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Nick Freemantle

Publications and source records attributed to Nick Freemantle.

At least 19 recordsLinked to original sources
PubMed2004

Clinical trials update from the American Heart Association meeting: Omega-3 fatty acids and arrhythmia risk in patients with an implantable defibrillator, ACTIV in CHF, VALIANT, the Hanover autologous bone marrow transplantation study, SPORTIF V, ORBIT and PAD and DEFINITE.

The American Heart Association meeting reported the results of several clinical trials of particular interest to those who care for patients with heart failure. Omega-3 fatty acids were associated with a trend to increased recurrence of ventricular arrhythmias but not mortality in patients with an implantable debrillator. The ACTIV in CHF study provides more evidence of a therapeutic role for arginine vasopressin antagonists in the treatment of heart failure. The VALIANT study provides further evidence to suggest that a combination of angiotensin receptor antagonist and ACE inhibitor does not reduce mortality but may reduce morbidity in post-MI patients with heart failure or major LV systolic dysfunction. A study of autologous bone marrow cell transplantation into myocardial scar give gave encouraging results. SPORTIF V showed ximelagation to be as effective as warfarin but with improved safety. ORBIT and PAD showed public access defibrillators saved lives but questioned their cost effectiveness. DEFINITE supported a role for ICDs in patients with non-ischemic cardiomyopathy, although cost-effectiveness remains in doubt.

Antidiuretic Hormone Receptor Antagonists↗
PubMed2004

Relation of sex, age and concomitant diseases to drug prescription for heart failure in primary care in Europe.

AIM: To study the role of sex, age and concomitant diseases for prescription of cardiovascular drugs among patients with heart failure cared for in the community. METHODS AND RESULTS: In 15 European countries, a survey was conducted during 1999 and 2000 among 1363 primary care physicians who included 8256 patients with symptoms of heart failure. Predictors of drug prescription were assessed with multivariate logistic regression. Overall prescription rates for ACE-inhibitors/angiotensin receptor blockers (ACE-I/ARB), beta-blockers, digitalis, diuretics and oral anticoagulants were 69%, 30%, 41%, 75% and 18%. Women had no reduced likelihood to receive ACE-I/ARB and beta-blockers (odds ratio [OR]=0.96 [95% CI 0.87-1.06] and 1.02 [0.92-1.13], respectively), but prescription of oral anticoagulants was decreased (OR=0.74, 95% CI 0.65-0.84). Compared to patients <65 years of age, ACE-I/ARB prescription did not materially decline up to 75-85 years (R=0.91, 95% CI 0.81-1.04), whereas beta-blocker prescription was already significantly decreased in this age category (OR=0.49, 95% CI 0.43-0.56). There was no general under-prescription of evidence-based cardiovascular drugs in patients with concomitant diseases. CONCLUSIONS: Among heart failure patients cared for in the community advanced age strongly predicts decreased prescription of beta-blockers. Female sex and comorbidity is not associated with a consistent underutilization of evidence-based cardiovascular drugs.

Aged↗
PubMed2004

Clinical trials update and cumulative meta-analyses from the American College of Cardiology: WATCH, SCD-HeFT, DINAMIT, CASINO, INSPIRE, STRATUS-US, RIO-Lipids and cardiac resynchronisation therapy in heart failure.

This article continues a series of reports on recent research developments in the field of heart failure. Key presentations made at the American College of Cardiology meeting, held in New Orleans, Louisiana, USA in March 2004 are reported. These new data have been added to existing data in cumulative meta-analyses. The WATCH study randomised 1587 patients with heart failure and left ventricular systolic dysfunction to warfarin, aspirin or clopidogrel. The study showed no difference between the effects of these agents on mortality or myocardial infarction, but hospitalisations for heart failure were higher on aspirin (22.2%) compared to warfarin (16.1%). The SCD-HeFT study showed that ICD therapy reduced all-cause mortality at 5 years by 23% in patients with predominantly NYHA class II heart failure and left ventricular systolic dysfunction, but amiodarone was ineffective. The DINAMIT study showed that ICD therapy was not beneficial in patients with left ventricular dysfunction after a recent MI, even in those with risk factors for arrhythmic death. In CASINO, levosimendan improved survival compared with dobutamine or placebo in patients with decompensated heart failure. INSPIRE showed that SPECT imaging can be used to assess risk early after acute MI safely and accurately. Rimonabant was shown to be safe and effective in treating the combined cardiovascular risk factors of smoking and obesity. An overview of new developments in cardiac resynchronisation therapy (CRT) in heart failure is also reported.

Anticoagulants↗
PubMed2004

Clinical trials update from the European Society of Cardiology Heart Failure meeting: SHAPE, BRING-UP 2 VAS, COLA II, FOSIDIAL, BETACAR, CASINO and meta-analysis of cardiac resynchronisation therapy.

This article continues a series of reports on recent research developments in the field of heart failure. Key presentations made at the European Society of Cardiology Heart Failure Update meeting, held in Wroclaw, Poland, in June 2004 are reported. The SHAPE study identified a need to educate general practitioners (GPs) in order to optimise treatment of heart failure in primary care. BRING-UP 2 VAS showed that cognitive impairment is very common in elderly heart failure patients and that these patients require specialist care. Carvedilol was shown to be well tolerated and effective in elderly heart failure patients in the observational COLA II study. In the FOSIDIAL study of patients with end-stage renal disease, fosinopril showed no benefit over placebo in reducing the incidence of cardiovascular events in these high-risk patients. The BETACAR study showed that carvedilol and metoprolol produced a similar effect on left ventricular ejection fraction (+13.1% and +12.0%, respectively). Revised mortality data for the CASINO study and a meta-analysis of the effects of cardiac resynchronisation therapy on mortality in the light of the recently published COMPANION study are reported.

Adrenergic beta-Antagonists↗
PubMed2004

Variation in activity rates of consultant surgeons and the influence of reward structures in the English NHS.

OBJECTIVES: To explore variation in the National Health Service (NHS) activity rates of consultant surgeons, and examine whether activity is dependent upon the type of contract held and/or bonus payments, after accounting for age and other consultant and hospital characteristics. METHODS: NHS Hospital Episode Statistics (HES) for England were used in combination with workforce data in five surgical specialties in 1998/99 and 1999/2000. Descriptive statistics were used to explore variation in activity rates. A multi-level model was used to analyse the relationship between NHS contract and bonus payments, and activity. RESULTS: There is considerable variation in activity rates of English NHS consultant surgeons, with and without adjustment for casemix. Interquartile variation shows that the top 25% of consultants have activity rates 60 to 85% higher than the bottom 25%. A multi-level model indicates that consultant surgeons with a 'maximum part-time' contract have significantly higher activity rates than those with a full time contract (129 more finished consultant episodes (FCEs) per year, 95% CI 97-160). Consultant surgeons who hold discretionary salary points undertake significantly more activity than those without (95 FCEs, 95% CI 62-128). Those with a distinction award (a type of bonus payment) have a tendency towards higher activity rates, but this does not reach statistical significance (48 FCEs, 95% CI -4 to 103). CONCLUSIONS: 'Maximum part-time contract' status is associated with higher absolute activity rates among NHS surgeons. Rich data sources like HES merit careful exploration and increased use as an essential first step in measuring and managing variations in specialists' performance.

Analysis of Variance↗
PubMed2003

The CHARM programme.

Explore the source record for details and available documents.

Angiotensin II Type 1 Receptor Blockers↗
PubMed2003

Meta-analysis of brain weight in schizophrenia.

Brain weight is often said to be decreased in schizophrenia, but a reduction has only been found in a minority of studies. We have therefore carried out a meta-analysis to answer this basic neuropathological question. Data were identified from literature searches and from contacting researchers in the field who were invited to submit unpublished data. Inclusion criteria were: an operational diagnosis of schizophrenia, or comparison subjects with no neurological or psychiatric history, aged 18 or over, for whom brain weight, age and sex were known. Exclusion criteria were: a history of head injury, epilepsy, substance dependence or leucotomy; neuropathological evidence of neurodegenerative disorder or focal brain lesion. Results were analysed by multilevel modelling. Brain weight was, as expected, related to age and sex (both p<0.0001). After control for these factors, there was an effect of diagnosis, with brains from the 540 schizophrenia subjects being 2% lighter than from the 794 controls (weighted mean difference=24 g [95% confidence interval, 1-47 g]; p=0.04). The difference was similar in male and female patients. There was no correlation with duration of illness. In conclusion, brain weight is slightly but significantly reduced in schizophrenia, consistent in direction and magnitude with MRI volumetric findings. The result encourages a continuing search for the histological and molecular correlates of schizophrenia.

Adolescent↗
PubMed2003

Composite outcomes in randomized trials: greater precision but with greater uncertainty?

Composite outcomes, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency. However, such measures may prove challenging for the interpretation of results. In this article, we examine the use of composite outcomes in major clinical trials, assess the arguments for and against them, and provide guidance on their application and reporting. To assess incidence and quality of reporting, we systematically reviewed the use of composite end points in clinical trials in Annals of Internal Medicine, BMJ, Circulation, Clinical Infectious Diseases, Journal of the American College of Cardiology, JAMA, Lancet, New England Journal of Medicine, and Stroke from 1997 through 2001 using a sensitive search strategy. We selected for review 167 original reports of randomized trials (with a total of 300 276 patients) that included a composite primary outcome that incorporated all-cause mortality. Sixty-three trials (38%) were neutral both for the primary end point and the mortality component. Sixty trials (36%) reported significant results for the primary outcome measure but not for the mortality component. Only 6 trials (4%) were significant for the mortality component but not for the primary composite outcome, whereas 19 trials (11%) were significant for both. Twenty-two trials (13%) were inadequately reported. Our review suggests that reporting of composite outcomes is generally inadequate, implying that the results apply to the individual components of the composite outcome rather than only to the overall composite. Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials.

Data Interpretation, Statistical↗
PubMed2003

Clinical trials update from the European Society of Cardiology: CHARM, BASEL, EUROPA and ESTEEM.

This article contains a series of reports on recent research developments in the field of heart failure. Reports of key presentations made at the European Society of Cardiology meeting, held in Vienna, Austria, between 30 August and 3 September 2003 are reported. In the CHARM study, candesartan reduced cardiovascular deaths and hospital admissions for heart failure, both in patients who were already taking an ACE-inhibitor and in those who were ACE intolerant. However, results in patients with preserved left ventricular function were less conclusive. The BASEL study supports the use of B-type natriuretic peptide testing to confirm the diagnosis of heart failure in patients presenting with acute dyspnoea. In EUROPA, the largest ever study of secondary prevention of coronary artery disease, long-term treatment with perindopril reduced the incidence of cardiovascular death, myocardial infarction (MI) and cardiac arrest. The ESTEEM study showed that the oral thrombin inhibitor ximelagatran plus aspirin was more effective than aspirin alone in the prophylaxis of major cardiovascular events following MI.

Angiotensin Receptor Antagonists↗
PubMed2003

A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?

Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.

Australia↗