科研之友
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摘要
Purpose This analysis evaluates the 2-year effectiveness and safety of lanreotide depot/autogel (LAN), as well as treatment convenience and acromegaly symptom relief, from the Somatuline (R) Depot for Acromegaly (SODA) registry, a post-marketing, open-label, observational, multi-center, United States registry study. Methods Patients with acromegaly treated with LAN were eligible for enrollment. Demographics, LAN dose, extended dosing interval (EDI) (interval of injections >= 42 days), insulin-like growth factor 1 (IGF-1), growth hormone (GH), glycated hemoglobin, adverse events (AEs), injection convenience, and symptom data were collected. Results As of September 29, 2014, 241 patients were enrolled in SODA. IGF-1 levels below age-and gender-adjusted upper normal limit (ULN) were achieved in 71.2% at month (M) 12 and 74.4% at M24; GH <= 2.5 mu g/L in 83.3% at M12 and 80.0% at M24; GH<1.0 mu g/L in 61.7% at M12 and 61.4% at M24. Both IGF-1 < ULN and GH <= 2.5 mu g/L were achieved in 65.0% at M12 and 54.8% at M24; both IGF-1 < ULN and GH < 1.0 mu g/L were achieved in 51.7 and 42.9% at M12 and M24, respectively. EDI regimen was 5.0% at baseline and 12.0% at M24. At M24, acromegaly symptoms appeared stable or improved. The most common AE was arthralgia (25.7%). Among 106 serious AEs reported by 42 patients, 10 were deemed related to therapy in 9 patients. At M24, 73.1% of patients rated LAN as convenient. Conclusions SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1 < ULN and GH <= 2.5 mu g/L. LAN was generally well tolerated with no new or unexpected safety signals reported during the observation period.
- 出版日期2017-12
