TY - JOUR
T1 - Comparison of low-normal and high-normal IGF-1 target levels during growth hormone replacement therapy
T2 - A randomized clinical trial in adult growth hormone deficiency
AU - van Bunderen, Christa C
AU - Lips, Paul
AU - Kramer, Mark H H
AU - Drent, Madeleine L
PY - 2016/6
Y1 - 2016/6
N2 - BACKGROUND: Current guidelines state that the goals of growth hormone (GH) therapy in adults should be an appropriate clinical response, avoidance of side effects, and an IGF-1 value within the age-adjusted reference range. There are no published studies on the target level for IGF-1 that offer specific guidance in this regard.OBJECTIVES: To compare low-normal and high-normal target levels of IGF-1 on efficacy and safety of GH treatment.METHODS: A randomized, open-label, clinical trial including thirty-two adults from one university hospital receiving GH therapy for at least one year with a stable IGF-1 concentration between -1 and 1 SD score (SDS). Subjects were randomized to receive either a decrease (IGF-1 target level of -2 to -1 SDS) or an increase of their daily GH dose (IGF-1 target level of 1 to 2 SDS) for a period of 24weeks. The effect on cardiovascular risk factors and physical performance, next to tolerability, was compared.RESULTS: Thirty subjects (65.6% men, mean age 46.6 (SD 9.9) years) could be analyzed. In subjects with a high-normal IGF-1 target level, waist circumference decreased (p=0.05), and overall they felt better (p=0.04), compared to subjects with a low-normal IGF-1 target level. However, increasing IGF-1 levels led to more myalgia, and decreasing IGF-1 levels to more fatigue. There was a gender-dependent difference in effect on HDL cholesterol.CONCLUSION: Although increasing GH dose to IGF-1 levels between 1 and 2 SDS improved waist circumference and well-being, safety was not guaranteed with the demonstrated effect on HDL cholesterol in men, and reported myalgia.
AB - BACKGROUND: Current guidelines state that the goals of growth hormone (GH) therapy in adults should be an appropriate clinical response, avoidance of side effects, and an IGF-1 value within the age-adjusted reference range. There are no published studies on the target level for IGF-1 that offer specific guidance in this regard.OBJECTIVES: To compare low-normal and high-normal target levels of IGF-1 on efficacy and safety of GH treatment.METHODS: A randomized, open-label, clinical trial including thirty-two adults from one university hospital receiving GH therapy for at least one year with a stable IGF-1 concentration between -1 and 1 SD score (SDS). Subjects were randomized to receive either a decrease (IGF-1 target level of -2 to -1 SDS) or an increase of their daily GH dose (IGF-1 target level of 1 to 2 SDS) for a period of 24weeks. The effect on cardiovascular risk factors and physical performance, next to tolerability, was compared.RESULTS: Thirty subjects (65.6% men, mean age 46.6 (SD 9.9) years) could be analyzed. In subjects with a high-normal IGF-1 target level, waist circumference decreased (p=0.05), and overall they felt better (p=0.04), compared to subjects with a low-normal IGF-1 target level. However, increasing IGF-1 levels led to more myalgia, and decreasing IGF-1 levels to more fatigue. There was a gender-dependent difference in effect on HDL cholesterol.CONCLUSION: Although increasing GH dose to IGF-1 levels between 1 and 2 SDS improved waist circumference and well-being, safety was not guaranteed with the demonstrated effect on HDL cholesterol in men, and reported myalgia.
KW - Clinical practice
KW - Efficacy
KW - Growth hormone deficiency
KW - Growth hormone treatment
KW - Insulin-like growth factor-1
KW - Journal Article
KW - Safety
U2 - https://doi.org/10.1016/j.ejim.2016.03.026
DO - https://doi.org/10.1016/j.ejim.2016.03.026
M3 - Article
C2 - 27118206
SN - 0953-6205
VL - 31
SP - 88
EP - 93
JO - European Journal of Internal Medicine
JF - European Journal of Internal Medicine
ER -