High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study
| Autor: | M. Montini, Gherardo Mazziotti, Renato Cozzi, Salvatore Cannavò, Enza Gatti, Filippo Maffezzoni, Ezio Ghigo, Giorgio Arnaldi, Anna Maria Formenti, Silvia Grottoli, Diego Ferone, Giovanna Bugari, Pietro Maffei, Massimo Terzolo, Andrea Giustina, Roberto Castello |
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| Přispěvatelé: | Giustina, Andrea, Mazziotti, Gherardo, Cannavã², Salvatore, Castello, Roberto, Arnaldi, Giorgio, Bugari, Giovanna, Cozzi, Renato, Ferone, Diego, Formenti, Anna Maria, Gatti, Enza, Grottoli, Silvia, Maffei, Pietro, Maffezzoni, Filippo, Montini, Marcella, Terzolo, Massimo, Ghigo, Ezio |
| Rok vydání: | 2017 |
| Předmět: |
Male
Time Factors Endocrinology Diabetes and Metabolism Clinical Biochemistry Octreotide Somatostatin analog therapy Octreotide-LAR Growth-hormone long-term Tumor shrinkage neuroendocrine tumors Clinical-trial metaanalysis mortality Lanreotide Severity of Illness Index Biochemistry Gastroenterology law.invention Tumor shrinkage chemistry.chemical_compound 0302 clinical medicine Endocrinology Randomized controlled trial law Odds Ratio Medicine Prospective Studies Insulin-Like Growth Factor I Prospective cohort study Cyclic Human Growth Hormone Subcutaneous Statistics Middle Aged Magnetic Resonance Imaging Diabetes and Metabolism Treatment Outcome Somatostatin Italy 030220 oncology & carcinogenesis Female Drug Human metaanalysis medicine.drug Adult medicine.medical_specialty Time Factor Maximum Tolerated Dose Injections Subcutaneous 030209 endocrinology & metabolism Context (language use) Injections Subcutaneou Peptides Cyclic Drug Administration Schedule Statistics Nonparametric Follow-Up Studie Injections Dose-Response Relationship 03 medical and health sciences Internal medicine Acromegaly Confidence Intervals Humans Nonparametric Adverse effect Aged Somatostatin analog therapy Growth-hormone Octreotide-LAR long-term Dose-Response Relationship Drug business.industry Biochemistry (medical) medicine.disease mortality Prospective Studie Follow-Up Studies chemistry Clinical-trial neuroendocrine tumors Peptides business Confidence Interval |
| Zdroj: | The Journal of Clinical Endocrinology & Metabolism. 102:2454-2464 |
| ISSN: | 1945-7197 0021-972X |
| DOI: | 10.1210/jc.2017-00142 |
| Popis: | 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 mg/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 serumIGF-I significantly correlated with serumLAN 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 onethird of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy. |
| Databáze: | OpenAIRE |
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