The Journal of clinical endocrinology and metabolism · 2018
Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Vokes Tamara J, Mannstadt Michael, Levine Michael A, Clarke Bart L, Lakatos Peter, Chen Kristina, Piccolo Rebecca, Krasner Alan, Shoback Dolores M, Bilezikian John P
Аннотация
CONTEXT: Reduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism treated conventionally with calcium and active vitamin D supplements.
OBJECTIVE: To examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study.
PATIENTS: Adults (N = 122) with chronic hypoparathyroidism.
INTERVENTION(S): After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
MAIN OUTCOME MEASURE(S): Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
RESULTS: Overall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment.
CONCLUSION: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.
OBJECTIVE: To examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study.
PATIENTS: Adults (N = 122) with chronic hypoparathyroidism.
INTERVENTION(S): After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
MAIN OUTCOME MEASURE(S): Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
RESULTS: Overall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment.
CONCLUSION: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.