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A Randomized Trial of Rosuvastatin in the Prevention of Venous
A Randomized Trial of Rosuvastatin in the Prevention of Venous
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A Randomized Trial of Rosuvastatin in the Prevention of Venous Thromboembolism: The JUPITER Trial Robert Glynn*, Eleanor Danielson, Francisco Fonseca*, Jacques Genest*, Antonio Gotto*, John Kastelein*, Wolfgang Koenig*, Peter

содержание презентации «A Randomized Trial of Rosuvastatin in the Prevention of Venous Thromboembolism: The JUPITER Trial Robert Glynn*, Eleanor Danielson, Francisco Fonseca*, Jacques Genest*, Antonio Gotto*, John Kastelein*, Wolfgang Koenig*, Peter.ppt»
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1A Randomized Trial of Rosuvastatin in 9with total mortality.
the Prevention of Venous Thromboembolism: 10JUPITER Baseline Clinical
The JUPITER Trial Robert Glynn*, Eleanor Characteristics. Rosuvastatin Placebo (N =
Danielson, Francisco Fonseca*, Jacques 8901) (n = 8901) Age, years (IQR) 66
Genest*, Antonio Gotto*, John Kastelein*, (60-71) 66 (60-71) Female, N (%) 3,426
Wolfgang Koenig*, Peter Libby*, Alberto (38) 3,375 (38) Ethnicity, N (%) Caucasian
Lorenzatti*, Jean MacFadyen, B?rge 6,358 (71) 6,325 (71) Black 1,100 (12)
Nordestgaard*, James Shepherd*, James 1,124 (13) Hispanic 1,121 (13) 1,140 (13)
Willerson, and Paul Ridker* on behalf of Body mass index ? 30 kg/m2, N (%) 3,338
the JUPITER Trial Study Group An (38) 3,336 (38) Waist circumference (cm)
Investigator Initiated Trial Funded by ?100 (men), ?95 (women), N (%) 4,503 (51)
AstraZeneca, USA * These authors have 4,546 (52) Smoker, N (%) 1,400 (16) 1,420
received research grant support and/or (16) Metabolic Syndrome, N (%) 3,652 (41)
consultation fees from one or more statin 3,723 (42) hsCRP?5 mg/L, N (%) 3,618 (41)
manufacturers, including Astra-Zeneca. Dr 3,726 (42) LDL>100 mg/dL, N (%) 5,781
Ridker is a co-inventor on patents held by (65) 5,747 (65) HDL<40 (men), <50
the Brigham and Women’s Hospital that (women), N (%) 2,833 (32) 2,856 (32) All
relate to the use of inflammatory values are median (interquartile range) or
biomarkers in cardiovascular disease that N (%). Glynn et al NEJM 2009.
have been licensed to Dade-Behring and 11JUPITER Total Venous Thromboembolism.
AstraZeneca. JUPITER ACC March 29, 2009. - 43 %. HR 0.57, 95%CI 0.37-0.86 P= 0.007.
2Presenter Disclosure Information. The Glynn et al NEJM 2009. Placebo 60 / 8901.
following relationship exists related to Cumulative Incidence. Rosuvastatin 34 /
this presentation: Research Grant 8901. 0.025. 0.020. 0.015. 0.010. 0.005.
AstraZeneca Significant Level The Brigham 0.000. 0. 1. 2. 3. 4. Follow-up (years).
& Women’s Hospital holds patents Number at Risk. Rosuvastatin. 8,901.
related to the use of inflammatory 8,648. 8,447. 6,575. 3,927. 1,986. 1,376.
biomarkers in cardiovascular disease that 1,003. 548. 161. Placebo. 8,901. 8,652.
have been licensed to Dade-Bering and 8,417. 6,574. 3,943. 2,012. 1,381. 993.
AstraZeneca. Robert J Glynn, PhD, ScD; 556. 182.
Brigham & Women’s Hospital, Boston, 12JUPITER Occurrence of VTE: Primary
MA. efficacy analysis. All cases identified by
3JUPITER Timeline First randomization: March 30, 2008 Endpoint Rosuvastatin
March 14, 2003 Last randomization: Placebo HR 95%CI P Any VTE 34 60 0.57
December 15, 2006 Termination for 0.37-0.86 0.007 Unprovoked VTE 19 31 0.61
efficacy: March 30, 2008 Last patient 0.35-1.09 0.09 Provoked VTE 15 29 0.52
visit: August 20, 2008 Trial results: 0.28-0.96 0.03 Pulmonary embolism 17 22
Primary end point: November 9, 2008 0.77 0.41-1.45 0.42 DVT only 17 38 0.45
Pre-specified VTE end point: March 29, 0.25-0.79 0.004. Glynn et al NEJM 2009.
2009 hsCRP and LDL reductions and end 13JUPITER Venous Thromboembolism –
points: March 30, 2009. JUPITER ACC March Unprovoked vs Provoked. HR 0.61, 95% CI
29, 2009. 0.35-1.09 P= 0.09. HR 0.52, 95% CI
4JUPITER Why Pre-specify Incident 0.28-0.96 P= 0.03. Clear clinical benefit
Venous Thromboembolism? Venous and in the absence of any bleeding hazard
arterial thrombosis are common, serious, (hemmorrhagic events: rosuvastatin 258,
age-related events that often co-occur and placebo 275, P=0.45). Unprovoked Venous
share some risk factors Controversies Thromboembolism. Provoked Venous
persist regarding the nature and extent of Thromboembolism. Placebo. Placebo.
their shared pathways and whether Rosuvastatin. Rosuvastatin. Follow-up
treatments of demonstrated efficacy for (years). Follow-up (years). 0.020. 0.020.
one condition have consistent benefits for 0.015. 0.015. Cumulative Incidence.
the primary or secondary prevention of the Cumulative Incidence. 0.010. 0.010. 0.005.
other Benefits of statins might accrue not 0.005. 0.000. 0.000. 0. 1. 2. 3. 4. 0. 1.
only through effects on lipids but also 2. 3. 4.
through influence on thrombosis and 14JUPITER Total Venous Thromboembolism –
inflammation. Specifically, statins Subgroup Analysis I. Rosuvastatin
downregulate the blood coagulation cascade Superior. Rosuvastatin Inferior. Incidence
through decreased tissue factor Rates. (Placebo). N. Events. Men. 11,001.
expression, which leads to reduced 66. 0.37. Women. 6,801. 28. 0.24. Age
thrombin formation* *Undas, 50-59 yr. 3,689. 17. 0.24. Age 60-69 yr.
Brummel-Ziedins, Mann. ATVB 8,418. 37. 0.30. 0.41. Age. > 70 yr.
2005;25:287-294. 5,695. 40. Caucasian. 12,683. 86. 0.39.
5Observational studies of statins & Black, Hispanic, Other. 5,117. 8. 0.11.
VTE. 1st Author. Publication. Study. Adj. 4,073. 15. BMI <25.0 kg/m. 0.20. 7,009.
RR. 95% CI. Grady. Ann Intern Med 2000. 32. BMI 25.0-29.9 kg/m. 0.30. 6,674. 46.
Heart & E/P Replacement. 0.5. 0.2-0.9. BMI. > 30.0 kg/m. 0.40. Waist
Ray. Arch Int Med 2001. Ontario residents Circumference(cm). 0.21.
65+ yrs. 0.8. 0.7-0.9. Yang. Br J Clin Men<100/Women<95. 8,586. 34. 0.41.
Pharm 2002. UK database f-up Case-control. Men. > 100/Women. > 95. 9,049. 57.
0.8 1.1. 0.3-2.7 0.3-4.3. Doggen. J Thromb Metabolic Syndrome. 7,373. 32. 0.29. 0.34.
Haemost 2004. Washington HMO. 0.6. No Metabolic Syndrome. 10,296. 60. 13.
0.4-1.1. Lacut. Fund Clin Pharm 2004. 0.22. Smoker. 2,820. 81. 0.34. Non-Smoker.
France, case-control. 0.4. 0.2-0.8. 14,975. 94. 0.32. All Participants.
Smeeth. Br J Cl Pharm 2008. UK database 17,802. 0.20. 0.5. 1.0. 2.0. 4.0. 2. 2. 2.
f-up. 1.0. 0.9-1.2. Ramcharan. J Thromb 15JUPITER Total Venous Thromboembolism –
Haemost 2009. Holland, case-control. 0.5. Subgroup Analysis II. Rosuvastatin
0.4-0.6. S?rensen. J Thromb Haemost 2009. Superior. Rosuvastatin Inferior. # of.
Denmark, case-control. 0.7. 0.6-0.9. Incidence Rates. N. Events. (Placebo).
6JUPITER Why Pre-specify Incident LDLC. < 100 mg/dL. 0.30. 6,269. 33.
Venous Thromboembolism? Observational LDLC > 100 mg/dL. 0.33. 11,528. 61.
Evidence: In non-randomized cohort and HDLC (mg/dL). Men<40, Women<50.
case-control studies and registries, 0.30. 5,689. 26. Men. > 40, Women. >
statins have often, but not always, been 50. 0.33. 12,112. 68. Triglycerides<150
associated with reduced risk of VTE. These mg/dL. 0.32. 11,965. 66. Triglycerides.
studies cannot exclude indication bias. > 150 mg/dL. 0.32. 5,836. 28.
Many included prevalent statin users, and hsCRP<5 mg/L. 0.27. 10,458. 49. hsCRP.
poor health affects the decision to > 5 mg/L. 0.39. 7,344. 45. Time of
initiate and persist in therapy. They also event. < 24 Months. 0.28. 17,802. 70.
did not consider the possibility that the Time of event>24 Months. 0.53. 7,870.
reduction in VTE events is secondary to a 24. All Participants. 17,802. 94. 0.32.
statin-induced reduction in arterial 0.20. 0.5. 1.0. 2.0. 4.0.
hospitalizations. Similar evidence from 16JUPITER Occurrence of VTE: Safety
observational studies indicated benefits analysis. All cases identified by final
for statins on mortality in heart failure, closeout visit and unblinding Endpoint
but trials (CORONA, GISSI) refuted this Rosuvastatin Placebo HR 95%CI P Any VTE 35
hypothesis Clear need for a prospective 64 0.55 0.36-0.82 0.003 Unprovoked VTE 20
randomized trial. 34 0.59 0.34-1.02 0.06 Provoked VTE 15 30
7JUPITER Inclusion and Exclusion 0.50 0.27-0.93 0.02 Pulmonary embolism 17
Criteria, Study Flow. Men > 50 years 24 0.71 0.38-1.32 0.27 DVT only 18 40 0.45
Women > 60 years No CVD, No DM LDL < 0.26-0.78 0.003. Glynn et al NEJM 2009.
130 mg/dL hsCRP > 2 mg/L. Ridker et al 17JUPITER Occurrence of VTE, CVD, and
NEJM 2008. 89,890 Screened. 17,802 death. Endpoint Rosuvastatin Placebo HR
Randomized. 17,802 Randomized. 8,901 95%CI P VTE without prior CVD 32 56 0.57
Assigned to Placebo. 8,901 Assigned to 0.37-0.88 0.009 CVD without prior VTE 141
Rosuvastatin 20 mg. 8,857 Completed Study 249 0.56 0.46-0.69 <0.001 VTE after CVD
44 Lost to follow-up. 8,864 Completed 2 4 0.98 0.18-5.34 0.98 First CVD or VTE
Study 37 Lost to follow-up. 8,901 Included 173 305 0.56 0.47-0.68 <0.001 Death
in Efficacy and Safety Analyses. 8,901 after VTE 7 14 0.88 0.35-2.18 0.78 First
Included in Efficacy and Safety Analyses. CVD, VTE or death 320 483 0.66 0.57-0.76
Reason for Exclusion (%) LDL > 130 <0.001. Glynn et al NEJM 2009.
mg/dL 52 hsCRP < 2.0 mg/L 36 Withdrew 18JUPITER Primary Trial Endpoint : MI,
Consent 5 Diabetes 1 Hypothyroid <1 Stroke, UA/Revascularization, CV Death.
Liver Disease <1 TG > 500 mg/dL Number Needed to Treat (NNT5) = 25. HR
<1 Age out of range <1 Current Use 0.56, 95% CI 0.46-0.69 P < 0.00001. 109
of HRT <1 Cancer <1 Poor Fewer Events. Placebo 251 / 8901.
Compliance/Other 3. Reason for Exclusion Rosuvastatin 142 / 8901. Cumulative
(%) LDL-C > 130 mg/dL 53 hsCRP < 2.0 Incidence. 0.08. 0.06. 0.04. 0.02. 0.00.
mg/L 37 Withdrew Consent 4 Diabetes 1 0. 1. 2. 3. 4. Follow-up (years). Number
Hypothyroid <1 Liver Disease <1 TG at Risk. Rosuvastatin. 8,901. 8,631.
> 500 mg/dL <1 Age out of range 8,412. 6,540. 3,893. 1,958. 1,353. 983.
<1 Current Use of HRT <1 Cancer 544. 157. Placebo. 8,901. 8,621. 8,353.
<1 Poor Compliance/Other 3. 4 week 6,508. 3,872. 1,963. 1,333. 955. 534. 174.
Placebo Run-In. 8,901 Assigned to 19JUPITER VTE + Primary Trial Endpoint.
Rosuvastatin 20 mg. 8,901 Assigned to Number Needed to Treat (NNT5) = 21. HR
Placebo. 8,600 Completed Study 120 Lost to 0.56, 95% CI 0.47-0.68 P < 0.00001. 132
follow-up. 8,600 Completed Study 120 Lost Fewer Events. Placebo 305 / 8901.
to follow-up. 8,901 Included in Efficacy Rosuvastatin 173 / 8901. Cumulative
and Safety Analyses. 8,901 Included in Incidence. Follow-up (years). 0.10. 0.08.
Efficacy and Safety Analyses. 89,863 0.06. 0.04. 0.02. 0.00. 0. 1. 2. 3. 4.
Screened. Number at Risk. Rosuvastatin. 8,901.
8JUPITER Symptomatic VTE. Symptomatic 8,624. 8,400. 6,525. 3,880. 1,951. 1,348.
venous thromboembolism was a pre-specified 979. 536. 157. Placebo. 8,901. 8,612.
secondary end point Upon identification of 8,338. 6,486. 3,854. 1,949. 1,320. 945.
a new VTE case, site investigators 525. 170.
indicated the source of confirmation 20JUPITER VTE + Primary Trial Endpoint +
(venous ultrasonogram or venogram for DVT; Total Mortality. Number Needed to Treat
angiogram, CT scan, or (NNT5) = 18. HR 0.66, 95% CI 0.57-0.76 P
ventilation-perfusion scan for PE) < 0.00001. 163 Fewer Events. Placebo
Initiation and indication for 483 / 8901. Rosuvastatin 320 / 8901. 0.14.
anticoagulation therapy also noted 0.12. 0.10. 0.08. Cumulative Incidence.
Unprovoked VTE: no trauma, 0.06. 0.04. 0.02. 0.00. 0. 1. 2. 3. 4.
hospitalization, or surgery within 3 Follow-up (years). Number at Risk.
months before diagnosis, and no malignancy Rosuvastatin. 8,901. 8,624. 8,400. 6,525.
diagnosed before or up to 3 months after 3,880. 1,951. 1,348. 979. 536. 157.
the VTE Unprovoked and provoked VTE, Placebo. 8,901. 8,612. 8,338. 6,486.
pulmonary embolism and deep vein 3,854. 1,949. 1,320. 945. 525. 170.
thrombosis alone were tertiary end points. 21VTE is a serious event that occurred
9JUPITER VTE analysis. Primary efficacy about as often as MI and stroke in the
analyses counted all events diagnosed by JUPITER study Rosuvastatin was associated
March 30, 2008 according to the intention with a significant 43 percent reduction in
to treat principle Safety analyses also risk of VTE with no increase in bleeding.
included additional events before the This benefit was comparable in magnitude
closeout visit and unblinding Competing and independent of the effect on arterial
risks analyses compared effects of events Widening the treatment target to
rosuvastatin on first VTE versus first include prevention of VTE and death in
primary cardiovascular event Estimates of addition to arterial thrombosis increases
net clinical benefits considered the the estimated benefit of statin use.
impact on the number needed to treat (NNT) JUPITER VTE in JUPITER: Conclusions.
of inclusion of VTE in a composite with 22Posted at NEJM.org. JUPITER VTE
the primary cardiovascular event, and also detailed results.
A Randomized Trial of Rosuvastatin in the Prevention of Venous Thromboembolism: The JUPITER Trial Robert Glynn*, Eleanor Danielson, Francisco Fonseca*, Jacques Genest*, Antonio Gotto*, John Kastelein*, Wolfgang Koenig*, Peter.ppt
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A Randomized Trial of Rosuvastatin in the Prevention of Venous Thromboembolism: The JUPITER Trial Robert Glynn*, Eleanor Danielson, Francisco Fonseca*, Jacques Genest*, Antonio Gotto*, John Kastelein*, Wolfgang Koenig*, Peter

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900igr.net > Презентации по английскому языку > Тексты на английском > A Randomized Trial of Rosuvastatin in the Prevention of Venous Thromboembolism: The JUPITER Trial Robert Glynn*, Eleanor Danielson, Francisco Fonseca*, Jacques Genest*, Antonio Gotto*, John Kastelein*, Wolfgang Koenig*, Peter