EFFICACY AND SAFETY OF TITRATED-DOSES LANREOTIDE AUTOGEL IN PATIENTS WITH ACROMEGALY
PJ Jenkins, on behalf of the Lanreotide Autogel Study Group
Introduction: Lanreotide Autogel(R) is a long-acting somatostatin analogue preparation that is presented in pre-filled syringes for deep subcutaneous (sc) injection. The efficacy and tolerability of lanreotide Autogel given in titrated doses (ATG-TITRATE) for the treatment of acromegaly was assessed during this study.
Methods: The study extended an existing study, during which fixed doses of lanreotide Autogel (ATG-FIX, 60, 90 and 120 mg) were given sc every 28 days for 3 months to patients with acromegaly. In total, 123 of these patients entered the extension phase, and each received 60, 90 or 120 mg of lanreotide Autogel sc every 28 days for 1 year. Doses were titrated at entry or months 4 or 8, according to the mean growth hormone (GH) and insulin-like growth factor (IGF)-I response: dose increased if GH > 2.5 ng/ml; decreased if GH < 1 ng/ml with normal IGF-I.
Results: After 1 year of ATG-TITRATE, mean GH concentrations were significantly decreased versus ATG-FIX (mean plus/minus SD, 2.4 plus/minus 0.2 ng/ml versus 2.87 plus/minus 0.22 ng/ml; p=0.001). Mean IGF-I concentrations were also decreased (287 plus/minus 12 ng/ml versus 323 plus/minus 16 ng/ml; p=0.02). GH hypersecretion was controlled (GH less than or equal to 2.5 or 5.0 ng/ml) in 68% or 93%, respectively, of patients with ATG-TITRATE compared with 55% or 81% on ATG-FIX. Normalised IGF-I levels were achieved in 50% of patients compared with 45% on ATG-FIX. There was a trend for improved control of acromegalic symptoms with ATG-TITRATE compared with ATG-FIX. Only four patients withdrew because of adverse events, of which only one was treatment-related.
Conclusion: Long-term treatment with titrated doses of lanreotide Autogel is well tolerated and more effective in controlling GH hypersecretion than a fixed-dose regime of lanreotide Autogel in patients with acromegaly.