Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS).
J Endocrinol Invest
; 43(10): 1447-1452, 2020 Oct.
Article
en En
| MEDLINE
| ID: mdl-32239476
ABSTRACT
BACKGROUND:
Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS).METHODS:
ECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs.RESULTS:
This study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline - 2.17 ± 0.97) 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027).CONCLUSION:
Adherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™-naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Hormona de Crecimiento Humana
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Cumplimiento de la Medicación
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Trastornos del Crecimiento
Tipo de estudio:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Límite:
Adolescent
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Child
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Female
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Humans
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Male
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Newborn
País/Región como asunto:
Mexico
Idioma:
En
Revista:
J Endocrinol Invest
Año:
2020
Tipo del documento:
Article
País de afiliación:
México