<International Circulation>: Could you talk about the main improvements in studies in the last 15 years and why we can see more precise results?
Prof. Kjeldsen: We have better protocols, larger sample sizes, better statistical power and better follow-up. There is much less discontinuation in these mass clinical trials. We get better precision. Differences are not overwhelming, but we get statistical significance.
<International Circulation>: In ACCOMPLISH, the biggest difference was the drop in cardiovascular endpoint in patients taking the CCB ACE inhibitor?
Prof. Kjeldsen:Yes, that’s right. There was a 20% reduction in the primary cardiovascular endpoint.
<International Circulation>: There didn’t seem to be much drop in blood pressure.
Prof. Kjeldsen: Blood pressure was the same. Blood pressure came down. Both office blood pressure and ambulatory blood pressure were the same with ACE and ACE CCB combination. Despite that there was a difference in the primary cardiovascular endpoint which was 20%. Still, in my opinion, the most important thing is to get the blood pressure down but there may be certain benefits from certain drug combinations, RAS inhibitor, CCB on top of standard treatment for blood pressure.
<International Circulation>: Do you have any idea why it brought down the cardiovascular endpoint if it did not bring down blood pressure?
Prof. Kjeldsen: There are benefits beyond the lowering of blood pressure. The atherosclerotic process as we saw in another presentation by Carlos Ferrario shows how these drugs work on the atherosclerotic process. They work on thrombosis, plaque formation, lipids and other additional effects beyond blood pressure. This can be explained from animal and experimental research.
<International Circulation>: Could you speak about treatment for diabetic and non-diabetic patients? How is treatment different or in your opinion, how should treatment be different?
Prof. Kjeldsen: It should not be different; it should actually be the same. We’ve shown in ACCOMPLISH, 60% of the study population had hypertension and diabetes and had the same good benefit from the ACE CCB combination as the non-diabetics. Similarly in all these hypertension trials, diabetic subgroup may have more endpoints, but the benefit from new drugs compared to standard treatment is more or less the same then non-diabetics. It is an important messagesince controlling hypertension is the number one issue for diabetics.
<International Circulation>: What do you think of blood sugar and lipid levels on hypertension in diabetic patients?
Prof. Kjeldsen:That is complicated. The effect on hypertension is the effect on lowering blood pressure, but it is important to give statins to control lipids in diabetics. The question in the long-term will be to see how they should control the glucose in diabetic patients. But the trials have not yet been that successful, they have been struggling so far for controlling glucose in diabetes, but over time we may find better ways of doing it.
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