News in brief from the world of cardiology
PCSK9 approvals in Europe
Two agents in a new cholesterol-lowering class – the PCSK9 inhibitors, which use human monoclonal antibodies to target PCSK9 (proprotein convertase subtilisin/kexin type 9) – have received European approval for lowering cholesterol.
Evolocumab (Repatha®, Amgen) is the first PCSK9 inhibitor to be granted marketing authorisation by the European Commission (EC) for use in people with primary hypercholesterolaemia or mixed dyslipidaemia, or in homozygous familial hypercholesterolaemia, who are unable to reach low-density lipoprotein cholesterol (LDL-C) goals with an optimal dose of statin (or a statin and other lipid-lowering agents), or in those who are statin-intolerant. The drug should be given in addition to a healthy diet.
Days later, alirocumab (Praluent®, Sanofi) also received EC marketing authorisation for lowering LDL-C in addition to diet and maximally tolerated doses of statins in patients with a primary hypercholesterolaemia or mixed dyslipidaemia who are not at target levels of LDL-C, or in those who are statin-intolerant.
Both agents are given by an injection every two weeks. The agents appear to be well tolerated with few patients having to discontinue treatment from adverse effects. Long-term safety, however, has not been established. Outcome studies on the effect of PCSK9 inhibitors on cardiovascular morbidity and mortality are awaited.
NICE recommendations for edoxaban
In two Final Appraisal Determinations, the National Institute for Health and Care Excellence (NICE) has recommended edoxaban (Lixiana®, Daiichi Sankyo) as an option for:
- the treatment and secondary prevention of deep vein thrombosis and pulmonary embolism
- preventing stroke and systemic embolism in people with non-valvular atrial fibrillation
The Final Appraisal Determinations are now out with consultees.
Young VTE patients require psychotropic drugs within five years
One in five young people who experience a venous thromboembolism (VTE) will require psychotropic medication within five years, reveals research presented at EuroHeartCare 2015, held recently in Dubrovnik, Croatia. The research, presented by nurse and PhD student Anette Arbjerg Højen (Aalborg Thrombosis Research Unit, Aalborg University Hospital, Aalborg, Denmark), showed young VTE patients were twice as likely to experience mental health problems requiring psychotropic medication as their healthy peers.
This study is the first to investigate the mental health prognosis of young VTE patients. Data from four nationwide registries was used: the Danish Civil Registration System, the Danish National Patient Register, the Danish National Prescription Registry, and the Danish Medical Birth Registry. The researchers identified 4,132 patients aged 13 to 33 years who had a first VTE between 1997 and 2010. A control group of 19,292 people without VTE was randomly selected and matched to the patients by sex and birth year.
All participants in the study were followed in the prescription registry for their first purchase of psychotropic drugs. The researchers found that psychotropic drug purchase was substantially higher among the young VTE patients compared to the control group. Among VTE patients the risk of purchasing psychotropic drugs following their diagnosis was 7.1% after one year and 22.1% after five years. Their excess risk relative to the controls was 4.7% after one year and 10.8% after five years.
Heart failure prognosis affected by cognitive impairment…
Heart failure patients with cognitive impairment may get progressively worse at adhering to medications, leading to poorer prognosis, according to research presented at Heart Failure 2015, held recently in Seville, Spain.
Researchers from the Kameda Medical Centre, Kamogawa, Japan, found that in a group of 136 elderly patients (average age 82 years), those who were cognitively impaired (74% of group) had a significantly worse prognosis than those who were not. Cognitive impairment also predicted a 7.5 times greater risk of worse prognosis than in those who were not cognitively impaired even after adjusting for other prognostic factors.
Other research presented at the meeting from the OPERA-HF (Observational Study to Predict Readmission for Heart Failure Patients) study showed that moderate to severe depression is associated with a five-fold increased risk of all-cause mortality in patients with heart failure compared with those with no or mild depression.
Professor John Cleland (Imperial College London, and University of Hull) told the meeting that depression is common in heart failure and affects 20–40% of patients. “Our research clearly shows a strong association between depression and risk of death in the year after discharge from hospital. Recognition and management of depression may reduce mortality for patients with heart failure,” Professor Cleland added.
Visualising calcification a ‘wake-up’ call for patients
Looking at images of their own calcified coronary arteries may be a wake-up call for patients with newly diagnosed coronary artery disease to change their lifestyles, according to research presented at EuroHeartCare 2015, held recently in Dubrovnik, Croatia.
The Danish study assessed the influence of visualising coronary artery calcification in addition to standard information about risk and lifestyle modification on cholesterol and other risk factors in 189 patients with hyperlipidaemia and a new diagnosis of non-obstructive coronary artery disease.
Patients were prospectively randomised in a 1:1 fashion to the intervention or to standard follow up in general practice which consisted of information about risk and lifestyle modification.
“We found that patients who looked at images of their calcified coronary arteries were more likely to stop smoking, lose weight, eat a healthy diet, take recommended statins and reduce their plasma cholesterol levels. The results of our study suggest that visualising their health threat motivates patients to make changes to reduce their risk,” said the study presenter, nurse and PhD student Rikke Elmose Mols (Aarhus University Hospital-Skejby, Denmark).