HIGH-DOSE AND HIGH-FREQUENCY LANREOTIDE AUTOGEL IN ACROMEGALY: A RANDOMIZED, MULTICENTER STUDY.

HIGH-DOSE AND HIGH-FREQUENCY LANREOTIDE AUTOGEL IN ACROMEGALY: A RANDOMIZED, MULTICENTER STUDY.

J Clin Endocrinol Metab. 2017 Apr 17;:

Authors: Giustina A, Mazziotti G, Cannavò S, Castello R, Arnaldi G, Bugari G, Cozzi R, Ferone D, Formenti AM, Gatti E, Grottoli S, Maffei P, Maffezzoni F, Montini M, Terzolo M, Ghigo E

Abstract
Context: The increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide autogel (LAN-ATG) at high-dose (HD) or high-frequency (HF) are still scanty and anecdotal.
Objective: To evaluate the biochemical efficacy and safety of HF- and HD LAN-ATG in patients with active acromegaly.
Design: 24-week prospective, multicentre, randomized, open-label trial.
Patients and Interventions: Thirty patients with active acromegaly, partial responder to SRL, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.
Outcomes: Normalization of serum IGF-I and reduction in random GH values <1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF- and HD-LAN-ATG, safety/tolerability evaluations.
Results: Serum IGF-I decreased significantly (p=0.007) during 24-week treatment, with greater decrease in HD (p=0.03) as compared to HF group (p=0.08). Normalization in serum IGF-I values occurred in 27.6% of patients (p=0.016 vs. baseline), without significant difference between HF and HD groups (p=0.59). Decrease in serum IGF-I significantly correlated with serum lanreotide values (p=0.04) and normalization of IGF-I was predicted by baseline IGF-I values (p=0.02). Serum GH values did not change significantly (p=0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms.
Conclusion: HF- and HD- LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRL therapy.

PMID: 28419317 [PubMed - as supplied by publisher]

http://ift.tt/2oUEeSB