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How to Make The Most Of Stand-up Calls

How to Make The Most Of Stand-up Calls. Central Regional Meeting August 30 & 31, 2007. Stand-up Calls-Value Questions. Need to answer 3 questions Does the Dr. understand/agree with the Pathophysiology? Does the Dr. think measuring and treating particle number is credible?

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How to Make The Most Of Stand-up Calls

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  1. How to Make The Most Of Stand-up Calls Central Regional Meeting August 30 & 31, 2007

  2. Stand-up Calls-Value Questions • Need to answer 3 questions • Does the Dr. understand/agree with the Pathophysiology? • Does the Dr. think measuring and treating particle number is credible? • Does the Dr. understand how to Identify and Manage patients? • In a stand up call we do not have time to address all questions effectively. • To have a greater impact address each question in a single call.

  3. Stand-up Call--Probing • Does the Dr. understand/agree with the Pathophysiology? • Probe to show common ground, and engage conversation to show particles more predictive and better management tool. • “Once you have determined risk factors what is your goal of therapy.” • “When I say LDL what do you think of.” • Others?

  4. Pathophysiology--Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Tools • 1st two pages of visual aid • Particle Article • Stein & McBride Book • VA-HIT • Cromwell Diabetes Article • Others?

  5. Check-In Questions • Check-in to see if Dr. is “with you” and understand/agrees with the Value questions. • Can be in the form of an closed or open-ended question. • The problem with closed ended question like, “Does this make sense?”, is that it gives the Dr. an out. • Open-ended force the Dr. to engage and will give greater insight into physician’s understanding. • Examples. • “How does this information affect your view of cholesterol and its ability to identify disease risk?” • “This cross-section of the lumen represents 2 patients who do you think is at more risk?” “Why?” • “Each of the patients have 100mg/dl of cholesterol what would you typically do for these patients based on the cholesterol info?” • “What are your thoughts?” • Others?

  6. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Particle Article • Page 381 • “The key role played by low-density lipoprotein particles in the pathogenesis of coronary heart disease (CHD) is well accepted, as is the public health benefit of lowering LDL in high-risk patients. What remains controversial is whether we are using the best measure(s) of LDL to identity all individuals who would benefit from LDL-altering therapy.” • “What is underappreciated is that the amount of cholesterol carried in inside of LDL particles is highly variable among individuals with the same measured LDL cholesterol. As a consequence of the magnitude and prevalence of this lipid compositional variability, even the most accurate LDL cholesterol measurements will, for many individuals provide an inaccurate measure of the number of circulating LDL particles and the CHD risk they confer.”

  7. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Particle Article • Page 382 • “In the face of LDL cholesterol variability of this magnitude, it is not difficult to understand why LDL cholesterol measurements do not always accurately reflect a patient’s LDL particle number and associated risk of CHD”

  8. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Particle Article • Page 386 • “Irrespective of LDL size distribution or phenotype, physicians and patients easily grasp the concept of having too many LDL particles interfering with the artery wall is bad.” … “Whether the particle is large or small in size, the therapeutic objective is the same: to reduce particle numbers to levels that confer an acceptable degree of risk. • Page 385 • “Collectively, the results of multivariate analysis of numerous clinical outcome trials provide persuasive evidence that it is the number of LDL particles, not size or the amount of cholesterol carried by patient’s LDL particles, that is the principle determination of CHD risk.”

  9. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Stein & McBride Book • Page 252-253 • “The number of LDL particles interacting with the arterial wall drives the disease, not the cholesterol within them.” • “The problem is that standard laboratory techniques do not allow direct measurement of the number of LDL particles, so instead we count the amount of cholesterol they carry.” • “A limitation of this approach is that particle sizes differ within and between individuals, so the number of particles can be inaccurately estimated by standard techniques.”

  10. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • VA-HIT • Page 1561 • “A possible reason (for our results) is that LDL and HDL cholesterol levels have more sources of variability, with levels differing either because of differences in cholesterol composition (amount of cholesterol per particle due to particle size or core lipid compositional differences), differences in particle number, or some combination of the two.”

  11. Pathophysiology—Proof Sources • Does the Dr. understand/agree with the Pathophysiology? • Cromwell T2DM Article • Page 1599 • “Measuring the amount of cholesterol in a patient’s LDL particles (LDL cholesterol) may not be the best gauge of risk attributable to LDL and the adequacy of LDL-lowering therapy.” • Patients with dyslipidemia of type 2 diabetes mellitus (low high density lipoprotein (HDL), high triglycerides) generally have LDL particles that are smaller and contain less cholesterol per particle than usual. As a result, many increased numbers of atherogenic LDL particles (LDL-P) despite having low or desirable levels of cholesterol.”

  12. Pathophysiology—Objections • Does the Dr. understand/agree with the Pathophysiology? 3. Objections • “Don’t understand why cholesterol not enough.” • 1ST 2 PAGES OF VISUAL AID • PARTICLE ARTICLE • STEIN & McBRIDE BOOK • VA-HIT • “Treat to 70” • CROMWEL DIABETES ARTICLE • “Use other lipid panel parameters (elevated trigs, low HDL, non-HDL to predict residual risk and/or excess particles).” • VA-HIT • Women’s Health Study

  13. Pathophysiology—Objections • Does the Dr. understand/agree with the Pathophysiology? • Objections • “Treat to 70” • What do we say next? • CROMWEL DIABETES ARTICLE

  14. 5th 20th 50th 80th percentile 1% (n=19) 24% (n=364) 43% (n=631) 21% (n=307) 11% (n=163) Percent of Subjects 700 1000 1300 1600 (nmol/L) 16% (n=147) 43% (n=377) 30% (n=260) 9% (n=76) 2% (n=15) 40% Percent of Subjects 700 1000 1300 1600 (nmol/L) LDL ParticleNumber Distribution in T2DM Subjects Page 1601 LDL-C 70-99 mg/dL (n=1,484) LDL-C < 70 mg/dL (n=871) Cromwell WC, Otvos JD. Am J Cardiol 2006;98:1599-1602

  15. Pathophysiology—Objections • Does the Dr. understand/agree with the Pathophysiology? • “I am already aggressive, I treat all my patient to 70.” • Results • Page 1600 “The results of the present study suggest that levels of LDL-P may be better than LDL cholesterol to assess the adequacy of LDL lowering therapy.” • Page 1601 “Our data suggest that using LDL-P values to gauge the adequacy of LDL-lowering therapy may be a more cost effective and less costly approach to optimizing the management of diabetic and other high-risk patients than the current population approach that advocates lower and lower LDL cholesterol goals to decrease residual risk to acceptable levels.”

  16. Pathophysiology-Transitions • “When can I come back again to discuss how particles have been shown to be a better predictor than cholesterol for CHD?” • Others

  17. Credibility-Probes/Opening Statements • “Last time you asked if we had any outcomes studies, I would like to share results from the VA-Hit.” • “Last time I showed how cholesterol can underestimate a patient’s risk for CHD. Today I would like to share the outcomes studies that show that particle number is a better predictor of CHD.” • Others?

  18. Credibility—Objections • Does the Dr. think measuring and treating particle number is credible? • Could be evident through body language. • Objection • “Are you in guidelines?” • “My cardiologist has not heard of/believe in your test.” • “Do you have any outcome studies?”

  19. Credibility—Objections • Does the Dr. think measuring and treating particle number is credible? • Objection • “Are you in guidelines?” • What do we say next? • Weight of Evidence • “My cardiologist has not heard of/believe in your test.” • What do we say next? • Weight of Evidence • Stein & McBride Book • Topol

  20. Credibility—Objections • Does the Dr. think measuring and treating particle number is credible? • Objection • “Do you have any outcome studies?”

  21. Credibility—Proof Sources • Does the Dr. think measuring and treating particle number is credible? • Tools • Weight of Evidence • VA-HIT • PLAC-I • Women’s Health Study • Cardiovascular Health Study • Healthy Women Study • Framingham (In Press) • Mesa (Future) • Others?

  22. LDL and HDL Particle Subclasses Predict Coronary Events and are Changed Favorably by Gemfibrozil in the Veterans Affairs HDL Intervention Trial (VA-HIT) Otvos JD, Collins D, Freedman DS, Shalaurova I,Schaefer EJ, McNamara MT, Bloomfield HE, Robins SJ, Circulation March 2006;113:1556-63

  23. VA-HIT Key Points • Page 1561 • “Notably, we found that both LDL and HDL particle numbers measured during the trial had significant independent associations with new CHD events whereas LDL and HDL cholesterol did not.”. • “our results clearly indicate that in this secondary prevention of men with low HDL and LDL, CHD risk is better reflected by the number of lipoprotein particles than by the amount of cholesterol these particles contain.”. • Page 1562 • “VA-HIT shows that fibrate therapy produces favorable changes in the cholesterol content of these lipoproteins. These lipoprotein particle changes may help to explain the reduction in major CHD events and CHD death achieved in this trial.”.

  24. VA-HIT Key Points • Page 1559 • Statistically Significant predictor is p<0.05

  25. VA-HIT Key Points Page 1559 • In VA-HIT, LDL-P was 2-3 times more strongly related to CHD events than LDL-C. • ** You will not find this statement in the paper: This statement is derived by Dr. Otvos from baseline and on-trial data in Table 3. However, looking at the graph “Measures of LDL” on the front of the reprint carrier, one can see that LDL-P is about 3 times more predictive than other measures of LDL in this study. p<0.001 Odds Ratio per 1-SD Increment LDL-C Non-HDL-C ApoB LDL-P

  26. VA-HIT Key Points • Page 1559 • Looking at Table 3: The baseline odds ratio (OR) for a 1 SD (standard deviation) increment in LDL-P is 1.20 vs. 1.10.  If you take .20 and divide by .10, you get a value of 2, which means at baseline LDL-P is twice as predictive as LDL-C.  • On-trial OR for a 1 SD increment on LDL-P is 1.28 vs. 1.08 for LDL-C. If you take .28 and divide by .08, you get a value of 3.5, which means on-trial LDL-P is more than 3 times as predictive.”

  27. VA-HIT Key Points • In this study, an increase of 350 nmol/L (1 standard deviation) of LDL particles was associated with a 28% increase in CHD events. • **This can be found on page 1559, first full paragraph. “In English” this means that for every LDL-P increase of 350 nmol/L, the risk for CHD events increased 28% (an Odds Ratio [OR] of 1.28).

  28. Pathophysiolgy—Non HDL-C Objection • Does the Dr. understand/agree with the Pathophysiology? • Objection • “Use other lipid panel parameters (elevated trigs, low HDL, non-HDL to predict residual risk and/or excess particles).” • VA-HIT

  29. Non HDL-C Non HDL-C • Non HDL-C is the difference of Total Cholesterol (TC) and HDL-C (TC minus HDL-C). • This more accurately assesses risk on patients with TG 200-499 mg/dL. • Non-HDL-C includes all of the athrogenic lipoprotein particles (LDL, VLDL, IDL) and should be less that 30 points higher than the LDL-C goal. • For example the non HDL-C goal for a patient with high risk patient should be less than 130 mg/dL. • The goal for a patient with moderate is less than 160 mg/dL.

  30. VA-HIT Key Points • Page 1559 • Non HDL-C. Looking at Table 3: The baseline odds ratio (OR) for a 1 SD (standard deviation) increment in LDL-P is 1.20 vs. 1.14.  If you take .20 and divide by .14, you get a value of 1.4, which means at baseline LDL-P is almost 1.5 times as predictive as Non-HDL-C.  • On-trial OR for a 1 SD increment on LDL-P is 1.28 vs. 1.09 for Non HDL-C. If you take .28 and divide by .09, you get a value of 3.1, which means on-trial LDL-P is 3 times as predictive as Non HDL-C.

  31. Relations of Lipoprotein Subclass Levels and Low-Density Lipoprotein Size to Progression of Coronary Artery Disease in the Pravastatin Limitation of Atherosclerosis in the Coronary Arteries (Plac-I) Trial Rosenson RS, MD, Otvos JD, PhD, Freedman DS,MD The American Journal of Cardiology July 2002;89-94

  32. PLAC-I Key Points • Page 91 • On trial “Independently of chemically determined levels of triglycerides, LDL cholesterol, and HDL cholesterol, lumen narrowing was associated with higher particle concentrations.” • Page 93 • “Although on-trial values of LDL cholesterol are generally not related to disease progression as assessed by coronary angiography, we found CAD progression to be associated with on-trial concentrations of LDL particles and the small LDL subclass, and with smaller average LDL particle sizes.” • Page 92 • “Lipid levels were not associated with CAD progression in the placebo in the placebo group, but significant associations were seen with average particle sizes and with levels of small LDL.

  33. Low-Density Lipoprotein Particle Concentration and Size as Determined by NMR Spectroscopy as Predictors of Cardiovascular Disease in Women Blake GJ, Otvos JD, Rifai N, Ridker PM Circulation 2002;106:1930-1937

  34. Women’s Health Study—Key Points • Page 1934 • “In this nested case control study of apparently healthy middle-aged women, we found that baseline LDL particle concentration measured by NMR was a predictor of future cardiovascular risk…” • Page 1936 • “In summary these prospective data are consistent with a role of LDL particle concentration (NMR) a a maker of cardiovascular risk prediction.” Blake GJ, et al. Circ 2002;106:1930-1937

  35. Women’s Health Study Key Points • Page 1934 Table 3 • Credibility Objection • Among the different measures of LDL concentration (direct LDL-C, apo B, and NMR LDL particle concentration), LDL particle concentration was the strongest predictor of future cardiovascular events. • NMR LDL particle concentration identifies a high-risk group of women with more than twice the risk of those classified as high-risk by LDL-C (relative risk of 4.17 vs. 2.06 for highest vs. lowest quartile). • - Apo B provided better prediction than LDL-C, but only marginally (relative risk of 2.43). Almost twice the risk (4.17 vs. 2.43) Blake GJ, et al. Circ 2002;106:1930-1937

  36. Women’s Health Study—Key Points • Non HDL-C Objection • NMR-measured LDL particle concentration gave significantly better risk prediction than any lipid variable evaluated, including non HDL-C (relative risk of 2.94). Almost 1 ½ times the risk (4.17 vs. 2.94) and the best combination marker, TC:HDL-C ratio (relative risk of 3.11). • Page 1932-1933 NMR-measured LDL particle concentration remained a strong and significant predictor upon adjustment for: • - lipid variables • (including HDL-C, TG, TC:HDL-C ratio, and the combination of TC:HDL-C ratio plus TG) • - hs-CRP Blake GJ, et al. Circ 2002;106:1930-1937

  37. Nuclear Magnetic Resonance Spectroscopy of Lipoproteins and Risk of Coronary Heart Disease in the Cardiovascular Heart Study Kuller L, Arnold A, Russell T,Otvos J,Burke G, Psaty B, Siscovick, D, Freedman D.S, Kronmal R Arteriosclerosis, Thrombosis, And Vascular Biology July 2002 22:7; 1175-1180

  38. Cardiovascular Health Study Key Points • Page 1179 • “…total LDLc is a relatively weak predictor of CVD, especially when the comparison group (controls) includes a large number of older individuals who have a subclinical CVD.” • “Our data suggest that at least for women, measurement of number and size of LDL particles may be important.” • Page 1175 (Abstract) • “In multivariate models for women that included triglycerides and HDLc, the number of particles (but not LDL size) remained significantly related to MI and angina.” • “Small LDL, the size of LDL particles, and the greater number of LDL particles (but not size) remained significantly related to MI and agina.”

  39. Cardiovascular Health Study Key Points • In this study, an increase of 100 nmol/L (1 standard deviation) of LDL particles was associated with a 11% increase in CHD events. • **This can be found on page 1177, In women, in bivariate analysis, LDL particle concentration (OR 1.11/100 nmol/L 1.03 to 1.09) was significantly different between the MI and angina case group and the healthy group.” • “In English” this means that for every LDL-P increase of 100 nmol/L, the risk for CHD events increased 11% (an Odds Ratio [OR] of 1.11).

  40. Relations of Lipoprotein Subclass and Coronary Artery Calcium in Postmenopausal Women from the Healthy Women Study Mackey R PhD,MPH, Kuller L MD, Sutton-Tyrrell K DrPH, Evans R PhD, Holubkov RPhD, Matthews K.A. PhD Arteriosclerosis, Thrombosis, And Vascular Biology July 2002 22:7; 1175-1180

  41. Healthy Women’s Key Points Page 75i • “In summary, mean LDL size (diameter), number of LDL particles, and the distribution of particles among subclasses may provide more accurate risk indexes than conventional lipid levels, which measure the total amount of cholesterol or triglycerides carried by all of the particles in a major class (e.g., LDL).” • “Our results suggest that measuring lipoprotein subclass levels may improve cardiovascular risk assessment and pharmacological treatment in postmenopausal women.” • “The efficacy of lipid-lowering therapy, especially statin drugs among diabetic men and women, was reinforced by the Heart Protection Study, reported at the 2001 American Heart Association meeting. This reported efficacy may be the result of the beneficial effect of statins in reducing the number of LDL particles.”

  42. Healthy Women’s Key Points • Page 73i • “In these postmenopausal women, increased coronary calcification was associated with higher levels of small LDL, and large VLDL, more LDL particles, smaller LDL size, and lower levels of large HDL.” • “The associations with small LDL, LDL particles, and large VLDL, remained significant after adjustment for LDL cholesterol, triglycerides, HDL cholesterol, age, smoking, and systolic blood pressure.” • These results suggest that prediction of cardiovascular risk in postmenopausal women may be improved by measuring lipoprotein subclasses in addition to conventional lipid values.

  43. Credibility-Transitions • “May I come in next week to review some of your results?” • Others

  44. Identify & Manage-Probes/Opening Statements • “May we review some of your patient results?” • “What questions do you have after receiving some of your patient results? • Others?

  45. Stand-up Calls Identify & Manage • Does the Dr. understand how to Identify and Manage patients? • Not going to change the way he/she treat will change the way he/she manages patients. • Will still use the same familiar therapies. • Statins • Fibrates • Niacin • etc

  46. Stand-up Calls Identify & Manage—Proof Sources • Visual Aid • Case Studies • NMR Profile Test Examples • Others?

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