CARDS study demonstrates benefits of atorvastatin
Lipitor significantly reduces heart attacks and strokes in patients with diabetes, according to data presented at this year’s meeting of the American Diabetes Association in Orlando. In the Collaborative Atorvastatin Diabetes Study (CARDS), which involved more than 2800 patients with type 2 diabetes, no history of heart disease, and relatively low levels of cholesterol, patients who took Lipitor had a 37% reduction in major CV events.
In addition, 48% fewer Lipitor-treated patients experienced strokes compared with those who received placebo, and the overall mortality rate for Lipitor patients was 27% lower than for those on placebo. ‘This important study has demonstrated that lowering cholesterol with atorvastatin in patients with diabetes (even those whose LDL levels were relatively low) will result in a dramatic cardiovascular benefit,’ said Professor Helen Colhoun, CARDS co-principal investigator, University College Dublin.
‘The benefit was so great that the trial had to be terminated early. CARDS demonstrates that statin therapy can be of great benefit to the vast majority of diabetes patients, and that atorvastatin is highly effective and safe.’
Levemir launched in the UK
The launch of the new long-acting basal insulin Levemir (insulin detemir) was announed on 21 June 2004. Levemir has a predictable action, giving similar blood glucose levels day after day compared with existing basal insulin preparations.
Proposed benefits include: increased predictability; fewer hypoglycaemic events; more effective glycaemic control; and no undesirable weight gain. According to Anne Dornhorst, consultant physician in London: ‘There are enough variables in diabetes on a day-to-day basis as it is; what you don’t need is for your insulin to be another one.’
Relief from diabetic neuropathic pain on the horizon
Long-term relief from chronic pain arising from diabetic neuropathy can be achieved satisfactorily with the anticonvulsant pregabalin, according to data presented at the American Diabetes Association meeting in Florida in June 2004. Pregabalin is currently in development as a treatment for neuropathic pain and epilepsy.
Neurologist Professor Russell Portenoy, of Beth Israel Hospital in New York City, and colleagues examined Visual Analogue Pain Scores (VAS) from a cohort of 217 patients with diabetic neuropathy or post-herpetic neuralgia who had at least one year’s exposure to pregabalin during open-label phases of fixed-dose randomised double-blind trials, initially run for 5 to 12 weeks. An effective dose is usually between 300–600mg tds or bd. However, during the one-year extension phase, patients had the option to increase or reduce the dose as required.
Results show patients experienced good pain relief from pregabalin compared to placebo and those receiving the drug during the open-label extension phase did not develop tolerance or need to increase the dose over time, say the researchers.
VALUE trial — 23% drop in new-onset diabetes with valsartan
A 23% relative risk reduction in new-onset diabetes over 4 years was observed in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial presented at the European Society of Hypertension meeting on 14 June and published simultaneously on-line by The Lancet. The 15,245-patient trial set out to see if, for the same blood-pressure control, an angiotensin receptor blocker-based treatment regimen using valsartan would reduce cardiac morbidity and mortality more than a calcium channel blocker-based regimen using amlodipine in hypertensive patients at high cardiovascular risk. The answer was negative. Patients receiving amlodipine achieved better and earlier blood pressure control, significantly reducing their risk of fatal and non-fatal myocardial infarction more than those on valsartan-based treatment (p=0.02).
Valsartan’s reduction in new-onset diabetes was statistically significant. However, some experts said that similar reductions were found in the LIFE (Losartan Intervention for Endpoint reduction in hypertension) trial and in most recent antihypertensive trials. Professor Bryan Williams of Leicester University said the study confirms people at high risk of developing diabetes are better off avoiding blood pressure-lowering combinations primarily using beta-blockers or diuretics. The real importance of VALUE was demonstrating the importance of establishing effective blood pressure control quickly, he commented.
PROactive trial focuses on CVD and type 2 diabetes
The landmark PROspective PioglitAzone Clinical Trial In MacroVascular Events Study (PROactive) is a European clinical trial assessing the effects of Actos (pioglitazone HCl) on mortality and morbidity associated with cardiovascular disease progression in patients with type 2 diabetes. The study has enrolled 5,238 patients in 19 countries who have experienced one or more cardiovascular events such as a heart attack, coronary artery bypass surgery or stroke.
‘Major studies have shown that sustained improvements in glycaemic control significantly reduce the risk of some microvascular complications, but data remain inconclusive that intervention with conventional glucose-lowering agents is successful in modifying macrovascular disease,’ said John Dormandy MD, Professor of Vascular Sciences at St George’s Hospital, London, and Chairman of the PROactive study steering committee.
‘Recent studies have shown Actos has a beneficial effect on markers of cardiovascular risk, such as atherogenic lipids and c-reactive protein (CRP). Through PROactive, we will determine if the beneficial effects of Actos on cardiovascular risk factors translate into a reduction in cardiovascular mortality and morbidity in a high-risk population of patients with type 2 diabetes.’