Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting ß2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care.

OBJECTIVE: The inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform®) has been available as fixed-dose combination (FDC) therapy for asthma patients aged ≥ 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months. METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models. RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label". CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.

Middle-aged and mobility-limited: prevalence of disability and symptom attributions in a national survey.

BACKGROUND: Lower limb mobility disabilities are well understood in older people, but the causes in middle age have attracted little attention. OBJECTIVES: To estimate the prevalence of mobility disabilities among noninstitutionalized adults in England and to compare the disabling symptoms reported by middle-aged and older people. DESIGN: Cross-sectional data from the 2002 English Longitudinal Study of Ageing (ELSA). Mobility disability was identified by level of reported difficulty walking a quarter mile. PARTICIPANTS: Eleven thousand two hundred sixteen respondents aged 50 years and older living in private households in 2002. RESULTS: The prevalence of difficulty walking a quarter mile increases sharply with age, but even in the middle-aged (50 to 64 years age-group) 18% (95% confidence interval [CI]: 16% to 19%) of men and 19% (95% CI: 17% to 20%) of women reported some degree of difficulty. Of the 16 main symptoms reported as causing mobility disability in middle age, 2 dominated: pain in the leg or the foot (43%; 95% CI: 40% to 46%) and shortness of breath/dyspnea (21%; 95% CI: 18% to 23%). Fatigue or tiredness, and stability problems were cited by only 5% and 6%, respectively. These proportions were slightly different from those in the 65 to 79-year age group: 40%, 23%, 6%, and 8%, respectively. CONCLUSIONS: Mobility (walking) disabilities in the middle-aged are relatively common. The symptoms reported as causes in this age group differ little from those reported by older groups, and are dominated by lower limb pain and shortness of breath. More clinical attention paid to disabling symptoms may lead to disability reductions in later life.

Performance of older adults on tests of cognitive estimation.

This study provides performance data for older adults on two existing tests of cognitive estimation ability (Cognitive Estimation Test [CET] and Temporal Judgement Test [TJT]) and a novel set of estimation questions (n-EQ) that make reference to familiar, everyday objects. It explores the relations between each of the three tests of estimation and verbal intelligence. The sample comprises 101 adults aged 55 years and over. Neither n-EQ nor TJT scores were associated with verbal IQ, but scores on the more established CET were. As well as providing performance data for older adults, this study confirms the limitations of existing measures of cognitive estimation. It is proposed that the novel questions devised for this study show promise as an assessment tool, and warrant further validation.