• First line treatment of cardiovascular disease is lifestyle modification followed by the pharmacologic intervention of HMG-CoA reductase inhibitors or statins
• Statins are commonly associated with intolerable side effects such as myalgia leading to medication non-compliance
• RYR preparations claim to inhibit cholesterol synthesis without causing myalgia
• RYR preparations have naturally occurring monacolins such as monacolin K which is chemically identical to lovastatin
• RYR is not regulated by the FDA leading to questionable manufacturing practices producing varying ingredient composition
• The purpose of this study is to investigate the role RYR in hyperlipidemia treatment compared to statins by evaluating efficacy, side effects, and the potential to reduce medication non-compliance in adults
• Clinicians potentially could recommend RYR as an alternative treatment to hyperlipidemia in patients unable to comply with statin treatment to decrease cholesterol levels and reduce the progression of atherosclerosishttps://commons.und.edu/pas-grad-posters/1132/thumbnail.jp

Froemke, Lisa

English

UND Scholarly Commons (University of North Dakota)

University of North DakotaUND Scholarly CommonsPhysician Assistant Scholarly Project Posters Department of Physician Studies2014Alternative Treatment with Red Yeast Rice toReduce HyperlipidemiaLisa FroemkeUniversity of North DakotaFollow this and additional works at: https://commons.und.edu/pas-grad-postersPart of the Alternative and Complementary Medicine Commons, and the CardiovascularDiseases CommonsThis Poster is brought to you for free and open access by the Department of Physician Studies at UND Scholarly Commons. It has been accepted forinclusion in Physician Assistant Scholarly Project Posters by an authorized administrator of UND Scholarly Commons. For more information, pleasecontact zeineb.yousif@library.und.edu.Recommended CitationFroemke, Lisa, "Alternative Treatment with Red Yeast Rice to Reduce Hyperlipidemia" (2014). Physician Assistant Scholarly ProjectPosters. 117.https://commons.und.edu/pas-grad-posters/117Alternative Treatment with Red Yeast Rice to Reduce Hyperlipidemia  Lisa Froemke, PA-S Physician Assistant Program, University of North Dakota School of Medicine & Health Sciences  Abstract Introduction • Statins reduce lipid levels when lifestyle modifications are not adequate • Potential adverse effects of statins include myalgia and rhabdomyolysis  • Non-compliance increases the risk of further atherosclerosis formation  potentially leading to cardiovascular disease and related events  • RYR has been utilized in China since the Tang Dynasty in 800 AD  • Over the counter RYR has flourished in popularity with claims of being a natural product formed from cultured Monascus purpureus yeast on rice (See Figure 1), conveniently ordered online, and costing less than prescription statins  • Clinicians desire alternative treatment options for patients to reduce non-compliance that are effective and safe to reduce lipid levels and slow the progression of atherosclerosis  Research Question Literature Review Applicability to Clinical Practice Acknowledgments  Discussion  Childress et al. (2013) summarized RYR utilization has increased in popularity exponentially due the public’s perception of RYR being “natural” compared to prescription medication, perceived less side effects such as myalgia, reduced cost, over the counter availability, and lack of drug-drug interactions   Verhoeven et al. (2013) proposed less patient non-compliance with RYR due to reduced monthly cost of RYR $20-30 vs statins $120-300    Becker et al. (2013) reported 40% statin discontinuation within first year due to fear of adverse effects, cost, and reluctance to take medication chronically   Becker et al. (2009) trial demonstrated RYR had a significant reduction in LDL and total cholesterol when compared to placebo without increased myalgia making RYR a potential treatment option  Halbert et al. (2010) trial reflected RYR and pravastatin were tolerated equally with both groups experiencing recurrent myalgia and achieving comparable LDL cholesterol values therefore not supporting RYR as an alternative option  The meta-analysis conducted by Liu et al. (2006) evaluated RYR supplements (Cholestin, Xuezhikang, and Zhibituo) vs placebo.  reflecting the three RYR variations significantly reducing total cholesterol levels compared when compared to placebo over a 12 week duration (See Figure 3)              – Figure 3: RYR supplements (Cholestin, Xuezhikang, and Zhibituo) vs placebo.  Adapted from “Chinese Medicine” (2006), Retrieved from: http://www.cmjournal.org/content/1/1/4 reflecting RYR significantly reducing total cholesterol levels   When 101 products containing RYR were reviewed none could be confirmed as passing any independent laboratory verification testing necessary to promote consistent composition of the active ingredient, monacolin, and no possible toxic byproducts including citrinin (Childress et al., 2013)   RYR supplements are not strictly regulated by the FDA due to being considered a food not a drug therefore side effects are not documented as systematically as prescription medications such as statins  Halbert et al. (2010) and Becker et al. (2009) highlight various RYR potency, unsupervised availability, and possible contamination with citrinin due to lack of consistency between different manufacturers supporting RYR is not safe for the general public’s consumption  Liu et al. (2006) assessed the safety concerns of not only the lack of regulation of red yeast rice preparation composition but also what is the recommended dosages and duration  Randomized trials prove RYR is effective in mild to moderate hyperlipidemia in various populations to lower LDL cholesterol, but it may not be sufficient to treat moderate to severe hyperlipidemia and should not be recommended for hyperlipidemia treatment (Gordon & Becker, 2011) • First line treatment of cardiovascular disease is lifestyle modification followed by the pharmacologic intervention of HMG-CoA reductase inhibitors or statins • Statins are commonly associated with intolerable side effects such as myalgia leading to medication non-compliance • RYR preparations claim to inhibit cholesterol synthesis without causing myalgia • RYR preparations have naturally occurring monacolins such as monacolin K which is chemically identical to lovastatin • RYR is not regulated by the FDA leading to questionable manufacturing practices producing varying ingredient composition • The purpose of this study is to investigate the role RYR in hyperlipidemia treatment compared to statins by evaluating efficacy, side effects, and the potential to reduce medication non-compliance in adults • Clinicians potentially could recommend RYR as an alternative treatment to hyperlipidemia in patients unable to comply with statin treatment to decrease cholesterol levels and reduce the progression of atherosclerosis     • In patients with hyperlipidemia does RYR supplement as compared to statin treatment provide efficacious hypolipidemic results?          • Figure 1: Red Yeast Rice PATHOPHYSIOLOGY OF HYPERLIPIDEMIA • Excess lipids form plaque in the arteries reducing blood flow (See Figure 4) • LDL cholesterol transfers cholesterol to cells in tissues and is equal to the risk of atherosclerosis in predicting coronary disease (Papadakis, Tierney, & McPhee, 2011) • HDL cholesterol transfers cholesterol from the cells in tissues to be eliminated and  is inversely equal to the risk of atherosclerosis (Papadakis et al., 2011) • 11.5 years of life is projected to be lost in consequence to the development of atherosclerosis leading to coronary heart disease (Sikka et al., 2011). TREATMENT OPTIONS FOR HYPERLIPIDEMIA • Statin and RYR have similar pathophysiology due to sharing the same active ingredient, monacolin • MOA: Interfere with the conversion of Acetyl CoA to Mevalonate by inhibiting the enzyme HMG-CoA reductase (See Figure 2) (Verhoeven et al., 2013) • RYR comes in variations that do not have equal potency due to varying active potentials just as statins do not have equal potency when compared to each other (Musselman, Pettit, & Derenski, 2012)  Acetyl CoA ↓ HMG-CoA         RYR or Statins (Monacolins)→     ↓   ←HMG-CoA Reductase (Inhibited) Mevalonate ↓ Cholesterol – Figure 2: Adapted from Applied Pharmacology by Bardal, Waechter, & Martin, 2011 reflecting the effects of stains and RYR on cholesterol biosynthesis EFFICACY OF RYR THERAPY • RYR was compared to placebos such as the American Heart Step 1 Diet, phytosterol tablets, lifestyle changes, fish oil with all trials resulting in the reduction of total and LDL cholesterol that was superior or equal to placebo • The meta-analysis conducted by Liu et al. (2006) evaluated 93 randomized trials consisting of 9,625 participants utilizing three different variations of RYR preparations, Cholestin, Xuezhikang, and Zhibituo, with treatment duration ranging from 4 to 24 weeks with all 3 variations of RYR significantly reducing total cholesterol EFFICACY OF STATINS VS RYR • Three trials involving prescription statin intervention reflected a reduction in coronary events by 23-34% and coronary heart disease mortality by 20-42% (Yang & Mousa, 2012) • Becker et al. (2008) compared RYR to simvastatin reflecting significant LDL reduction without significant differentiation between test groups • Halbert et al. (2010) compared tolerability of pravastatin to RYR without significant difference in LDL reduction between test groups STATINS VS RYR SIDE EFFECTS  • Statins are generally well tolerated, possible side effects include: myalgia, myositis, rhabdomyolysis, and hepatoxicity with 10-15% of statin users developing myalgias (Bardal et al., 2011) • 57% statin users experience myalgias when trying a second statin (Abd & Jacobson, 2011) • RYR side effects include: dizziness, decreased appetite, nausea, abdominal  pain, distension, and diarrhea occurring in 1.3-36% of patients (Liu et al., 2006) • Halbert et al. (2010) compared tolerability of pravastatin to RYR with 67% in RYR group reporting pain and 68% in the pravastatin group therefore similar tolerability STATINS VS RYR SAFETY • Heber et al. (2001) analyzed 9 different commercially available RYR products and discovered varying monacolin content from 0-0.58% and toxic citrinin byproduct in 7 out of 9 preparations • No studies are available regarding long-term cardiovascular prevention with RYR as with statin use • Statin safety concern addressed by the FDA ten years ago involved Bayer removing the statin, cerivastatin, after 31 patients died from rhabdomyolysis (Bardal et al., 2011) • Between 1987 and 2001 the FDA recorded 42 deaths or one death per million 30-day supply prescriptions of statins from rhabdomyolysis (Sikka et al., 2011)    RYR has potential to reduce hyperlipidemia as reflected in short duration trials but at this time can not be recommended due to lack of standardization, long-term side effects, narrow test populations, and secondary cardiovascular prevention  RYR is not practical in healthcare setting due to lack of FDA regulation allowing for varying amounts of monacolin and potential toxic citrinin byproduct  Current FDA approved pharmacologic lipid modifying agents include niacin (vitamin B5), bile acid sequestrants, HMG-CoA reductase inhibitors, fibrates, and Ezetimibe with each group of agents having a unique mechanism of action to prevent further atherosclerosis (See Figure 4)           Figure 4: Atherosclerosis          • Sincere appreciation to Dr. Timothy Nyarandi who served not only as a mentor for this project, but as my primary family medicine preceptor • Cody Froemke, family, and friends for support and encouragement • UND Physician Assistant Program faculty for their relentless commitment to graduate students Statement of the Problem • Studies are needed to determine if RYR supplement in the treatment of hyperlipidemia is a comparable treatment option to statins in efficacy, side effects, and safety to potentially reduce medication non-compliance.  References Abd, T. T., & Jacobson, T. A. (2011). Statin-induced myopathy: A review and update. Expert Opinion on Drug Safety, 10(3), 373-387.   doi: 10.1517/14740338.2011.540568 Bardal, S. K., Waechter, J. E., & Martin, D. S. (2011). Applied pharmacology. (pp. 114-118). St. Louis: Elsevier Saunders. Becker, D. J., French, B., Morris, P. B., Silvent, E., & Gordon, R. Y. (2013). Phytosterols, red yeast rice, and lifestyle changes instead of  statins: A  randomized, double-blinded, placebo-controlled trial. American Heart Journal, 166(1), 187-196.e2.   Retrieved from: http://dx.doi.org.ezproxy.library.und.edu/10.1016/j.ahj.2013.03.019 Becker, D. J., Gordon, R. Y., Halbert, S. C., French, B., Morris, P. B., & Rader, D. J. (2009). Red yeast rice for dyslipidemia in statin-                            Intolerant patients: A  randomized trial. Annals of  Internal Medicine, 150(12), 830-839.   doi:10.7326/0003-4819-150-12-2 00906160-00006 Becker, D. J., Gordon, R. Y., Morris, P. B., Yorko, J., Gordon, Y. J., Li, M., & Iqbal, N. (2008). Simvastatin vs therapeutic lifestyle  changes and supplements: Randomized primary prevention trial. Mayo Clinic Proceedings, 83(7), 758-764.   Retrieved from: http://www.mayoclinicproceedings.com.ezproxy.library.und.edu/ Childress, L., Gay, A., Zargar, A., & Ito, M. K. (2013). Review of red yeast rice content and current food and drug administration  oversight. Journal of  Clinical Lipidology, 7(2), 117-122.   Retrieved from: http://dx.doi.org.ezproxy.library.und.edu/10.1016/j.jacl.2012.09.003 Gordon, R. Y., & Becker, D. J. (2011). The role of red yeast rice for the physician. Current Atherosclerosis Reports, 13(1), 73-80.   doi: 10.1007/s11883-010-0145-0 Halbert, S. C., French, B., Gordon, R. Y., Farrar, J. T., Schmitz, K., Morris, P. B., Thompson, P. D., & Rader, D. J. (2010). Tolerability  of  red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance.  The American Journal of Cardiology, 105(2), 198-204. doi: 10.1016/j.amjcard.2009.08.672 Heber, D., Lembertas, A., Lu, Q. -., Bowerman, S., & Go, V. L. W. (2001). An analysis of nine proprietary chinese red yeast rice dietary  supplements: Implications of variability in chemical profile and contents. Journal of Alternative and Complementary  Medicine, 7(2), 133-139. Retrieved from: http://dx.doi.org.ezproxy.library.und.edu/10.1089/107555301750164181 Liu, J., Zhang, J., Shi, Y., Grimsgaard, S., Alraek, T., & Fønnebø, V. (2006). Chinese red yeast rice (monascus purpureus) for primary   hyperlipidemia: A meta-analysis of randomized controlled trials. Chinese Medicine, 1.   Retrieved from: http://www.cmjournal.org/content/1/1/4 Musselman, M. E., Pettit, R. S., & Derenski, K. L. (2012). A review and update of red yeast rice. Journal of Evidence-Based  Complementary and Alternative  Medicine, 17(1), 33-39. doi: 10.1177/2156587211429703 Papadakis, M., Tierney, L., & McPhee, S. (2011). Current medical diagnosis and treatment. (52 ed., pp. 1245-1255). San Francisco:  Lange Medical Books/McGraw- Hill. Sikka, P., Kapoor, S., Bindra, V. K., Sharma, M., Vishwakarma, P., & Saxena, K. K. (2011). Statin intolerance: Now a solved problem.  Journal of  Postgraduate Medicine, 57(4), 321-328. doi: 10.4103/0022-3859.90085 Verhoeven, V., Lopez Hartmann, M., Remmen, R., Wens, J., Apers, S., & Van Royen, P. (2013). Red yeast rice lowers cholesterol in  physicians - a double  blind, placebo controlled randomized trial. BMC Complementary and Alternative Medicine, 13.  Retrieved from: http://www.biomedcentral.com/1472-6882/13/178 Yang, C. W., & Mousa, S. A. (2012). The effect of red yeast rice (monascus purpureus) in dyslipidemia and other disorders.  Complementary Therapies in Medicine, 20(6), 466-474.   Retrieved from: http://dx.doi.org.ezproxy.library.und.edu/10.1016/j.ctim.2012.07.004 

Alternative Treatment with Red Yeast Rice to Reduce Hyperlipidemia

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Alternative Treatment with Red Yeast Rice to Reduce Hyperlipidemia

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