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Population Impact of Losartan Use on Stroke in the European Union (EU)

Downloaded from www.cozaar.aeReprinted by permission from the Journal of Human Hypertension/Macmillan Publishers Ltd.


A Landmark Study

Investigator-initiated, prospective, double-blind, active-controlled, intention-to-treat, community-based study comparing the effect of losartan vs. atenolol in reducing CV morbidity and mortality in hypertensive patients with LVH

9193 patients, 55–80 years of age

Mean 4.8-year follow-up

44,119 patient-years of follow-up

945 study sites in 7 countries

1096 patients with primary endpointsCV=cardiovascular; LVH=left ventricular hypertrophy

Adapted from Dahlöf B et al Lancet 2002;359:995–1003.

Ref 2, p 995,C2, ¶4, L14-20;p 996, C1, ¶2,L1-3; p 998,C2, ¶1, ¶2, L2


Age 55–80 years

Previously treated or untreated hypertension

Diastolic BP 95–115 mmHg or systolic BP 160–200 mmHg

ECG-confirmed LVH

– Cornell Voltage Product >2440 mm msec

– Sokolow-Lyon >38 mm

Inclusion Criteria

ECG=electrocardiography

Adapted from Dahlöf B et al Am J Hypertens 1997;10:705–713.

Ref 1, p 708, C2, ¶1, L1-8, ¶2, L8-11


0

2

4

6

8

10

12

14

16

Pro

po

rtio

n o

f p

atie

nts

w

ith

fir

st e

ven

t (%

)

Primary composite of CV death, stroke, and MI*

Losartan

Atenolol

Benefits Beyond Blood Pressure Control: Primary Composite Endpoint and Stroke

Adjusted risk reduction 13.0%, p=0.021Unadjusted risk reduction 14.6%, p=0.009

*No significant differences in CV death and MI vs. atenolol

Adapted from Dahlöf B et al. J Hum Hypertens. Advance online publication. Available at doi:10.1038/sj.jhh.1001710. Accessed March 18, 2004.

Study month

0 6 12 18 24 30 36 42 48 54 60 66

Losartan (n) 4605 4524 4460 4392 4312 4247 4189 4112 4047 3897 1889 901

Atenolol (n) 4588 4494 4414 4349 4289 4205 4135 4066 3992 3821 1854 876

Number at risk

Losartan

Atenolol

Adjusted risk reduction 24.9%, p=0.001Unadjusted risk reduction 25.8%, p=0.0006

0 6 12 18 24 30 36 42 48 54 60 66

0

1

2

3

4

5

6

7

8

Losartan 4605 4528 4469 4408 4332 4273 4224 4166 4117 3974 1928 925Atenolol 4588 4490 4424 4372 4317 4245 4180 4119 4055 3894 1901 897

Fatal and nonfatal stroke

Pro

po

rtio

n o

f p

atie

nts

w

ith

fir

st e

ven

t (%

)

Ref 1,p 999,Fig 4,Fig 5, middle

Study month


EU Stroke Impact Study: Objectives

To estimate the number of strokes that could be averted in the EU with the use of losartan-based therapy in comparison to atenolol-based therapy in patients with hypertension and LVH confirmed by ECG

To project the reduction in stroke observed with a losartan- vs. an atenolol-based antihypertensive treatment regimen in the LIFE study to the EU population


Ref 1,p 2, C1, ¶3,4


EU Stroke Impact Study: Methods

Projection was based on a combination of the following estimates

– Number of individuals meeting LIFE criteria National census figures

Population-based hypertension prevalence

ECG-LVH prevalence from LIFE pilot study

CHF prevalence (exclusion criteria) from NHANES III

– Cumulative incidence of stroke from LIFE database

Projection subject to one-way sensitivity analysis

Ref 1,

p 2, C2, ¶2, L1-4

p 2, C1, ¶4

p 2, C2, ¶3

p 3, C1, ¶3

p 3, C1, ¶4, L4-7

p 3, C2, ¶2, L1-2

p 3, ¶3, L1-2



Results: Estimated EU Population Meeting the LIFE Entry Criteria

377.4 million residents in EU in 2000

90.3 million were aged 55–80 years

45.7 million had hypertension

10.1 million met LVH criteria

(exclude those with heart failure)

7.8 million met main LIFE inclusion criteriaAdapted from Dahlöf B et al. J Hum Hypertens. Advance online publication. Available at doi:10.1038/sj.jhh.1001710. Accessed March 18, 2004.

Ref 1,p 4, C1, ¶1


Example Calculation

LIFE criteria population x LIFE difference in stroke risk reduction = projected number of strokes averted

Germany: 2,214,900 (2.7 % of total population meet LIFE criteria) x difference in cumulative incidence of stroke from LIFE (atenolol vs. losartan at 5.5 years): 1.6% (CI 0.6, 2.6) = 35,438 strokes averted


Ref 1,p 4, C1, ¶2, L9, Table 1 (Germany); p 4, C2, L2,3,Table 2,last L


Projected First Strokes Averted with Losartan vs. Atenolol in the EU After 5.5 Years of Treatment

Strokes averted

1. Austria2. Belgium3. Denmark4. Finland5. France6. Germany7. Greece8. Ireland9. Italy

10.Luxembourg11.Portugal12.Spain13.Sweden14.The Netherlands15.United Kingdom

3117231214981576

18,43035,438

3448870

19,17088

319612,877

27253050

17,472

EU total 125,267

1

2

3

4

5

6

7

8

9

10

11 12

13

1415

Ref 1,p 5, Table 3

Note: Among 7.8 million who would qualify for the LIFE trial



Projected Cumulative Number of First Stroke Events Potentially Averted with Losartan- vs. Atenolol-Based Regimen in the EU over 5.5 Years


No

. o

f st

roke

s av

erte

d

0

130,000

0

120,000110,000100,000

90,00080,00070,00060,00050,00040,00030,00020,00010,000

1 2 3 4 5

Year

Ref 1,p 5, Fig 2


One-Way Sensitivity Analysis: Impact of Losartan- vs. Atenolol-Based Therapy to Potentially Avert Strokes in EU: High, Low Estimates

46,976

203,562

84,728

148,663 143,121

107,417

51,246

227,761

0

50,000

100,000

150,000

200,000

250,000

Prevalence of LVH

Stroke cumulative incidence difference

No

. of

stro

kes

aver

ted

Low Estimate

High Estimate

Prevalence of hypertension

Prevalence of CHF


Ref 1,p 5, Fig 3


Conclusion: Population Impact of Losartan- Based Therapy to Avoid Strokes in the EU

7.8 million meet LIFE criteria in the EU, representing 2.1% of the total EU population

If losartan-based therapy was implemented for these patients instead of conventional beta-blocker therapy, an estimated 125,267 additional first strokes could be avoided in a 5.5-year period*

Losartan-based therapy has the potential to have a major public health impact by reducing morbidity, mortality, and costs of stroke in the EU

*Based on the stroke cumulative risk difference observed in LIFE


Ref 1,p 6,C1, ¶1, L7-13, C2, ¶2, L6-9


Bibliography

Dahlöf B, Burke TA, Krobot K et al. Population impact of losartan use on stroke in the European Union (EU): Projections from the Losartan Intervention For Endpoint reduction in hypertension (LIFE) study. J Hum Hypertens advance online publication. Available at: doi:10.1038/sj.jhh.1001710. Accessed March 18, 2004.

Dahlöf B, Devereux R, de Faire U et al. The Losartan Intervention For Endpoint reduction (LIFE) in hypertension study. Rationale, design, and methods. Am J Hypertens 1997;10:705–713.

Dahlöf B, Devereux RB, Kjeldsen SE et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol. Lancet 2002;359:995–1003.


Population Impact of Losartan Use on Stroke in the European Union (EU)

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Merck does not recommend the use of any productin any different manner than as described

in the prescribing information.

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slide 1 downloaded from population impact of losartan use on stroke in the european union (eu)

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