NICE costing statement for its guidance on apixaban for prevention of stroke and systemic embolism in non-valvular atrial fibrillation (TA 275)
Source: NICE Area: News NICE has published a costing statement to accompany its guidance on the use of apixaban for preventing stroke and systemic embolism in nonvalvular atrial fibrillation (TA 275).   The statement notes that "Apixaban provides an alternative treatment option at a comparable cost and therefore it is anticipated that there will not be a significant cost impact as a result of implementing this guidance." (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news

Supplemental New Drug Application (sNDA) for icosapent capsules (VascepaT) for hypertriglyceridaemia and mixed dyslipidaemia
Source: BioSpace Area: News Amarin Corporation has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for icosapent ethyl capsules (VascepaT) for use as an adjunct to diet in the treatment of adult patients with hypertriglyceridaemia (triglyceride (TG)  =200 mg/dL and <500 mg/dL) with mixed dyslipidaemia.   The FDA has approved the product (an ultrapure capsule containing  96% eicosapentaenoic acid), as an adjunct to diet to reduce TG  levels in adult patients with severe hypertriglyceridaemia (TG ?500mg/dL/ 5.69 mmol/L). &#...
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news

RCT: Effect of spironolactone on diastolic function and exercise capacity in diastolic heart failure (Aldo-DHF)
Source: JAMA Area: News Diastolic heart failure (heart failure with preserved ejection fraction) is a common condition affecting more than half of the total heart failure population but without established therapy. Furthermore, aldosterone stimulation may contribute to its progression.   The Aldo-DHF trial, a multicentre, prospective, randomised, double-blind, placebo-controlled trial, evaluated the effect of long-term spironolactone on diastolic function and exercise capacity in patients with diastolic heart failure.   The study randomised 422 ambulatory patients (mean age, 67 years; 52% female) with ch...
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news

Exploring beliefs about heart failure treatment in adherent and nonadherent patients: use of the repertory grid technique
This study utilised the repertory grid technique to elicit individuals' beliefs about their heart failure treatment and to investigate whether generated constructs were different between adherent and nonadherent patients. Methods: 92 patients with heart failure were interviewed using a structured questionnaire that applied the repertory grid technique.  Patients were asked to compare and contrast their medicines and self-care activities for their heart failure.  This led to the generation of individual constructs (perceptions towards medicines), and from these, beliefs were elicited about their heart failu...
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news

Mediterranean diet associated with some reduction in the risk of major cardiovascular events among high-risk persons
Source: NEJM Area: News The New England Journal of Medicine has featured the results of a randomised, controlled trial evaluating the Mediterranean diet for the primary prevention of cardiovascular events.   The multi-centre trial, conducted in Spain, randomised 7447 participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational...
Source: NeLM - Cardiovascular Medicine - February 26, 2013 Category: Cardiology Source Type: news

Review: Postpartum management of hypertension
Source: BMJ Area: News The British Medical Journal has featured a review on the postpartum management of hypertension. The most common cause of postpartum hypertension is gestational hypertension or pre-eclampsia that persists after delivery.   In terms of medical management, the review states that suggested first line antihypertensive drugs that are safe in breastfeeding mothers include labetalol, nifedipine, and enalapril. (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 26, 2013 Category: Cardiology Source Type: news

RCT: Metoprolol vs carvedilol, or carvedilol plus N-acetylcysteine on post-operative atrial fibrillation
Source: Eur Heart J Area: News The aim of this study was to evaluate the efficacy of metoprolol, carvedilol, and carvedilol plus NAC on the prevention of post-operative atrial fibrillation (POAF).   Three hundred and eleven patients undergoing cardiac surgery were randomised to metoprolol, carvedilol, or carvedilol plus NAC. The incidence of POAF was statistically lower in the carvedilol plus NAC group compared with the metoprolol group (P < 0.0001) or the carvedilol group (P = 0.03). Duration of hospitalisation was statistically lower in the carvedilol plus NAC group compared to the metoprolol group (P = 0.0...
Source: NeLM - Cardiovascular Medicine - February 22, 2013 Category: Cardiology Source Type: news

In pursuit of certainty: can the systematic review process deliver?
Source: BMC Medical Informatics and Decision Making Area: Evidence > Medicines Management > References Background: There has been increasing emphasis on evidence-based approaches to improve patient outcomes through rigorous, standardised and well-validated approaches.  Clinical guidelines drive this process and are largely developed based on the findings of systematic reviews (SRs).  This paper presents a discussion of the SR process in providing decisive information to shape and guide clinical practice, using a purpose-built review database: the Cochrane reviews; and focussing on a highly prevalent...
Source: NeLM - Cardiovascular Medicine - February 22, 2013 Category: Cardiology Source Type: news

Review: Diagnosis and management of pulmonary embolism
Source: BMJ Area: News There is a wealth of high quality individual studies and meta-analyses to guide the diagnosis and treatment of pulmonary embolism (PE), and in this article, the authors provide an overview and synthesis of that evidence, that addresses the following questions:   . Why is PE important? . Who is at risk? . How does PE present? . How is PE diagnosed? . How is PE treated? (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 21, 2013 Category: Cardiology Source Type: news

Expert position paper on use of proton pump inhibitors in patients with cardiovascular disease and antithrombotic therapy
Source: Eur Heart J Area: News The European Society of Cardiology NSTEMI and STEMI guidelines and an ACCF/ACG/AHA consensus document recommend treatment with proton pump inhibitors (PPIs) in patients treated with dual antiplatelet treatment (DAPT) during the initial phase of an acute coronary syndrome (ACS), particularly in patients with a history of GI bleeding or peptic ulcer. Several studies have raised concerns that many PPIs, especially omeprazole, might diminish the antiplatelet effects of clopidogrel, most likely through inhibition of CYP2C19 and, consequently, the conversion of clopidogrel into its active metaboli...
Source: NeLM - Cardiovascular Medicine - February 21, 2013 Category: Cardiology Source Type: news

RCT: Extended use of dabigatran, warfarin, or placebo in venous thromboembolism (RE-MEDY and RE-SONATE trial)
Source: N Engl J Med Area: News Patients with provoked venous thromboembolism caused by transient risk factors can usually stop anticoagulation after 3 months of treatment. For patients with unprovoked venous thromboembolism (VTE), for which the risk of recurrence is as high as 40% at 5 years, a longer course of therapy may be considered. However, there are difficulties in balancing the risks and benefits of extended anticoagulation. Warfarin has greater than 90% efficacy in preventing recurrences but is associated with a risk of major bleeding of 1 to 2% per year.   Two studies in the New England Journal of Medi...
Source: NeLM - Cardiovascular Medicine - February 21, 2013 Category: Cardiology Source Type: news

SIGN: Updated guideline on acute coronary syndromes
Source: SIGN Area: Evidence > Guidelines The Scottish Intercollegiate Guidelines Network (SIGN) has updated its 2007 clinical guideline on the in-hospital management of patients with an acute coronary syndrome (Guideline no:93).   The updated guideline contains a revised recommendation around optimal timing for delivery of primary percutaneous coronary intervention, in line with new European consensus guidelines, and incorporates two new good practice points.   See link below for further details. (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 20, 2013 Category: Cardiology Source Type: news

Implementation of a web-based tool for patient medication self-management: the Medication Self-titration Evaluation Programme (Med-STEP) for blood pressure control
Source: Informatics in Primary Care Area: Evidence > Medicines Management > References Background: Informatics tools may help support hypertension management. Objective: To design, implement and evaluate a web-based system for patient antihypertensive medication self-titration. Methods: Study stages included: six focus groups (50 patients) to identify barriers/facilitators to patient medication self-titration, software design informed by qualitative analysis of focus group responses and a 6-month single-arm pilot study (20 patients) to assess implementation feasibility. Results: Focus groups emphasised patie...
Source: NeLM - Cardiovascular Medicine - February 19, 2013 Category: Cardiology Source Type: news

Pharmacotherapy for hyperuricemia in hypertensive patients
Source: Cochrane Area: Evidence > Disease Focused Reviews Background High blood pressure represents a major public health problem. Worldwide, approximately one fourth of the adult population has hypertension. Epidemiological and experimental studies suggest a linkage between hyperuricemia and hypertension. Hyperuricemia affects 25-40 % of patients with untreated hypertension. A much lower prevalence has been reported in normotensives or in the general population. However, whether lowering serum uric acid (SUA) might lower blood pressure (BP) is an unanswered question.   Objectives To determine whether ur...
Source: NeLM - Cardiovascular Medicine - February 18, 2013 Category: Cardiology Source Type: news

CADTH review of the clinical effectiveness of thrombolytic drugs for cardiac arrest
Source: Canadian Agency for Drugs and Technologies in Health (CADTH) Area: News This Canadian review looks at the clinical effectiveness of thrombolytic drugs in people experiencing cardiac arrest.   A limited literature search of the literature identified three publications suitable for inclusion - one systematic review and two observational studies. The authors summarise the findings of each of the included publications and discusses the limitations of the currently available evidence in this area.   Based on the evidence included in the review, the authors conclude that while thrombolytics may increas...
Source: NeLM - Cardiovascular Medicine - February 18, 2013 Category: Cardiology Source Type: news

Pharmacotherapy for hyperuricemia in hypertensive patients
Source: Cochrane Area: Evidence > Disease Focused Reviews Background High blood pressure represents a major public health problem. Worldwide, approximately one fourth of the adult population has hypertension. Epidemiological and experimental studies suggest a linkage between hyperuricemia and hypertension. Hyperuricemia affects 25-40 % of patients with untreated hypertension. A much lower prevalence has been reported in normotensives or in the general population. However, whether lowering serum uric acid (SUA) might lower blood pressure (BP) is an unanswered question.   Objectives To determine whether ur...
Source: NeLM - Cardiovascular Medicine - February 18, 2013 Category: Cardiology Source Type: news

NSAIDs and cardiovascular risk: An examination of sales and Essential Medicines Lists in low-, middle-, and high-income countries
Source: PLoS Medicine Area: News It is known that certain non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of myocardial infarction and stroke and should be avoided in patients at high risk of cardiovascular events. A study, published in PLoS medicine, investigated the extent to which evidence on cardiovascular risk with NSAIDs has translated into guidance and sales in 15 countries.   The authors identified that three drugs (rofecoxib, diclofenac, and etoricoxib) ranked consistently highest in terms of cardiovascular risk compared with nonuse and naproxen was associated with a low risk. Diclofenac...
Source: NeLM - Cardiovascular Medicine - February 15, 2013 Category: Cardiology Source Type: news

Review: Diagnosis and treatment of familial hypercholesterolaemia
Source: European Heart Journal Area: News A review of the diagnosis and treatment of familial hypercholesterolaemia has been published early online in the European Heart Journal.   Familial hypercholesterolaemia (FH) is an autosomal dominant genetic disorder, associated with elevated levels of low-density lipoprotein-cholesterol (LDL-C), which can lead to premature cardiovascular disease. Early diagnosis of FH is important to prevent morbidity and mortality.   Current guidelines highlight the importance of reducing LDL-C levels in patients with FH. Statins are the current standard treatment for the major...
Source: NeLM - Cardiovascular Medicine - February 15, 2013 Category: Cardiology Source Type: news

Revisiting the medication possession ratio threshold for adherence in lipid management
Source: Current Medical Research and Opinion Area: Evidence > Medicines Management > References Objective: We sought to evaluate the relationship between different levels of medication possession ratio (MPR) attained and achievement of clinically meaningful reductions in lipid levels. Methods: This was a retrospective cohort study of 4691 new statin users from the US Dept of Veteran Affairs (VA).  Subjects were required to be eligible for VA medical and pharmacy services throughout the 1-year study period from index date and to have complete data for exposure, outcome and adjustment variables....
Source: NeLM - Cardiovascular Medicine - February 15, 2013 Category: Cardiology Source Type: news

Selenium supplementation for the primary prevention of cardiovascular disease
Source: Cochrane Area: Evidence > Complementary Medicine Background Selenium is a key component of a number of selenoproteins which protect against oxidative stress and have the potential to prevent chronic diseases including cardiovascular disease (CVD). However, observational studies have shown inconsistent associations between selenium intake and CVD risk; in addition, there is concern around a possible increased risk of type 2 diabetes with high selenium exposure.     Objectives To determine the effectiveness of selenium only supplementation for the primary prevention of CVD and examine the ...
Source: NeLM - Cardiovascular Medicine - February 14, 2013 Category: Cardiology Source Type: news

Patient adherence to evidence-based pharmacotherapy in systolic heart failure and the transition of follow-up from specialized heart failure outpatient clinics to primary care
The objective of this study was to examine long-term adherence to and dosages of evidence-based pharmacotherapy during and after participation in specialised HFCs. Methods and Results: Initiation, dosages and adherence were studied in patients with systolic HF attending HFCs in Denmark from 2002 to 2009.  Information was obtained from an electronic patient file and research database used in the HFCs combined with prescription data from the Danish Registry of Medicinal Product Statistics.  A total of 8792 patients were included in the study.  The mean age was 68 years; with a mean LVEF of 30%, and 72% were ...
Source: NeLM - Cardiovascular Medicine - February 14, 2013 Category: Cardiology Source Type: news

Uptake of the NHS Health Check programme in an urban setting
Source: Family Practice Area: Evidence > Medicines Management > References Background: The NHS Health Check programme aims to improve prevention, early diagnosis and management of cardiovascular disease (CVD) in England.  High and equitable uptake is essential for the programme to effectively reduce the CVD burden. Objectives: Assessing the impact of a local financial incentive scheme on uptake and statin prescribing in the first 2 years of the programme. Methods: Cross-sectional study using data from electronic medical records of general practices in Hammersmith and Fulham, London on all patients aged 40...
Source: NeLM - Cardiovascular Medicine - February 14, 2013 Category: Cardiology Source Type: news

RCT: Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: (IMPRES)
Source: Circulation Area: News A recent phase II study has reported that imatinib could improve pulmonary haemodynamics, especially in those with greater haemodynamic impairment. The aim of the present international RCT (IMPRES) was to evaluate the safety, tolerability and efficacy of imatinib in patients with advanced pulmonary arterial hypertension (PAH).   Patients with pulmonary vascular resistance (PVR) ?800 dynes/sec/cm5 who were symptomatic on more than 2 PAH therapies (41% patients received 3 PAH therapies with the remainder on 2 therapies) were randomised to imatinib (n=103; starting dose of 200mg) or pl...
Source: NeLM - Cardiovascular Medicine - February 13, 2013 Category: Cardiology Source Type: news

Horizon scanning: Riociguat filed in the EU and US for pulmonary arterial hypertension
Source: PharmaTimes Area: News Bayer has submitted riociguat for filing in the US and EU as an oral  treatment for patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), a related condition.   The application is based on PAH data from the PATENT-I trial (see NELM abstract below) and data from the CHEST-1 study in CTEPH patients which reported similar improvements (no absolute data available for CHEST-1). (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - February 13, 2013 Category: Cardiology Source Type: news

European Medicines Agency starts safety review of Diane 35 (cyproterone acetate and ethinylestradiol) and its generics
Source: European Medicines Agency (EMA) Area: News The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has formally started a safety review of Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics.   As reported previously on NeLM, this review has been initiated at the request of the French medicines regulatory agency (ANSM), following the announcement of its plan to suspend the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months (see link below). These medicines are widely used across Europe; how...
Source: NeLM - Cardiovascular Medicine - February 11, 2013 Category: Cardiology Source Type: news

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 tha...
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). Previous...
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 st...
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 wh...
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 pro...
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 ind...
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 mega-tri...
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 have ...
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 (25...
Source: NeLM - Cardiovascular Medicine - February 4, 2013 Category: Cardiology Source Type: news

Why are we failing to implement effective therapies in cardiovascular disease?
Source: European Heart Journal Area: Evidence > Medicines Management > References Worldwide, there are approx 18 million deaths each year from cardiovascular disease and at least 2-3 times as many experience non-fatal cardiovascular events.  Numerous evidence-based prevention and management guideline recommendations for cardiovascular disease are available.  However, significant gaps between the evidence and its implementation persist ('evidence-practice gap').  There exist 'under-use' gaps with lack of implementation of proven effective strategies and 'over-use' gaps with inappropriate use of stra...
Source: NeLM - Cardiovascular Medicine - February 4, 2013 Category: Cardiology Source Type: news

EMA update on Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and generics for treatment of acne following French decision to suspend marketing authorisation
Source: Eur Meds Agency (EMA), Reuters Health News Area: News The French medicines agency (ANSM) has announced its plan to suspend the marketing authorisation for Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics for acne treatment (its only licensed indiction in that country) within three months. In other countries, these medicines are also licensed for the treatment of acne in women who wish to receive oral contraception, as well as for the treatment of other skin conditions. This announcement follows a review by ANSM of known data which led it to conclude that Diane 35 and its generics carry a...
Source: NeLM - Cardiovascular Medicine - January 31, 2013 Category: Cardiology Source Type: news

FDA approves mipomersen ( KynamroT) to treat homozygous familial hypercholesterolemia
Source: FDA Area: News The U.S. Food and Drug Administration has granted approval of mipomersen sodium injection( KynamroT) to treat homozygous familial hypercholesterolemia (HoFH ) in addition to lipid-lowering medications and diet.   The approval was based on a clinical trial of 51 patients with HoFH and is accompanied by a Risk Evaluation and Mitigation Strategy (REMS) which includes a Boxed Warning on the serious risk of liver toxicity and other elements to assure safe use.   The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion, rec...
Source: NeLM - Cardiovascular Medicine - January 30, 2013 Category: Cardiology Source Type: news

MHRA Drug Safety Update: TredaptiveT (niacin-laropiprant) no longer recommended for prescribing
Source: MHRA Area: News The January issue of the MHRA's Drug Safety Update has featured new data from a long-term study (HPS2-THRIVE) involving over 25 000 patients which indicated that adding TredaptiveT (fixed dose niacin-laropiprant) to simvastatin did not provide significant additional benefit in reducing the risk of major vascular events compared with statin therapy alone. In addition, a higher frequency of bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes was seen in patients taking Tredaptive with simvastatin, compared with patients taking simvastatin alone.   In li...
Source: NeLM - Cardiovascular Medicine - January 30, 2013 Category: Cardiology Source Type: news

Meta-analysis: Efficacy and safety of dual blockade of the renin-angiotensin system
The objective of the current systematic review and meta-analysis was to compare the long term efficacy of dual RAS blockade (any two of ACE inhibitors, angiotensin receptor blockers, or aliskiren) with monotherapy, and to evaluate adverse events in patients receiving dual therapy compared with monotherapy. A systematic literature search (PubMed, Embase, Cochrane central register of controlled trials; Jan 1990-Aug 2012; no language restriction) identified 33 RCTs (total n=68,405; 71% men) reporting the outcomes of ... (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - January 29, 2013 Category: Cardiology Source Type: news

European Medicines Agency to review third- and fourth-generation combined oral contraceptives
Source: European Medicines Agency Area: News The European Medicines Agency (EMA) has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives. This request has been made as part of recent initiatives in France to reduce the use of these medicines in favour of using second-generation oral contraceptives.   It is well established that the risk of venous thromboembolism associated with use of the third- and fourth-generation contraceptives is higher ...
Source: NeLM - Cardiovascular Medicine - January 29, 2013 Category: Cardiology Source Type: news

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review
Source: European Heart Journal Area: Evidence > Medicines Management > References Myocardial infarction (MI) is a key endpoint in randomised controlled trials (RCTs), but heterogeneous definitions limit comparisons across RCTs or meta-analyses.  The 2000 European Society of Cardiology/American College of Cardiology MI redefinition and the 2007 universal MI definition consensus documents made recommendations to address this issue. In cardiovascular randomised trials, we evaluated the impact of implementation of three key recommendations from these reports - troponin use to define MI; separate reporting of s...
Source: NeLM - Cardiovascular Medicine - January 29, 2013 Category: Cardiology Source Type: news

Comparison of US, Canadian and European atrial fibrillation guidelines
Source: Eur Heart J Area: News The European guidelines for the management of patients with atrial fibrillation (AF) were published in 2010 with a focused update in 2012. The Canadian Cardiovascular Society (CCS) published AF guidelines in 2011, which was updated in 2012. The American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society issued two focused updates that were subsequently integrated into their previous 2006 guidelines. In this paper in the European Heart Journal, the authors systematically compared the recommendations in the three sets of guidelines and tried to chara...
Source: NeLM - Cardiovascular Medicine - January 25, 2013 Category: Cardiology Source Type: news

Novartis Europharm Ltd withdraws marketing authorisation application for Ruvise (imatinib mesilate) for treatment of pulmonary arterial hypertension
Source: Eur Meds Agency Area: News The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for centralised marketing authorisation of Ruvise (imatinib mesilate) tablets, intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH). The company stated that it is withdrawing the application since additional data are required to address questions relating to the benefit-risk assessment of imatinib in PAH patients. These data will not be available within the timeframe allowed in the centralised procedure. (Sou...
Source: NeLM - Cardiovascular Medicine - January 25, 2013 Category: Cardiology Source Type: news

National utilization patterns of warfarin use in older patients with atrial fibrillation: a population-based study of Medicare Part D beneficiaries
Source: Annals of Pharmacotherapy Area: Evidence > Medicines Management > References Background: Although warfarin therapy reduces stroke incidence in patients with atrial fibrillation (AF), the rate of warfarin use in this population remains low.  In 2008, the US Medicare Part D programme was expanded to pay for medications for Medicare enrollees. Objective: To examine rates and predictors of warfarin use in Medicare Part D beneficiaries with AF. Methods: This population-based retrospective cohort study used claims data from 41,447 Medicare beneficiaries aged 66 and older with at least 2 AF diagnoses in ...
Source: NeLM - Cardiovascular Medicine - January 24, 2013 Category: Cardiology Source Type: news