After replacing GH treatment with placebo for just 4 months, researchers in Sweden found that patients experienced deteriorated quality-of-life and were at greater risk for cardiovascular risk factors.
The effects of the discontinuation of GH treatment on quality-of-life, body composition and metabolism were studied by Helena F. Nyström, MD, PhD, and colleagues, from the departments of endocrinology and oncology within the Institute of Clinical Sciences at Sahlgrenska University Hospital, Sahlgrenska Academy at University of Gothenburg, Sweden.
Sixty adults aged 25 to 75 years were involved in the randomized, double-blind, placebo-controlled 4-month crossover trial. All patients had been on a continuous GH replacement therapy for more than 3 years.
According to data, mean serum IGF-I decreased from 168 mcg/L to 98 mcg/L during the first placebo period (P<.001). Two quality-of-life questionnaires also deteriorated during placebo compared with GH treatment (P<.05).
Waist circumference and subcutaneous and visceral fat mass increased when GH was replaced with placebo, and extracellular water and muscle area decreased during the placebo period (P<.05), they wrote.
Moreover, C-reactive protein and total–, LDL–, and HDL–cholesterol increased and insulin sensitivity improved during placebo, compared to GH treatment (P<.05).
During the GH period, four serious adverse events were reported, including: tibia fracture, cholecystectomy, severe hip pain, and atrial fibrillation (AF). Six events were reported during the placebo period, including: reoccurring hypoglycemia, multiple fractures due to trauma, diarrhea, incidentally discovered abdominal aorta aneurysm and two episodes of AF in one patient, the researchers wrote.
“The 4-month discontinuation of GH resulted in deterioration in quality-of-life that was not all universal. On the other hand, the deterioration in body composition and metabolism strongly suggests the importance of continuous long-term GH replacement to adult hypopituitary patients that may reduce their previously documented increased cardiovascular mortality rate,” the researchers wrote.
Disclosure: Gudmundur Johannsson, MD, PhD is consultant for Viropharma and Astra Zeneca and has received lecture fees from Novo Nordisk, Eli Lilly, Merck Serono, Otsuka, and Pfizer. Dr. Nyström has research grants from Novo Nordisk. All other researchers report no relevant financial disclosures.