OBJECTIVE: The GH receptor antagonist pegvisomant is a highly effective new treatment option in acromegaly. The German Pegvisomant Observational Study (GPOS) was started to monitor long-term safety and efficacy of pegvisomant as prescribed in clinical practice. DESIGN: GPOS is an observational, multi-center, surveillance study, which comprises non-interventional data collection. METHODS: Of the 229 patients included in the study, 90.4% had previous pituitary surgery, 43.2% were treated by radiation therapy, and 94.3% had previous medical therapy for acromegaly that had been discontinued mainly due to persistent IGF-I elevation or side effects. The intention-to-treat population included 177 patients with at least one post-baseline efficacy measurement. RESULTS: IGF-I levels decreased from 1.75+/-0.91-fold the upper limit of normal at baseline to 1.05+/- 0.62 at the 6-month visit, 0.96+/-0.60 at the 12-month visit, and to 0.89+/-0.41-fold after 24 months (P<0.0001). Mean duration of pegvisomant therapy was 51.8+/-35.8 weeks (median=51.9 weeks). IGF-I was normalized in 64.4% at 6 months with a median dose of 15.0 mg/day, in 70.9% at 12 months, and in 76.3% at 24 months. Fasting glucose levels improved from 114.4+/-45.9 to 101.5+/- 42.8 mg/dl after 6 months (P<0.01) and to 100.6+/-33.2 mg/ml after 12 months (P<0.01). General physical condition measured by specific signs and symptoms score improved significantly. Adverse events occurring in >1% were injection site reactions in 7.4%, elevated liver enzymes (>3 times of normal) in 5.2% (3.1% spontaneously normalized during continued treatment), reported increase of pituitary tumor volume in 5.2% (which was verified in 3.1%), and headache in 1.7%. CONCLUSIONS: Pegvisomant is generally well tolerated with a safety profile similar to that reported in clinical trials and can effectively reduce IGF-I in patients with acromegaly refractory to conventional therapy.
OBJECTIVE: The GH receptor antagonist pegvisomant is a highly effective new treatment option in acromegaly. The German Pegvisomant Observational Study (GPOS) was started to monitor long-term safety and efficacy of pegvisomant as prescribed in clinical practice. DESIGN: GPOS is an observational, multi-center, surveillance study, which comprises non-interventional data collection. METHODS: Of the 229 patients included in the study, 90.4% had previous pituitary surgery, 43.2% were treated by radiation therapy, and 94.3% had previous medical therapy for acromegaly that had been discontinued mainly due to persistent IGF-I elevation or side effects. The intention-to-treat population included 177 patients with at least one post-baseline efficacy measurement. RESULTS:IGF-I levels decreased from 1.75+/-0.91-fold the upper limit of normal at baseline to 1.05+/- 0.62 at the 6-month visit, 0.96+/-0.60 at the 12-month visit, and to 0.89+/-0.41-fold after 24 months (P<0.0001). Mean duration of pegvisomant therapy was 51.8+/-35.8 weeks (median=51.9 weeks). IGF-I was normalized in 64.4% at 6 months with a median dose of 15.0 mg/day, in 70.9% at 12 months, and in 76.3% at 24 months. Fasting glucose levels improved from 114.4+/-45.9 to 101.5+/- 42.8 mg/dl after 6 months (P<0.01) and to 100.6+/-33.2 mg/ml after 12 months (P<0.01). General physical condition measured by specific signs and symptoms score improved significantly. Adverse events occurring in >1% were injection site reactions in 7.4%, elevated liver enzymes (>3 times of normal) in 5.2% (3.1% spontaneously normalized during continued treatment), reported increase of pituitary tumor volume in 5.2% (which was verified in 3.1%), and headache in 1.7%. CONCLUSIONS:Pegvisomant is generally well tolerated with a safety profile similar to that reported in clinical trials and can effectively reduce IGF-I in patients with acromegaly refractory to conventional therapy.
Authors: S Grottoli; P Maffei; F Bogazzi; S Cannavò; A Colao; E Ghigo; R Gomez; E Graziano; M Monterubbianesi; P Jonsson; L De Marinis Journal: Endocrine Date: 2014-08-23 Impact factor: 3.633
Authors: Alison M Boyce; McKinley Glover; Marilyn H Kelly; Beth A Brillante; John A Butman; Edmond J Fitzgibbon; Carmen C Brewer; Christopher K Zalewski; Carolee M Cutler Peck; H Jeffrey Kim; Michael T Collins Journal: J Clin Endocrinol Metab Date: 2012-10-23 Impact factor: 5.958
Authors: S Cannavo; F Bogazzi; A Colao; L De Marinis; P Maffei; R Gomez; E Graziano; M Monterubbianesi; S Grottoli Journal: J Endocrinol Invest Date: 2015-04-28 Impact factor: 4.256
Authors: E Ghigo; B M K Biller; A Colao; I A Kourides; N Rajicic; R K Hutson; L De Marinis; A Klibanski Journal: J Endocrinol Invest Date: 2009-12-04 Impact factor: 4.256
Authors: A Giustina; A Barkan; P Chanson; A Grossman; A Hoffman; E Ghigo; F Casanueva; A Colao; S Lamberts; M Sheppard; S Melmed Journal: J Endocrinol Invest Date: 2008-09 Impact factor: 4.256