Random-intercept Effects Research Articles

Diurnal shifts of rumen fermentation and microbial profiles revealed circadian rhythms of rumen bacteria, methanogens, and protozoa under high-grain and high-forage diets

In this study, we investigated how the composition and population of rumen microbiota shifted in response to diurnal oscillations under 2 different diets (high grain vs high forage). Five multiparous Holstein dairy cows with similar body weight, days in milk, and parity were enrolled in this study. The cows were fed high-grain (HG) diet for 21 d and then shifted to high-forage (HF) diet in the next 21 d (7-d washout and 14-d experimental period). During the experimental period, dry matter intake (DMI) and rumination activity were recorded, and rumen fluid was collected 8 times post-feeding every 6 h during the last 2 d of each dietary feeding period. The rumen microbial (bacterial, archaeal, and protozoal) population and composition were assessed using quantitative PCR and amplicon sequencing respectively. The daily dynamic of measurements was assessed using cosinor model. The associations between microbial taxa and rumen fermentation profiles were assessed using linear mixed model, in which the cows were termed as random intercept effects. Daily rhythmicity was observed for DMI, rumination activity, and rumen fermentation profiles under both diets. Additionally, rumination time, rumen pH, and acetate/propionate ratio had a higher mesor (the average level of diurnal fluctuations) under HF diet than in HG diet. The amplitude (the distance between the peak and mesor) of DMI, rumen pH, ammonia nitrogen, and total volatile acid concentration were higher under HG diet than in HF diet. Although no significant diurnal oscillation was observed in rumen microbial population, the relative abundance of 14 bacterial genera, one protozoal genus, and 2 archaeal species had significant diurnal oscillations under both HF and HG diets. Among them, the bacterial genera Ruminococcus and Colidextribacter had time at peak of rhythm within 0 to12 h after feeding, which were also negatively associated with the rumen acetate/propionate ratio. The bacterial genus Rikenellaceae_RC9_gut_group had time at peak of rhythm within 12 to 24 h after feeding, which was also positively associated with the rumen acetate/propionate ratio. Our study illustrated the daily dynamic on the rumen microbiota population and composition under different diets, and also identified the feeding-responsive rumen microbiota, highlighting a more targeted approach is needed to manipulate rumen microbiota.

Association of Hospitalist Care and Outcomes on an Inpatient Elective Anticancer Therapy Service

Background: Hospitalist care is becoming increasingly common at cancer centers. Here, we assess the impact of oncology hospitalist care on quality outcomes on an inpatient elective anticancer therapy service for patients with leukemia and lymphoma. Methods: On July 26, 2021, the Smilow Cancer Hospital transitioned the elective anticancer therapy team from a hematologic oncologist-led traditional service (TS) to an oncology hospitalist-led service (HS). We compared quality outcomes for patients with leukemia and lymphoma requiring elective anticancer therapy who were admitted during two parallel 18-month periods (TS: July 1, 2018 to December 31, 2019; HS: July 26, 2021 to December 31, 2022). Longitudinal data analysis using mixed linear regression models with random effects for intercept (individual) and slope (time) were used to estimate the association between service and outcome, accounting for patients with multiple admissions reflecting sequential cycles of chemotherapy. The outcomes were length-of-stay (LOS), time from admission to first anticancer therapy administration, and discharge time of day. Models were adjusted for age, sex, race/ethnicity, diagnosis, anticancer therapy type, Severity of Illness index, and total elapsed time since cycle 1/day 1 of the index regimen. Results: The study included 161 patients, 59 from the TS and 102 from the HS. There were 65 patients with leukemia and 96 with lymphoma. No significant differences in median age, sex, race/ethnicity, or severity of illness index between services were observed (p>0.05). The most common anticancer regimen was etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) for lymphoma (TS n=16 (27%); HS n=31 (30%)). For anticancer regimens with a fixed number of treatment days, after adjustment, we observed a significant reduction of length of stay that exceeded one full day (TS=6.09 days (95% CI: 6.09, 6.95 days); HS=3.82 days (95% CI:3.48, 4.16 days); p<0.001), the adjusted mean time from admission to first anticancer therapy administration decreased by 4.12 hours (95% CI: 0.66, 7.59 hours; p<0.001), and the adjusted mean discharge time decreased by 66 minutes (95% CI: 9, 211 minutes; p=0.01) ( Table 1). For those regimens that required variable monitoring for post-treatment methotrexate clearance or tumor lysis syndrome, no significant difference in outcomes was noted (p>0.05). Conclusions: Hospitalist care on an inpatient elective anticancer therapy service was associated with significant improvements in LOS, time from admission to anticancer therapy administration, and discharge time.

Colour Doppler study of blood flow in the portal vein in relation to blood flow in the milk vein, milk yield and body condition of dairy cows during dry period and lactation

In dairy cows, the liver supports the increased nutrient demands of the udder for milk production. Blood flow is key for the transport of these nutrients. This study investigated portal vein blood flow volume (PVBFVol) in relation to daily milk yield (DMY), milk vein blood flow volume (MVBFVol) and body condition parameters of high-producing dairy cows, starting from late lactation, throughout dry period, and consecutive early lactation. Seventeen repeated examinations were performed on 19 Holstein cows and 313 measurement days were finally included. Vein morphology and blood flow were examined via B-mode and spectral Doppler (triplex) ultrasonography, respectively. Body condition parameters recorded were body condition score (BCS), backfat thickness (BFT) measurement with ultrasonography, heart girth circumference (HG) and withers height (WH). Longitudinal relationship of PVBFVol with MVBFVol, DMY, BCS, BFT, HG and WH was analyzed with linear mixed models, with random intercept effects, using restricted cubic splines. A significant increase of 8.28% (p < 0.01) in PVBFVol appeared for every 1 L/min increase in MVBFVol in the univariable model. PVBFVol presented a significant negative association with BCS (p < 0.01) and BFT (p = 0.02), while interaction with production stage was significant, too. PVBFVol significantly increased by 0.38% (p = 0.04) for every 1 kg increase in DMY in the multivariable model. In conclusion, the increased PVBFVol during lactation accompanies the escalation in metabolic activity of the liver and the increased blood circulation through the udder, coping with the udder's escalating nutrient demands for milk synthesis.

Long-term Testosterone Therapy Improves Erectile Function and Reduces Mortality in Men with Hypogonadism and Type 2 Diabetes – Updated Results from a Registry Study

ABSTRACT Introduction Erectile dysfunction affects nearly two-thirds of all men with type 2 diabetes mellitus (T2DM), in whom it is approximately 3.5 times more prevalent, has greater severity, and is less responsive to phosphodiesterase-5 (PDE5) inhibitors than in men without diabetes (Fonseca et al. Diabetologia 2004;47:1914–1923). Long-term testosterone therapy (TTh) resulted in improved erectile function in men with hypogonadism and T2DM (Diabetes Obes Metab. 2020;22:2055–2068). Objective to investigate effects of long-term TTh for up to 12 years on erectile function and mortality in men with hypogonadism and T2DM in comparison to an untreated control group. Methods In a registry study in men with hypogonadism (defined by total testosterone ≤350 ng/mL and at least moderate symptoms assessed by the Aging Males’ Symptoms scale) in a single urology office, 361 men had T2DM. 183 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 178 opted against TTh and served as controls (CTRL). IIEF-EF (5+1 questions, maximum score: 30), was assessed at each visit, and mortality recorded based on reports from the patients’ general practitioners. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. Results Mean (median) follow-up: T-group 8.2±3.2 (8), CTRL 9.2±2.8 (10) years, total observation time: T-group 1508, CTRL 1641 years. Baseline age was 60.7±5.5 (T-group) and 63.0±4.9 years (CTRL) (p&amp;lt;0.0001). At baseline, PDE5-Inhibitors were used by 27.3% (T-group) and 34.3% (CTRL) (p=0.1527). ED was reported at first visit by 64.5% in the T-group and by 54.5% in CTRL. In patients not reporting ED, ED was diagnosed by use of the IIEF-EF in 30.6% and 44.4%, respectively. 4.9% in the T-group and 1.1% in CTRL had no ED (p&amp;lt;0.01 for all). Erectile function: In the T-group, IIEF-EF increased by 12.1±0.4 (least squares means ± standard errors) in year 12. In CTRL, IIEF-EF decreased by 14.2±0.4. The estimated adjusted difference between groups was 26.3 (95% CI: 25.1;27.5) (p&amp;lt;0.0001 for all). Mortality: During the entire observation period, 15 patients (8.2%) died in the T-group and 61 patients (34.3%) in CTRL (p&amp;lt;0.0001). Adherence to TTh was 100 per cent as all injections were administered in the office and documented. Conclusions Long-term testosterone therapy in men with hypogonadism and T2DM improved erectile function and reduced mortality. In the untreated control group, erectile function deteriorated. Our mortality data confirm the results by Hackett et al., BJU Int 2019;123:519–529 who observed the lowest mortality in a subgroup of men receiving continuous long-term TTh. Disclosure Yes, this is sponsored by industry/sponsor: Bayer 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

How Long Does it Take to Achieve Maximal Improvements of Erectile Function in Men with Functional Hypogonadism Receiving Long-term Testosterone Therapy? Results from a Registry Study

ABSTRACT Introduction While beneficial effects of testosterone therapy (TTh) on erectile function (EF) are well established, there is limited information about the duration of TTh required to achieve maximum effects. Hackett et al. demonstrated that EF kept improving for 3.8 years in men with hypogonadism and type 2 diabetes receiving continuous TTh (World J Men's Health 2020;38:68-77). Objective to investigate year-to-year changes in IIEF-EF in men receiving long-term TTh up to 11 years in comparison to an untreated control group. Methods In an ongoing registry study in men with hypogonadism (defined by total testosterone ≤350 ng/mL and at least a moderate symptom score on the Aging Males’ Symptoms scale) in a single urology office, men with primary hypogonadism (for instance, Klinefelter's syndrome) were excluded from the analysis. 779 men had functional hypogonadism. 386 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 393 opted against TTh and served as controls (CTRL). IIEF-EF (5+1 questions, maximum score: 30) was assessed at each visit. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. Results Mean (median) follow-up: T-group 8.9±2.6 (10), CTRL 9.6±2.3 (11) years, total observation time: T-group 3431, CTRL 3765 years. Baseline age was 58.4±6.4 (T-group) and 63.1±4.8 years (CTRL) (p&amp;lt;0.0001). At baseline, PDE5-Inhibitors were used by 25.9% (T-group) and 22.1% (CTRL) (p=0.2181). T-group: IIEF-EF increased by 9.8±0.2 (least squares means ± standard errors) in year 11, p&amp;lt;0.0001 vs. baseline. For the first 6 years, the change was always statistically significant vs. previous year with p&amp;lt;0.0001, from year 7 to 6 with p&amp;lt;0.005, from year 8 to 7 with p&amp;lt;0.0005, from year 9 to 8 with p&amp;lt;0.0001, from year 10 to 9 with p&amp;lt;0.05, and from year 11 to 10 with p&amp;lt;0.0001. CTRL: IIEF decreased by 12.7±0.2. Estimated adjusted difference between groups: 20.8. The year-to-year changes were statistically significant at a level of p&amp;lt;0.0001 throughout the observation time. The estimated adjusted difference between groups at 11 years was 22.5 (95% confidence interval: 21.9;23.2). Adherence to TTh was 100 per cent as all injections were administered in the office and documented. Conclusions Long-term testosterone therapy in men with functional hypogonadism improved erectile function continuously over the full observation time, despite advancing age. In the untreated control group, erectile function deteriorated progressively. Hypogonadism is a chronic disease which requires lifelong treatment to achieve maximum benefits. Disclosure Yes, this is sponsored by industry/sponsor: Bayer 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

Effects of Long-term Testosterone Therapy on Erectile Function in Obese Men with Functional Hypogonadism Receiving Long-term Testosterone Therapy- results From a Registry Study

ABSTRACT Introduction Erectile dysfunction (ED) is common in men with obesity and hypogonadism. We have previously shown long-term testosterone therapy (TTh) to result in improved erectile function and reductions in waist circumference (WC) and weight in obese men with hypogonadism with different etiologies. The FDA advises against treating hypogonadism in men with non-organic, age-related (“functional”) hypogonadism. Objective to investigate effects on erectile function, waist circumference and weight in with functional hypogonadism receiving long-term TTh up to 12 years, compared with an untreated control group. Methods In a registry study in men with hypogonadism (defined by total testosterone ≤350 ng/mL and at least moderate symptoms assessed by the Aging Males’ Symptoms scale) in a single urology office, men with primary hypogonadism were excluded from the analysis. 476 men had functional hypogonadism and were obese (BMI ≥30 kg/m²). 281 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 195 opted against TTh and served as controls (CTRL). IIEF-EF (5+1 questions, maximum score: 30), WC, and weight were assessed at each visit. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. Results Mean (median) follow-up: T-group 9.4±3.0 (12), CTRL 8.9±3.0 (12) years, total observation time: T-group 2630, CTRL 1737 years. Baseline age was 59.9±5.5 (T-group) and 62.9±5.0 years (CTRL) (p&amp;lt;0.0001). At baseline, PDE5-Inhibitors were used by 23.1% (T-group) and 26.2% (CTRL) (p=0.4501). ED was reported at first visit by 62.3% in the T-group and by 40.5% in CTRL. In patients not reporting ED, ED was diagnosed by use of the IIEF-EF in 30.2% and 58.5%, respectively. 7.5% in the T-group and 1% in CTRL had no ED (p&amp;lt;0.0001 for all). Erectile function: In the T-group, IIEF-EF increased by 11.1±0.3 (least squares means ± standard errors) in year 12. In CTRL, IIEF-EF decreased by 14.4±0.4. The estimated adjusted difference between groups was 25.5 (95% CI: 24.5;26.5) (p&amp;lt;0.0001 for all). WC: In the T-group, WC decreased by 13.7±0.3 cm in year 12. In CTRL, WC increased by 8.1±0.4. The estimated adjusted difference between groups was -21.8 (95% CI: -22.9;-20.7) (p&amp;lt;0.0001 for all). Weight: In the T-group, weight decreased by 23.7±0.4 kg in year 12. In CTRL, weight increased by 7.3±0.5. The estimated adjusted difference between groups was -31.0 (95% CI: -32.5;-29.6) (p&amp;lt;0.0001 for all). Adherence to TTh was 100 per cent as all injections were administered in the office and documented. Conclusions Long-term testosterone therapy in obese men with functional hypogonadism improved erectile function and resulted in reductions in waist circumference and weight. In the untreated control group, erectile function and anthropometric parameters deteriorated. Disclosure Yes, this is sponsored by industry/sponsor: Bayer 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

MP27-16 GLYCEMIC CONTROL AND INSULIN RESISTANCE IN HYPOGONADAL MEN WITH TYPE 2 DIABETES (T2DM) WITH LONG-TERM TESTOSTERONE THERAPY (TTH): 15-YEAR DATA FROM A PROSPECTIVE CONTROLLED REGISTRY STUDY

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation I (MP27)1 Sep 2021MP27-16 GLYCEMIC CONTROL AND INSULIN RESISTANCE IN HYPOGONADAL MEN WITH TYPE 2 DIABETES (T2DM) WITH LONG-TERM TESTOSTERONE THERAPY (TTH): 15-YEAR DATA FROM A PROSPECTIVE CONTROLLED REGISTRY STUDY Omar Aboumarzouk, Ahmad Al-Qudimat, Mustafa Alwani, Khalid Al-Rumaihi, Raidh Talib, Karim Haider, Farid Saad, and Raed M. Al-Zoub Omar AboumarzoukOmar Aboumarzouk More articles by this author , Ahmad Al-QudimatAhmad Al-Qudimat More articles by this author , Mustafa AlwaniMustafa Alwani More articles by this author , Khalid Al-RumaihiKhalid Al-Rumaihi More articles by this author , Raidh TalibRaidh Talib More articles by this author , Karim HaiderKarim Haider More articles by this author , Farid SaadFarid Saad More articles by this author , and Raed M. Al-ZoubRaed M. Al-Zoub More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002024.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Hypogonadism is highly prevalent in men with T2DM and via versa. Studies have shown promising results of TTh in hypogonadal patients with T2DM. METHODS: Registry study of hypogonadal men in a urological office. Of 805 patients, 311 (39%) had T2DM diagnosed and treated elsewhere. 141 received TTh with TU 1000 mg/12 weeks (T-group). 170 had opted against TTh and served as controls (CTRL). Measurements were performed 1-4 times a year. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. RESULTS: Baseline age: 61.8±5.3 (T-group), 63.5±4.9 years (CTRL). Mean (median) follow-up was 7.2 (8) years in the T-group and 7.7 (8) years in CTRL. 89% in the T-group and 70% in CTRL were obese. HbA1c progressively decreased from 8.98±1.15 to 5.94±0.3% after 10 years (T-group) and increased from 7.79±0.7 to 10.55±1.68% in CTRL, adjusted difference between groups: 6.15% (p<0.0001 for all). Fasting glucose decreased from 7.7±1.2 to 5.3±0.1 mmol/L (T-group) and increased from 6.3±0.7 to 8.2±2.7 mmol/L in CTRL, difference between groups: 3.6 mmol/L (p<0.0001 for all). HOMA-IR decreased from 10.2±2.1 to 3.3±1.2 after 10 years (T-group) and increased from 7.5±1.3 to 17.1±6.3 in CTRL, difference between groups: 14.8 (p<0.0001 for all). CONCLUSIONS: Long-term TTh in hypogonadal men with T2DM improved glycaemic control. Correcting hypogonadism in men with T2DM sustainably supports standard diabetes treatment. Source of Funding: No Funding © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e477-e478 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Omar Aboumarzouk More articles by this author Ahmad Al-Qudimat More articles by this author Mustafa Alwani More articles by this author Khalid Al-Rumaihi More articles by this author Raidh Talib More articles by this author Karim Haider More articles by this author Farid Saad More articles by this author Raed M. Al-Zoub More articles by this author Expand All Advertisement Loading ...

187 Improvement of Metabolic Syndrome (MetS) Parameters in Men with Hypogonadism With and Without Testosterone Therapy (TTh): Real-Life Evidence from more than 7,000 Patient-Years

We have previously published benefits of testosterone therapy (TTh) on cardiometabolic risk factors over 8 years. To study effectiveness and safety of depot injections of testosterone undecanoate (TU) in a urological setting in comparison to an untreated hypogonadal control group. At time of analysis, 823 men with hypogonadism participated in a registry study established in 2004. 428 men received parenteral TU 1000 mg/12 weeks following an initial 6-week interval (T-group) for up to 11 years, 395 men decided against TTh and served as controls (CTRL). Measurements were performed 1-4 times a year for approximately 7,116 patient-years. Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids, and quality of life scale AMS to account for baseline differences between groups.

314 Improvement of Urinary Function Improves in Hypogonadal Men Receiving Long-term Treatment with Testosterone Compared to a Hypogonadal Control Group: 7116 Patient-years of Clinical Experience

In the most recent version of the EAU Guidelines on Male Hypogonadism, the contraindication severe LUTS due to BPH has been removed. In an ongoing registry study we monitored urinary function for a maximum of 12 years. We report data from 823 men with symptomatic hypogonadism participating in a registry study started in 2004. 428 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 395 opted against TTh serving as controls (CTRL). Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. Mean (median) follow-up: T-group 8±3 (9), CTRL 9±2 (10) years. Total observation time: T-group 3594, CTRL 3522 years. Baseline age: 58±7 (T-group) vs. 64±5 years (CTRL).

378 Improvement of Erectile Function in Hypogonadal Men Receiving Long-term Treatment with Testosterone Compared to a Hypogonadal Control Group: 7116 Patient-years of Clinical Experience

Testosterone Deficiency was added to the 2018 AUA Guidelines with 31 Statements, with a moderate recommendation in informing patients about improvement of erectile function (EF) under treatment. In an ongoing registry study in a single urology practice, we monitored EF for up to 12 years. We report data from 823 men with symptomatic hypogonadism participating in a registry study started in 2004. 428 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 395 opted against TTh and served as controls (CTRL). Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. Mean (median) follow-up: T-group 8±3 (9), CTRL 9±2 (10) years. Total observation time: T-group 3594, CTRL 3522 years. Baseline age: 58±7 in T-group, 64±5 years in CTRL.

1124-P: Beneficial Changes in Glycemic Control in Patients with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Injectable Testosterone Undecanoate (TU): Ten-Year Data from a Registry

Background: Men with T2DM have a high prevalence of hypogonadism. Methods: In a registry of 823 men with hypogonadism, 324 men (39%) had T2DM. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean follow-up 7.9±2.4, age: 62.8±5.1 years. T-group: baseline HbA1c: 9.1±1.2%. HbA1c progressively decreased by 2.7±0.3% at 10 years. CTRL: baseline HbA1c: 7.8±0.7%. HbA1c increased by 2.9±0.3%. Estimated adjusted difference between groups: 5.6% (p&amp;lt;0.0001 for all). Fasting glucose (mmol/L) decreased in T-group by 1.7±0.2 and increased in CTRL by 1.6±0.2, difference between groups: 3.2 (p&amp;lt;0.0001 for all). Fasting insulin (µU/mL) decreased in T-group by 17.4±0.4 and increased in CTRL by 10.7±1.1, difference between groups: 28.1 (p&amp;lt;0.0001 for all). In the T-group, baseline HOMA-IR was 10.2±2.1. HOMA-IR progressively decreased by 6.9±0.2 at 10 years. CTRL: baseline HOMA-IR: 7.5±1.3. HOMA-IR increased by 7.6±0.5. Difference between groups: 14.5 (p&amp;lt;0.0001 for all). In the T-group, 92 men (60.5%) received insulin at baseline at a mean dose of 36.5±12.2 U/d and 66 in CTRL at a mean dose of 30.8±6.0 U/d. The dose requirement in the T-group declined by 17.7±1.0 U/d and increased in CTRL by 17.7±1.0 U/d. Difference between groups: 35.3 U/d (p&amp;lt;0.0001 for all). In CTRL, 20 patients were started on insulin during the observation time. Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM progressively improved glycemic control which worsened in untreated hypogonadal controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. Funding Bayer AG

2084-P: Sustained Weight Loss in Men with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Injectable Testosterone Undecanoate (TU): Ten-Year Data from a Urological Registry Study

Background: Testosterone is inversely correlated with weight and waist circumference (WC). Methods: Of 324 men with hypogonadism and T2DM in a registry, 257 (79.3%) were obese, 60 (18.5%) overweight and 7 (2.2%) had normal weight. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: 62.7±5.1, follow-up: mean: 7.9, median: 9 years. T-group: weight decreased by 21.4±0.5 kg at 10 years. CTRL: weight increased by 4.8±0.4 kg. Estimated adjusted difference between groups: 26.2 kg (p&amp;lt;0.0001 for all). T-group: WC decreased by 12.8±0.4 cm at 10 years. CTRL: WC increased by 5.6±0.4 cm, difference between groups: 18.4 cm (p&amp;lt;0.0001 for all). T-group: BMI decreased by 6.9±0.2 kg/m² at 10 years. CTRL: BMI increased by 1.5±0.1 kg/m², difference between groups: 8.4 kg/m² (p&amp;lt;0.0001 for all). Weight loss was 18.8±0.4% in the T-group and weight gain 5.5±0.3% in CTRL, difference between groups: 24.3% (p&amp;lt;0.0001 for all). T-group: waist:height ratio decreased by 0.07±0.00 at 10 years. CTRL: waist:height ratio increased by 0.03±0.00, difference between groups: 0.10 (p&amp;lt;0.0001 for all). T-group: Visceral adiposity index (VAI) decreased by 2.5±0.2. CTRL: VAI increased by 2.5±0.2, difference between groups: 5.0 (p&amp;lt;0.0001 for all). Since injections were administered in the office and documented, there was a 100% adherence to testosterone therapy. Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM sustainably improved anthropometric measures which worsened in untreated controls. Disclosure A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. Funding Bayer AG

1123-P: Reduction of Mortality and Major Adverse Cardiovascular Events (MACE) in Men with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Injectable Testosterone Undecanoate (TU): Ten-Year Data from a Urological Registry Study

Background: Potential cardiovascular risk as a result of testosterone therapy is controversially discussed. Methods: In a registry of 823 men with hypogonadism, 324 men (39%) had T2DM. 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: T-group: 61.8±5.1, CTRL: 63.6±4.9 years. Follow-up: T-group (CTRL): mean: 7.4 (8.3), median: 8 (9) years. T-group: 54 patients (35.5%) had had a previous cardiovascular disease (CVD, defined as myocardial infarction, stroke, or diagnosis of coronary artery disease). CTRL: 68 patients (39.5%) (p=0.4574). 64 men (42.1%) had been smokers at baseline (T-group), 66 (38.4%) in CTRL (p=0.4939). Most classical risk factors were significantly higher at baseline in the T-group compared to CTRL: BMI (36.4±4.5 vs. 33.3±5.3 kg/m²), systolic blood pressure (162.6±13.1 vs. 145.4±14.7 mmHg), diastolic blood pressure (97.2±10.7 vs. 84.7 vs. 10.3 mmHg), LDL (4.6±0.7 vs. 4.0±1.4 mmol/L), with no significant difference in HDL. Glycemic control was worse in the T-group: HbA1c 9.1±1.2 vs. 7.8±0.7%, HOMA-IR 10.2±2.1 vs. 7.5±1.3. Mortality: during the entire observation time, 12 patients (7.8%) died in the T-group and 43 (25%) in CTRL (p&amp;lt;0.0001). MACE: in the T-group, there were no myocardial infarctions or strokes. In CTRL, 49 myocardial infarctions (28.5%) and 42 strokes (24.4%) occurred. Conclusions: Mortality, myocardial infarctions and strokes were reduced in men with hypogonadism and T2DM receiving long-term testosterone therapy. Disclosure K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. Funding Bayer AG

178-OR: Long-Term Treatment with Injectable Testosterone Undecanoate (TU) Improves Lipid Profile in Men with Hypogonadism and Type 2 Diabetes in Comparison to an Untreated Control Group: Ten-Year Data from a Urological Registry Study

Background: In the literature, effects of testosterone on lipid pattern in men with hypogonadism are inconsistent. Methods: Of 324 men with hypogonadism and T2DM in a registry, 152 received TU 1000 mg/12 weeks (T-group), 172 opted against treatment (CTRL). Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, fasting glucose, blood pressure (BP), lipids and quality of life to account for baseline differences between the two groups. Results: Mean age: 62.7±5.1 years. Follow-up: Mean: 7.9, median: 9 years. All values are in mmol/L ±SE. Total cholesterol decreased by 2.8±0.1 at 10 years (T-group) and increased by 1.0±0.1 (CTRL). Estimated adjusted difference between groups: 3.9 (p&amp;lt;0.0001 for all). HDL increased by 0.3±0.0 (T-group) and decreased by 0.3±0.0 (CTRL), difference between groups: 0.6 (p&amp;lt;0.0001 for all). LDL decreased by 1.8±0.1 (T-group) and increased by 0.8±0.1 (CTRL), difference between groups: 2.7 (p&amp;lt;0.0001 for all). Triglyceride decreased by 1.1±0.1 (T-group) and increased by 0.4±0.0 (CTRL), difference between groups: 1.6 (p&amp;lt;0.0001 for all). Non-HDL decreased by 4.6±0.3 (T-group) and increased by 3.8±0.3 (CTRL), difference between groups: 8.4 (p&amp;lt;0.0001 for all). Remnant cholesterol decreased by 1.3±0.1 (T-group) and increased by 0.4±0.1 (CTRL), difference between groups: 1.8 (p&amp;lt;0.0001 for all). The lipid accumulation product (LAP, cm*mmol/L) decreased by 85.0±3.7 (T-group) and increased by 40.3±3.2 (CTRL), difference between groups: 125.3 (p&amp;lt;0.0001 for all). Conclusions: Long-term TTh with TU in men with hypogonadism and T2DM sustainably improved lipid profile which worsened in untreated controls. Disclosure F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Amgen Inc., Bayer AG. K.S. Haider: Speaker's Bureau; Self; Bayer AG. A. Haider: Research Support; Self; Bayer AG. Speaker's Bureau; Self; Bayer AG. Funding Bayer AG

SAT-533 Men with Hypogonadism and Osteoporosis Benefit from Long-Term Testosterone Therapy (TTh) with Testosterone Undecanoate Injections (TU) Regardless of Co-Medication with Bisphosphonates: 10-Year Data from a Controlled Registry Study in a Urological Setting

Background: Testosterone and its metabolite estradiol are essential factors in bone metabolism, and hypogonadism is an established risk factor for osteoporosis. Material and Methods: In a registry study of otherwise unselected men with hypogonadism in a urological office, 102 of 805 patients (13%) had osteoporosis diagnosed and treated elsewhere. 69 received TTh with TU 1000 mg/12 weeks (T-group). 33 had opted against TTh and served as controls (CTRL). BMD was measured at least once a year by using a whole body dual-energy X-ray densitometer (Norland XR-800). 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 54.5±8.2 (T-group), 64.9±4.1 years (CTRL). Mean (median) follow-up was 7.5±2.3 (8) years in the T-group and 8.9±1.1 (9) years in CTRL. 36 (52%) in the T-group had Klinefelter’s syndrome (KS) which, in the majority of cases, was diagnosed secondary to the diagnosis of osteoporosis. 7 patients had primary hypogonadism other than KS, 6 had a history of alcohol abuse, 4 had Crohn’s disease, and 3 had had a kidney transplant. All patients were on Vitamin D-calcium supplements. 64 patients (93%) in the T-group and 23 (70%) in CTRL were on bisphosphonates at baseline. 11 patients (16%) in the T-group and 11 (33%) in CTRL discontinued bisphosphonates due to side effects. T-scores progressively improved from -3.39±0.56 to -1.19±0.03 after 10 years (T-group) and worsened from -3.01±0.3 to -3.83±0.53 in CTRL, adjusted difference between groups: 2.45 (p<0.0001 for all). At the last measurement, 64 patients (93%) in the T-group had osteopenia; only 5 with a maximum treatment duration of 42 months still had osteoporosis. In CTRL, no patient achieved osteopenia. There were 6 fractures in CTRL but none in the T-group. Adherence to TTh was 100 per cent as all injections were administered in the doctor’s office and documented. Conclusion: Long-term TTh with TU in an unselected cohort of hypogonadal men with osteoporosis resulted in sustained improvements in T-scores with a high proportion of resolution of osteoporosis which depended on duration of TTh. In untreated controls, T-scores worsened and fractures occurred. Bisphosphonate treatment did not result in any improvement of bone density in the untreated hypogonadal controls.

SUN-226 Improvements In Quality Of Life In Men With Hypogonadism Under Long-term Testosterone Therapy (TTh) With Testosterone Undecanoate Injections (TU): Experience From 6,500 Patient-years Ina Registry Study Ina Urological Setting

Background: Quality of life in men is influenced by general health, sexual function and urinary function. These components are associated with both weight and inflammatory status. Material and Methods: 805 men with hypogonadism are enrolled in a registry study in a urological office. 412 received TTh with TU 1000 mg/12 weeks (T-group) while 393 opted against TTh and served as controls (CTRL). 43 men (10.4%) in the T-group had Klinefelter’s syndrome and contributed to lowering the mean age of the treated group. Measurements were performed 1-4 times a year. 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 57.7±7.4 (T-group), 63.7±4.8 years (CTRL). Mean (median) follow-up: 8 (8) years (T-group) and 8 (9) years (CTRL). Total observation time: 6471 patient-years. The Aging Males’ Symptoms scale (AMS) decreased by 29.2±0.3 (p<0.0001) (T-group) and increased by 15.1±0.4 (p<0.0001) in CTRL, estimated adjusted difference between groups: 44.3 (p<0.0001). The International Index of Erectile Function - Erectile Function Domain (IIEF-EF) increased by 27.5±0.2 (p<0.0001) (T-group) and decreased by 8.0±0.2 (p<0.0001) in CTRL, difference between groups: 19.5 (p<0.0001). The International Prostate Symptom Score (IPSS) decreased by 4.6±0.1 (p<0.0001) (T-group) and increased by 2.6±0.1 (p<0.0001) in CTRL, difference between groups: 7.2 (p<0.0001). C-reactive protein (CRP) decreased by 3.9±0.1 (p<0.0001) (T-group) and by 0.8±0.2 (p<0.0001) in CTRL, difference between groups: 3.1 (p<0.0001). Per cent weight loss was 16.6±0.3% (p<0.0001) in the T-group, per cent weight gain 4.6±0.3% (p<0.0001) in CTRL, difference between groups: 21.2% (p<0.0001). Waist circumference declined by 9.9±0.2 cm (p<0.0001) (T-group) and increased by 4.4±0.2 cm (p<0.0001) in CTRL, difference between groups: 14.3 cm (p<0.0001). Adverse events: During the entire observation time, there were 16 deaths (3.9%) in the T-group. In CTRL, there were 74 deaths (18.8%), 70 MIs (17.8%) and 59 strokes (15%). Incident prostate cancer was diagnosed in 13 men (3.2%) in the T-group and in 27 (6.9%) in CTRL. Medication adherence in the T-group was 100 per cent as all TU-injections were performed in the office and documented. Conclusion: Long-term TTh in men with hypogonadism resulted in improvements of different aspects of quality of life. These improvements may have been mediated by weight loss and improved inflammatory status. Mortality and major adverse cardiovascular events were reduced in the T-group compared to untreated men with hypogonadism.

SUN-055 Reduction of Mortality and Major Adverse Cardiovascular Events (MACE) in Men with Hypogonadism Treated with Long-Term Testosterone Therapy (TTh) with Testosterone Undecanoate Injections (TU): 10-Year Data from a Registry Study in a Urological Setting

Background: 3 studies reported an increased cardiovascular risk with TTh while hundreds of studies have demonstrated cardiovascular benefits of TTh in men with hypogonadism. Material and Methods: A prospective, cumulative registry study to investigate long-term effectiveness and safety of depot TU to treat hypogonadism was established in 2004 in a urological setting. Of 805 hypogonadal men, 412 received parenteral TU 1000 mg/12 weeks following an initial 6-week interval (T-group) for up to 12 years. 393 men opted against TTh and served as controls (CTRL). Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 57.7±7.4 (T-group), 63.7±4.8 years (CTRL) (p<0.001). Total follow-up time comprised approximately 6.500 patient-years. Testosterone levels at baseline were 9.7 nmol/L in both groups (p=0.841). Anthropometry: 66.3% (T-group) and 48% (CTRL) were obese. Waist circumference decreased by 9.9 cm (T-group) and increased by 4.4 cm (CTRL). Weight decreased by 16.6% (T-group) and increased by 4.6% (CTRL). Glycemic control: 34.2% (T-group) and 43.3% (CTRL) had type 2 diabetes. HbA1c decreased by 2.1% (T-group) and increased by 2.1% (CTRL). Lipids: HDL increased by 1.5 mmol/L (T-group) and by 0.9 mmol/L (CTRL). LDL decreased by 1.6 mmol/L (T-group) and increased by 0.9 mmol/L (CTRL). Non-HDL decreased by 4.1 mmol/L (T-group) and increased by 3.3 mmol/L (CTRL). Blood pressure (BP): systolic BP decreased by 21.2 mmHg (T-group) and increased by 9 mmHg (CTRL), diastolic BP decreased by 11.3 mmHg (T-group) and increased by 5.2 mmHg (CTRL). In the T-group, 45 patients (10.9%) had had a previous myocardial infarction (MI), in CTRL, 43 patients (10.9%) (p=0.993). 162 men (39.3%) had been smokers at baseline, 145 (36.9%) in CTRL (p=0.359). The mean baseline Framingham risk score was 15.5 in the T-group and 15.8 in CTRL (p<0.05). The mean 10-year risk was 22.7% in the T-group and 23.5% in CTRL (p=0.11). The risk declined in the T-group to 17% after 1 year and 13% after 2 years and remained stable thereafter. In CTRL, risk remained unchanged during the first 4 years and then increased to 29% for the remaining observation period. During the entire observation, there were 16 deaths (3.9%) in the T-group. In CTRL, there were 74 deaths (18.8%), 70 MIs (17.8%) and 59 strokes (15%). The reduction of cardiovascular events by TTh after applying a linear mixed effect model was 24.7% and 15.5% after applying a random effect longitudinal model. Medication adherence in the T-group was 100 per cent as all TU-injections were performed in the office and documented. Conclusions: In hypogonadal men, long-term TTh reduces MACE and mortality.

SUN-083 Hypertension and Hemodynamic Parameters in Men with Hypogonadism Improve Under Long-Term Treatment with Testosterone Undecanoate Injections (TU) Compared to Untreated Hypogonadal Control Patients

Background: The prevalence of hypogonadism in men with hypertension is high and may be related to overweight and obesity. In an ongoing registry study in a single urology practice, we monitored blood pressure and hemodynamic parameters for up to 12 years. Material and Methods: In a registry study of men with hypogonadism in a urological office, 676 of 805 patients (84%) had hypertension defined as systolic blood pressure (SBP) ≥130 and/ or diastolic blood pressure (DBP) ≥85 mmHg according to the harmonized definition of the metabolic syndrome. 376 received testosterone therapy (TTh) with TU 1000 mg/12 weeks following an initial 6-week interval (T-group). 304 had opted against TTh and served as controls (CTRL). 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Mean (median) follow-up: T-group 7.7±2.6 (9), CTRL 8.1±2.1 (9) years. Total observation time: T-group 2900, CTRL 2463 years. Baseline age was 58.5±6.8 (T-group) and 63.8±4.8 years (CTRL). In the T-group, 189 men were and 187 were not aware of their hypertension at their first visit to the urologist, in CTRL, 139 and 161, respectively. Antihypertensives were used by 52.7% in T-group and 46.7% in CTRL. All patients were encouraged to improve their lifestyle at baseline. SBP decreased in the T-group by 23.6±0.7mmHg [95% CI: -24.9;-22.3] (p<0.0001) and increased in CTRL by 7.7±0.8mmHg [95% CI: 6.0;9.3] (p<0.0001), estimated adjusted difference between groups: -31.3mmHg [95% CI: -33.7;-28.9] (p<0.0001). DBP decreased in the T-group by 12.8±0.7 mmHg [95% CI: -14.1;-11.4] (p<0.0001) and increased in CTRL by 4.4±0.9 mmHg [95% CI: 2.6;6.1] (p<0.0001), difference between groups: -17.1 mmHg [95% CI: -19.5;-14.7] (p<0.0001). Heart rate decreased in the T-group by 1.6±0.3 bpm [95% CI: -2.3;-1.0] (p<0.0001) and increased in CTRL by 1.2±0 bpm [95% CI: 0.4;2.1] (p<0.005), difference between groups: -2.9 mmHg [95% CI: -4.0;-1.7] (p<0.0001). (p<0.0001). Pulse pressure, a surrogate marker of arterial stiffness, decreased in the T-group by 10.3±0.7 mmHg [95% CI: -11.7;-9.0] (p<0.0001) and increased in CTRL by 2.4±0.9 mmHg [95% CI: 0.7;4.0] (p<0.01), difference between groups: -12.7 mmHg [95% CI: -15.0;-10.4] (p<0.0001). Adverse events: T-group: 15 deaths (4%), no myocardial infarctions (MIs) or strokes. CTRL: 65 deaths (21.7%), 59 MIs (19.7%), 52 strokes (17.3%). Conclusion: Long-term testosterone therapy in hypogonadal men improved blood pressure, heart rate and arterial stiffness. In the untreated control group, all these parameters increased. Considerably less major adverse cardiovascular events occurred in the T-group.

MON-091 Profound and Sustained Weight Loss in Men With Hypogonadism and Obesity Receiving Long-Term Testosterone Therapy (TTh) with Testosterone Undecanoate Injections (TU): 10-Year Data from a Registry Study in a Urological Setting

Background: Weight loss in obese subjects is notoriously difficult to achieve through lifestyle interventions, and even harder to maintain long-term. Testosterone therapy has shown promising results in long-term but not short-term studies. Material and Methods: In an observational registry study of 805 men with hypogonadism in a urological office, 462 (57.4%) were obese. 273 received TTh with TU 1000 mg/12 weeks (T-group) while 189 opted against TTh and served as controls (CTRL). Measurements were performed 1-4 times a year. 10-year data are reported. Changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Baseline age: 59.8±6.1 (T-group), 63.5±5 years (CTRL). Mean (median) follow-up: 8 (9) years (T-group) and 7.5 (8) years (CTRL). Total observation time: 3588 patient-years. Weight progressively decreased by 22.9±0.3 kg (p<0.0001) (T-group) and increased by 3.2±0.5 kg (p<0.0001) in CTRL, estimated adjusted difference between groups: 26.1 kg (p<0.0001). Waist circumference declined by 12.5±0.2 cm (p<0.0001) (T-group) and increased by 4.6±0.4 cm (p<0.0001) in CTRL, difference between groups: 17.1 cm (p<0.0001). BMI decreased by 7.3±0.1 kg/m2 (p<0.0001) (T-group) and increased by 0.9±0.2 kg/m2 (p<0.0001) in CTRL, difference between groups: 8.2 kg/m2 (p<0.0001). Per cent weight loss was 20.3±0.3% (p<0.0001) in the T-group, per cent weight gain 3.9±0.4% (p<0.0001) in CTRL, difference between groups: 24.3% (p<0.0001). Waist-to-height ratio decreased by 0.07±0.001 (p<0.0001) (T-group) and increased by 0.03±0.002 (p<0.05) in CTRL, difference between groups: 0.1 (p<0.0001). Adverse events: During the entire observation time, there were 12 deaths (4.4%) in the T-group. In CTRL, there were 57 deaths (30.2%), 47 MIs (24.9%) and 44 strokes (23.3%). Medication adherence in the T-group was 100 per cent as all TU-injections were performed in the office and documented. Conclusion: Long-term TTh in men with hypogonadism and obesity resulted in profound and sustained improvements in anthropometric parameters, as well as reduction of mortality and major adverse cardiovascular events. As recommended by the AACE/ACE 2016 obesity guidelines, testosterone should be measured in obese men and testosterone treatment offered if indicated.

OR21-2 Lipid Profiles Improve in Men With Hypogonadism and Pre-existing Cardiovascular Disease Under Long-term Testosterone Therapy (TTh) With Testosterone Undecanoate Injections (TU): 10-year Data From a Controlled Registry Study in a Urological Setting

Background: Effects of testosterone on lipid patterns are inconsistent. While in short-term studies, testosterone usually lowers HDL, long-term studies seem to increase HDL. Total cholesterol, LDL and triglycerides are either reduced by TTh, or effects are neutral. Effects of TTh on lipids may depend on treatment duration. Material and Methods: In a registry study of 805 men with hypogonadism in a urological office, 194 194 had a pre-existing cardiovascular disease, defined as previous myocardial infarction (MI), stroke, or diagnosis of coronary heart disease (CHD). 78 men received parenteral TU 1000 mg/12 weeks following an initial 6-week interval (T-group) for up to 10 years, 116 men decided against TTh and served as controls (CTRL). Most measurements were performed 1-4 times a year for approximately 1,500 patient-years. 10-year data are reported. Mean changes over time between groups were compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction and adjusted for age, weight, waist circumference, fasting glucose, blood pressure and lipids to account for baseline differences between groups. Results: Mean baseline age: 61.3±4.7 years (T-group), 63.8±5 (CTRL) (p<0.001). Mean (median) follow-up was 8.6±2.5 (10) years in the T-group and 7.0±2.6 (7) years in CTRL. Total cholesterol (mmol/L) decreased by 2.6±0.1 in the T-group and increased by 1.2±0.1 in CTRL, estimated adjusted difference between groups: 3.8 (p<0.0001 for all). HDL (mmol/L) increased by 0.4±0.0 in the T-group and decreased by 0.2±0.0 in CTRL, estimated adjusted difference between groups: 0.6 (p<0.0001 for all). LDL (mmol/L) decreased by 1.9±0.1 in the T-group and increased by 0.8±0.1 in CTRL, estimated adjusted difference between groups: 2.8 (p<0.0001 for all). Triglycerides (mmol/L) decreased by 1.1±0.1 in the T-group and increased by 0.4±0.1 in CTRL, estimated adjusted difference between groups: 1.5 (p<0.0001 for all). Non-HDL (mmol/L) decreased by 4.2±0.3 in the T-group and increased by 3.8±0.3 in CTRL, estimated adjusted difference between groups: 7.9 (p<0.0001 for all). Remnant cholesterol (mmol/L) decreased by 1.1±0.1 in the T-group and increased by 0.6±0.1 in CTRL, estimated adjusted difference between groups: 1.7 (p<0.0001 for all). Outcomes T-group: 8 deaths (10.3%). 1 deaths was a traffic accident, 7 were due to surgery (sepsis or thromboembolism). Outcomes CTRL: 39 deaths (33.6%), all cardiovascular, 26 non-fatal myocardial infarctions (22.4%), and 27 non-fatal strokes (23.3%). Medication adherence to testosterone was 100% as all injections were administered in the medical office and documented. Conclusion: In men with hypogonadism and pre-existing cardiovascular disease, long-term TTh improves the lipid profile which may be a contributing factor to the observed reduction in cardiovascular events and mortality.