TASK №12

The following situations define true and indirect efficacy criteria. In which case, you
can continue to use an indirect criterion for evaluating the clinical efficacy? For which
drugs?
In randomized clinical studies in 10,000 patients over 4 years showed that the ACEI
reduces the index of left ventricular mass by 15% in patients with left ventricular hypertrophy.
The incidence of cardiovascular complications in the experimental group, 20% lower than in the
placebo group.
In randomized clinical trials on 500 patients for 5 years shows that the ARB reduce
microproteinuria in hypertensive patients by 25%. The incidence of chronic renal failure in the
experimental group and the group treated with ACEI is the same.

Clinical Efficacy - Efficacy trials (explanatory trials) determine whether an intervention produces the
expected result under ideal circumstances.

For ACE Inhibitors

Amount of patients – 10,000

Years experiment conducted – 4
Percentage of reduction of left ventricular mass in patients with LVH – 15 %
Incidence of Cardiovascular complications – 20% lower than placebo group

For ARB

Amount of patients – 500

Years of experiment conducted – 5
Percentage of reduction of microproteinuria in hypertensive patients – 25%
Incidence of chronic renal failure in experimental group – Equals the group treated with ACEIs

Based on the clinical randomized data obtained we can evaluate that for ACEI a large amount of
patients were tested in comparison to Angiotensin Receptor Blockers.
And that the clinical efficacy of ACEIs is better than ARB when evaluated and compared.
It shows that ACEI fits the criteria of Primary endpoint – Prognosis improvement.

Therefore it can be identified as the drug to continue to indirect efficacy criteria ( Surrogate
endpoint ), to continue forward towards phase 4 of the clinical trials ( Post Marketing )