SMC accepts apixaban (Eliquis®) for prevention of stroke and systemic embolism in adults with AF
Source: Scottish Medicines Consortium (SMC)
Area: Evidence > Drug Specific Reviews
The Scottish Medicines Consortium has accepted apixaban (Eliquis®) for use within NHS Scotland for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ?75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class ?II).
The Detailed Advice accompanying the recommendation (see link below) summarises the evidence on efficacy and safety, the clinical effective...
Source: NeLM - Cardiovascular Medicine - February 11, 2013 Category: Cardiology Source Type: news
US FDA requests more cardiovascular data on long-acting insulin products
Source: DIA daily
Area: News
Novo Nordisk AS has received a Complete Response Letter from the US FDA, requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before its New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) can be completed. Novo Nordisk has noted that it would not be able to provide the requested data during 2013.
The FDA has also stated that these approvals cannot be granted until violations cited in a previously announced Warning Letter (issued December 2012) have been resolved. The DIA Daily report suggests th...
Source: NeLM - Cardiovascular Medicine - February 11, 2013 Category: Cardiology Source Type: news
European Medicines Agency starts safety review of third and fourth generation combined contraceptives
Source: European Medicines Agency (EMA)
Area: News
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has formally started a review of all combined hormonal contraceptives authorised in the EU that contain third or fourth generation progestogens, including chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.
As reported previously on NeLM, this review has been initiated at the request of the French medicines regulatory agency (ANSM) due to concerns about the risk of venous thromboembolism (VTE). Previou...
Source: NeLM - Cardiovascular Medicine - February 11, 2013 Category: Cardiology Source Type: news
Cohort study: Statin therapy may reduce the risk of recurrent pulmonary embolism (PE)
Source: European Heart Journal
Area: News
Several studies suggest that treatment with statins reduces the incidence of a first episode of VTE, but data on the effects in patients with a previous episode are lacking. A study has been published early online in the European Heart Journal which examined the effect of statin therapy on the risk of recurrent PE.
Using a Dutch based record of pharmacy records linked with hospital discharge records, patients hospitalised with an acute episode of PE were identified between 1998 and 2008. Prescription-based use of statins and vitamin K antagonist (VKA) were identified s...
Source: NeLM - Cardiovascular Medicine - February 8, 2013 Category: Cardiology Source Type: news
NICE consults on draft guideline on treatment of acute myocardial infarction
Source: NICE
Area: News
NICE has issued a draft guideline for public consultation on the acute management of myocardial infarction with ST-segment-elevation (STEMI). The draft guideline is open to comments from stakeholders up until Friday 22nd March.
The draft key recommendations include the following:
. All people with acute STEMI are immediately assessed for their eligibility for coronary reperfusion therapy (either primary percutaneous coronary intervention (PPCI) or fibrinolysis).
. Do not use level of consciousness after cardiac arrest caused by suspected acute STEMI to determine...
Source: NeLM - Cardiovascular Medicine - February 8, 2013 Category: Cardiology Source Type: news
Report: Deaths from cardiovascular diseases- implications for end of life care in England
This report describes patterns in mortality from cardiovascular diseases in England, highlighting variation in place and cause of death by age, sex, socioeconomic deprivation and disease group. It was commissioned to support the development of a new national strategy for tackling cardiovascular diseases and will be of interest to commissioners and providers of end of life care focused on supporting and caring for patients with cardiovascular diseases, as well as the patients themselves, their carers and families. (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 7, 2013 Category: Cardiology Source Type: news
Epidemiological study: Use of anticoagulants in the management of atrial fibrillation among general practices in England
Source: Heart
Area: News
Despite the fact that anticoagulation is very effective in preventing strokes due to atrial fibrillation (AF), there is extensive evidence that anticoagulants (AC) remain underused. The Guidance on Risk Assessment and Stroke Prevention in Atrial Fibrillation (GRASP-AF) tool is a software suite based on the CHADS2 risk evaluation system, which searches general practice clinical information systems to enable practices to identify patients with a history of AF and review their individual risk profile.
The aggregated uploaded information from GRASP-AF forms the basis of this study which pr...
Source: NeLM - Cardiovascular Medicine - February 7, 2013 Category: Cardiology Source Type: news
RCT: Rivaroxaban for thromboprophylaxis in acutely ill medical patients (MAGELLAN)
Source: N Engl J Med
Area: News
RCTs of hospitalised patients at increased risk for venous thromboembolism (VTE) have shown the benefits of administering anticoagulant agents for up to 14 days. There is some evidence that the risk of VTE in acutely ill medical patients persists after hospital discharge, but no studies have supported the routine use of extended thromboprophylaxis.
Rivaroxaban is an oral, direct factor Xa inhibitor that is used for the prevention of VTE after elective hip-replacement or knee-replacement surgery in adults. The 'Multicenter, Randomised, Parallel Group Efficacy and Safety Study for...
Source: NeLM - Cardiovascular Medicine - February 7, 2013 Category: Cardiology Source Type: news
Direct Healthcare Professional communication: Pradaxa® (dabigatran etexilate) now contraindicated in patients with prosthetic heart valve requiring anticoagulant treatment
Source: Boehringer Ingelheim Limited
Area: News
Boehringer Ingelheim has issued this letter to reiterate that the use of Pradaxa® (dabigatran etexilate) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment. The existing warning in section 4.4 of the SPC not to use the drug in patients with prosthetic heart valves is strengthened to a contraindication based on the availability of new data from clinical trials.
The basis for this change is data from one investigational phase II trial and its extension trial in 252 patients examining dabigatran and warfarin use in pati...
Source: NeLM - Cardiovascular Medicine - February 7, 2013 Category: Cardiology Source Type: news
Pharmaceutical care for patients with acute myocardial infarction in Hungary
Source: International Journal of Clinical Pharmacology and Therapeutics
Area: Evidence > Medicines Management > References
Objective: To obtain information on the main causes of acute myocardial infarction (AMI), the background needs to be analysed. Our aim was to identify those pharmaceutical aspects of this polymorbidity where the pharmacist can contribute. Previous and more recent European and Hungarian studies show similar results: cardiovascular (CV) death is still the leading cause of mortality. The quality of life is much lower and life expectancy is shorter in the population of&...
Source: NeLM - Cardiovascular Medicine - February 7, 2013 Category: Cardiology Source Type: news
NICE unlicensed medicine evidence summary: Midodrine for postural hypotension in adults
Source: NICE
Area: Evidence > Drug Specific Reviews
These evidence summaries review the published data for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. The summaries provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies.
The latest summary addresses the use of midodrine for the treatment of postural (orthostatic) hypotension. This medicine does not have a UK marketing authorisation for this or any other in...
Source: NeLM - Cardiovascular Medicine - February 5, 2013 Category: Cardiology Source Type: news
Antithrombotic outcome trials in acute coronary syndromes: seeking the optimal balance between safety and efficacy
This article highlights key points from discussions around antithrombotic drug development for acute coronary syndromes (ACS) that took place during the 7th and 8th Global Cardiovascular Clinical Trialists (CVCT) forums in December 2010 and 2011.
The following are discussed:
. Dose selection
. Phase II designs and endpoints
. Reporting bleeding risks
. Determining therapeutic benefit and risk profiles
. Challenges facing future trials
In the conclusion, the authors comment that: "Previous advances in ACS management have reduced event rates such that meg...
Source: NeLM - Cardiovascular Medicine - February 5, 2013 Category: Cardiology Source Type: news
Study finds high intake of supplementary calcium may increase risk of CVD in men
Source: JAMA Internal Medicine
Area: News
According to research published early online in JAMA Internal Medicine, supplemental but not dietary calcium intake was associated with an increased cardiovascular disease (CVD) mortality in men but not in women.
The authors note that calcium supplementation has become widely used, especially among the elderly population. Although it has an established role in the prevention and treatment of osteoporosis, the health effects of calcium on non-skeletal outcomes remain largely unknown and are becoming increasingly contentious.
Recent analyses of RCTs hav...
Source: NeLM - Cardiovascular Medicine - February 5, 2013 Category: Cardiology Source Type: news
Science minister lobbies health department over ticagrelor
Source: BMJ
Area: News
According to a report in the British Medical Journal (BMJ), Government ministers are stepping up efforts to boost NHS prescriptions of recommended new drugs made by companies with a significant presence in the United Kingdom. This follows growing complaints from the drug industry that doctors are not prescribing drugs which have been recommended by NICE.
The example of ticagrelor is highlighted - this has been approved by NICE as a treatment option for adults with acute coronary syndromes but is more costly than clopidogrel (£54.60 versus £3.40 per month). AstraZeneca say that only 42% ...
Source: NeLM - Cardiovascular Medicine - February 4, 2013 Category: Cardiology Source Type: news
Direct Healthcare Professional Communication on approved dosing regimens for bivalirudin (Angiox®) following reports of inappropriate use
Source: MHRA
Area: News
The Medicines Company has issued a Direct Healthcare Professional Communication regarding bivalirudin (Angiox®, which states that the approved dosing regimen for patients undergoing percutaneous coronary intervention (PCI) must be followed (i.e. an IV bolus injection of 0.75 mg/kg body weight should be followed immediately by an IV infusion at 1.75 mg/kg/hour for at least the duration of the PCI).
Post-marketing data suggest that some patients are only treated with an IV bolus dose of bivalirudin, without the required subsequent IV infusion. Due to the short half-life of bivalirudin (2...
Source: NeLM - Cardiovascular Medicine - February 4, 2013 Category: Cardiology Source Type: news
