Avapro Clinical Pharmacology

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Avapro - Clinical Pharmacology [Irbesartan]

Table 1.
IDNT: Components of Primary Composite Endpoint
AVAPRO N=579 (%) Comparison with placeboComparison with amlodipinePlacebo N=569 (%) Hazard Ratio 95% Cl Amlodipine N=567 (%) Hazard Ratio 95% Cl Primary Composite Endpoint 32.639.00.800.66-0.97 (p=0.0234) 41.10.770.63-0.93Breakdown of first occurring event contributing to primary endpoint2x creatinine14.219.5--22.8--ESRD7.48.3--8.8--Death11.111.2--9.5--Incidence of total events over entire period of follow-up2x creatinine16.923.70.670.52-0.8725.40.630.49-0.81ESRD14.217.80.770.57-1.0318.30.770.57-1.03Death15.016.30.920.69-1.2314.61.040.77-1.40

The secondary endpoint of the study was a composite of cardiovascular mortality and morbidity (myocardial infarction, hospitalization for heart failure, stroke with permanent neurological deficit, amputation). There were no statistically significant differences among treatment groups in these endpoints. Compared with placebo, AVAPRO significantly reduced proteinuria by about 27%, an effect that was evident within 3 months of starting therapy. AVAPRO significantly reduced the rate of loss of renal function (glomerular filtration rate), as measured by the reciprocal of the serum creatinine concentration, by 18.2%.

Table 2 presents results for demographic subgroups. Subgroup analyses are difficult to interpret and it is not known whether these observations represent true differences or chance effects. For the primary endpoint, AVAPRO's favorable effects were seen in patients also taking other antihypertensive medications (angiotensin II receptor antagonists, angiotensin converting enzyme inhibitors and calcium channel blockers were not allowed), oral hypoglycemic agents, and lipid-lowering agents. Table 2.

IDNT: Primary Efficacy Outcome Within Subgroups
Baseline Factors AVAPRO N=579 (%) Comparison with placeboPlacebo N=569 (%) Hazard Ratio 95% ClGenderMale27.536.70.680.53-0.88Female42.344.60.980.72-1.34RaceWhite29.537.30.750.60-0.95Non-White42.643.50.950.67-1.34Age (years) <6531.839.90.770.62-0.97>6535.136.80.880.61-1.29