Control of IGF‐I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly

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  • TGthe Lanreotide Acromegaly Study Group
    the Lanreotide Acromegaly Study Group
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Abstract
Summary: Background  An essential criterion for control of acromegaly is normalization of IGF‐I levels. Somatostatin analogues act to suppress IGF‐I and GH levels.Objective  To assess the efficacy and safety of 48 weeks titrated dosing of lanreotide Autogel.Design  Open‐label, multicentre, phase III, 48‐week trial.Methods  Patients with active acromegaly (IGF‐I levels > 1·3 times upper limit of age‐adjusted normal range) were recruited. Twelve injections of lanreotide Autogel were given at 28‐day intervals: during the 16‐week fixed‐dose phase, patients received 90 mg; in the 32‐week dose‐titration phase, patients received 60, 90 or 120 mg according to GH and IGF‐I levels. Intention‐to‐treat analysis was performed to determine the proportion of patients with normalized age‐adjusted IGF‐I levels at study end. Secondary evaluations included GH levels, clinical acromegaly signs and safety.Results  Fifty‐seven of 63 patients completed the study. Lanreotide Autogel resulted in normalized age‐adjusted IGF‐I levels in 27 patients (43%, 95% CI 31–55). Mean GH levels decreased from 6·2 to 1·5 µg/l at study end, with 53 of 62 patients (85%) having GH levels ≤ 2·5 µg/l (95% CI 76·7–94·3) and 28 of 62 patients (45%) with levels < 1 µg/l (95% CI 32·8–57·6). Twenty‐four (38%) had both normal IGF‐I levels and GH levels ≤ 2·5 µg/l. Acromegaly symptoms reduced significantly in most patients throughout the study. The most common adverse events were gastrointestinal, as expected for somatostatin analogues.Conclusions  Using IGF‐I as primary end‐point, 48 weeks lanreotide Autogel treatment, titrated for optimal hormonal control, controlled IGF‐I and GH levels effectively, reduced acromegaly symptoms and was well tolerated.

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