Growth and Sexual Maturation in a 2-year, Open-label Clinical Study of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD

2017 ◽  
Vol 41 (S1) ◽  
pp. S130-S130
Author(s):  
I. Hernández Otero ◽  
T. Banaschewski ◽  
M. Johnson ◽  
P. Nagy ◽  
C.A. Soutullo ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Sexual Maturation ◽  
Tanner Stage ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Stage Of Development ◽  
Control And Prevention ◽  
Z Scores ◽  
The Impact

IntroductionIndividuals with attention-deficit/hyperactivity disorder (ADHD) may require long-term medication.ObjectivesTo measure growth and sexual maturation of children and adolescents with ADHD receiving lisdexamfetamine dimesylate (LDX) in a 2-year trial (SPD489-404).AimsTo investigate the impact of long-term LDX treatment on growth and maturation.MethodsParticipants (6–17 years) received dose-optimized, open-label LDX (30–70 mg/day) for 104 weeks. Weight, height and BMI z-scores were derived using the Centers for Disease Control and Prevention norms [1]. Sexual maturation was assessed using the Tanner scale (participant-rated as closest to their stage of development based on standardized drawings).ResultsOf 314 enrolled participants, 191 (60.8%) completed the study. Mean z-scores at baseline and last on-treatment assessment (LOTA) were 0.53 (standard deviation, 0.963) and 0.02 (1.032) for weight, 0.61 (1.124) and 0.37 (1.131) for height, and 0.32 (0.935) and–0.27 (1.052) for BMI. In general, z-scores shifted lower over the first 36 weeks and then stabilized. At LOTA, most participants remained at their baseline Tanner stage or shifted higher, based on development of hair (males, 95.5%; females, 92.1%) or genitalia/breasts (males, 94.7%; females, 98.4%).ConclusionsConsistent with previous studies of stimulants used to treat ADHD [2], z-scores for weight, height and BMI decreased, mostly in the first year, then stabilized. No clinically concerning trends of LDX treatment on sexual maturation or the onset of puberty were observed.Disclosure of interestStudy funded by Shire Development LLC.Dr Isabel Hernández Otero (Alicia Koplowitz Foundation, Eli Lilly, Forest, Janssen-Cilag, Junta de Andalucia, Roche, Shire, Shire Pharmaceuticals Iberica S.L., and Sunovion).

Time-course of treatment-emergent adverse events in a long-term safety study of lisdexamfetamine dimesylate in children and adolescents with ADHD

2016 ◽  
Vol 33 (S1) ◽  
pp. S132-S132
Author(s):  
I. Hernández Otero ◽  
T. Banaschewski ◽  
P. Nagy ◽  
C.A. Soutullo ◽  
A. Zuddas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Children And Adolescents ◽  
Time Course ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Safety Population ◽  
First Onset ◽  
Stimulant Medications ◽  
Competing Interest

IntroductionThe long-term safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention deficit/hyperactivity disorder (ADHD) was evaluated in a European 2-year, open-label study (SPD489-404).ObjectiveTo evaluate the time-course of treatment-emergent adverse events (TEAEs) in SPD489-404.MethodsParticipants aged 6–17 years received open-label LDX (30, 50 or 70 mg/day) for 104 weeks (4 weeks dose-optimization; 100 weeks dose-maintenance).ResultsAll enrolled participants (n = 314) were included in the safety population and 191 (60.8%) completed the study. TEAEs occurred in 282 (89.8%) participants; most were mild or moderate. TEAEs considered by the investigators as related to LDX were reported by 232 (73.9%) participants with the following reported for ≥ 10% of participants: decreased appetite (49.4%), weight decreased (18.2%), insomnia (13.1%). TEAEs leading to discontinuation and serious TEAEs occurred in 39 (12.4%) and 28 (8.9%) participants, respectively. The median (range) time to first onset and duration, respectively, of TEAEs identified by the sponsor as being of special interest were: insomnia (insomnia, initial insomnia, middle insomnia, terminal insomnia), 17.0 (1–729) and 42.8 (1–739) days; weight decreased, 29.0 (1–677) and 225.0 (26–724) days; decreased appetite, 13.5 (1–653) and 169.0 (1–749) days; headache, 22.0 (1–718) and 2.0 (1–729) days. Reports of insomnia, weight decreased, decreased appetite and headache were highest in the first 4–12 weeks.ConclusionsTEAEs associated with long-term LDX treatment were characteristic of stimulant medications, with the greatest incidence observed during the first 4–12 weeks.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe

CNS Drugs ◽  
2017 ◽  
Vol 31 (7) ◽  
pp. 625-638 ◽  
Author(s):  
David R. Coghill ◽  
Tobias Banaschewski ◽  
Peter Nagy ◽  
Isabel Hernández Otero ◽  
César Soutullo ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Phase Iv

scholarly journals The effect of long-term, non-suppressive levothyroxine treatment on quantitative ultrasonometry of bone in women

2000 ◽  
pp. 445-450 ◽  
Author(s):  
P Hadji ◽  
O Hars ◽  
G Sturm ◽  
T Bauer ◽  
G Emons ◽  
...  
Keyword(s):  
Hormone Replacement ◽  
Menopausal Status ◽  
Broadband Ultrasound Attenuation ◽  
Stiffness Index ◽  
Slight Reduction ◽  
Quantitative Ultrasonometry ◽  
Z Scores ◽  
The Impact ◽  
Control Study

OBJECTIVE: To evaluate the impact of long-term, non-suppressive levothyroxine (L-T(4)) treatment on quantitative ultrasonometry in women. DESIGN: This was a case-control study. SUBJECTS AND METHODS: Altogether 667 women (mean age+/-s.d., 49.5+/-13.1 years) were studied. Of these, 156 (23%) had non-toxic goitre or hypothyroidism and had been taking L-T(4) (75-100 microg/day) for at least 5 years (mean+/-s.d., 12.5+/-7.5 years); the remaining 511 (77%) women were not receiving L-T(4). All women had completed a questionnaire on risk factors for thyroid dysfunction and osteoporosis, and those with diseases or treatments known to effect bone metabolism - other than thyroxine or hormone replacement therapy (HRT) - were excluded. Women underwent quantitative ultrasonometry (QUS) at the heel. Speed of sound (SOS), broadband ultrasound attenuation (BUA) and the stiffness index (SI) were compared, first, in all women taking L-T(4) and controls and, secondly, in women taking L-T(4) and controls pair-matched for age, weight, body mass index (BMI), menopausal status and HRT use. RESULTS: Even after matching for age, weight, BMI, menopausal and HRT status, women taking L-T(4) had significantly lower values for SOS and SI (P<0.05), but not for BUA. However, absolute T- and Z-scores for SI were not low in either the study or control groups. Lower values were associated, but not significantly so, with years since the menopause and duration of L-T(4) treatment. CONCLUSIONS: Long-term, non-suppressive L-T(4) treatment in women with goitre or hypothyroidism was associated with a slight reduction in QUS values, which was more pronounced in postmenopausal women. This group could be at higher risk for osteoporotic fracture.

scholarly journals Age, maturation and serum lipid parameters: findings from the German Health Survey for Children and Adolescents

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Anja Schienkiewitz ◽  
Julia Truthmann ◽  
Andrea Ernert ◽  
Susanna Wiegand ◽  
Karl Otfried Schwab ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Sexual Maturation ◽  
Serum Lipid ◽  
Serum Lipids ◽  
Physical Growth ◽  
Pubertal Stage ◽  
Cross Sectional ◽  
Pubertal Stages ◽  
The Impact ◽  
Lipid Parameters

Abstract Background Recommendations on preventive lipid screening among children and adolescents remain controversial. The aim of the study was to assess age and puberty-related changes in serum lipids, including total cholesterol (TC), and high-density (HDL-C) and non-high-density lipoprotein cholesterol (Non-HDL-C). Methods Using cross-sectional data from the National Health Interview and Examination Survey for Children and Adolescents in Germany (KiGGS 2003–2006; N = 13,676; 1–17 years), changes in distributions of serum lipids were visualized according to sex, age and maturation. Youth aged 10–17 years were classified as prepubescent, early/mid-puberty, and mature/advanced puberty. Multiple linear regressions were used to quantify the impact of pubertal stage on serum lipid levels, adjusted for potential confounding factors. Results Among children 1–9 years mean serum lipid measures increased with age, with higher mean TC and Non-HDL-C among girls than boys. Among children 10–17 years, advanced pubertal stage was independently related to lower lipid measures. Adjusted mean TC, HDL-C and Non-HDL-C was 19.4, 5.9 and 13.6 mg/dL lower among mature/advanced puberty compared to prepubescent boys and 11.0, 4.0 and 7.0 mg/dL lower in mature/advanced puberty compared to prepubescent girls. Conclusions Lipid concentrations undergo considerable and sex-specific changes during physical growth and sexual maturation and significantly differ between pubertal stages. Screening recommendations need to consider the fluctuations of serum lipids during growth and sexual maturation.

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