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Phase 3 Short-term. Diuretic Treatment of Edema – Week 24. 3 - 3 - 42. Heart Failure vs. Edema. Phase 2 and 3 Short-term and Long-term. † Data available for phase 3 only. 4 - 54. Microscopic Hematuria – Urology Consultations. Phase 2 and 3 Short-term and Long-term.

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Presentation Transcript
heart failure vs edema
Heart Failure vs. Edema

Phase 2 and 3 Short-term and Long-term

†Data available for phase 3 only

4 - 54

microscopic hematuria urology consultations
Microscopic Hematuria – Urology Consultations

Phase 2 and 3 Short-term and Long-term

Subjects Referred to Urologic Consultation (N = 89)

Completed Consultation (N = 85)

  • Did Not Complete Consultation (N = 4):
    • 3 refused consultation
    • 1 discontinued early from study

Normal Consults (N = 41)

  • Clinical Findings (N = 44):
    • Kidney stones (N = 11)
    • Infections (N = 9)
    • Prostate disease (N = 5)
    • Inflammation (N = 5)
    • Bladder cancer (N = 2)†
    • More than 1 finding (N = 4)
    • Miscellaneous (N = 8)††

† 2 additional bladder cancers (recurrences)

† † e.g. Pyuria, suture materials, urethral obstruction, cystic cystitis

3 - 1 - 12

urolithiasis incidence
Urolithiasis Incidence

Phase 2 and 3 Short-term and Long-term

Incidence per 1,000 patient-years (n)

3 - 1 - 14

summary bladder cancer
Summary – Bladder Cancer

Phase 2 and 3 Short-term and Long-term

  • 4 cases (2 on Mura, 2 on Pio)
    • 2 recurrent cases
      • Mura 10 mg – onset D58
      • Pio 15 / 45 mg – onset D256
    • 2 new-onset cases
      • Mura 10 mg – onset D573
        • Relevant PMH: microscopic hematuria at baseline, smoking history
      • Pio 30 mg – onset D170
        • Relevant PMH: foundry, carpet warehouse worker
    • Males, age range 62-71 years
    • 2 subjects with history of smoking
    • 3 cases identified as superficial or non-invasive

3 - 1 - 17

observed and expected incidence rates for bladder cancer
Observed and Expected Incidence Rates for Bladder Cancer

Phase 2 and 3 Short-term and Long-term

aPharMetrics Research Database – Integrated claims from 2000-2003

3 - 1 - 15

change from baseline in a1c by quartiles of change from baseline in weight at week 24 locf

Monotherapy Studies

Change from Baseline in A1C by Quartiles of Change from Baseline in Weight at Week 24 (LOCF)

Muraglitazar 5 mg

 B/L in Weight (kg)

n =

Baseline Mean (%)

≤ 0

127

8.47

0 – 2.0

93

8.69

2.0 – 4.1

107

8.66

>4.1

108

9.0

 A1C (%)With95% CI

-1.24

-1.23

-1.50

-2.11

006 ST, 018 ST + OL

3 - 5 - 20

in db db mice muraglitazar improves insulin sensitivity increases insulin content in the pancreas
In db/db Mice, Muraglitazar Improves Insulin Sensitivity, Increases Insulin Content in the Pancreas

oGTT

Pancreas – Insulin

Glucose

(mg/dL)

Insulin

(ng/mL)

  • db/db mice (~10 week old) were treated for2 weeks; Animals were overnight fasted.* p < 0.05 vs vehicle

Minutes After Glucose

Administration

8 - 27

muraglitazar prevents loss of pancreatic islet insulin content in pre diabetic db db mice
Muraglitazar Prevents Loss of Pancreatic Islet Insulin Content in Pre-Diabetic db/db Mice

Insulin (islet)

Insulin (pancreas)

Vehicle

Mura

(10 mg/kg)

  • ~ 5 week old db/db mice were treated for 12 weeks; Insulin staining after 8 weeks
  • Animals were fasted overnight. *p <0.05 vs vehicle

8 - 30

plot of mean change from baseline in a1c at week 24 locf by race

White

Black

Study

Dose

Other

Mura 5

CV168006

CV168018

Mura 2.5

Mura 5

CV168021

Mura 2.5 + Gly

Mura 5 + Gly

CV168022

Mura 2.5 + Met

Mura 5 + Met

CV168025

Mura 5 + Met

-2.0

-1.5

-1.0

-0.5

0.0

0.5

Change from Baseline A1C (%)

Plot of Mean Change from Baseline in A1C at Week 24 (LOCF) by Race

1g - 1

plot of mean change from baseline in a1c at week 24 locf by ethnicity

Hispanic/Latino

Study

Dose

Mura 5

CV168006

Non-Hispanic/Latino

CV168018

Mura 2.5

Mura 5

CV168021

Mura 2.5 + Gly

Mura 5 + Gly

CV168022

Mura 2.5 + Met

Mura 5 + Met

CV168025

Mura 5 + Met

-2.0

-1.5

-1.0

-0.5

0.0

0.5

Change from Baseline A1C (%)

Plot of Mean Change from Baseline in A1C at Week 24 (LOCF) by Ethnicity

1h - 1

mean hemoglobin levels over time week 24

Mura 0.5 mg

Mura 1.5 mg

Mura 5 mg

Mura 10 mg

Mura 20 mg

Pio 15 mg

Mean Hemoglobin Levels Over Time – Week 24

Dose-Ranging Study

Hemoglobin (g/dL)

Week

Study 006 ST

3 - 7 - 25

aes of anemia 24 weeks
AEs of Anemia – 24 Weeks

Phase 2 and 3, Short-term

  • 1 SAE of anemia on muraglitazar 5 mg (GI bleeding)
  • 1 SAE of anemia on pioglitazone 30 mg (gastric bleeding)
  • 2 subjects on muraglitazar were discontinued due to anemia

3 - 7 - 32

change from baseline in anc at week 24
Change from Baseline in ANC at Week 24

Dose-Ranging Study

Muraglitazar

Study 006 ST

3 - 7 - 5

number of subjects with anc 1000 on 2 consecutive visits
Number (%) of Subjects with ANC < 1000on 2 Consecutive Visits
  • No cases were associated with clinical sequelae
  • 2 subjects on muraglitazar discontinued

Phase 2 and 3 ST + 006 LT

3 - 7 - 2

cv mortality in combination therapy studies
CV Mortality in Combination Therapy Studies

Events / 1000 PY Exposure (n)

HR = hazard ratio relative to Pbo / Pio.

SA - 39

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