ABSTRACT
Obstructive sleep apnoea is highly prevalent in acute coronary syndrome patients eligible for enrolment in cardiac rehabilitation programmes. This condition is an independent predictor of increased morbidity and comorbid conditions in the general population and can lead to an increase in major adverse cardiac events such as revascularization, heart failure and hospital readmission in cardiac patients. There is convincing evidence that treatments such as continuous positive airway pressure or mandibular advancement devices can successfully treat obstructive sleep apnoea and these conditions can be improved or negated resulting in improved cardiac rehabilitation outcomes and improved health related quality of life. Given the potential benefits of obstructive sleep apnoea treatment it would make sense to screen for this condition upon entry to out-patient cardiac rehabilitation programmes. A two-stage approach to screening is recommended, where patients are initially evaluated for the probability of having obstructive sleep apnoea using a brief questionnaire (The STOP-Bang) and then followed up with objective evaluation (portable home monitor or polysomnography) where necessary. Potential barriers to further referral and treatment could be partly mitigated by the training of cardiac rehabilitation staff in sleep disorders and screening.
Subject(s)
Cardiac Rehabilitation/methods , Cardiology , Coronary Artery Disease , Mass Screening , Sleep Apnea, Obstructive , Societies, Medical , Australia/epidemiology , Coronary Artery Disease/complications , Coronary Artery Disease/epidemiology , Coronary Artery Disease/rehabilitation , Humans , Prevalence , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/epidemiology , Sleep Apnea, Obstructive/etiologyABSTRACT
BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.