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Treatment with high doses of pegvisomant in 56 patients with acromegaly: experience from ACROSTUDY

2016; Oxford University Press; Volume: 175; Issue: 4 Linguagem: Inglês

10.1530/eje-16-0008

1479-683X

Aart Jan van der Lely, Peter Jönsson, Patrick Wilton, Ann‐Charlotte Åkerblad, José Cara, Ezio Ghigo,

Adrenal and Paraganglionic Tumors

To investigate the characteristics of patients who need more or less pegvisomant (PEGV) to normalize serum IGF-I.ACROSTUDY is a global noninterventional safety surveillance study of long-term treatment outcomes in patients treated with PEGV. As of June, 2014, ACROSTUDY included data on 2016 patients. All patients treated for at least 6weeks at a dose above 30mg/day and who had two consecutive normal serum IGF-I values were included in the 'high'-dose group (H; n=56; mean daily dose 44±12.5; median dose 40, 35-60 (10-90%)). Patients with two consecutive normal IGF-I values and who never received a PEGV dose above 10mg/day were included in the 'low'-dose group (L; n=368; mean daily dose 7.5±2.5; median dose 8.6, 4.3-10 (10-90%)).Patients in the H group were significantly younger (median 47 vs 52years) and had a significantly higher BMI (median 31.8 vs 26.5kg/m(2)). They had more diabetes (55% vs 21%), sleep apnea (25% vs 14 %) and more hypertension (61% vs 43%). The incidence of (serious) adverse events was low and was not different between the groups.Patients who need more PEGV to normalize IGF-I have more aggressive disease, as they are younger, have higher baseline IGF-I levels, more hypertension, more sleep apnea and diabetes and are more overweight. A better understanding of this dose-efficacy relationship of PEGV might avoid inappropriate dosing and prevent serum IGF-I levels from remaining unnecessarily uncontrolled.