Pd50-08 Improvement of Arterial Endothelial Function Following Initiation of Testosterone Replacement Therapy
Year: 2016
Type: article
Abstract: RESULTS: 210 subjects were randomized to LPCN 1021 and 105 to active control.Eugonadal T levels were restored with LPCN 1021 (Week 13 mean [SD] Cavg of 446 [171] ng/dL) and were reliably maintained throughout 52 weeks.AEs occurred in 67% of LPCN 1021 subjects and 65% of T gel 1.62% subjects.No hepatic, cardiac, or drug-related serious AEs occurred.The most common drug-related AEs (adverse drug reactions, ADRs) for LPCN 1021 and T gel 1.62% were acne (2.9% vs 2.9%, respectively), headache (0.5% vs 3.8%, respectively), weight increase (2.4% vs 0%, respectively), hematocrit increase (1.9% vs 0%, respectively), liver enzyme level increase (1.4% vs 0%, respectively), fatigue (0.5% vs 1.9%, respectively), and hypertension (0.5% vs 1.9%, respectively).All ADRs were mild or moderate in severity.Subjects receiving LPCN 1021 reported few androgenic ADRs with no reports of sleep apnea or oily skin and 1% or fewer subjects reporting peripheral edema and polycythemia.Most lipid parameters (cholesterol, LDL, HDL, and TG) were comparable between treatment groups at Week 52.Other androgenic parameters including hematocrit, hemoglobin, platelet, prothrombin, and PSA showed no significant differences in change from baseline to end of study between treatments.CONCLUSIONS: LPCN 1021 was well tolerated and had a favorable safety profile in the long-term management of hypogonadal subjects.Notably, no hepatic safety concerns were identified and gastrointestinal AEs with oral LPCN 1021 were generally comparable to active control.
Source: The Journal of Urology
Authors: Daniel Shoskes, Kathryn Dunlap, Barbara Tucky
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2329801955