Margaret Bermingham

Natriuretic peptide-based screening and collaborative care for heart failure: the STOP-HF randomized trial.

IMPORTANCE Prevention strategies for heart failure are needed. OBJECTIVE To determine the efficacy of a screening program using brain-type natriuretic peptide (BNP) and collaborative care in an at-risk population in reducing newly diagnosed heart failure and prevalence of significant left ventricular (LV) systolic and/or diastolic dysfunction. DESIGN, SETTING, AND PARTICIPANTS The St Vincents Screening to Prevent Heart Failure Study, a parallel-group randomized trial involving 1374 participants with cardiovascular risk factors (mean age, 64.8 [SD, 10.2] years) recruited from 39 primary care practices in Ireland between January 2005 and December 2009 and followed up until December 2011 (mean follow-up, 4.2 [SD, 1.2] years). INTERVENTION Patients were randomly assigned to receive usual primary care (control condition; n=677) or screening with BNP testing (n=697). Intervention-group participants with BNP levels of 50 pg/mL or higher underwent echocardiography and collaborative care between their primary care physician and specialist cardiovascular service. MAIN OUTCOMES AND MEASURES The primary end point was prevalence of asymptomatic LV dysfunction with or without newly diagnosed heart failure. Secondary end points included emergency hospitalization for arrhythmia, transient ischemic attack, stroke, myocardial infarction, peripheral or pulmonary thrombosis/embolus, or heart failure. RESULTS A total of 263 patients (41.6%) in the intervention group had at least 1 BNP reading of 50 pg/mL or higher. The intervention group underwent more cardiovascular investigations (control, 496 per 1000 patient-years vs intervention, 850 per 1000 patient-years; incidence rate ratio, 1.71; 95% CI, 1.61-1.83; P<.001) and received more renin-angiotensin-aldosterone system-based therapy at follow-up (control, 49.6%; intervention, 56.5%; P=.01). The primary end point of LV dysfunction with or without heart failure was met in 59 (8.7%) of 677 in the control group and 37 (5.3%) of 697 in the intervention group (odds ratio [OR], 0.55; 95% CI, 0.37-0.82; P = .003). Asymptomatic LV dysfunction was found in 45 (6.6%) of 677 control-group patients and 30 (4.3%) of 697 intervention-group patients (OR, 0.57; 95% CI, 0.37-0.88; P = .01). Heart failure occurred in 14 (2.1%) of 677 control-group patients and 7 (1.0%) of 697 intervention-group patients (OR, 0.48; 95% CI, 0.20-1.20; P = .12). The incidence rates of emergency hospitalization for major cardiovascular events were 40.4 per 1000 patient-years in the control group vs 22.3 per 1000 patient-years in the intervention group (incidence rate ratio, 0.60; 95% CI, 0.45-0.81; P = .002). CONCLUSION AND RELEVANCE Among patients at risk of heart failure, BNP-based screening and collaborative care reduced the combined rates of LV systolic dysfunction, diastolic dysfunction, and heart failure. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00921960.

Are beta2-agonists responsible for increased mortality in heart failure?

Previous large‐scale, retrospective studies have shown increased mortality in heart failure (HF) patients using β2‐agonists (B2As). We further examined the relationship between B2A use and mortality in a well‐characterized population by adjusting for natriuretic peptide levels as a measure of HF severity.

Cost‐effectiveness of natriuretic peptide‐based screening and collaborative care: a report from the STOP‐HF (St Vincent's Screening TO Prevent Heart Failure) study

Prevention of cardiovascular disease and heart failure (HF) in a cost‐effective manner is a public health goal. This work aims to assess the cost‐effectiveness of the St Vincents Screening TO Prevent Heart Failure (STOP‐HF) intervention.

Aspirin Use in Heart Failure Is Low-Dose Therapy Associated With Mortality and Morbidity Benefits in a Large Community Population?

Background— Aspirin use in heart failure (HF) is controversial. The drug has proven benefit in comorbidities associated with HF; however, retrospective analysis of angiotensin-converting enzyme inhibitor trials and prospective comparisons with warfarin have shown increased risk of morbidity with aspirin use. This study aims to evaluate the association of low-dose aspirin with mortality and morbidity risk in a large community-based cohort. Methods and Results— This was a retrospective cohort study of patients attending an HF disease management program. Aspirin use at baseline and its association with mortality and HF hospitalization in the population was examined. Of 1476 patients (mean age, 70.4±12.4 years; 63% men), 892 (60.4%) were prescribed aspirin. Low-dose aspirin (75 mg/d) was prescribed to 828 (92.8%) patients. Median follow-up time was 2.6 (0.8–4.5) years. During the follow-up period, 464 (31.4%) patients died. In adjusted analysis, low-dose aspirin use was associated with reduced mortality risk compared with nonaspirin use (hazard ratio=0.58; 95% confidence interval, 0.46–0.74), and this was confirmed by a propensity-matched subgroup analysis. Low-dose aspirin use was associated with reduced risk of HF hospitalization compared with nonaspirin use in the total population (adjusted hazard ratio=0.70; 95% confidence interval, 0.54–0.90). In adjusted analysis, there was no difference in mortality or HF hospitalization between high-dose aspirin users (>75 mg/d) and nonaspirin users. Conclusions— In this study, low-dose aspirin therapy was associated with a significant reduction in mortality and morbidity risk during long-term follow-up. These results suggest that low-dose aspirin may have a continuing role in secondary prevention in HF and underline the need for more trials of low-dose aspirin use in HF.Background— Aspirin use in heart failure (HF) is controversial. The drug has proven benefit in comorbidities associated with HF; however, retrospective analysis of angiotensin-converting enzyme inhibitor trials and prospective comparisons with warfarin have shown increased risk of morbidity with aspirin use. This study aims to evaluate the association of low-dose aspirin with mortality and morbidity risk in a large community-based cohort. Methods and Results— This was a retrospective cohort study of patients attending an HF disease management program. Aspirin use at baseline and its association with mortality and HF hospitalization in the population was examined. Of 1476 patients (mean age, 70.4±12.4 years; 63% men), 892 (60.4%) were prescribed aspirin. Low-dose aspirin (75 mg/d) was prescribed to 828 (92.8%) patients. Median follow-up time was 2.6 (0.8–4.5) years. During the follow-up period, 464 (31.4%) patients died. In adjusted analysis, low-dose aspirin use was associated with reduced mortality risk compared with nonaspirin use (hazard ratio=0.58; 95% confidence interval, 0.46–0.74), and this was confirmed by a propensity-matched subgroup analysis. Low-dose aspirin use was associated with reduced risk of HF hospitalization compared with nonaspirin use in the total population (adjusted hazard ratio=0.70; 95% confidence interval, 0.54–0.90). In adjusted analysis, there was no difference in mortality or HF hospitalization between high-dose aspirin users (>75 mg/d) and nonaspirin users. Conclusions— In this study, low-dose aspirin therapy was associated with a significant reduction in mortality and morbidity risk during long-term follow-up. These results suggest that low-dose aspirin may have a continuing role in secondary prevention in HF and underline the need for more trials of low-dose aspirin use in HF.

Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland

ABSTRACT Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed. The majority of medical specialists (85%) and pharmacists (77%) claimed to be either very familiar or familiar with the term biosimilar, whereas many GPs (60%) were unable to define or had never heard of the term. One in five (21%) healthcare professionals responded that biosimilars were the same as generic medicines. The majority of medical specialists opposed pharmacist‐led substitution of biological medicines but some thought it could be appropriate if agreed with the clinician in advance. Medical specialists who prescribe biosimilars (n = 43) were more likely to do so on treatment initiation (67%), than switch a patient from an originator medicine to a biosimilar (28%). The findings will aid the design of educational initiatives for healthcare professionals and highlight attitudes of healthcare professionals to biosimilars, so informing regulators, policy makers and industry. HIGHLIGHTSHealthcare professionals were surveyed on awareness and attitudes to biosimilars.Familiarity with the term ‘biosimilar’ varies amongst different professions.One in five respondents considered biosimilars to be the same as generics.Physicians more likely to prescribe biosimilars at treatment initiation than switch.Most medical specialists opposed substitution of biological medicines.

Intrauterine insemination—No more Mr. N.I.C.E. guy?

OBJECTIVE To determine the per cycle chance of a live birth and to identify factors that may support a more individualised application of IUI in view of National Institute for Health and Care Excellence (NICE) updated guideline on fertility 2013. STUDY DESIGN A retrospective, cohort study of 851 couples (1688 cycles) with unexplained, mild endometriosis, one patent Fallopian tube (with ovulation occurring in the corresponding ovary), mild male factor or ovulatory dysfunction, who initiated their first cycle of IUI/COH during the study period 2009-2013 and completed up to 3 cycles. Exclusion criteria included donor sperm and diminished ovarian reserve. Success factors and probabilities were determined based on live birth rates. RESULTS Mean age was 33.8±3.3years and mean duration of subfertility was 2.28±1.47years. Independent associates of successful outcome factors were lower age (AOR 0.93; 95%CI 0.89-0.98, p=0.007) and multiparity (AOR 1.72; 95%CI 1.17-2.52). Live-birth rates declined independently of other factors from 15.3% (n=130/851) in cycle 1-7.0% (n=19/273) in cycle 3 (AOR 0.76; 95%CI, 0.62-0.93, p=0.008). Per cycle probabilities of live birth ranged from 21.4% to 5.1% dependent on age, cycle number and previous parity. The unadjusted cumulative pregnancy rate for live birth per cycle started, over three cycles, was 34.9% with a multiple live birth rate per cycle started of 5.4%. The associates of live birth amongst those with unexplained sub-fertility only (n=632, first cycle attempt) were also analysed, yielding similar results. CONCLUSIONS IUI/COH is a simple treatment that produces good live birth rates, especially in younger patients and/or those with previous parity. More than 90% of total live births with IUI/COH is achieved during the first two cycles. As a retrospective, observational study, there is no comparator group and therefore we cannot comment on the relative efficacy of up to three IUI cycles over expectant management in a similar cohort. Our study suggests that probabilities of success can be used to individualise treatment decisions and that there is merit in continuing to offer IUI before resorting to IVF for certain patients.

The St Vincent's potentially inappropriate medicines study: development of a disease-specific consensus list and its evaluation in ambulatory heart failure care

Heart failure (HF) patients may be at risk of prescription of potentially inappropriate medicines (PIMs) yet no disease‐specific list is available to assess PIM use in this population. A Consensus Potentially Inappropriate Medicines in Heart Failure (PIMHF) list was developed, assessed, and compared with an established, general tool in an ambulatory HF population.

A tool for assessment of heart failure prescribing quality: A systematic review and meta-analysis

Heart failure (HF) guidelines aim to standardise patient care. Internationally, prescribing practice in HF may deviate from guidelines and so a standardised tool is required to assess prescribing quality. A systematic review and meta‐analysis were performed to identify a quantitative tool for measuring adherence to HF guidelines and its clinical implications.

Regulation of biosimilar medicines and current perspectives on interchangeability and policy

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an ‘interchangeable product’ is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government agencies. RSI is conducting a research project, the objective of which is to enhance understanding of biosimilar medicines amongst stakeholders and encourage best practice in the use of these medicines.