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Pegvisomant
General information
Pegvisomant is a genetically engineered growth hormone analogue that acts as a growth hormone receptor antagonist and is used to treat acromegaly.
Drug studies
Observational studies
In 229 patients with a 9 year history of acromegaly who were treated with pegvisomant in a mean dose of 16.5 mg/day for a median duration of 1 year, adverse events included injection site reactions, including erythema, swelling, and lipohypertrophy (n = 17, 7.4%), raised liver enzymes (21, 9.1%), increased pituitary volume (12, 5.2%), and headache (4, 1.7%) [ ]. This was an observational study, and 94% of the patients had received previous medical therapy for acromegaly. Liver function abnormalities had previously been reported and in this study, 12 of the patients developed aminotransferase activities more than three times the upper limit of the reference range. In 7 of these 12 cases, the activities returned to normal while pegvisomant was continued. Four patients stopped therapy and their liver function normalized. The effect of pegvisomant on pituitary volume is hard to interpret. Review of the MRI scans by an independent neurosurgeon suggested that the increase in tumor volume occurred after the start of treatment in only four patients (see also below under Tumorigenicity).
Organs and systems
Nervous system
In 112 patients with active acromegaly who received pegvisomant in a 12 week, randomized, double-blind study of three different daily subcutaneous doses of pegvisomant (10,15, and 20 mg), headache was reported in the placebo group as often as in the active treatment groups (12%) [ ]. In a longer follow-up study for up to 18 months, 26% of 160 patients had headache, but there was no control group for comparison [ ].
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