Abstract
Purpose
In clinical research involving acromegalic patients naïve to somatostatin-receptor ligands (SRLs), 19 and 31% of those receiving the SRLs octreotide LAR and pasireotide LAR, respectively, achieved GH < 2.5 ng/mL + normalized IGF-1 concentrations. The proportions achieving control appeared higher in the post-surgery compared with the de-novo setting with pasireotide, but more similar with octreotide. Using pooled data from multicenter clinical trials, we examined the biochemical efficacy of lanreotide depot/Autogel in similar settings.
Methods
Inclusion criteria: Ipsen-sponsored, 48–52-week trials in SRL-naïve acromegalic populations receiving lanreotide depot (60–120 mg); patients were included if de novo (no prior acromegaly treatment) or post-surgery (no medical treatment; radiotherapy allowed unless within previous 3 years). Efficacy endpoints included normalized IGF-1 levels and GH < 2.5 ng/mL + normalized IGF-1 at study end/last value available. Analyses: all patients (analysis #1) and subset with baseline GH > 5 ng/mL (analysis #2).
Results
Three studies were included. Analysis #1: normalized IGF-1 was achieved by 42% (71/171) of patients overall (post-surgery, 46% [21/46]; de-novo, 40% [50/125]); GH < 2.5 ng/mL + normalized IGF-1 was achieved by 35% (59/171) (39% [18/46] and 33% [41/125], respectively). Analysis #2: normalized IGF-1 levels, 39% (46/118) (post-surgery, 40% [10/25]; de-novo, 39% [36/93]); GH < 2.5 ng/mL + normalized IGF-1, 31% (36/118) (28% [7/25] and 31% [29/93], respectively).
Conclusion
In these pooled analyses of SRL-naïve patients receiving lanreotide depot, 39–42% achieved IGF-1 control and 31–35% achieved GH and IGF-1 control. Control rates within post-surgery cohorts did not differ markedly from those in corresponding de-novo cohorts.
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Acknowledgements
We thank the patients and investigators who participated in the studies in this analysis. Medical writing for later drafts of the manuscript (funded by Ipsen) was provided by Watermeadow Medical, an Ashfield Company, part of UDG Healthcare plc.
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HA reports no conflict of interests; MdPS and BM are employees of Ipsen; AB received research funding from Novartis and served as consultant for Ipsen, Novartis and Pfizer.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was taken from all participants in these studies.
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Alquraini, H., del Pilar Schneider, M., Mirakhur, B. et al. Biochemical efficacy of long-acting lanreotide depot/Autogel in patients with acromegaly naïve to somatostatin-receptor ligands: analysis of three multicenter clinical trials. Pituitary 21, 283–289 (2018). https://doi.org/10.1007/s11102-018-0867-5
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DOI: https://doi.org/10.1007/s11102-018-0867-5