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 l...
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
Cost-utility analysis of antihypertensive medications in Nigeria: a decision analysis
The objective of this study was to evaluate the cost-effectiveness of drugs from 4 classes of antihypertensive medications commonly used in Nigeria in management of hypertension where there is no compelling indication to use a particular antihypertensive drug.
Methods: The study employed decision analytic modelling. Interventions were obtained from a meta-analysis. The Markov process model calculated clinical outcomes and costs during a life cycle of 30 years of 1000 hypertensive patients stratified by 3 cardiovascular risk groups, under the alternative intervention scenarios. Quality adjusted...
Source: NeLM - Cardiovascular Medicine - January 24, 2013 Category: Cardiology Source Type: news
NICE issues final appraisal determination on apixaban for prevention of stroke and systemic embolism in non-valvular atrial fibrillation
Source: NICE
Area: News
In its final appraisal determination (FAD), NICE has supported the use of apixaban as an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with nonvalvular atrial fibrillation with one or more risk factors (prior stroke or ischaemic attack, age 75 years or older, hypertension, diabetes mellitus or symptomatic heart failure).
The appeal period for this appraisal will close on 6 February 2013. (Source: NeLM - Cardiovascular Medicine)
Source: NeLM - Cardiovascular Medicine - January 23, 2013 Category: Cardiology Source Type: news
Diuretic use in black patients with uncontrolled hypertension
This study assessed diuretic prescribing patterns in a sample of black patients with uncontrolled hypertension who were identified from a population of home care recipients.
Methods: The study was conducted in an urban home health organisation in New York, USA. Participants were black, aged 21 to 80 years, and had a diagnosis of hypertension. Participants with uncontrolled hypertension were identified, and in-home interviewers collected information on prescribed antihypertensive medications.
Results: Of 658 participants, 5.5% were not prescribed any antihypertensives, and only 46% were prescribed a diuretic...
Source: NeLM - Cardiovascular Medicine - January 23, 2013 Category: Cardiology Source Type: news
Shared decision making sheets to facilitate conversations about treatment options
Source: Right Care
Area: News
The BMJ Group has developed a number of shared decision making sheets, designed to facilitate a conversation between patients and healthcare professionals about the reasons for choosing one treatment option over and above another treatment option. The information sheets are both prompts for use in consultations by health professionals with their patients, and aide-memoires for patients with instructions for accessing the corresponding web-based patient decision aid.
Shared decision making sheets on the following are currently available:
- AAA repair
-...
Source: NeLM - Cardiovascular Medicine - January 22, 2013 Category: Cardiology Source Type: news
Long-term aspirin use associated with age-related macular degeneration
Source: JAMA Internal Medicine
Area: News
JAMA Internal Medicine has featured a study evaluating whether regular aspirin use is associated with a higher risk for developing age-related macular degeneration (AMD).
Data from an Australian population-based cohort over a 15-year period (1992-1994 to 2007-2009) were analysed. Participants with at least 4 examinations over the 15 year period were included, and they completed a detailed questionnaire at baseline assessing aspirin use, cardiovascular disease status, and AMD risk factors. Age-related macular degeneration was graded side-by-side from retinal photographs ...
Source: NeLM - Cardiovascular Medicine - January 22, 2013 Category: Cardiology Source Type: news
