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Short-term effects of lisdexamfetamine dimesylate on cardiovascular parameters in a 4-week clinical trial in adults with attention-deficit/hyperactivity disorder.
J Clin Psychiatry 2009; 70(12):1652-61JC

Abstract

OBJECTIVE

To evaluate the short-term impact of lisdexamfetamine dimesylate on cardiovascular parameters in adults with attention-deficit/hyperactivity disorder (ADHD).

METHOD

Medically healthy adults (18-55 years of age) with DSM-IV-TR-defined ADHD were randomly assigned to placebo or 30, 50, or 70 mg/d of lisdexamfetamine dimesylate for 4 weeks between May and November 2006. Electrocardiograms, systolic and diastolic blood pressure, and pulse were assessed pretreatment and weekly thereafter.

RESULTS

There were no significant differences for mean systolic or diastolic blood pressure in any lisdexamfetamine dimesylate dose group versus placebo. Changes in pulse from baseline to endpoint were 0.0, 2.8, 4.2, and 5.2 bpm in the placebo and lisdexamfetamine dimesylate 30, 50, and 70 mg/d groups, respectively (P < .05, all lisdexamfetamine dimesylate groups vs placebo). Post hoc pulse outliers (pulse > or = 100 bpm; any 1 event) ranged from 3.3% to 8.5% of subjects in the lisdexamfetamine dimesylate groups, and no subjects in the placebo group were pulse outliers (P < .05 for lisdexamfetamine dimesylate 50 mg vs placebo only). There were no clinically meaningful electrocardiogram abnormalities. Overall, 8.3% (35/420; safety population) of subjects had treatment-emergent cardiovascular adverse events, and 1.7% (7/420) withdrew from the study because of cardiovascular complaints. Cardiovascular adverse events with lisdexamfetamine dimesylate in these medically healthy adults were generally mild to moderate in severity.

CONCLUSIONS

Lisdexamfetamine dimesylate had limited short-term effects on heart rate, blood pressure, and electrocardiogram parameters that were of minimal clinical concern. These findings support the relative safety of lisdexamfetamine dimesylate. However, considering the potential of outliers, it is advisable to monitor cardiovascular parameters in stimulant-treated patients. Interpretation of these findings is limited to patients with no preexisting cardiac conditions who are taking their medication as prescribed.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00334880.

Authors+Show Affiliations

Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA. Lenard.Adler@nyumc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20141706

Citation

Adler, Lenard A., et al. "Short-term Effects of Lisdexamfetamine Dimesylate On Cardiovascular Parameters in a 4-week Clinical Trial in Adults With Attention-deficit/hyperactivity Disorder." The Journal of Clinical Psychiatry, vol. 70, no. 12, 2009, pp. 1652-61.
Adler LA, Weisler RH, Goodman DW, et al. Short-term effects of lisdexamfetamine dimesylate on cardiovascular parameters in a 4-week clinical trial in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2009;70(12):1652-61.
Adler, L. A., Weisler, R. H., Goodman, D. W., Hamdani, M., & Niebler, G. E. (2009). Short-term effects of lisdexamfetamine dimesylate on cardiovascular parameters in a 4-week clinical trial in adults with attention-deficit/hyperactivity disorder. The Journal of Clinical Psychiatry, 70(12), pp. 1652-61. doi:10.4088/JCP.09m05335pur.
Adler LA, et al. Short-term Effects of Lisdexamfetamine Dimesylate On Cardiovascular Parameters in a 4-week Clinical Trial in Adults With Attention-deficit/hyperactivity Disorder. J Clin Psychiatry. 2009;70(12):1652-61. PubMed PMID: 20141706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-term effects of lisdexamfetamine dimesylate on cardiovascular parameters in a 4-week clinical trial in adults with attention-deficit/hyperactivity disorder. AU - Adler,Lenard A, AU - Weisler,Richard H, AU - Goodman,David W, AU - Hamdani,Mohamed, AU - Niebler,Gwendolyn E, PY - 2009/05/05/received PY - 2009/09/28/accepted PY - 2010/2/10/entrez PY - 2010/2/10/pubmed PY - 2010/2/24/medline SP - 1652 EP - 61 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 70 IS - 12 N2 - OBJECTIVE: To evaluate the short-term impact of lisdexamfetamine dimesylate on cardiovascular parameters in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Medically healthy adults (18-55 years of age) with DSM-IV-TR-defined ADHD were randomly assigned to placebo or 30, 50, or 70 mg/d of lisdexamfetamine dimesylate for 4 weeks between May and November 2006. Electrocardiograms, systolic and diastolic blood pressure, and pulse were assessed pretreatment and weekly thereafter. RESULTS: There were no significant differences for mean systolic or diastolic blood pressure in any lisdexamfetamine dimesylate dose group versus placebo. Changes in pulse from baseline to endpoint were 0.0, 2.8, 4.2, and 5.2 bpm in the placebo and lisdexamfetamine dimesylate 30, 50, and 70 mg/d groups, respectively (P < .05, all lisdexamfetamine dimesylate groups vs placebo). Post hoc pulse outliers (pulse > or = 100 bpm; any 1 event) ranged from 3.3% to 8.5% of subjects in the lisdexamfetamine dimesylate groups, and no subjects in the placebo group were pulse outliers (P < .05 for lisdexamfetamine dimesylate 50 mg vs placebo only). There were no clinically meaningful electrocardiogram abnormalities. Overall, 8.3% (35/420; safety population) of subjects had treatment-emergent cardiovascular adverse events, and 1.7% (7/420) withdrew from the study because of cardiovascular complaints. Cardiovascular adverse events with lisdexamfetamine dimesylate in these medically healthy adults were generally mild to moderate in severity. CONCLUSIONS: Lisdexamfetamine dimesylate had limited short-term effects on heart rate, blood pressure, and electrocardiogram parameters that were of minimal clinical concern. These findings support the relative safety of lisdexamfetamine dimesylate. However, considering the potential of outliers, it is advisable to monitor cardiovascular parameters in stimulant-treated patients. Interpretation of these findings is limited to patients with no preexisting cardiac conditions who are taking their medication as prescribed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00334880. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/20141706/Short_term_effects_of_lisdexamfetamine_dimesylate_on_cardiovascular_parameters_in_a_4_week_clinical_trial_in_adults_with_attention_deficit/hyperactivity_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2009/v70n12/v70n1205.aspx DB - PRIME DP - Unbound Medicine ER -