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- November 19, 2008 |
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"Cardiovascular disease trials with implications for diabetes: Getting the evidence in the modern era"Prof. Timothy Davis (biography)
English - 2008-02-05 - 35 minutes
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Summary :
Professor Davis reviews several cardiovascular trials with implications for diabetes that have been conducted in recent years, with a focus on understanding the results. There are certain potential influences on clinical trials to keep in mind: the decrease in effect size due to the Hawthorn effect on the placebo group and due to more intensive management approaches, and the decrease in the number of involved patients when a new treatment is approved.
The DIGAMI-1 study was a randomized prospective study conducted from 1990 to 1995 that suggested a significantly lower mortality rate among diabetic patients treated with insulin therapy following an acute myocardial infarction. However, it was not clear from this study whether the benefits observed were a result of the acute insulin administration as opposed to the long-term effects of insulin therapy, of the avoidance of sulphonylurea and its cardiotoxic effects, or of other influences altogether.
Thus, DIGAMI-2 was conducted to elaborate these findings with the creation of an arm of patients receiving acute insulin/glucose therapy with conventional long-term treatment. However, there were no statistically significant differences between the three groups and the overall mortality rate was lower than in the intensive group of DIGAMI-1. This may in part be explained by the greater take-up of cardiovascular therapies that took place during this second study. It was concluded that such modern intensive management can reduce event rates and mask the potential effects of new therapies.
Next, Professor Davis discusses the PROACTIVE study, which aimed to characterize the safety of pioglitazone and to demonstrate that it reduces total mortality and macrovascular morbidity in high-risk patients with type-2 diabetes. The endpoint, however, was non-significant because of fewer events in the group taking pioglitazone than in the control group. Thus, Professor Davis explains, the selection of primary endpoints must be carefully conducted in order to yield clinically significant results.
Also, a study by the name of FIELD was conducted in order to provide the first randomized evidence of the effect of fenofibrate on the risk of major coronary disease events in diabetic patients. The main problem that occurred in the setting of this trial was that the Heart Protection Study reported benefits from use of statin treatment in all patients. As statin drop-ins were not prohibited by the FIELD protocol, these increased, especially in the control group, which was not receiving the HDL-increasing benefits of fenofibrate. It is therefore important to consider the impact of time-dependent effects on endpoints. Also, fenofibrate may have had an pleiotrophic effect on renal function and homocysteine levels.
The ASPEN study investigated the potential cardiovascular benefits of atorvastatin. The results were not satisfactory, mainly because of the participation of a number of low-risk patients. Professor Davis explains that trials conducted with low risk patients require a greater number of participants than those with high-risk patients.
The ASCOT trial, though not directly related to diabetes, shows the consequences of stopping rules on the results. The blood pressure lowering arm of this study was stopped early due to higher mortality and other secondary endpoints, which led to inconclusive results concerning the primary endpoint, non-fatal myocardial infarction and fatal coronary heart disease.
Professor Davis closes by saying that, with such background challenges, cardiovascular trials are becoming harder to perform.
Copyright © 2008 E-MedHosting.com Inc.
Learning objectives :
After viewing this presentation the participant will be able to discuss:
The reasons for recent negative results in CVD trials with implications for diabetes, specifically -
DIGAMI 2
PROACTIVE
FIELD
ASPEN
ASCOT-BPLA
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