News in brief from the world of cardiology.
NHA joins with BHS
The Nurses Hypertension Association (NHA) has become part of the British Hypertension Society (BHS) after the BHS decided to invite nurses working in the field of hypertension and cardiovascular disease to be full members of the society. “This acknowledges the shift of care towards specialist nurses, particularly in primary care,” said Naomi Stetson, former head of the NHA. “In the current economic climate, it also made good business sense to have one united organisation.”
All members of the NHA are now full BHS members and so the NHA has disbanded. “There is a strong Nurses Working Party within the society, which offers study days and updates in England and Scotland. As the nurses membership increases, the training opportunities will also expand,” said Naomi Stetson.
The British Journal of Cardiology, which has been the official journal for the NHA, will continue to work with the former group in their new position.
Rivaroxaban approvals sought
Bayer has applied to the European Medicines Agency (EMA) for marketing authorisation for the oral anticoagulant, rivaroxaban, a direct factor Xa inhibitor, in three indications.
The submission for stroke prevention in patients with non-valvular atrial fibrillation follows results from the ROCKET AF clinical study at the American Heart Association Congress in November 2010 (see page 12). Submission for the treatment of deep vein thrombosis (DVT), and the prevention of recurrent DVT and pulmonary embolism follows results from the EINSTEIN-DVT and EINSTEIN-Extension studies, which were also published last year.
Rivaroxaban is already approved in Europe for the prevention of venous thromboembolism in adults patients underoing elective hip or knee replacement surgery.
New recommendations for the use of dronedarone
Further to the report of two cases of serious liver injury in patients taking the anti-arrhythmic agent dronedarone (Multaq®, Sanofi-Aventis), the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has started a benefit-risk review on the new medicine. It has recommended, as a precautionary measure, changes to the product information to help manage the possible risk of severe liver complications.
The Committee noted that although the two patients requiring a liver transplant were also taking other medications, a causal relationship with dronedarone could not be excluded. Therefore, the CHMP decided that there was a need for urgent regulatory action to help manage the possible risk of severe liver complications with the medicine. The Committee recommended that warnings and precautions be introduced into the medicine’s prescribing information, to ensure that patients’ liver function is tested before initiation of treatment, closely monitored during treatment, and treatment is stopped if there are signs of potential liver damage. The Committee also agreed that Sanofi-Aventis should provide a letter to healthcare professionals explaining the changes in recommendations for use of dronedarone.
The Committee will assess all available data concerning the possible risks of liver injury associated with the use of dronedarone and their impact on its benefit-risk balance before it reaches its final opinion.
BACR name change
The British Association for Cardiac Rehabilitation (BACR) has recently changed its name to the British Association for Cardiovascular Prevention and Rehabilitation (BACPR).
New society comes on board
The British Heart Valve Society has recently formed and the BJC will be its official journal. More details to follow in the next issue.
Anti-cholesterol treatment reduces vascular events from chronic kidney disease
A recent investigational study, SHARP (Study of Heart and Renal Protection), demonstrates the benefit of lowering low-density lipoprotein cholesterol on major vascular events. The study, carried out by the Oxford University Clinical Trial Service Unit and sponsored by Merck (MSD), involved 9,438 patients with chronic kidney disease (CKD). It found that ezetimibe/simvastatin (Inegy’®) 10/20 mg reduced the incidence of first major vascular events by
16.0% compared to placebo (p=0.0012).
Ezetimibe/simvastatin is not currently indicated to reduce major vascular events or atherosclerotic events in patients with CKD and Merck plans to seek regulatory approvals for its use in these patients. For full results, visit http://www.sharpinfo.org
Higher HDL may cut Alzheimer’s risk
High levels of high-density lipoprotein (HDL) cholesterol may be of more benefit than just reducing heart disease risk. It now appears that increased HDL may also help protect against Alzheimer’s disease.
A study, published in the December 2010 issue of the Archives of Neurology, examined the association of lipid profiles and Alzheimer’s in 1,130 individuals recipients aged 65 and older with no history of dementia or cognitive impairment at baseline.
During follow-up, 89 cases of probable Alzheimer’s and 12 cases of possible Alzheimer’s were diagnosed. Levels of HDL above 55 mg/dL (1.42 mmol/L) were associated with a decreased risk of both probable and possible Alzheimer’s after multivariate adjustment for confounding factors. There was a definite threshold effect, the researchers say, with a clear reduction in risk for people in the highest HDL quartile (>56 mg/dL [1.45 mmol/L]).NICE issues first technology guidance on balloon catheters
The National Institute for Health and Clinical Excellence (NICE) has developed medical technology guidance on the SeQuent Please balloon catheter. The guidance says that treatment with the catheter reduces the need for subsequent re-intervention for coronary stenosis, as well as the duration of clopidogrel therapy, compared with a paclitaxel-eluting stent. The SeQuent Please balloon catheter is associated with a cost saving of £467 per patient compared with the paclitaxel-eluting stent, according to NICE.
NICE recommends that further research should be carried out in a UK setting to compare the outcomes of patients treated with a SeQuent Please balloon catheter with the outcomes of patients treated with other types of drug-eluting balloon catheters and stents. If research shows that the SeQuent Please balloon catheter reduces the rate of restenosis in patients with drug-eluting stents or in native coronary arteries, compared with other technologies, then NICE suggests that the number of patients for whom it might be suitable would increase significantly.
For full guidance visit
Apixaban runs into problems in ACS
The factor Xa inhibitor, apixaban (in development by Bristol-Myers Squibb and Pfizer) has run into problems in the ACS indication. The phase 3 APPRAISE-2 trial in high-risk patients with recent ACS was stopped late in 2010 after it became clear that the increase in bleeding risk in patients randomised to apixaban would not be offset by reductions in ischaemic events. The trial was randomising patients to 5 mg twice daily apixaban or placebo, in addition to mono or dual antiplatelet therapy.
Apixaban continues in clinical trials for the prevention of stroke in atrial fibrillation.
Sitaxentan withdrawn due to serious liver injury
Pfizer has voluntarily withdrawn its pulmonary arterial hypertension drug, sitaxentan (Thelin®), from the market worldwide after further information has become available on two cases of fatal liver injury. All clinical trials of the drug have also been discontinued.
Sitaxentan has been available in Europe since 2006. It has been known to be associated with liver toxicity and has always been contra-indicated in patients with any degree of hepatic impairment or elevated aminotransferases prior to initiation of treatment.
Pfizer says its decision is based on “a review of emerging safety information from clinical trials and postmarketing reports”. While liver toxicity is a known complication of the class of drugs to which sitaxentan belongs, the company says a new potentially life-threatening idiosyncratic risk of liver injury has been observed. “Given the availability of alternative treatments, Pfizer has concluded that the overall benefit of Thelin® no longer outweighs the risks in the general population of PAH patients.”
Hysterectomy linked to raised CV risk in younger women
Women under 50 undergoing hysterectomy appear to be at an increased risk of heart disease, a new Swedish study suggests. The study, led by Dr Erik Ingelsson (Karolinska Institute, Stockholm, Sweden), was published online in the European Heart Journal (December 24th, 2010 issue).
The authors used nationwide healthcare registers to identify 184,441 Swedish women having a hysterectomy for benign indications between 1973 and 2003. They compared cardiovascular events in these women with a control group of women who had not undergone hysterectomy.
Results showed that in women aged below 50 at study entry, hysterectomy was associated with a significantly increased risk of cardiovascular disease during follow-up. But in women aged 50 or above, there were no significant associations between hysterectomy and incident cardiovascular disease.
Edoxaban results in VTE
Edoxaban, the investigational direct factor Xa inhibitor in development by Daiichi Sankyo Company Ltd, has shown superiority to enoxaparin sodium in preventing venous thromboembolic events (VTE) in patients following total hip replacement.
The study carried out in Japan and presented at the 52nd Annual Meeting of the American Society of Hematology in Orlando, USA, recently showed that deep vein thrombosis occurred in 2.4% of patients receiving edoxaban (30 mg) once daily compared with 6.9% of patients who received enoxaparin sodium (2,000 IU) twice daily over 11-14 days, a relative risk reduction of 65.7% (p=0.016).
Other results in the STARS J-V (Studying Thrombosis After Replacement Surgery) study carried out on 610 patients, showed no pulmonary embolism events observed in either treatment group, and there was no statistically significant difference in major and clinically relevant non-major bleeding (p=0.475). There were no cases of intracranial haemorrhage or death in either group.