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High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study
Andrea Giustina1, Gherardo Mazziotti2, Salvatore Cannavò3
1Department of Molecular and Translational Medicine, University of Brescia, 25123 Brescia, Italy.
The Journal of Clinical Endocrinology and Metabolism
|April 19, 2017
Summary
High-dose or high-frequency lanreotide autogel effectively normalizes IGF-I in acromegaly patients partially responding to therapy. These regimens show comparable safety and efficacy, offering a viable treatment option for inadequately controlled acromegaly.
Area of Science:
- Endocrinology
- Pharmacology
Background:
- Acromegaly requires effective treatment to manage elevated growth hormone and IGF-I levels.
- Long-acting somatostatin receptor ligands (SRLs) are a cornerstone therapy, but some patients exhibit partial responses.
- Increasing dose or frequency of SRLs is a strategy for partially responsive patients, yet data on high-dose (HD) or high-frequency (HF) lanreotide autogel (LAN-ATG) are limited.
Purpose of the Study:
- To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG regimens.
- To assess IGF-I normalization and GH reduction in acromegaly patients with partial response to SRLs.
Main Methods:
- A 24-week, prospective, multicenter, randomized, open-label trial.
- Thirty patients with active acromegaly and partial response to SRLs were randomized to either HF LAN-ATG (120 mg/21 days) or HD LAN-ATG (180 mg/28 days).
- Outcomes included IGF-I and GH levels, IGF-I normalization, and adverse events.
Main Results:
- IGF-I levels significantly decreased in both groups (P = 0.007), with a trend towards greater reduction in the HD group.
- IGF-I normalization occurred in 27.6% of patients, with no significant difference between HF and HD groups.
- Serum GH levels did not change significantly (P = 0.22).
- Adverse events were mild to moderate, transient, and occurred in 63.3% of patients, with no significant difference between groups.
Conclusions:
- Both HF and HD LAN-ATG regimens are effective in normalizing IGF-I in approximately one-third of acromegaly patients.
- These intensified regimens provide a valuable therapeutic option for patients with active acromegaly inadequately controlled by standard SRL therapy.
- The safety profile of HF and HD LAN-ATG is comparable and acceptable.