Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study

Introduction: Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited. Methods: ALETHEIA is an observational, multi-country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post-MI patients who initiate ticagrelor 60 mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60 mg ≥1 year post-MI. Assuming an a priori threshold of 5000 person-years on-treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60 mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60 mg and meta-analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60 mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60 mg are expected to be included. Discussion: An increased understanding of patterns of ticagrelor 60 mg use and associated clinical outcomes among high-risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision-making and treatment optimization

Patterns Of Speech Articulation In Subjects With Neurogenic Dysphagia And Dysarthria Patterns Of Speech Articulation In Subjects With Neurogenic Dysphagia And Dysarthria

Abstract The purpose of this descriptive study was to examine place-manner-voicing features and neuromuscular substrates of articulation and swallowing in a group of nursing home residents having concurrent dysarthria and dysphagia. Similar muscle groups function in speech articulation and swallowing, accounting for the high coincidence of dysarthria and dysphagia in neurological impairment. Subjects were forty patients residing in two skilled nursing facilities in Las Vegas, Nevada. The results described place, manner, and voicing characteristics of articulation patterns in neurologically impaired nursing home subjects with and without dysphagia. Place-of-articulation anomalies identified for the dysphagia group were most frequently at the blade-prepalatal site. Manner-of-articulation anomalies among the dysphagia group occurred most often for fricatives. Perceptual changes of soft or weak vocal loudness were most common quality anomalies among the dysphagia group subjects

Burden of Pertussis in COPD: A Retrospective Database Study in England

Chronic obstructive pulmonary disease (COPD) may increase the risk and severity of pertussis infection. Health care resource utilization (HCRU) and direct medical costs (DMC) of treating pertussis among patients with COPD are unknown. Reported incidence of pertussis among individuals aged ≥ 50years with COPD was assessed in Clinical Practice Research Datalink and Hospital Episode Statistics databases during 2009-2018 using a retrospective cohort design. HCRU and DMC from the National Health Service perspective were compared between patients with COPD and pertussis and propensity score-matched patients with COPD without pertussis. Seventy-eight new pertussis events were identified among 387 086 patients with COPD aged ≥ 50years (incidence rate: 4.73; 95% confidence interval 3.74-5.91 per 100 000 person-years). HCRU and DMC were assessed among 67 patients with COPD and pertussis and 267 matched controls. During the month before the pertussis diagnosis, the rates of general practitioner (GP)/nurse visits (4289 vs. 1774 per 100 patient-years) and accident and emergency visits (182 vs. 18 per 100 patient-years) were higher in the pertussis cohort; GP/nurse visits (2935 vs. 1705 per 100 patient-years) were also higher during the following 2months (all p<0.001). During the month before the pertussis diagnosis, annualized per-patient total DMC were £2012 higher in the pertussis cohort (£3729 vs. £1717; p<0.001); during the following 2 months, they were £2407 higher (£5498 vs. £3091; p<0.001). In conclusion, a pertussis episode among individuals with COPD resulted in significant increases in HCRU and DMC around the pertussis event