PMID- 29371335 OWN - NLM STAT- MEDLINE DCOM- 20180403 LR - 20181113 IS - 1479-683X (Electronic) IS - 0804-4643 (Print) IS - 0804-4643 (Linking) VI - 178 IP - 4 DP - 2018 Apr TI - Increasing frequency of combination medical therapy in the treatment of acromegaly with the GH receptor antagonist pegvisomant. PG - 321-329 LID - 10.1530/EJE-17-0996 [doi] AB - Pegvisomant monotherapy is effective and safe in treatment of acromegaly. However, some clinicians combine pegvisomant with somatostatin analogues (SSA) or dopamine agonist (DA). In this analysis of ACROSTUDY, a long-term non-interventional study, the use of combination regimens was evaluated. Based on their baseline treatment, 2043 patients were retrospectively categorized as: long-acting SSA combined with pegvisomant, 'Combo SSA' 768 patients (38%); DA combined with pegvisomant, 'Combo DA' 123 (6%); pegvisomant monotherapy, 'Peg mono' 1128 (55%). Treatment patterns changed over the 10-year period, with recent patients more likely to receive any combination (20% in 2003 vs 54% in 2012). Combo SSA use varied widely among countries from 22% to 78%. Exposure periods of the three treatment modalities were defined from pegvisomant start until the last visit in ACROSTUDY; patients could switch treatment categories. At year 4, IGF-I was normal in 62% of Combo SSA, 63% of Combo DA and 65% of Peg mono groups. Pegvisomant was initiated as daily injections in 94% of patients in the Peg mono group, 66% of Combo SSA and 91% of Combo DA patients. During 6169 years of treatment exposure, 3424 adverse events (AEs) were reported in 946 (51%) patients, of which 617 (18%) were serious and 401 (12%) were considered treatment related. The reported incidence of serious AEs and treatment-related non-serious AEs were similar among the three treatment modalities. This analysis describes real-world clinical care and shows favorable efficacy and safety for Peg mono and combinations. Novel findings include an increased use of combination therapy over time and variability in treatment modalities between countries. CI - (c) 2018 The authors. FAU - Strasburger, Christian J AU - Strasburger CJ AD - Department of Medicine for EndocrinologyDiabetes and Nutritional Medicine, Charite Universitatsmedizin, Campus Mitte, Berlin, Germany Christian.Strasburger@Charite.de. FAU - Mattsson, Anders AU - Mattsson A AD - Endocrine CarePfizer Health AB, Sollentuna, Sweden. FAU - Wilton, Patrick AU - Wilton P AD - Endocrine CarePfizer Health AB, Stockholm, Sweden. FAU - Aydin, Ferah AU - Aydin F AD - Endocrine CarePfizer Health AB, Sollentuna, Sweden. FAU - Hey-Hadavi, Judith AU - Hey-Hadavi J AD - Endocrine CarePfizer Inc., New York City, New York, USA. FAU - Biller, Beverly M K AU - Biller BMK AD - Neuroendocrine UnitMassachusetts General Hospital, Boston, Massachusetts, USA. LA - eng PT - Journal Article PT - Observational Study DEP - 20180125 PL - England TA - Eur J Endocrinol JT - European journal of endocrinology JID - 9423848 RN - 0 (Dopamine Agonists) RN - 0 (Receptors, Somatotropin) RN - 12629-01-5 (Human Growth Hormone) RN - 51110-01-1 (Somatostatin) RN - N824AOU5XV (pegvisomant) SB - IM MH - Acromegaly/blood/diagnosis/*drug therapy MH - Adult MH - Aged MH - Cross-Sectional Studies MH - Dopamine Agonists/*administration & dosage MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Human Growth Hormone/administration & dosage/*analogs & derivatives/antagonists & inhibitors/blood MH - Humans MH - Male MH - Middle Aged MH - Receptors, Somatotropin/*antagonists & inhibitors/blood MH - Retrospective Studies MH - Somatostatin/*administration & dosage MH - Treatment Outcome PMC - PMC5863474 EDAT- 2018/01/27 06:00 MHDA- 2018/04/04 06:00 PMCR- 2018/03/22 CRDT- 2018/01/27 06:00 PHST- 2017/11/29 00:00 [received] PHST- 2018/01/25 00:00 [accepted] PHST- 2018/01/27 06:00 [pubmed] PHST- 2018/04/04 06:00 [medline] PHST- 2018/01/27 06:00 [entrez] PHST- 2018/03/22 00:00 [pmc-release] AID - EJE-17-0996 [pii] AID - EJE170996 [pii] AID - 10.1530/EJE-17-0996 [doi] PST - ppublish SO - Eur J Endocrinol. 2018 Apr;178(4):321-329. doi: 10.1530/EJE-17-0996. Epub 2018 Jan 25.