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The Use of a Clinical Utility Index to Compare Insomnia Compounds: A Quantitative Basis for Benefit–Risk Assessment
Author(s) -
Ouellet D,
Werth J,
Parekh N,
Feltner D,
McCarthy B,
Lalonde RL
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.235
Subject(s) - insomnia , sleep onset latency , medicine , clinical pharmacology , confidence interval , backup , dose , primary insomnia , sleep onset , anesthesia , pharmacology , sleep disorder , computer science , database
The use of a clinical utility index (CUI) was proposed in order to compare two calcium channel α2δ ligands that were in development for the treatment of insomnia. The important attributes included in the CUI were two measures of residual sedation and five measures of efficacy (wake after sleep onset, sleep quality, sleep latency, and sleep stages (stage 1 and stages 3–4)). Dose–response analyses were conducted on each end point, and a sensitivity analysis was conducted to determine a clinically meaningful difference in CUI. Nonparametric bootstrap parameters were used to build confidence intervals (CIs). Peak CUI (80% CI) was 0.345 (0.25–0.43), observed at a dose of ~30 mg with the lead compound and 0.436 (0.35–0.52) observed at >600‐mg dose for the backup. Although CUI was slightly greater for the backup, peak CUI values were observed at doses that were not considered viable, and therefore development of the ligand was discontinued. The use of the CUI allowed an efficient, quantitative, and transparent decision. Clinical Pharmacology & Therapeutics (2009); 85 , 3, 277–282 doi: 10.1038/clpt.2008.235