Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China

简要总结

主要结局

次要结局

• Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization(At 12 months)
• Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)(At 12 months)
• Mean change in vital signs heart rate(From baseline to 3, 6, and 12 months)
• Mean change in physical examination results(From baseline to 3, 6, and 12 months)
• Mean change in the proportion of patients experiencing each of the symptoms (headache, excessive sweating, joint pain, fatigue, and soft tissue swelling) as evaluated by physicians.(From baseline to 6 and 12 months)
• Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)(From baseline to 12 months)
• Mean change in Clinical laboratory assessments(From baseline to 6, and 12 months)
• Mean change in fasting GH and IGF-1 concentrations.(From baseline to 3, 6, and 12 months)
• Mean change in free thyroxine (FT4) and cortisol for males and females(From baseline to 6 and 12 months)
• Mean change in vital signs blood pressure(From baseline to 3, 6, and 12 months)
• Mean change in testosterone for males only(From baseline to 6 and 12 months)
• Mean change in Quality of Life (QoL) scores(From baseline to 6 and 12 months)
• Treatment utilisation of LAN, evaluated by the total number of injections received(From baseline to 12 months)
• Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.(From baseline to 6 and 12 months)
• Incidence of all Adverse Events (AEs)(From baseline to 3, 6 and 12 months)