%0 Journal Article
%T Double-blind, placebo-controlled, two-period, crossover trial to examine the pharmacokinetics of lisdexamfetamine dimesylate in healthy older adults
%A Ermer J
%A Haffey MB
%A Richards C
%A Lasseter K
%A Adeyi B
%A Corcoran M
%A Stanton B
%A Martin P
%J Neuropsychiatric Disease and Treatment
%D 2013
%I Dove Medical Press
%R http://dx.doi.org/10.2147/NDT.S38377
%X uble-blind, placebo-controlled, two-period, crossover trial to examine the pharmacokinetics of lisdexamfetamine dimesylate in healthy older adults Original Research (652) Total Article Views Authors: Ermer J, Haffey MB, Richards C, Lasseter K, Adeyi B, Corcoran M, Stanton B, Martin P Published Date February 2013 Volume 2013:9 Pages 219 - 229 DOI: http://dx.doi.org/10.2147/NDT.S38377 Received: 21 September 2012 Accepted: 04 December 2012 Published: 12 February 2013 James Ermer,1 Mary B Haffey,1,  Cynthia Richards,1 Kenneth Lasseter,2 Ben Adeyi,1 Mary Corcoran,1 Beverly Stanton,1 Patrick Martin1 1Shire Development LLC, Wayne, PA, 2Clinical Pharmacology of Miami, Inc., Miami, FL, USA  This author is now deceased Background: Pharmacokinetic and safety data on stimulants in older adults are limited. The objective of this study was to characterize the pharmacokinetics of lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, in older adults. Methods: In this two-period crossover trial, healthy adults (n = 47) stratified by age (55每64, 65每74, and ≡ 75 years) and gender received randomized, double-blind, single doses of LDX 50 mg or placebo. Baseline creatinine clearance, d-amphetamine and intact LDX pharmacokinetics, and safety were assessed. Results: Mean (㊣standard deviation) baseline creatinine clearance in participants aged 55每64, 65每74, and ≡ 75 years was 102.5 ㊣ 26.1, 105.3 ㊣ 23.1, and 94.9 ㊣ 27.3 mL per minute, respectively. In the groups aged 55每64, 65每74, and ≡ 75 years, the mean maximum plasma d-amphetamine concentration in men was 44.2 ㊣ 11.1, 47.7 ㊣ 7.0, and 53.4 ㊣ 19.4 ng/mL, respectively; area under the concentration time curve from time 0 extrapolated to infinity (AUC0每inf) was 915.0 ㊣ 164.9, 1123.0 ㊣ 227.0, and 1325.0 ㊣ 464.4 ng   hour/mL; median time to reach peak plasma concentration was 4.5, 3.5, and 5.5 hours; in women, mean maximum plasma d-amphetamine concentration was 51.0 ㊣ 6.7, 50.2 ㊣ 6.8, and 64.3 ㊣ 12.1 ng/mL, AUC0每inf was 1034.5 ㊣ 154.6, 988.4 ㊣ 80.5, and 1347.8 ㊣ 198.9 ng   hour/mL, and median time to reach peak plasma concentration was 3.5, 4.1, and 5.5 hours, respectively. d-Amphetamine clearance was unrelated to baseline creatinine clearance. Five participants aged 55每64 years reported treatment-emergent adverse events (versus one each aged 65每74 and ≡ 75 years), and as did six women (versus one man). No trends in blood pressure or pulse changes were seen with LDX according to age. In participants aged 55每64, 65每74, and ≡ 75 years, the mean change from time-matched baseline pulse ranged from -5.0 to 14.7, -4.3 to 9.5, and -3.0 to 14.7 beats per minute; for systolic blood pressure, from -3.9 to 18.5 mmHg, -2.1 to 14.5 mmHg, and -5.9 to 16.0 mmHg; for diastolic blood pressure from -2.5 to 8.3 mmHg, from -0.8 to 9.4 mmHg, and -0.6 to 9.5 mmHg. Vital sign changes were similar between men and women. Conclusion: Clearance of d-amphetamine decreased with age and was unrelated to creatinine clearance. No trends in pulse or b
%K lisdexamfetamine dimesylate
%K older adults
%K pharmacokinetics
%K attention-deficit/hyperactivity disorder
%K d-amphetamine
%U https://www.dovepress.com/double-blind-placebo-controlled-two-period-crossover-trial-to-examine--peer-reviewed-article-NDT