Crestor (rosuvastatin) package insert. Recommendations for management of clinically significant drug-drug interactions with statins and select agents used in patients with cardiovascular disease: a scientific statement from the American Heart Association. IMS Institute for Healthcare Informatics. In July of 2003, an 86-year-old driver with an excellent driving record plowed into a farmers market in Santa Monica, California, killing ten people. Lancet. Outcomes of using high- or low-dose atorvastatin in patients 65 years of age or older with stable coronary heart disease. Lipitor is the most popular and most potent member of the statin family of drugs, which is the most widely prescribed class of medications in the United States. American College of Cardiology. Combination treatment involving the addition of a second agent to ongoing statin therapy remains a somewhat controversial topic. Banach M, Serban C, Sahebkar A, et al. J Am Coll Cardiol. Mayo Clin Proc. The proportion of the population over 80 years, the so-called “old old”, is increasing most rapidly. www.acc.org/latest-in-cardiology/articles/2018/03/05/15/53/sat-9am-odyssey-outcomes-cv-outcomes-with-alirocumab-after-acs-acc-2018. 2011;377:2181-2192.19. 2017;26:45-55.45. Copyright © 2000 - 2021 Jobson Medical Information LLC unless otherwise noted. Balancing primary prevention and statin-induced diabetes mellitus prevention. 2015;90:24-34.47. - Frankly Speaking EP 207, Guest: Robert Baldor, MD, FAAFPMusic Credit: Richard Onorato. Sabatine MS, Giugliano RP, Keech AC, et al. Between October 26, 2005, and July 8, 2010, a total of 18,144 patients underwent randomization at 1147 sites in 39 countries. Whitehouse Station, NJ: Merck & Co, Inc; February 2015.8. Erectile dysfunction (ED) is one of the most common chronic diseases affecting men and its prevalence increases with aging. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. Ginsberg HN, Elam MB, Lovato LC, et al. With six statins available generically, the selection of an appropriate agent may be determined based on drug-specific factors, including dosing considerations, drug interactions, and adverse events. Effects of combination lipid therapy in type 2 diabetes mellitus. Rhabdomyolysis is a potentially life-threatening syndrome resulting from the breakdown of skeletal muscle fibers with leakage of muscle contents into … Patients Table 1. Lancet. N Engl J Med. Gupta A, Thompson D, Whitehouse A, et al. In individuals with very high-risk ASCVD, use an LDL-C threshold of 70 mg/dL (1.8 mmol/L) to consider the addition of nonstatins to statin therapy. To comment on this article, contact rdavidson@uspharmacist.com. Dementia is a major illness and cause of disability among the elderly. Evolocumab and clinical outcomes in patients with cardiovascular disease. The widespread generic availability of statins has made these agents increasingly more accessible. This activity is part of the Frankly Speaking with Dr. Frank Domino podcast series. Pedro-Botet J, Rubiés-Prat J. Statin-associated muscle symptoms: beware of the nocebo effect. Circulation. From there, properties of each statin must be taken into account to determine the best option for the individual patient. All rights reserved. 22-24 Additionally, patients with heart failure have not been found to experience the same benefits from statin therapy as those without heart failure. High cholesterol levels can actually protect elderly people against dementia and the inverse is also true; low cholesterol levels are linked to a higher risk of dementia. Matalka MS, Ravnan MC, Deedwania PC. Rhus Tox – Best Remedy for Back Pain. Cannon CP, Blazing MA, Giugliano RP, et al. N Engl J Med. How to balance cardiorenometabolic benefits and risks of statins. 2017;70:1785-1822.31. The opinions, ideas, and recommendations expressed in this educational activity are those of the faculty only and are not necessarily endorsed by, nor do they necessarily reflect, those of their affiliated institutions, Pri-Med Institute, Pri-Med Institute Advisory Boards and Consultants, DBC Pri-Med, LLC. UMass Medical School/Baystate, The following financial relationships have been disclosed by faculty. We apologize for the inconvenience, but you may be able to find it instead through your library resources. These unprecedented times have resulted in efforts by the medical community to rapidly organize and publish any and all information regarding COVID-19. 2008;358:1431-1443.28. If using a different browser, such as Safari, Firefox or Edge, make sure you are using the most up-to-date version. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. The Alternate Day Versus Daily Dosing of Atorvastatin Study (ADDAS). Circulation. Pri-Med Institute requires all individuals in a position to influence educational content for Pri-Med Institute-certified CME/CE activities to disclose relevant personal financial relationships with commercial interests prior to contributing to its educational activities. Rosuvastatin in older patients with systolic heart failure. Rhus Tox is a top grade medicine for treating back pain. Princeton, NJ: Bristol-Myers Squibb Company; July 2016.6. Ridker PM, Danielson E, Fonseca FA, et al. The COVID-19 pandemic has consumed global attention and caused the medical community to quickly learn how to best diagnose and manage this emerged infectious disease. LaRosa JC, Grundy SM, Waters DD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of dyslipidemia and prevention of cardiovascular disease. Meta-analysis of impact of different types and doses of statins on new-onset diabetes mellitus. New York, NY: Pfizer Inc; October 2017.36. N Engl J Med. When a statin is suspected as the cause of mild-to-moderate symptoms, temporary withdrawal is recommended. In patients with clinical ASCVD, reduce low-density lipoprotein cholesterol (LDL-C) levels with high-intensity statin therapy or the maximally tolerated statin therapy. Vytorin (ezetimibe/simvastatin) package insert. These recommendations do not automatically apply to certain subgroups of patients. N Engl J Med. Common causes include old age, drug interactions, impaired renal or hepatic function, increased physical activity, and vitamin D deficiency.20,41, Next, the clinician should compare the patient’s presentation with commonly seen statin-induced symptoms. Is alternate daily dose of atorvastatin effective in treating patients with hyperlipidemia? If the symptoms do not resolve after approximately 2 weeks, the statin is likely not the cause and should be reinitiated at the original dose. Lim S, Oh PC, Sakuma I, Koh KK. www.federalregister.gov/documents/2016/04/18/2016-08894/abbvie-inc-withdrawal-of-approval-of-new-drug-applications-for-advicor-and-simcor. A number of different diseases potentially worsening sexual function may occur in elderly people, together with polypharmacy. Each statin has different concerns regarding drug-drug and drug-food interactions because of the specific pathways through which each is metabolized (TABLE 5). Pri-Med Institute educational activities are developed and conducted in accordance with the ACCME's Essential Areas and Policies. Zocor (simvastatin) package insert. During the day, her legs seem fine for the most part. Baseline Characteristics. Has disclosed no relevant financial relationships. Sydney cardiologist Dr Ross Walker says that common health checks for blood pressure and cholesterol were not the best predictors of heart attacks. Stone NJ, Robinson JG, Lichtenstein AH, et al. Financial disclosures are listed in the activity syllabus and will also be printed on the slides and announced at the start of each presentation. Livalo (pitavastatin) package insert. Clinical judgment must guide each clinician in weighing the possible risks, benefits, or contraindications of any diagnostics, interventions or treatments discussed. 2007;147:1-9.23. If cookies and/or JavaScript are disabled, the site may not function properly. 2015;32:649-661.25. Several heavily debated treatment guidelines discuss the role of statins in treating hyperlipidemia. If you have questions about this activity, please email support@pri-med.com or call (877) 477-4633. 2012;380:581-590.18. Cannon CP, Braunwald E, McCabe CH, et al. Data are limited regarding statin therapy for primary prevention of atherosclerotic cardiovascular disease in adults 75 years and older. Accessed March 18, 2018. In T2D, Canagliflozin Not Linked to Increased Fracture Risk Versus GLP-1 Agonists. Goldberg AS, DeGorter MK, Ban MR, et al. Of the seven different statins on the market, six are available generically (TABLE 1).2-7 Three available branded formulations are pitavastatin (Livalo), simvastatin oral suspension (FloLipid), and lovastatin extended-release (Altoprev).8-10 The role of branded agents in therapy is limited given the widespread availability of generic options. Steven Kheloussi, PharmDAssistant Professor of Pharmacy PracticeWilkes University, Nesbitt School of PharmacyWilkes-Barre, Pennsylvania. Accessed March 18, 2018.14. To that end, we welcome your comments about how to better serve your needs. Daily dosing versus alternate-day dosing of simvastatin in patients with hypercholesterolemia. Brooksville, FL: Salerno Pharmaceuticals LP; July 2017.10. Lescol/Lescol XL (fluvastatin) package insert. N Engl J Med. Although statin use for secondary prevention in elderly patients confers significant benefit, its use for primary prevention is unclear.22-24 Additionally, patients with heart failure have not been found to experience the same benefits from statin therapy as those without heart failure.25 Based on these findings, treatment recommendations include limiting initiation of high-intensity statins to patients aged younger than 75 years and possibly avoiding statins in patients with heart failure.20 Overall, the decision to use statins in these groups is not clear-cut and should involve an ongoing conversation between provider and patient about potential risks and benefits of therapy.20, Contrary to the 2013 ACC/AHA recommendation to initiate therapy according to treatment-group classification, the 2017 AACE guideline recommends that individual patients be treated based on laboratory findings.14 According to this guideline, patient risk is determined by a variety of major, additional, and nontraditional risk factors. Too many drug interactions exist to discuss each in detail; therefore, only a selected few are described below. Life expectancy at all ages is also increasing. Frank J. Domino, MD. Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. Response: CMS believes plans are in the best position to develop the processes and technical specifications for documenting how they meet this requirement and that a face-to-face encounter for purpose of satisfying this regulation has taken place. We are pleased to announce a new free Case Based Urology Learning Program from the Cleveland Clinic Glickman Urological and Kidney Institute, Rainbow Babies and Children’s Hospital, and University Hospitals Case Medical Center. The 2013 ACC/AHA guideline introduced four treatment groups to be targeted for statin therapy: 1. Views presented related to unapproved uses of products are solely those of the presenter(s) and are not endorsed by Pri-Med Institute or DBC Pri-Med, LLC. Am J Cardiol. During the course of their presentations, the faculty may mention uses of products that have not been approved in the United States for the indication(s) being discussed. ↑ "Study says there's no link between cholesterol and heart disease" Physicians should claim only the credit commensurate with the extent of their participation in the activity. Am J Cardiol. Liver enzymes (specifically, the cytochrome P-450 liver enzymes) are responsible for eliminating all statins from the body with the exception of pravastatin and rosuvastatin. Meta-analysis of placebo-controlled randomized controlled trials on the prevalence of statin intolerance. 2010;362:1563-1574.27. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. It is estimated that 20% of people in Europe will be over 65 years of age in the year 2000. Myositis-Specific Antibodies (MSA\'s) and others, called Myositis-Associated antibodies (MAA), were identified several years ago and can assist your doctor in helping to confirm a diagnosis of certain types of inflammatory myopathies. PQQ and Statin Damage The vital role of PQQ in mitochondrial support has only been documented in the past 15 years. 1. "Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review". Has disclosed no relevant financial relationships. You may have reached this page because the site or link you have tried to access no longer exists. BMJ Open Diabetes Res Care. Cerebrovascular disease or multi infarct dementia is the second leading cause of dementiiig illness among Caucasians, preceded only by Alzheimer's disease. Memory loss is one of the documented side effects of statins, which reduce the body’s production of CoQ10, a nutrient that protects the brain and the heart. We are an aging population. Fibrates: Although the combination of a fibrate and a statin has not been shown to meaningfully alter clinical outcomes, patients may still be prescribed gemfibrozil, fenofibrate, or fenofibric acid together with a statin to target severely uncontrolled hypertriglyceridemia.14,20,26,33 Because both of these classes are associated with muscle-related toxicity, combination therapy significantly increases this risk compared with either therapy alone.33 This additive toxicity is more frequently seen with gemfibrozil than with other fibrates.33 Therefore, gemfibrozil use is contraindicated with simvastatin and should be avoided with other statins.7,20 If a statin and a fibrate will be used together, fenofibrate or fenofibric acid is preferred.20,33 However, if gemfibrozil must be used, fluvastatin—or, with careful monitoring, atorvastatin or rosuvastatin (maximum 10 mg daily)—is the agent of choice.33, Amiodarone: This antiarrhythmic agent indicated for ventricular fibrillation is a known inhibitor of P-glycoprotein (Pgp) and the CYP450 enzyme system, specifically CYP3A4 and, to a lesser extent, CYP2C9.33,34 As a result, maximum recommended dosages exist for lovastatin (maximum 40 mg daily) and simvastatin (maximum 20 mg daily) when used with amiodarone.4,7,33 Although atorvastatin is metabolized through CYP3A4, no dosage adjustment is necessary (similarly to other statins) because data do not suggest serious AEs when atorvastatin and amiodarone are used concomitantly.2,33, CCBs: Both dihydropyridine (amlodipine) and nondihydropyridine CCBs (diltiazem, verapamil) have been shown to have meaningful drug interactions with statins. Lipitor (atorvastatin) package insert. However, if the symptoms resolve, a retrial of the same statin at the same or a lower dose should be undertaken. An interesting question is whether widespread statin-induced neuropathy makes our elderly drivers (and even not-so-elderly drivers) more accident prone? Statins and the risk of diabetes: evidence from a large population-based cohort study. Statins are generally well tolerated; however, discontinuation rates remain high.38 Discontinuation of statin therapy and failure to resume statin therapy after the occurrence of adverse drug reactions are associated with increased rates of CVEs.39 Patients’ concerns about statin safety in light of two major statin-related AEs—myotoxicity and new-onset diabetes—may lead to statin discontinuation. Many of my patients are asking how they can stay healthy in the setting of COVID-19. AbbVie Inc.; withdrawal of approval of new drug applications for Advicor and Simcor. In addition, specific slides will include notation of the off-label use or investigational agent being discussed. Lancet. Pri-Med Institute assesses disclosed relationships and follows a defined process to resolve real or implied conflicts to ensure, to the best of its ability, that all educational content is free of commercial bias. Teng M, Lin L, Zhao YJ, et al. Reproduction in whole or in part without permission is prohibited. For APRNs and PAs, AANPCB and NCCPA accept AMA PRA Category 1 Credit™ as the number of hours of participation (AANPCB) or as Category 1 CME credits (NCCPA). 2016;5. Discussion of Off-Label Uses and Investigational Products All presenters are instructed to notify participants when they are discussing unapproved uses or investigational agents. Can J Cardiol. Ann Intern Med. Accessed March 18, 2018.46. Wallace A, Chinn D, Rubin G. Taking simvastatin in the morning compared with in the evening: randomised controlled trial. 2004;350:1495-1504.20. First, owing to a higher likelihood of symptoms, the clinician may choose to avoid the most lipophilic statins (lovastatin and simvastatin) in favor of more hydrophilic statins (fluvastatin, pravastatin, and rosuvastatin).44 Simvastatin 80 mg should never be initiated as new therapy in any patient because of an unusually high frequency of statin-associated muscle symptoms.7,45 Alternative therapies, such as coenzyme Q10, have not demonstrated consistent benefit but may be considered in patients experiencing psychologically induced symptoms.41,44,46 Finally, extended-interval dosing, which involves dosing statin medications several times weekly rather than once daily, may be considered. Low-density lipoprotein cholesterol should be <55 mg/dL (1.4 mmol/L) in patients with established cardiovascular disease or multiple risk factors. Individualized patient-care plans can be developed based on data from important clinical studies, differences in guidelines, and current management recommendations for two major adverse events associated with statin use. A statin should be added to lifestyle modifications if low-density lipoprotein cholesterol is >70 mg/dL (1.8 mmol/L). Risk factors for statin-associated muscle damage, e.g.