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Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

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Hexabrix Key Clinical Review Study Objective(s): To compare data from the SCAAR registries in order to asses contrast media induced renal failure.

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Page 1: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review Liss, 2006

Mid-Year Sales MeetingBloomington, IN

July 13th – 17th

Page 2: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Title:Renal Failure in 57,925 Patients Undergoing Coronary Procedures Using Iso-Osmolar or Low-Osmolar Contrast Media

Main Author: Dr. P. Liss

Publication: Kidney International

Date: 2006

Page 3: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Study Objective(s):

To compare data from the SCAAR registries in order to asses contrast media induced renal failure.

Page 4: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Patient Population Details:

57,925 patients from 23 hospitals in SwedenData collected from 2000-2003 (1990 to include iohexol)Coronary procedures only (angiography or PCI)Patients at risk (diabetic or with previous renal failure) were evaluated separately to avoid bias.

Page 5: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Endpoints:

Does not rely on serum creatinine concentration as a marker for the potential development of renal failure. Incidence of kidney damage is assessed by re-hospitalization with a diagnosis of renal failure or required dialysis.

Page 6: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Outcomes & Results:

Patients receiving Visipaque had a higher risk of being re-hospitalized with a diagnosis of renal failure.Diabetic patients receiving Visipaque, experienced clinically significant renal failure twice as often as those receiving Hexabrix.Authors conclude that they found no indication that the use of Visipaque results in less damage to the kidney than the use of Hexabrix.

Page 7: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Page 8: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Other Important Notes:

Retrospective, registry dataEven after statistical adjustments were made for bias, the results remained the same.Three year follow-up data presented at RSNA confirmed results again.

Page 9: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Role Play (15 min)

Pairs of 3 (MCP, MD & Observer)Each MCP detail the paper to groupBe sure to summarize the key points

Page 10: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th

Hexabrix Key Clinical Review

Examples of use in the field?

Page 11: Hexabrix Key Clinical Review Liss, 2006 Mid-Year Sales Meeting Bloomington, IN July 13 th – 17 th