High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study.

Abstract

Context:

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 (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty.

Objective:

To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly.

Design:

Twenty-four-week prospective, multicenter, randomized, open-label trial.

Patients and Interventions:

Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG.

Outcomes:

Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (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, adverse events.

Results:

IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN 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 SRLs therapy.

• Authors: Andrea Giustina, Gherardo Mazziotti, Salvatore Cannavò, Roberto Castello, Giorgio Arnaldi, Giovanna Bugari, Renato Cozzi, Diego Ferone, Anna Maria Formenti, Enza Gatti, Silvia Grottoli, Pietro Maffei, Filippo Maffezzoni, Marcella Montini, Massimo Terzolo, Ezio Ghigo
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 102 Issue 7 Pg. 2454-2464 (07 01 2017) ISSN: 1945-7197 [Electronic] United States
• PMID: 28419317 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 Endocrine Society

Chemical References

• Peptides, Cyclic
• lanreotide
• Human Growth Hormone
• Somatostatin
• Insulin-Like Growth Factor I
• pegvisomant
• Octreotide

Topics

• Acromegaly (diagnostic imaging, drug therapy)
• Adult
• Aged
• Confidence Intervals
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Human Growth Hormone (administration & dosage, analogs & derivatives)
• Humans
• Injections, Subcutaneous
• Insulin-Like Growth Factor I (drug effects, metabolism)
• Italy
• Magnetic Resonance Imaging (methods)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Octreotide (administration & dosage)
• Odds Ratio
• Peptides, Cyclic (administration & dosage)
• Prospective Studies
• Severity of Illness Index
• Somatostatin (administration & dosage, analogs & derivatives)
• Statistics, Nonparametric
• Time Factors
• Treatment Outcome