Long-term metabolic effectiveness and safety of growth hormone replacement therapy in patients with adult growth hormone deficiency: a single-institution study in Japan.

IGF-1 SDS increased after the start of GHRT and remained constant for more than 11 years.

• 110 patients with AGHD receiving GHRT were enrolled in this retrospective single-institution study
• 46.4% were males, 70.9% had adult-onset GHD
• Follow-up was up to 196 months, with a median of 68 months
• 17 patients were followed up for more than 11 years
• Statistical analysis was performed using a linear mixed-effects model

Body mass index increased during GHRT, while waist circumference showed a biphasic pattern of short-term decrease followed by long-term increase.

• Waist circumference decreased in the short term but increased in the long term
• BMI showed a net increase over the course of GHRT
• These body composition changes were assessed across a follow-up period of up to 196 months

GHRT had differential effects on blood pressure, with diastolic blood pressure decreasing in the short to medium term and systolic blood pressure increasing in the long term.

• Diastolic blood pressure decreased 1–5 years after the start of GHRT
• Systolic blood pressure increased 11 years after GHRT
• These changes were observed in the same cohort of 110 AGHD patients

GHRT was associated with favorable long-term lipid profile changes including decreased LDL cholesterol and increased HDL cholesterol.

• A long-term decrease in low-density lipoprotein cholesterol was observed
• A long-term increase in high-density lipoprotein cholesterol was observed
• These lipid changes persisted over the long-term follow-up period of up to 196 months

GHRT was associated with improvement in liver enzyme levels over the long term.

• A long-term decrease in aspartate aminotransferase (AST) levels was observed
• A long-term decrease in alanine aminotransferase (ALT) levels was observed
• These hepatic effects were identified across the full follow-up period using a linear mixed-effects model

Glycosylated hemoglobin (HbA1c) levels increased after 3 years of GHRT.

• The increase in HbA1c was observed starting at 3 years after the start of GHRT
• This finding suggests a potential adverse glycemic effect of long-term GHRT
• HbA1c changes were monitored annually as part of the clinical and laboratory data collection

Bone mineral density in both the lumbar spine and total hip increased significantly 3 years after the start of GHRT.

• Bone mineral density in the lumbar spine increased significantly 3 years after the start of GHRT
• Bone mineral density in the total hip also increased significantly at the same time point
• BMD was among the clinical parameters collected annually from the beginning of the study

GHRT demonstrated an acceptable safety profile with a low number of adverse events over the long follow-up period.

• The total number of adverse events was eight across 110 patients
• Follow-up extended up to 196 months (median 68 months)
• The authors concluded that GHRT demonstrated both metabolic effectiveness and safety in Japanese AGHD patients over 16 years