Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.

BACKGROUND: Sativex® (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients. METHODS: Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2). SUMMARY: Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID ≥18% improvement vs. baseline) and clinically important difference (CID, ≥30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history. CONCLUSIONS: THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history.

Comparison of 'anatomically designed' and 'point-by-point' catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals.

AIMS: The purpose of the FAST-PVI study was to compare 'traditional' ablation tools based on 'point-by-point' technology with the new 'anatomically designed' technologies in terms of procedure times and related costs for the treatment of paroxysmal atrial fibrillation. METHODS AND RESULTS: Four hundred and fifty-two consecutive ablation procedures (222 'anatomically designed', 136 Arctic Front® and 86 PVAC®) and 230 'point-by-point' ablations (100 CARTO XP and 130 NavX navigation systems) performed by nine university centres across Germany from 2006 to 2010 were evaluated retrospectively. Staffing and resources times for each procedure were documented together with patient morbidities, complications, and pulmonary veins isolations. On the basis of DRG data from 2006 to 2010, human resources use and equipment maintenance costs were assigned to ablation procedure and calendar year. All procedural times were significantly higher in 'point-by-point' technologies compared with 'anatomically designed' ablations [average lab occupancy time 185.30 vs. 280.28 min; physician time 152.21 vs. 238.04 min; support time 183.43 vs. 278.34 min and fluoroscopy time 29.11 vs. 40.72 min; P < 0.001 (95% confidence interval, CI)]. For each ablation procedure human resource use per operating minute resulted in lower costs for 'anatomically designed' ablations [€744.24 per patient; P < 0.001 (95% CI)]. Savings due to reduced duration in 'anatomically designed' technologies accrued to 20% lower human resource costs. Sensitivity analyses did not lead to any significant variations on the outcomes parameter cost per minute. CONCLUSION: FAST-PVI showed reductions in ablation procedural time may lead to increased hospital capacity and non-device-related cost-savings, while maintaining quality.