(496) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on the Lipid Pattern – Results from a Registry Study

Abstract

Abstract Introduction The lipid pattern plays a role in the assessment of cardiometabolic risks such as atherogenicity (non-HDL), arteriosclerotic cardiovascular disease (remnant cholesterol), or insulin resistance (TG:HDL ratio). A recent meta-analysis suggested that, in patients with metabolic disorders, only a reduction of triglycerides achieved statistical significance across controlled and uncontrolled studies (Corona G et al. Exp Rev Clin Pharmacol 2021;14:1091-1103). The lipid pattern plays a role in the assessment of cardiometabolic risks such as atherogenicity (non-HDL), arteriosclerotic cardiovascular disease (remnant cholesterol), or insulin resistance (TG:HDL ratio). A recent meta-analysis suggested that, in patients with metabolic disorders, only a reduction of triglycerides achieved statistical significance across controlled and uncontrolled studies (Corona G et al. Exp Rev Clin Pharmacol 2021;14:1091-1103). Another recent meta-analysis suggested significant reductions of total cholesterol, LDL, HDL and triglycerides (Hudson J et al. Lancet Healthy Longev 2022;3:e381–93). Objective to investigate effects of long-term TTh up to 13 years on the lipid pattern in men with functional hypogonadism and obesity compared to an untreated control group. Methods In an ongoing registry study in men with hypogonadism (total testosterone ≤350 ng/mL and at least moderate symptoms on the Aging Males’ Symptoms scale, AMS) in a single urology office, 491 men had functional hypogonadism and obesity (BMI ≥30 kg/m2). 292 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 199 opted against TTh and served as controls (CTRL). Total cholesterol, LDL, HDL, and triglycerides were assessed at each visit. Absolute measures with standard deviations (SDs) as well as changes over time, adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids, and quality of life to account for baseline differences between groups, are reported for a duration of 13 years. Results Mean (median) follow-up: T-group 10.1±3.1 (11), CTRL 9.4±3.3 (10) years, total observation time: T-group 2944, CTRL 1861 patient-years. Baseline age: 59.5±6.0 (T-group) and 63.0±5.0 years (CTRL) (p<0.0001). Total cholesterol (TC) (mmol/L for all lipids) decreased by 2.9±0.1 (least squares means ± SEs) from 8.2±1.0 to 5.1±0.3 (means ± SDs) in T-group and increased by 1.38±0.1 from 7.3±1.0 to 8.6±1.2 in CTRL (p<0.0001 for all). HDL increased by 0.5±0.0 from 1.0±0.4 to 1.6±0.3 in T-group and decreased by 0.4±0.0 from 1.1±0.5 to 0.8±0.4 in CTRL (p<0.0001 for all). The TC:HDL ratio decreased by 5.4±0.2 from 9.2±3.8 to 3.4±0.6 in T-group and increased by 6.5±0.3 from 8.0±3.8 to 12.6±5.8 in CTRL (p<0.0001 for all). LDL decreased by 1.9±0.0 from 4.5±0.9 to 2.5±0.3 in T-group and increased by 1.2±0.1 from 4.2±1.3 to 5.4±1.3 in CTRL (p<0.0001 for all). Triglycerides (TG) decreased by 1.1±0.0 from 3.4±0.5 to 2.2±0.1 in T-group and increased by 0.7±0.0 from 3.2±0.5 to 3.9±0.5 in CTRL (p<0.0001 for all). Non-HDL decreased by 3.4±0.1 from 7.2±1.0 to 3.5±0.2 in T-group and increased by 1.6±0.1 from 6.2±1.1 to 7.8±1.3 in CTRL (p<0.0001 for both). Remnant cholesterol decreased by 1.5±0.1 from 2.7±0.9 to 1.0±0.3 in T-group and increased by 0.5±0.1 from 2.1±1.0 to 2.4±0.7 in CTRL (p<0.0001 for both). The TG:HDL ratio decreased by 5.0±0.2 from 8.7±3.9 to 3.2±0.6 in T-group and increased by 6.8±0.3 from 8.1±3.9 to 13.6±6.7 in CTRL (p<0.0001 for both). Conclusions Long-term TTh in men with functional hypogonadism and obesity improved all components of the lipid pattern. In the untreated control group, the lipid pattern deteriorated. Disclosure Yes, this is sponsored by industry/sponsor: Bayer AG, Berlin, Germany. Clarification Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Bayer AG.