1 / 17

IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 3

IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 345:870-878, 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of Nephrology Section of Nephrology Rush University Medical Center Chicago, IL. Definitions IRMA-2.

meris
Télécharger la présentation

IRMA-2 Trial ( IR besartan in M icro A lbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 3

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IRMA-2 Trial (IRbesartan in MicroAlbuminuria, Type 2 Diabetic Nephropathy Trial) HH Parving et al N Eng J Med 345:870-878, 2001 Edmund J. Lewis, M.D. Muehrcke Family Professor of Nephrology Section of Nephrology Rush University Medical Center Chicago, IL

  2. DefinitionsIRMA-2 Measure of Albuminuria: • Overnight urine albumin for 3 consecutive days • AER 20-200 µG/min in 2 of 3 consecutive overnight urine samples • Urine albumin determined by nephelometry Primary efficacy measure: • Time to event from baseline visit to overt nephropathy (AER >200 µG/min and at least 30% higher than baseline on 2 consecutive visits).

  3. Secondary OutcomesIRMA-2 • Changes in level of albuminuria • Restoration of normal albumin excretion rate AER <20 µG/min) by the time of the last visit

  4. Some relevant points about studying microalbumunuria. (CSG: Pilot trial of sulodexide in microalbuminuria associated with type 2 diabettes)

  5. 24 Hr Albumin ExcretionvsMean Albumin/Creatinine Ratio (MACR) (3 Consecutive First Morning Voids)

  6. 24 Hr Albumin/Creatinine RatiovsMean Albumin/Creatinine Ratio (MACR) (3 Consecutive First Morning Voids)

  7. Variance in Albumin Parameters

  8. Within Patient Variation in MACR (3 Consecutive First Morning Voids) Average CV of 3 consecutive voids = 33%

  9. IRMA-2 Trial Irbesartan

  10. IRMA-2 Trial Change in Albumin Excretion

  11. IRMA-2 Trial Unadjusted hazard ratio for overt diabetic nephropathy HR 95% CI P irbesartan 150 mg 0.61 0.34-1.08 <0.08 irbesartan 300 mg 0.30 0.14-0.61 <0.001 Adjusted hazard ratio (baseline AER, BP) irbesartan 150 mg 0.56 0.31-0.99 0.05 irbesartan 300 mg 0.32 0.15-0.65 <0.001

  12. IRMA-2 TrialH.H.Parving et al, NEJM 345:870-878, 2001

  13. IRMA-2 Trial Restoration of Normoalbuminuria

  14. IRMA-2 Trial Mean Arterial Blood Pressure

  15. Conclusions IRMA-2 • Irbesartan was effective in diminishing the rate of progression from “microalbuminuria” to “overt nephropathy” • This effect was dose dependent • This study did not document the long-term durability of the result. • Taken with the results of IDNT, this effect appeared to be a valid surrogate in this patient population.

  16. Potential End Points For Study of Microalbuminuria in Type 1 or Type 2 diabetes mellitus • decreased albumin excretion rate • decreased progression from “microalbuminuria” (albumin excretion <300 mg/day) to overt nephropathy (>300 mg/day) • regression of albuminuria (normalize or “significantly reduce”

  17. Redefining the Categories of Diabetic Nephropathy 0 30 300 mg/d Normal Microalbuminuria Overt ACEi ARB Normal Early diabetic glomerulopathy Overt New Therapies

More Related