The JUPITER trial of rosuvastatin versus placebo has been stopped early because of “unequivocal evidence” of a reduction in cardiovascular morbidity and mortality with the drug.
Rosuvastatin trial stopped for benefit
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal low-density lipoprotein cholesterol but elevated C-reactive protein with rosuvastatin 20 mg once daily would reduce major cardiovascular events.
New Masters degrees in cardiology
The National Heart and Lung Institute at Imperial College London is running a new Masters degree course in preventive cardiology which is accepting its first intake of students this October. The course is open to hospital and primary care physicians, nurses, dietitians, physiotherapists, physical activity specialists, psychologists, occupational therapists, pharmacists and any other health professionals with an interest in cardiovascular disease prevention. Full time (one year) or part time (two years) students are welcome. More information can be obtained from: Jennifer Jones at J.Jones@imperial.ac.uk or tel: 0781 505 8599.
Canterbury Christ Church University is also launching a new Masters degree in cardiology at its Medway Campus. The programme is designed for medical practitioners who wish to enhance their knowledge and skills in cardiology. Further information can be obtained from Helen Lawrence at firstname.lastname@example.org or tel: 01227 782178.
Biomatrix drug-eluting stent launched in Europe
A new drug-eluting stent has been launched in Europe. Developed by Biosensors, the stent, known as BioMatrix®, combines a biodegradable PLA polymer and the company’s proprietary limus drug, Biolimus A9®, which is said to be more lipophilic than other limus analogues, enabling rapid absorption of the drug into the targeted tissue and reduced systemic exposure.
More than 3,000 patients have already been treated with the stent, the company says. In a press release, Professor Bernhard Meier (University Hospital of Bern, Switzerland) said: “We have treated about 200 patients with BioMatrix® and our impression is excellent. The stent is very deliverable and we have had no stent-related adverse events. We will continue to use this new drug-eluting stent in our daily practice.”
Together with the commercial launch, Biosensors has also begun enrollment in a comprehensive patient registry to collect five-year data on the safety and efficacy of BioMatrix® in up to 5,000 patients. The unique design of the e-BioMatrix online registry involves two parallel studies using the same protocol: a post-marketing surveillance study with 100% monitoring of 1,000 patients across more than 10 study sites, and a post-marketing registry with 10% monitoring of 4,000 patients across 40 global sites.
New treatments for type 2 diabetes
A new oral treatment for patients with type 2 diabetes, the DPP-4 inhibitor vildagliptin, is now available. Studies have shown that vildagliptin can achieve additional reductions in glycosylated haemoglobin (HbA1c) of 1.1% versus placebo when added to metformin, and it can reduce HbA1c by an additional 1.5% in metformin-treated patients with a baseline HbA1c over 9%. A further benefit is that it does not cause weight gain. Vildagliptin is marketed by Novartis.
New treatment for PAH
The first pulmonary arterial hypertension (PAH) medicine approved for World Health Organisaion (WHO) Functional Class II patients in Europe, ambrisentan (Volibris®), has received marketing authorisation from the European Commission.
Combined analysis of two clinical trials (ARIES-1 and ARIES-2) demonstrated that treatment with ambrisentan resulted in significant improvements in exercise capacity six-minute walk distance, and beneficial changes in other parameters, such as time to clinical worsening, WHO Functional Class and the Borg Dyspnoea Index. It is the first non-sulphonamide class endothelin receptor antagonist (ERA) and will be marketed by GlaxoSmithKline.
But NICE may limit treatment
The National Institute for Health and Clinical Excellence (NICE) has published the preliminary recommendations of its Appraisal Committee on the use of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for the treatment of pulmonary arterial hypertension in adults.
This document is for consultation only and does not constitute the Institute’s final guidance to the NHS but if implemented without any revisions, these proposals will significantly limit the prescribing options for pulmonary arterial hypertension.
Rimonabant receives NICE approval
The National Institute for Health and Clinical Excellence (NICE) Final Appraisal Determination (FAD) on rimonabant (Acomplia®) proposes guidance recommending the use of the drug in England and Wales, within its licensed indications. These are as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of, or are contraindicated to other antiobesity agents that have previously been reviewed by NICE.