Phase II data suggest it can improve lean body mass and quality of life.
Growth hormone therapy may safely improve lean body mass (LBM), cardiovascular risk factors, and quality of life in adult patients on maintenance hemodialysis, data suggest.
In a Phase II study, researchers studied 139 patients with serum albumin levels of 40 g/L or lower. Investigators randomly assigned pa-tients to six months of treatment with placebo or one of three doses of growth hormone (Norditropin, Novo Nordisk A/S). Patients had a mean age of 60 years, and 40% were female. The mean BMI was 24 kg/m2. The mean duration of dialysis for patients in the placebo and low-, medium-, and high-dose growth hormone groups was 45, 48, 42, and 26 months, respectively.
The growth hormone groups experienced a 2.5 kg increase in LBM compared with placebo recipients. The increase was similar across dose groups. said lead investigator Bo Feldt-Rasmussen, MD, PhD, professor of medicine and the head of nephrology at the University of Copenhagen in Denmark. Patients in the low-dose growth hormone group had a 1.5 g/L increase in serum albumin levels compared with placebo recipients.
Dr. Feldt-Rasmussen and his colleagues initially observed a drop in serum albumin levels in all treatment groups, but the decline was more pronounced in the medium- and high-dose growth hormone groups. The mortality rate was 11% in the placebo group compared with 8% for the growth-hormone groups, Dr. Feldt-Rasmussen said. Study findings suggest that growth hormone could provide a new way to correct malnutrition in dialysis patients, Dr. Feldt-Rasmussen said.
The researchers observed no apparent treatment-dependent patterns in reported adverse events. The rate of adverse events due to fluid retention was similar among treatment groups and similar to what was observed in the placebo group. These events were transient, and none led to study withdrawal. No clinically relevant safety issues related to glucose metabolism or left ventricular mass were associated with growth hormone treatment.
“In all of the [growth hormone] treatment groups we saw an improvement in quality of life parameters and we saw an improvement in markers of cardiovascular health. There were decreases in homocysteine levels and increases in HDL cholesterol levels in all three of the groups on growth hormone,” Dr. Feldt-Rasmussen said. “There were also no real safety issues.”
Researchers plan to embark on a phase III trial that will enroll 2,000 hemodialysis patients in the United States and Europe. Investigators will follow patients for 24 months, and mortality will be the primary end point. The growth hormone used in this trial will involve daily injections that patients can give themselves at home.