Dispatcher-assisted telephone cardiopulmonary resuscitation using a French-language compression-only protocol in volunteers with or without prior life support training: A randomized trial.

OBJECTIVES: Due to the recent interest in hands-only protocols for dispatcher-assisted cardiopulmonary resuscitation (CPR) and the lack of any validated algorithms in French, our primary objective was to evaluate a new French-language protocol in terms of its efficacy to help previously untrained volunteers in performing basic life support efforts of appropriate quality, and secondarily to investigate its potential utility in subjects with previous training. METHODS: Untrained volunteers were recruited among adults in a public movie centre and previously trained volunteers among undergraduate nursing students. Participants were randomly assigned to 'phone CPR' versus 'no phone CPR' by drawing sets of envelopes. Primary outcome measures were the results of the Cardiff evaluation test; the secondary measures were global scoring of a complete 5min period of CPR, in a manikin model of cardiac arrest. RESULTS: Out of 146 volunteers assessed for eligibility, 36 previously untrained candidates declined participation. 110 participants, distributed into four groups, completed the study: the previously untrained non-guided group (group A, n=30), the previously untrained guided group (group B, n=30), the previously trained non-guided group (group C, n=25) and the previously trained guided group (group D, n=25). Results of the Cardiff test and global evaluation of CPR performance revealed a significant improvement in group B as compared with group A, approaching the level of the group C. Previously trained guided bystanders had the best CPR scores, notably because of an improvement in the quality of airway management. CONCLUSION: When used by dispatchers, this new French-language algorithm offers the opportunity to help previously untrained bystanders initiate CPR. The same protocol may serve to guide volunteers with prior basic life support training to reach their best CPR performance

Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.

Importance In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. Objective To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Design, Setting, and Patients Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. Interventions Patients (n = 2067) were randomized to 1 of 24 treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. Main Outcomes and Measures Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the mean of weeks 10 and 12 and at week 12. Results Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all <2%). Conclusions and Relevance In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering. Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. Trial Registration clinicaltrials.gov Identifier: NCT0176386