Pivotal Clinical Trials

Question 1

What was the ASCOT trial?

Answer 1

Anglo-Scandinavian Cardiac Outcomes Trial
Presented to British Hypertension Society in 1996 and launched in 1997 at Royal College of Physicians.
It was a RCT with almost 20,000 patients, done to compare the effect on non-fatal MI and fatal CHD of the standard antihypertensive regimen with a more contemporary regimen. It also compared the effect on non fatal MI and fatal CHD of a atorvastatin 10mg vs. placebo among patients with a total cholesterol < 6.5 mmol/l.

Question 2

What was the standard antihypertensive regimen in the ASCOT trial?

Answer 2

Atenolol
+/- bendroflumethiazide + K
+/- doxazosin

Question 3

What was the new antihypertensive regimen in the ASCOT trial?

Answer 3

Amlodipine
+/- Perindopril
+/- Doxazosin

Question 4

What did the ASCOT trial find with regards to the new antihypertensive regimen?

Answer 4

Amlodipine ± perindopril based therapy confers an

advantage over atenolol ± thiazide based therapy on all major CV end points, all-cause mortality and new-onset diabetes.

Question 5

Compared with standard antihypertensive therapy without statin therapy, the amlodipine ± perindopril regimen plus atorvastatin reduced coronary and stroke events by how many %?

Answer 5

Almost 50%

Question 6

What is Torcetrapib?

Answer 6

Potent and selective inhibitor of CETP (which metabolises cholesterol), so raises HDL-c and lowers LDL-c.

Question 7

Why was torcetrapib’s development stopped?

Answer 7

The trial was terminated based on a statistically significant excess of deaths and cardiovascular events in the group treated with torcetrapib.