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Presentation Outline ICHP Annual Meeting September 13-15

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70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

Inhaled Iloprost Added to Bosentan<br />

(STEP)<br />

0<br />

Mean 6MWD Change<br />

from Baseline (m)<br />

Bosentan<br />

+ Iloprost<br />

(n=32)<br />

p=0.051 0 051<br />

Bosentan<br />

+ Placebo<br />

(n=33)<br />

1.00<br />

0.75<br />

0.50<br />

0.25<br />

*log-rank test.<br />

McLaughlin VV, et al. Am J Respir Crit Care Med. 2006;174:1257-1263.<br />

Proportion Free of<br />

Clinical Worsening Iloprost<br />

Placebo<br />

p=0.02*<br />

0.00<br />

0 28 56 84<br />

Time (d)<br />

Inhaled Treprostinil Added to Bosentan or<br />

Sildenafil (TRIUMPH)<br />

Meters<br />

30<br />

25<br />

20<br />

<strong>15</strong><br />

10<br />

5<br />

Change in Peak 6MWD<br />

by Specific Combination:<br />

6<br />

Background<br />

sildenafil<br />

Background<br />

bosentan<br />

Entire population<br />

22<br />

7<br />

6<br />

11<br />

25<br />

0<br />

Day 1 Week 6<br />

Time<br />

Week 12<br />

McLaughlin VV, et al. J Am Coll Cardiol. 2010;55:19<strong>15</strong>-1922.<br />

19<br />

9<br />

20<br />

Change from baselinee<br />

> defined value (meterss)<br />

% Achieving Specific<br />

6MWD Improvements<br />

Placebo<br />

Inhaled treprostinil<br />

50<br />

12<br />

31<br />

45<br />

14<br />

35<br />

40<br />

17<br />

37<br />

35<br />

22<br />

39<br />

30<br />

28<br />

43<br />

25<br />

32<br />

48<br />

20<br />

32<br />

52<br />

0 20 40 60<br />

Percentage of patients<br />

Combination Therapy Caveats<br />

• Experience evolving<br />

• Most data from ‘add-on’ - ? De novo? Order?<br />

• More drugs available<br />

– more options<br />

– more ways to get it wrong<br />

• More questions than answers<br />

• Costs/expenditures; third-party hurdles<br />

Taichman DB. Ann Intern Med. 2008;149:583-585.<br />

21

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