LANDMARK CLINICAL TRIAL DEMONSTRATES THAT DILATREND THERAPY IS WELL TOLERATED IN ELDERLY PATIENTS WITH CHRONIC HEART FAILURE

Results of the COLA II (Carvedilol Open Label Assessment) study, which investigated the tolerability of Dilatrend (carvedilol) treatment in elderly chronic heart failure (CHF) patients, were released today at the European Heart Failure Meeting, Wroclaw, Poland. This study of more than 1,000 CHF patients aged 70 years or older has established that Dilatrend therapy was well tolerated in 80% of cases and that with appropriate monitoring elderly CHF patients should not be denied this effective therapy because of tolerability concerns.

Results of the COLA II (Carvedilol Open Label Assessment) study, which investigated the tolerability of Dilatrend (carvedilol) treatment in elderly chronic heart failure (CHF) patients, were released today at the European Heart Failure Meeting, Wroclaw, Poland. This study of more than 1,000 CHF patients aged 70 years or older has established that Dilatrend therapy was well tolerated in 80% of cases and that with appropriate monitoring elderly CHF patients should not be denied this effective therapy because of tolerability concerns.Large-scale, multinational clinical trials in over 10,000 patients have provided conclusive proof of the benefits of beta-blocker therapy in CHF. Beta-blockers, when used in conjunction with ACE inhibitors and diuretics, have been shown to reduce mortality by 30% and reduce hospitalisation by 40%, prompting Australian, American and European CHF practice guidelines to endorse the use of beta-blockers in all CHF patients unless specifically contraindicated. However, the elderly have comprised only a small minority of patients in these studies, therefore it has remained uncertain whether the benefits of beta-blockade extend to this population.?Compelling clinical trial evidence indicates that beta-blockade provides significant survival benefits to patients with CHF, however, elderly patients have comprised only a small minority of patients in these studies. The results of the COLA II trial indicate that Dilatrend, a beta-alpha blocker, is very well tolerated in the elderly and therefore provided that these patients are appropriately monitored they should no longer be denied beneficial treatment with this drug due to concerns over tolerability? says Professor Henry Krum, University of Monash, VIC, lead investigator in the COLA II trial.?Physicians need to be aware of the potential for adverse effects upon the initiation of beta-blocker therapy. These adverse effects can be minimised by a combination of treatment initiation at a low dose, slowly increasing the dose and monitoring the patient carefully? says Professor Krum.The primary objective of the COLA II study was to assess the tolerability of Dilatrend therapy in an elderly patient population. This open label study recruited patients over 70 years of age with symptomatic CHF and was conducted in multiple centres in nine countries, including Australia. Patients were assessed at baseline (before initiation of Dilatrend) and were monitored for 6 months. Tolerability was defined as receiving a minimal twice-daily Dilatrend dose of 6.25mg by the end of the six-month study period. Additionally, each patient must have received Dilatrend therapy for at least three months during the six-month study. Analysis of 1,009 CHF patients aged 70 years or over revealed that the overall tolerability rate for Dilatrend therapy in these patients was 80% (70 ?75 years, 84%; 76 ? 80 years, 77%; >80 years, 77%). Furthermore, tolerability was maintained even in patients with obstructive airways disease (72%) or diabetes (85%), both co-morbid diseases in which beta-blockade is considered to be contraindicated to some degree.?Elderly patients represent the majority of CHF patients seen in general practice, therefore the results of this study are particularly welcome. We can now be far more confident in prescribing Dilatrend to the patients who will benefit most from this therapy, even in those patients with co-morbidities? says Dr Damian Flanagan, General Practitioner, Blairgowrie, Victoria.Elderly patients represent a significant and rapidly growing proportion of the CHF patient population. There is a clear relationship between incidence of CHF and advancing age. The Cardiac Awareness Survey and Evaluation (CASE) study, investigating CHF in Australian general practice, found that more than one-third of patients aged 70 years or over seen in general practice suffered from CHF. Although no data exists regarding the incidence of heart failure in Australia, hospitalisation rates in which heart failure was the principal diagnosis indicate that the vast majority of hospitalisations due to CHF occur in patients over 70 years of age. The number of elderly CHF patients is likely to increase significantly as the Australian population aged 65 and over is projected to rise from 1.3 million in 2002 to 2.2 million (or 22% of the population) by 2030.Dilatrend is a unique heart failure medication known as a beta-alpha blocker, which works on a wider range of receptors in the heart and blood vessels than conventional beta-blockers. Dilatrend has been shown to significantly decrease mortality in patients with mild to moderate heart failure by 65% and severe heart failure by 35%.