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Slow Release Lanreotide Comparable to Octreotide LAR in Acromegaly: Presented at ECE

By Alison Palkhivala

LYON, FRANCE -- April 29, 2003 -- A slow release formulation of the somatostatin analogue lanreotide, called lanreotide AutogelŪ, is at least as effective as octreotide LARŪ for the control of patients with acromegaly.

Dr. Simon G. Ashwell, from the department of medicine, University of Newcastle, England, and colleagues performed an open-label, multicentre study involving 12 patients with acromegaly. All these patients had previously been treated with octreotide LARŪ 20 mg every 4 weeks for at least 4 months. They were also all sensitive to somatostatin analogues, as determined by a mean plasma growth hormone level of 10 mU/L or less.

Findings were presented in a poster here on April 29^th at the 6^th European Congress of Endocrinology.

After undergoing baseline screening that included measurement of plasma growth hormone and insulin like growth factor 1 (IGF-1), patients received 90 mg injections of Autogel, which was repeated every 4 weeks for a total treatment period of 28 weeks.

Patients' levels of growth hormone and IGF-1 were measured repeatedly throughout the study, and interim results were used to titrate the dose of Autogel.

Among the 10 patients who completed the 28-week study, mean growth hormone levels were slightly increased (but not to a statistically significant level) at Week 8 but were similar to baseline at Week 28.

Levels of IGF-1 decreased continuously throughout the study period, decreasing from a baseline of 212 to 154 mcg/L by the end of the trial (P=0.027). Six patients had IGF-1 levels within the normal range at baseline, and eight had normal levels by the end of the study. Most patients experienced a consistent reduction in IGF-1 levels, suggesting that this effect was not dependent on titration of the Autogel dose.

Mean plasma levels of Autogel increased sharply during the first 8 weeks and continued to increase slightly through Week 12. Dose titration resulted in changes in plasma levels, as expected. Only patients taking 60 mg of Autogel attained a steady state of the drug, starting at Week 16.

Side effects that may have been related to Autogel included pain and swelling at the injection site, joint pain and intermittent back pain. All these events were considered mild to moderate.

On their poster, the authors concluded that, "lanreotide AutogelŪ is effective and well tolerated in patients with acromegaly. Plasma growth hormone control was comparable with AutogelŪ and LARŪ. The plasma IGF-1 levels were significantly lower after AutogelŪ treatment than at baseline. The majority of patients switched from 20 mg LARŪ will be equally or better controlled with 90 mg AutogelŪ.


[A Comparative Study Of The Efficacy And Safety Of Lanreotide Autogel, In Patients With Acromegaly, Previously Treated With Octreotide Lar. Abstract: P1056.]

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