Disclosures. Objectives. Cardiovascular Risk. Patient Case. JUPITER: The final frontier in statin utilization or an idea from outer space?

Transcription

1 Disclosures JUPITER: The final frontier in statin utilization or an idea from outer space? Kathy E. Komperda, PharmD, BCPS Midwestern University Chicago College of Pharmacy 4/25/09 No financial disclosures to report Presentation will discuss off-label indications for medications Objectives To discuss the use of high sensitivity C reactive protein (hs-crp) as a screening tool for cardiovascular risk. To explain the implications of expanded inclusion criteria for primary prevention based on the JUPITER trial results. Patient Case KZ is a 64 y.o. WF who had her annual physical PMH: HTN, GERD Meds: Lisinopril/HCTZ 20/12.5 mg daily Ranitidine 150 mg BID FH: father had MI at 58; mom - alive and well SH: (-) tobacco/ethanol BP: 146/86 BMI: 28.5 Labs: TC: 190 LDL: 110 HDL: 48 TG:160 hs-crp: 3.1 mg/l (avg of 2 readings) Patient Case KZ has a few questions What does an elevated CRP mean? What is the benefit of starting a statin if her LDL is already within goal? Cardiovascular Risk More than 1.5 million people have a MI or stroke in the U.S. each year 1 Almost ½ of these cases occur in patients without evidence of hyperlipidemia and 15 to 20% have no significant risk factors 2,3 Current mechanisms for determining CV risk for asymptomatic patients may be suboptimal 1. Circulation 2006;113:e85-e JAMA 2003;290: JAMA 2003;290:

2 hs-crp: Predictor Of CV Risk Independent of other CV risk factors (LDL) Several trials have demonstrated hs-crp as a valuable tool for predicting future CV events AFCAPS/TexCAPS 2 Physician s Health Study 3 2. NEJM 2001;344: Circulation 1998;97: Primary prevention study (N = 39,876) 27,939 healthy American women (> 45 yrs) Baseline CRP and LDL levels were measured Patient Demographics Mean age ~54 years old 25% HTN 12% current smokers 2.5% DM Mean BMI: 25.9 kg/m 2 77% of events occurred in LDL < % of events occurred in LDL < 130 Cardiovascular event rates increased with increasing CRP and LDL levels High levels of either identified different higher risk groups Median LDL 124 mg/dl Median CRP 1.52mg/L hs-crp Testing Evidence supports the predictive ability of hs-crp levels for CVD Current recommendations include optional testing in intermediate risk patients Anticipated larger impact in primary prevention than secondary prevention Potential algorithm to assess CV risk using hs-crp results Reynolds Risk Score A new mechanism for calculating cardiovascular risk which incorporates hs- CRP levels and family history Algorithm has been validated in both males and females 1, Circulation 2008;118: JAMA 2007;297:611-9.

3 JUPITER 1 Trial Primary prevention trial (N=17,802) Healthy population hs-crp > 2.0 mg/l LDL < 130 mg/dl Rosuvastatin 20 mg vs placebo End Points 1 Primary end point Combined MI, stroke, arterial revascularization, hospitalization for UA, or CV death Secondary end points Primary end point events individually Death from any cause Baseline Characteristics 1 Mean age: 66 years old BMI: 28.3 kg/m 2 Median BP: 134/80 ~16% smokers Median LDL: 108 Median Glucose: 94 Results 1 Terminated early Combined 1 o endpoint 44% RRR; 1.2% ARR (p < ) Any Death 20% RRR; 0.5% ARR (p < 0.02) No major differences in ADRs Physician-reported DM higher in rosuvastatin group (270 vs. 216; p < 0.01) Back To KZ Elevated CRP? Statin therapy despite at goal LDL?

4 What Questions Still Remain? What about other statins? What about other doses? What are the long term effects of having such low LDL? What about other age groups (younger)? Do we titrate medications to get to a goal hs- CRP? What about other medications that can lower hs- CRP? JUPITER: The final frontier in statin utilization or an idea from outer space? Kathy E. Komperda, PharmD, BCPS Midwestern University Chicago College of Pharmacy kkompe@midwestern.edu 4/25/09

5 1. Which of the following statements is true regarding hs-crp testing? a. No evidence exists to support using hs-crp for cardiovascular risk prediction. b. It is highly recommended to order hs-crp on all patients. c. hs-crp levels above 3mg/L are considered high cardiovascular risk. d. None of the above.