ESPE: Saizen Improves Cardiac Performance As Well As Body Composition in Hormone Deficient Adults
By Cameron Johnston
Special to DG News
MONTREAL, QC -- July 9, 2001 -- Recombinant human growth hormone (Saizen, Serono International SA) has been shown, in one of the largest clinical trials of its type to have a profound impact on adult cardiac function and body composition.
The findings were presented during a presentation at the 6th joint meeting of the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology (ESPE) in collaboration with the Australasian Paediatric Endocrine Group, the Japanese Society for Pediatric Endocrinology, and the Latin American Society for Paediatric Endocrinology in Montreal, Quebec, Canada.
Adults enrolled in the trial were between the ages of 20 and 70 years, and had acquired idiopathic hormone deficiency for at least 24 months as established by an insulin tolerance test, or a GH-releasing hormone and arginine test. They had not taken any kind of growth hormone for a period of at least 24 months.
The 60 subjects in the study group received 0.005 to 0.010 mg/kg/day of Saizen and 55 subjects received placebo.
Those in the study group showed a mean change in left ventricular ejection fraction of 5.05 percent compared with 3.01 percent in the placebo group. They also showed a decrease in systolic volume of 4.29 percent compared with a decrease of 1.14 percent in the placebo group. Neither of these measurements was statistically significant.
Nonetheless, the investigators, Ezzat and Fear et al, from the Saizen Study Group, based in Geneva, Switzerland, said there was no difference in the cardiac function improvements seen between men and women, despite the fact that there were significant changes in body mass between the two groups.
Men who used the hormone had a mean increase in lean body mass approaching 4 kg, whereas women experienced an increase of less than 1 kg. Similarly, the average man’s total fat decreased by more than 2 kg while women’s total fat decreased by less than 2 kg (p=<0.0001 compared with placebo).
These changes were established by dual energy x-ray absoptiometry (DEXA) and confirmed by bioelectric impedence analysis of the mid-arm, leg, waist and hip circumference. Body mass index and body weight remained unchanged in both groups.
These findings support the use of Saizen for the maintenance of normal cardiac performance in both men and women with clearly demonstrated growth hormone deficiency.
A further improvement in lean body mass and a decrease in total body fat can also be expected, the researchers said, although this change in body composition is likely to be more profound in men than in women.
Reply With Quote
Originally Posted by Mealticket
