ANI Pharmaceuticals (ANIP)

[Just the facts maam]

The long term male testosterone data is starting to come out the following data on 13 years of study funded by Bayer makes it interesting to see what Libigel data will reveal.

Long-Term Treatment with Testosterone Leads to Profound Weight Loss in Men with Hypogonadism and Type 2 Diabetes:

Results: Mean baseline age: 62.0±5.2 years, mean (median) follow-up: 9.3±3.1 (10) years. Waist circumference (cm) decreased from 117.9±14.8 to 98.2±4.3 in the T-group (p<0.0001) and increased in CTRL from 116.9±13.5 to 119.0±8.4 (p<0.0001) . Difference between groups at 13 years: 21.8 (p<0.0001) . Weight (kg) decreased from 114.4±13.8 to 88.3±7.6 in the T-group (p<0.0001) and increased in CTRL from 102.7±14.1 to 104.5±10.2 (p<0.0001) . Difference between groups: 21.4 (p<0.0001) .

Conclusions: Long-term treatment with testosterone undecanoate injections results in profound weight loss maintained over up to 13 years. Untreated hypogonadal patients gain weight.

Wow! A 46 pound difference.

Lipid Pattern in Men with Hypogonadism and Type 2 Diabetes Receiving Long-Term Testosterone Treatment Compared with an Untreated Control Group:

Results: Mean baseline age: 62.0±5.2, mean (median) follow-up: 9.3±3.1 (10) years. Total cholesterol (TC) (mmol/L for all lipids) decreased from 8.3±1.1 to 5.1±0.3 in T-group and increased from 7.1±1.2 to 8.4±1.4 in CTRL (p<0.00for both) . HDL increased from 1.0±0.4 to 1.6±0.3 in T-group and decreased from 1.1±0.5 to 0.8±0.4 in CTRL (p<0.00for both) . The TC:HDL ratio decreased from 9.8±4.2 to 3.2±0.6 in T-group and increased from 8.0±3.9 to 13.8±6.8 in CTRL (p<0.00for both) .LDL decreased from 4.7±0.8 to 2.6±0.2 in T-group and increased from 4.1±1.4 to 5.2±1.6 in CTRL (p<0.00for both) . Triglycerides decreased from 3.5±0.6 to 2.2±0.1 in T-group and increased from 3.1±0.6 to 3.8±0.8 in CTRL (p<0.00for both) . Non-HDL decreased from 7.3±1.1 to 3.5±0.3 in T-group and increased from 6.0±1.4 to 7.7±1.5 in CTRL (p<0.00for both) . Remnant cholesterol decreased from 2.7±0.9 to 0.9±0.3 in T-group and increased from 2.0±1.0 to 2.5±0.7 in CTRL (p<0.00for both) . The triglyceride:HDL ratio decreased from 9.4±4.4 to 3.1±0.7 in T-group and increased from 8.0±4.0 to 14.1±6.9 in CTRL (p<0.00for both) .

Conclusions: Long-term treatment with TU in men with hypogonadism and T2DM improved the lipid profile, which worsened in controls.

Long-Term Testosterone Treatment Improves Estimated Glomerular Filtration Rate (eGFR) in Men with Hypogonadism and Type 2 Diabetes Mellitus

Results: Mean baseline age: 62.0±5.2, mean (median) follow-up: 9.3±3.1 (10) years. Creatinine (mg/dL) decreased from 0.95±0.15 to 0.81±0.in the T-group and increased from 1.00±0.14 to 1.27±0.22 in CTRL (p<0.00for both) .

Systolic blood pressure (mmHg) decreased in the T-group from 163.0±13.3 to 129.8±6.5 and increased in CTRL from 145.5±14.5 to 162.9±13.1 (p<0.00for both)

Diastolic blood pressure decreased in the T-group from 97.3±10.7 to 74.8±3.1 and increased in CTRL from 84.7±10.2 to 96.8±7.5 (p<0.00for both) .

T-group: eGFR (MDRD) (mL/min/1.73 m²) increased from 82.5±12.8 to 94.4±9.1. CTRL: eGFR decreased from 77.2±12.1 to 56.9±10.6) (p<0.00for both) .

T-group: eGFR (CKD-EPI) (mL/min/1.73 m²) increased from 84.0±15.4 to 87.5±4.7. CTRL: eGFR decreased from 77.0±13.9 to 49.8±12.3) (p<0.00for both) .

21 deaths (11.1%) and no cardiovascular events occurred in the T-group. In CTRL, 62 deaths (34.4%) , 62 myocardial infarctions (34.4%) and 51 strokes (28.3%) were recorded (p<0.00for all) . Nephropathy occurred in 1 man (0.01%) in the T-group and in 7 (0.4%) in CTRL (p=0.05) .

Conclusions: Long-term testosterone therapy in men with hypogonadism and T2DM prevents age-related deterioration in GFR.

Long-Term Testosterone Treatment Improves Liver Function Parameters in Men with Hypogonadism and Type 2 Diabetes Mellitus

Results: Mean baseline age: 62.0±5.2, mean (median) follow-up: 9.3±3.1 (10) years. ?-GT (U/L) decreased from 43.9±22.9 to 21.9±6.8 in the T-group and increased from 35.2±11.3 to 62.3±6.7 in CTRL (p<0.00for both) . Triglycerides decreased from 3.5±0.6 to 2.2±0.1 in T-group and increased from 3.1±0.6 to 3.8±0.8 in CTRL (p<0.00for both) . Waist circumference (cm) decreased from 117.9±14.8 to 98.2±4.3 in the T-group (p<0.0001) and increased in CTRL from 116.9±13.5 to 119.0±8.4 (p<0.0001) .

BMI (kg/m2) decreased from 36.5±4.4 to 28.5±2.4 in the T-group (p<0.0001) and increased in CTRL from 32.8±4.7 to 33.3±3.6 (p<0.0001) . AST (U/L) decreased from 39.0±12.8 to 20.8±1.8 in the T-group and increased from 28.6±9.5 to 55.7±10.8 in CTRL (p<0.00for both) . ALT (U/L) decreased from 42.4±13.0 to 24.7±2.0 in the T-group and increased from 32.8±10.0 to 62.3±13.2 in CTRL (p<0.00for both) . FLI decreased from 95.1±6.0 to 63.8±11.3 in the T-group and increased from 90.2±10.8 to 96.2±4.4 in CTRL (p<0.00for both) .

Conclusions: Long-term testosterone therapy in men with hypogonadism and T2DM improved surrogate parameters of liver function indicating an improvement in NAFLD. All parameters deteriorated in untreated controls.

Testosterone Treatment Improves Glycemic Control and Leads to Remission in 56.8% of Patients with Hypogonadism and Type 2 Diabetes (T2DM)

Results: Mean follow-up 9.3±3.2, baseline age: 61.0±5.3 (T-group) and 63.0±4.9 (CTRL) years.

HbA1c decreased from 9.5±1.4% to 5.5±1.2% (79.8±15.5 to 36.6±1.9 mmol/mol) in the T-group and increased from 7.8±0.7% to 10.5±1.2% (61.8±7.7 to 91.7±13.3 mmol/mol) in CTRL (p<0.00for both) .

Fasting glucose (mmol/L) decreased from 7.9±1.3 to 5.4±0.1 in the T-group and increased from 6.4±0.8 to 8.2±1.3 in CTRL (p<0.00for both) .

HOMA-IR decreased from 10.2±2.1 to 1.5±0.3 in the T-group and increased from 7.3±1.3 to 14.8±2.5 in CTRL (p<0.00for both) .

In the T-group, 89 men (46.8%) received insulin at baseline at a mean dose of 38.0±13.3 U/d. Dose requirement declined from 38.0±13.3 to 4.1±5.7 during the observation period. In CTRL, 71 men (39.4%) received insulin at baseline at a mean dose of 31.2±6.1 U/d. Dose requirement increased from 31.2±6.1 to 44.5±5.6 (p<0.00for both) .

In the T-group, 1patients (56.8%) went into remission. The median time to remission was 87 months.

Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM progressively improved glycemic control. More than half of men achieved remission. Glycemic control deteriorated in untreated men.