April 20, 2017
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High-frequency, high-dose lanreotide autogel normalizes IGF-I in acromegaly

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Insulin-like growth factor I values can be effectively normalized with high-frequency and high-dose lanreotide autogel in adults with active acromegaly uncontrolled by long-term conventional somatostatin receptor ligand therapy, according to researchers from Italy.

Andrea Giustina, MD, chair of endocrinology, department of molecular and translational medicine at the University of Brescia in Italy, and colleagues evaluated 30 adults (mean age, 52 years) with active acromegaly that was partially responsive to somatostatin receptor ligands. Participants were randomly assigned to high-frequency (120 mg per day every 21 days; n = 15) or high-dose (180 mg per day every 28 days; n = 15) lanreotide autogel (Somatuline Depot, Ipsen) for 24 weeks to determine the biochemical efficacy and safety of each.

Primary outcomes included normalization of serum IGF-I and reductions from baseline in IGF-I and growth hormone values.

During the study period, serum IGF-I decreased from a median of 430 ng/mL to 382 ng/mL (P = .007); the decrease in serum IGF-I value was significant in the high-dose group at 12 weeks compared with baseline (P = .006) and 24 weeks compared with baseline (P = .03), but not in the high-frequency group. The proportion of participants who achieved normalization of serum IGF-I was 27% and did not significantly differ between the two groups. More participants in the high-dose group achieved at least a 20% reduction in serum IGF-I concentration (53.3%) compared with the high-frequency group (21.4%; P = .05). Baseline IGF-I levels were correlated with IGF-I values (P < .001) and normalization of IGF-I (P = .02) at the end of follow-up. Baseline serum IGF-I was lower in participants who achieved normalization of serum IGF-I compared with those who did not in the high-frequency group (P = .01).

During the study period, serum GH values did not change significantly.

“Our trial provides the first convincing evidence that [lanreotide autogel] is safe and effective when used at high doses and frequencies, reinforcing the concept supported by the current guidelines that drug titration over the conventional regimen should be undertaken in acromegaly patients (with) partial responder to conventional [somatostatin receptor ligand] doses before switching to other treatment options,” the researchers wrote. – by Amber Cox

Disclosure: Giustina reports various financial ties with Ipsen, Novartis and Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.