:

?

?

, ..., .
.,
GSK

Presentation Department Author

GSK

Presentation Department Author

(1,2)

43% 1

(3)

GSK

Presentation Department Author

1.

Spenser et al., 2002

2.

OReily et al., 2003

3.

onnors et al, 1996

,

( )

GSK

Presentation Department Author

GOLD 2009

(, )
1< 50%
(3 3
)


( )
GSK

Presentation Department Author

GOLD 2009

-2-

,
( )

GSK

Presentation Department Author


TRISTAN, VIVACE .

GSK

Presentation Department Author

6 1

Improvement in breathlessness
(Transition Dyspnoea Index)

2.5

.
*p<0.001 . , p=0.033 .

2.1*

1.5

,
2

1.3
0.9

0.5

0.4
0

50 g b.d.
500 g b.d.
GSK Presentation Department Author

50/500 g b.d.

1. Mahler DA et al. Am J Respir Crit Care Med 2002; 166: 1084-1091

2. Witek TJ and Mahler DA. J Clin Epidemiol 2003; 56: 248-255

TRISTAN:

1.0

0.75

50 2/

500 2/

50/500

2/

0.50

43%*

0.25

0
,
GSK

# p = 0.059
* p < 0.002

Presentation Department Author

Pauwels et al. ERS 2002

VIVACE:

34%

*
- ,
, ,

50 2/

50/500

p<0,0001

2/

1,4
0,92

Kardos P. et al., ERJ 2005; 26 (Suppl 49):292S;

Vogelmeier C et al. Abstract at the Nordic Lung Meeting,
Trondheim, Norway, June 9-11, 2005; GSK data on file

GSK

Presentation Department Author

GSK

Presentation Department Author

,
/

( )

1.0

0.9
0.8
0.7
0.6
0

12

18

24

30

36

GSK

Presentation Department Author

Soriano et al. Eur Respir J 2002

TOwards a Revolution in COPD Health

( )
GSK

Presentation Department Author

TORCH:

50/500 g 2 /
500 g 2 /
2

50 g 2 /

3
GSK

~ 6,200

Presentation Department Author

Calverley P.M.A. NEJM 2007; 356: 775-89

TORCH:

,
3
:



GSK

Presentation Department Author

Calverley P.M.A. NEJM 2007; 356: 775-89


, (%)

3
18
16
14
12
10
8
6
4
2
0
0

12

24 36 48

60 72 84

96

17,5%

156

()
GSK

Presentation Department Author

Calverley P.M.A. NEJM 2007; 356: 775-89

 -
3-

25%
12%

1,2

p < 0,001 vs ;
9% p = 0,002 vs ;

p = 0,024 vs

1,13
0,97*

0,93*

0,8

0,85*

0,6
0,4
0,2
0

GSK

Presentation Department Author

Calverley P.M.A. NEJM 2007; 356: 775-89

/ ,
1

1350
1300

-39 /*

1250
1200

-42 /
-42 /

1150

1110
0

24

48

72

96

120

-55 /
156

,
*p<0,001

GSK

Presentation Department Author

Celli B., e.a. Am J Resp Crit Care Med 2008; 178: 332-38
GOLD report 2009. Available from URL:http://www.goldcopd.com

- 30
- 39
- 42

- 42
- 55
GSK

Presentation Department Author

Celli e.a., AJRCCM 2008.


/
/ 50/500 2 /

(=0,001);
/


-

,


GSK

Presentation Department Author

Celli B., e.a. Am J Resp Crit Care Med 2008; 178: 332-38

,


...

Celli B.R., e.a. Am J Resp Crit Care Med 2008; 178: 332-8
Suissa S. Am J Resp Crit Care Med 2008; 178: 322-3



SGRQ ()

SGRQ

3
2
1

2
3
4
5

24

48

72
96
,

120

156

/

HO Pop Source Figure: 7.3.004

* p = 0,057 vs ; p < 0,001 vs ; p < 0,001 vs , ;

Calverley P.M.A. NEJM 2007; 356: 775-89


TORCH
/
, :


,







GSK

Presentation Department Author

 /
II-IV :

TORCH

 1
II-IV

0

-23
-28 -28
-34
-43
-49

-11 /
-56
1<30%

-40

-16 /

130 <50%

1 *, /
*

-40 -46 -44

-60

-16 /
1 >50%

Jenkins C.R., e.a. Resp Res 2009;10:59

. -

1,79

-14%
-26%

1,53 1,54
1,40

1,24
1,08
0,99
0,91

1<30%

130 <50%

-31%
0,82

0,71

0,68
0,57

1 >50%
Jenkins C.R., e.a. Resp Res 2009;10:59

, %
24,3 24,6 24,1

-30%
-5%

17,7

18,0
15,2

14,6

12,6

1<30%

130 <50%

11,4

-33%
9,2 9,9

7,8

1 >50%
Jenkins C.R., e.a. Resp Res 2009;10:59

 TORCH
- ,
.
2020 ,
.

.
TORCH
,
50/500

TORCH
,

GSK

Presentation Department Author


INSPIRE

( /)
() ,
,
104 ( 1< 50%)

,

1

SGRQ

& ,

V1 = 1
SGRQ =
- St
Georges
Respiratory
Questionnaire
GSK
Presentation
Department
Author

Wedzicha JA et al. Am J Respir Crit Care Med 2007

 INSPIRE

30 / +

50 2 /

50/500 2 /
(n=658)

2-

18 1 /
(n=665)

GSK

Presentation Department Author

Wedzicha JA et al. Am J Respir Crit Care Med 2007


44

29%
P=0,005

40
(%)

36
32
28
24
20

16

12
8
4
0

656
663

560
547

531
501

510
474

494
450

476
434

456
415

445
397

160
140

13

26

39

52

65

78

91

104

()
GSK

Presentation Department Author

Wedzicha JA et al. Am J Respir Crit Care Med 2007



P=0,651

19%
P=0,039

GSK

18%
P=0,028

Presentation Department Author

Wedzicha JA et al. Am J Respir Crit Care Med 2007


SGRQ

GSK

Presentation Department Author

Wedzicha JA et al. Am J Respir Crit Care Med 2007

(%)

7
6

52%
P=0,012

5
4
3
2

0
0

13

26
39
52
65
78
91
104
()

Department
Author
, GSK
2Presentation

;
7 (3 , 4 ).
Wedzicha JA et al. Am J Respir Crit Care Med 2007

 INSPIRE

,

, ,

,


2 .

GSK

Presentation Department Author

 INSPIRE
, ,
:


,
,

,

GSK

Presentation Department Author

GSK

39

Presentation Department Author






1,2
1-3

- 4

1-4
GSK

40

Presentation Department Author

1.
2.
3.
4.

Calverley et al., 2003;

Burge et al., 2000;
Mahler et al., 2002;
Ferguson et al., 2003

(/)

500

TRISTAN

400

300

* p 0.041 vs placebo

ISOLDE

200
100
0

12

GSK

: ; :

41

12

36

Presentation Department Author

1. Calverley et al., 2003;

2. Burge et al., 2000

()

500 mcg bid

/
50/500 mcg bid

1 (n=181)

1 (n=168)

3 (n=165)

TRISTAN2

12

6 (n=361)

5 (n=374)

5 (n=358)

ISOLDE3

36

17 (n=370)

9 (n=372)

NA

Mahler et al1

( )
GSK

Presentation Department Author

1. Mahler et al., 2002;

2 .Calverely et al.,
2003;
3. Burge et al., 2000



,
,
. 1,2

, ,
,
,
3
66% ,
TORCH, /
(
)4
GSK

Presentation Department Author

1.
2.
3.
4.

Adinoff and Hollister, 1983;

Gross, 2001;
van Staa et al 2001
Pauwels et al., 2003

(n=1,443)

(50
2 /) (n=1,410)

8%

8%

2%

2%

<1%

<1%

<1%

<1%

<1%

<1%

<1%

<1%

<1%

<1%

<1%
GSK

Presentation Department Author

<1%

Ferguson GT et al. Chest 2003



TRISTAN1 (1 )

ISOLDE2 (3 )

(n =361)

(n =374)

/
(n =358)

(n=370)

(n=372)

11

<1

<1

<1

<1

<1

12
5

15

12

16

20

36

41

%
GSK

* TRISTAN
: ; :

Presentation Department Author

1. Calverley et al., 2003;

2. Burge et al., 2000

 -

: Copenhagen City Health Study -
, 25
- : 14233
- , : 3333
N (%)

1411 (42%)

0,0001

312 (9%)

0,0001

64 (2%)

0,78

54 (1,5%)

0,001

64 (2%)

0,02

714 (21%)

0,89

197 (6%)

0,48

401 (12%)

0,78

1105 (33%)

0,97

T

C


GSK

Presentation Department Author

Benfield T., e.a. Chest 2008;134;46-53



Calverley

Rennard

Bourbeau

Pauwels

(n=1022)

(n =1964)

(n=75)

(n=1175)

290 .

295 .

290 .

339 .

, %

35

42

40

100

,
- (>10)

640

640/320

1280

640

1(%) .

36

37

38

78

, %

6*

(/)

*<0,01 , ,
, ,

GSK

Presentation Department Author

Calverley P. e a. Eur Resp J 2003;22:912-19; Rennard SI., e a. Drugs 2009;69:54965


/*

, %
,
-
,%
1(%) ()
, %

TRISTAN

TORCH

VIVACE

INSPIRE

(*n=358)

(*n =1533)

(*n=507)

(*n=658)

52 .

44 .

52

43

40,6

38

42,0 (22,4)

47,026,5

36,8

41,3

50

19

49,7

48

44,2 (13,7)

44,112,3

1,13 (0,38) L

1,05 L

<1

19,6

*(1000 / )
GSK

Presentation Department Author

Calverley P., e a. Lancet 2003; 361:449-56; Calverley P., e a. NEJM 2007; 356:775-89
Kardos P. e a. AmJRCCM 2007; 175:144149; Wedzicha J. e a. AmJRCCM 2008; 177:1926

 ( ):
Rx-

GSK

Presentation Department Author

Drummond . e.a; JAMA 2008;300(20): 2407-16



(
()
( IgA?)
< 1 ,

Rx
( vs. ?)
C


GSK

Presentation Department Author

Welte T. Lancet 2009;374;668-70; *Garcia-Vidal C., e.a. Eur Resp J 2007; 30:951-56

 case-control

Primary Care Respiratory Journal, 2009

5438
: , ,
/,
2154

193 -
Rx
Mapel D., e.a. Prim Car Resp J 2009; 18


( )

:
Mapel D., e.a. Prim Car Resp J 2009; 18



( )

Mapel D., e.a. Prim Car Resp J 2009; 18

(24 )


,

2
, ,
,
, ,

( 42%
,
)
GSK

Presentation Department Author

 1 <60%
/

: GOLD 2009, www.goldcopd.org

/,
1 < 60% :

 GOLD

GSK

Presentation Department Author

www.goldcopd.org