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A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.

ABSTRACT: The purpose of this study was to compare the safety and efficacy of the short-acting β1-receptor blocker, landiolol hydrochloride (0.06 and 0.125-mg/kg), to placebo during coronary computed tomography angiography (CTA) in a phase 2 dose-finding study. A total of 183 patients suspected of having ischemic cardiac disease and scheduled to undergo an invasive coronary angiography were randomized to groups treated with landiolol hydrochloride (0.06 or 0.125-mg/kg) or placebo. The heart rate, safety, and the performance of coronary diagnosis using landiolol hydrochloride were evaluated in a multicenter, double-blind, randomized, parallel study. The patients' heart rates during the coronary CTA were 67.6 ± 8.7 and 62.6 ± 7.8 beats/min in the 0.06 and 0.125-mg/kg landiolol hydrochloride groups, respectively, both of which were significantly lower than the heat rate of 73.7 ± 11.8 beats/min in the placebo group (P = 0.003 and P < 0.001, respectively). No adverse events or reactions occurred at an incidence of 5 % or greater, confirming the safety of landiolol hydrochloride. The proportion of correctly classified patients was significantly higher in the 0.125-mg/kg landiolol hydrochloride group than in the placebo group (73.6 vs. 50.0 %). Landiolol hydrochloride at doses of 0.06 and 0.125-mg/kg significantly decreased the heart rate compared with a placebo. The present findings suggest that landiolol hydrochloride is safe and useful at a dose of 0.125-mg/kg to improve coronary diagnostic performance during coronary CTA.

SUBMITTER: Jinzaki M

PROVIDER: S-EPMC3722440 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionTreatment options for adults with attention deficit hyperactivity disorder (ADHD) are limited. The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release (MPH-LA) in adults with ADHD and evaluate the maintenance of effect of MPH-LA.MethodsThe study consisted of three treatment phases. The double-blind dose-confirmation phase: 9-week double-blind period (3-week titration period, 6-week fixed dose) with randomization to MPH-LA 40, 60, or 80 mg/day or placebo. The real-life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double-blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase. The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase.Results725 of 863 screened patients were randomized to 40 (N = 181), 60 (N = 182), or 80 mg (N = 181) MPH-LA or placebo (N = 181), and 584 (80.6%) completed. 489 (83.7%) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 (48.1%) of them completed. Improvement from baseline in DSM-IV ADHD RS (P < 0.0001 for all comparisons) and SDS (40 mg, P = 0.0003; 60 mg, P = 0.0176; 80 mg, P < 0.0001) total scores was significantly greater vs. placebo for all MPH-LA doses. Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase. Safety profile was consistent with the profile for MPH-LA in children; percentage of serious adverse events was comparable between all MPH-LA arms (1.3%) and placebo (1.5%), while percentage of adverse events was higher in MPH-LA arms.ConclusionMPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients.

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A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.

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