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This document discusses integrating proteomic biomarkers into personalized drug dosing of erythropoietin (EPO) for treating anemia. It reviews the rise of EPO therapy and emerging safety concerns that led to lowered dosing guidelines. Proteomic analysis identified serum biomarkers that distinguish EPO resistant from sensitive patients. A model predictive control tool was developed to personalize EPO dosing based on these biomarkers, achieving superior results to standard protocols. The combination of biomarkers and intelligent dosing control shows promise for guiding individualized EPO treatment.
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Their beneficial effects on cardiovascular morbidity and mortality have been demonstrated both in primary and in secondary prevention.
They are generally safe, but in some patients, statin therapy is stopped because of intolerance to the drug that may result in muscle aches and weakness, gastrointestinal symptoms, liver enzyme abnormalities, or other nonspecific discomforts.
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Jupiter Slides translate
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Statin combinations
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Abst cardiac toxicity from ethanol exposure in human induced pluripotent stem...
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A technical paper. However, it supports all the research on animals that show prenatal alcohol interferes with cardiac developmentStatins-cornerstone in lipid management
1) Statins are highly effective in reducing LDL-C and cardiovascular risk, playing a cornerstone role in lipid management. They work by inhibiting HMG-CoA reductase.
2) Atorvastatin has been extensively studied in large trials and shown to significantly reduce major cardiovascular events when doses are increased from 10 mg to 80 mg.
3) Studies in India found that high dose atorvastatin (80 mg) was well tolerated and more effective at reducing LDL-C and hs-CRP than lower doses in ACS patients. However, many ACS patients in India were not receiving statins as recommended.
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Poster
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Comparative effectiveness of acei and arbi
Although many are still concerned with an ARB–MI paradox, our study of close to 60 000 patients with MI should serve as reassurance that ARBs are not associated with adverse outcomes compared with ACEIs. Potential benefits of ARBs as compared with ACEIs in older women with MI should be further evaluated.
Jupiter Slides translate
The JUPITER trial was a randomized, double-blind, placebo-controlled trial that investigated whether rosuvastatin 20 mg could decrease major cardiovascular events in apparently healthy people with elevated levels of C-reactive protein (hsCRP > 2 mg/L) but normal cholesterol levels (LDL < 130 mg/dL). The trial enrolled 17,802 participants across 26 countries who were randomized to rosuvastatin 20 mg or placebo. Rosuvastatin significantly reduced the primary endpoint of myocardial infarction, stroke, hospitalization for unstable angina, arterial revascularization procedures, or cardiovascular death by 44% compared to placebo. Rosuvastatin also significantly lowered levels of LDL cholesterol, hsCRP, and triglycerides
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Payne
1) The document discusses the increasing distance between data generation through electronic health records and knowledge generation in biomedicine. Regulatory, technical, and cultural barriers have artificially partitioned access to clinical data for knowledge generation purposes.
2) It proposes creating a "learning healthcare system" using a systems approach to leverage various data sources and reduce the barriers between data and knowledge. Strategies include eliminating boundaries, semantic integration, and addressing technical, regulatory and cultural challenges.
3) The goal is to learn from every patient encounter to improve individual and community care through applications of healthcare IT, biomedical informatics, and cultural harmonization between these fields.
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Osu lesko 6 oct final
Recent Development in Pharmacogenomics
The summary discusses recent developments in pharmacogenomics including:
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Rizer for distribution
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1) A meta-analysis of 27 randomized trials found that treating anemia in chronic kidney disease patients with erythropoiesis-stimulating agents (ESAs) to achieve higher hemoglobin levels increased risks of stroke, worsening hypertension, and vascular access thrombosis compared to lower hemoglobin targets.
2) No significant differences were found between higher and lower hemoglobin targets for risks of death, cardiovascular events, or progression to kidney failure requiring dialysis.
3) While higher hemoglobin targets reduced need for blood transfusions, they increased use of intravenous iron therapy.
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This document discusses novel strategies for treating anemia, including erythropoietin mimetic peptides and hypoxia-inducible factor stabilizers. It provides a history of erythropoietin discovery and treatment of anemia in chronic kidney disease patients. Two clinical trials of the erythropoietin mimetic peginesatide showed it was effective at maintaining hemoglobin levels but also found an increased risk of cardiovascular events. Other experimental erythropoietin therapies mentioned include CNTO 528-530 peptides and modified erythropoietin-albumin fusion proteins. HIF stabilizers are also discussed as a potential future anemia treatment by upregulating endogenous erythropoietin production.
Anemia where we stand
This document summarizes the current state of anemia treatment in chronic kidney disease (CKD) patients. It discusses the magnitude of the problem, clinical management including use of erythropoiesis-stimulating agents (ESAs), and future therapies. ESAs are currently the mainstay of treatment but have limitations like requiring high doses and increased risks at higher hemoglobin levels. Newer approaches being researched include stabilizing hypoxia-inducible factor to stimulate endogenous erythropoietin production, modulating the iron-regulating hormone hepcidin, and gene therapy to introduce the erythropoietin gene directly.
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EVALUATING RISK OF HEART FAILURE WITH ERYTHROPOIETIN IN CHRONIC ANEMIA
Erythropoietin (EPO) is the primary regulatory hormone of
erythropoiesis. Hypoxia induces an increase in EPO hormone
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(epoetinalfa) by the US FDA in 1989, epoetinalfa and similar agents
now collectively known as erythropoietin stimulating agents (ESA)
have become the standard of care for the treatment of the
erythropoietin-deficient anemia. Studies suggest that in patients with
high serum erythropoietin is associated with risk of recurrent heart
failure (HF) and mortality. Thromboembolic complications can be
increased in patients receiving erythropoietin. the use of
erythropoiesis-stimulating agents though reduces the need for transfusions it is associated
with increased complications, including higher mortality and increased risk of
thromboembolic and cardiovascular events leading to congestive heart failure.
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ANEMIA_IN_CKD.pptx
This document discusses anemia in chronic kidney disease (CKD). It notes that anemia is associated with increased risks of cardiac disease, stroke, mortality, and hospitalization in CKD patients. The main causes of anemia in CKD are decreased erythropoietin production and iron deficiency/restriction. Evaluation involves assessing red blood cell indices, iron status, and ruling out other causes. Management includes red blood cell transfusions, erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa, and iron therapy. ESAs effectively treat anemia in CKD and reduce transfusion needs but must be used cautiously due to potential cardiovascular risks with high hem
The Importance of Biomarkers in Hematology/Oncology Drug Development - Steven...
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The patient is a 71-year-old female who presented to the emergency room with shortness of breath, feeling faint, and dizziness. She has a history of diabetes, hypertension, chronic kidney disease, and myelodysplastic syndrome. Laboratory tests showed low red blood cell counts and hemoglobin due to bone marrow failure from her myelodysplastic syndrome. She was given two units of red blood cells due to her anemia. Her diagnoses is symptomatic anemia from her myelodysplastic syndrome, which carries a poor prognosis including a high risk of developing leukemia.
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This document discusses hypertension and its effects on the kidney. It provides an overview of key considerations in the pathophysiology of hypertension, including the roles of the renin-angiotensin-aldosterone system and other factors. Several studies are summarized that examine the use of diuretics and other antihypertensive drugs to control blood pressure and reduce proteinuria in patients with chronic kidney disease. Angiotensin receptor blockers are highlighted as effective treatments for slowing the progression of kidney disease through blood pressure control and additional renoprotective effects.
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- 1. Integrating Proteomic Biomarkers Into Personalized Drug Dosing Jon Klein, M.D., Ph.D. University of Louisville Pharos Medicine
- 2. Disclosure Verification for: Name: Jon Klein, MD PhD The presenter listed above: ___ Does not have any significant financial relationships to disclose _x_ Has disclosed the following relationships: __Research Grants __Speakers Bureau Patent holder x __Consultant for fee _x_Stock/Ownership Employment x Partnership __Advisory Committee/Board ___Other _x_ Has disclosed this activity will not include discussion of unapproved/investigational uses of products or devices __ Has disclosed this activity will include discussion of unapproved/investigational uses of products or devices Was this activity Supported by an educational grant or received in-kind support? __ Yes Name of Company: _X_No
- 3. Goals Define the problem of anemia in end-stage renal disease (ESRD). Review the rise of recombinant erythropoietin (rEPO) as a therapy. Review the emerging doubts about rEPO and subsequent changes in dosing. Describe proteomic data of biomarkers of rEPO response. Describe the merger of biomarkers with a model predictive control tool to adjust rEPO dose.
- 4. The Golden Age of Anemia Treatment The WHO defines anemia as a Hgb < 13 in males and < 12 in premenopausal females By this definition > 90% of patients with kidney disease are anemic Beginning in 1989, kidney patients began receiving FDA approved rEPO. EPO use in cancer and HIV patients soon followed
- 5. The Golden Age of Anemia Treatment
- 6. The Golden Age Begins to End NlHct = 42 Low Hct = 30 N Engl J Med. 1998 Aug 27;339(9):584-90.
- 7. N Engl J Med 2006;355:2085-98. Conclusions The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life.
- 9. The Golden Age Ends WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1). • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. • Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1). “Clinicians should use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions”
- 10. Clinicians’ Response EPO weekly dose fell 12.5% in 2 years. Hgb targets are shifted from 10-13 to 10-11 g/dl
- 11. Discovery of EPO Response Biomarkers
- 12. Hypothesis The plasma proteome may distinguish between patients that are resistant and sensitive to RhEpo
- 14. Peptide Extraction Peptide Quantification Peptide Separation 1D RP capHPLC Robotic Fraction Collection MALDI Plate Spotting Precursor Ion Peak List Subsequent TOF/TOF MS Analytical workflow for peptide separation and identification Computer-Aided Modeling Bioinformatics Assignment of Peptide Identity
- 15. Results
- 16. Peptide and Protein Biomarkers
- 17. Sensitivity of the Candidate Biomarkers
- 18. Applying Intelligent Control to EPO Dosing
- 20. EPO DOSE VS RESPONSE
- 21. Model Predictive Control Model Dose Optimizer EPO Hb Pharmacodynamic Response Model EPO Dose Increment Target Range Minimization 12 10 Patient Hb 0 1 2 3 Months
- 22. Multiple Model Predictive Control (MMPC) System for Anemia Management
- 23. MMPC Results
- 24. Combining EPO Biomarkers and MMPC Use serum biomarker of EPO resistance to “prime” the MMPC anemia manager
- 25. Epo Resistance vs. OSMR
- 26. Biomarker Incorporation for Dosing
- 27. Conclusions The treatment of anemia in ESRD remains challenging. Concerns about unbridled EPO treatment have emerged. Proteomic analysis revealed serum biomarkers of EPO resistance and susceptibility The use of intelligent control methods (MMPC) provided personalized EPO dosing with results superior to standard protocols The combination of proteomic biomarkers and MMPC shows promise in guiding individualized EPO dosing.
- 29. NIH, DVA, DOE
- 30. KY Research Challenge Trust
- 31. The Ohio State Univ.
- 32. Brad Rovin
Editor's Notes
- Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)4 and Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE)
- The standard control protocol was based on an interpretation of national anemia guidelines from The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (5) and the package insert for EPOGEN
- For this example I am using OSMR as the biomarker of choice since the OSMR data seem to correlate much nicer with Epo Resistance Index (ERI), hence are more illustrative. Here you see the data plot of ERI vs. total OSMR abundance with a nice “exponential” curve fit to show the relationship between the two. Using this fit, I was able to calculate Epo responsiveness for different levels of OSMR abundance (not shown here). ERI = EPO Dose/Hgb 1 month later
- This is hypo-responder simulation when no OSMR value is provided at the beginning