria Colao; Marcello D Bronstein; Thierry Brue; Laura De Marinis; Maria Fleseriu; Mirtha Guitelman; Gerald Raverot; Ilan Shimon; Jürgen Fleck; Pritam Gupta; Alberto M Pedroncelli; Mônica R Gadelha Journal: Eur J Endocrinol Date: 2020-06 Impact factor: 6.664