PMID- 36173649 OWN - NLM STAT- MEDLINE DCOM- 20221028 LR - 20221122 IS - 1479-683X (Electronic) IS - 0804-4643 (Print) IS - 0804-4643 (Linking) VI - 187 IP - 6 DP - 2022 Dec 1 TI - Durable biochemical response and safety with oral octreotide capsules in acromegaly. PG - 733-741 LID - 10.1530/EJE-22-0220 [doi] AB - OBJECTIVE: The objective of this study is to report results from the open-label extension (OLE) of the OPTIMAL trial of oral octreotide capsules (OOC) in adults with acromegaly, evaluating the long-term durability of therapeutic response. DESIGN: The study design is an OLE of a double-blind placebo-controlled (DPC) trial. METHODS: Patients completing the 36-week DPC period on the study drug (OOC or placebo) or meeting predefined withdrawal criteria were eligible for OLE enrollment at 60 mg/day OOC dose, with the option to titrate to 40 or 80 mg/day. The OLE is ongoing; week 48 results are reported. RESULTS: Forty patients were enrolled in the OLE, 20 each having received OOC or placebo, with 14 and 5 patients completing the DPC period as responders, respectively. Ninety percent of patients completing the DPC period on OOC and 70% of those completing on placebo completed 48 weeks of the OLE. Maintenance of response in the OLE (i.e. insulin-like growth factor I (IGF1)