2017 focused update of the 2016 ACC Expert Consensus Decision Pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. Lipitor (atorvastatin) package insert. Statin-induced muscle toxicity usually presents as pain, tenderness, cramps, and weakness, usually in the leg muscles.20,41 These symptoms are typically worse after exercise and do not resolve without discontinuation of the offending agent.41. 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. Circulation. Bridgewater, NJ: Valeant Pharmaceuticals; November 2016.37. The ACC/AHA guideline also introduced the idea of grouping statins by intensity (i.e., their expected LDL-C–lowering ability) (TABLE 2).20 Based on the treatment group (as defined above), the guideline recommends specific statin intensities for particular clinical situations (TABLE 3).20 Several treatment groups require calculation of an ASCVD risk score using an ASCVD risk estimator. Maple Grove, MN: Upsher-Smith Laboratories LLC; July 2017.35. LaRosa JC, Grundy SM, Waters DD, et al. Upon symptom resolution, a low dose of an alternative statin should be initiated and titrated to the maximum tolerated dose.20,41 Patient acceptance and understanding of this process are important because the nocebo effect may otherwise lead to further perceived reactions. Has disclosed no relevant financial relationships. By understanding that not all statins are the same, the pharmacist can help ensure the best possible outcome for each patient. Age is not a basis for exclusion from this criterion.3. Outcomes of using high- or low-dose atorvastatin in patients 65 years of age or older with stable coronary heart disease. But during the night, needle-poking type of pain occurs in her thighs and knees. 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. 2017;70:1785-1822.31. ... New-Onset Diabetes After Statin Exposure in Elderly Women: The Australian Longitudinal Study on Women’s Health. In patients with clinical ASCVD, reduce low-density lipoprotein cholesterol (LDL-C) levels with high-intensity statin therapy or the maximally tolerated statin therapy. 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. N Engl J Med. Crandall JP, Mather K, Rajpathak SN, et al. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. Is alternate daily dose of atorvastatin effective in treating patients with hyperlipidemia? 2017;120:774-781.39. Medicines use and spending in the U.S.: a review of 2015 and outlook to 2020. https://morningconsult.com/wp-content/uploads/2016/04/IMS-Institute-US-Drug-Spending-2015.pdf. Ann Intern Med. Mihaylova B, Emberson J, Blackwell L, et al. Pharmacol Rep. 2011;63:859-866.41. Lancet. American College of Cardiology. Corrao G, Ibrahim B, Nicotra F, et al. Myotoxicity: Statins have long been associated with muscle-related toxicity, including myalgia (muscle pain without elevated creatine kinase [CK]), myopathy (general term for muscle disease), and myositis (muscle inflammation), the last two of which involve significant CK elevations.40,41 All statins share a warning for the rare but serious side effect of rhabdomyolysis.2-7 Often, however, myotoxicity attributed to statins is due to the nocebo effect; that is, a person believes that a medication will cause harm and subsequently the medication causes the anticipated harm.42,43 Therefore, to ensure the best outcome, pharmacists must be well versed in this commonly reported side effect and its proper management. We apologize for the inconvenience, but you may be able to find it instead through your library resources. renal or hepatic impairment; Best Practice Tip: If testing is required, “serum creatine kinase” should be specifically requested on the form along with a note that the purpose of testing is the investigation of myalgia. During this episode we will review recent studies on the use of statins in elderly patients and discuss how to consider this data in your clinical practice. Based on current levels and individualized goals, statins alone or in combination with other agents should be initiated based on expected LDL-C– or non–HDL-C–lowering ability.14. If using a different browser, such as Safari, Firefox or Edge, make sure you are using the most up-to-date version. Frank J. Domino, MD. Vytorin (ezetimibe/simvastatin) package insert. 2002;144:674-677.49. 2015;90:24-34.47. 2007;357:2248-2261.26. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of dyslipidemia and prevention of cardiovascular disease. N Engl J Med. Lancet. 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. BMJ. 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. Baseline Characteristics. Older adults often take many medications, and some medications might interact negatively with statin drugs typically prescribed to lower cholesterol. The proportion of the population over 80 years, the so-called “old old”, is increasing most rapidly. Ann Intern Med. However, its role in the primary prevention of … 2015;36:1012-1022.42. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. The 2013 ACC/AHA guideline introduced four treatment groups to be targeted for statin therapy: 1. N Engl J Med. BMJ Open Diabetes Res Care. Zhang H, Plutzky J, Shubina M, Turchin A. Pri-Med Institute educational activities are developed and conducted in accordance with the ACCME's Essential Areas and Policies. A year after the release of new guidelines for treating high cholesterol, doctors and patients are still confused about just who needs to take statin drugs. Rhabdomyolysis is a potentially life-threatening syndrome resulting from the breakdown of skeletal muscle fibers with leakage of muscle contents into … Norvasc (amlodipine) package insert. Atorvastatin and simvastatin are also available generically in several combination products. Patients Table 1. If cookies and/or JavaScript are disabled, the site may not function properly. 2016;5. When a statin is suspected as the cause of mild-to-moderate symptoms, temporary withdrawal is recommended. Diabetes Care. They are concerned because they have read that those with heart disease, high blood pressure, and diabetes may be at an even higher risk for serious illness from the novel coronavirus (COVID-19, which is also called SARS-CoV-2).. And they are right to be concerned. During this episode we will review recent studies on the use of statins in elderly patients and discuss how to consider this data in your clinical practice. 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. If you have questions about this activity, please email support@pri-med.com or call (877) 477-4633. The preferred browser is Google Chrome. Am J Cardiol. Meta-analysis of placebo-controlled randomized controlled trials on the prevalence of statin intolerance. In T2D, Canagliflozin Not Linked to Increased Fracture Risk Versus GLP-1 Agonists. 2016;134:e468-e495.34. It is estimated that 20% of people in Europe will be over 65 years of age in the year 2000. Practical aspects in the management of statin-associated muscle symptoms (SAMS). These include the combination of atorvastatin and amlodipine, a calcium channel blocker (CCB) indicated for hypertension, and the combination of simvastatin and ezetimibe, an intestinal cholesterol-absorption inhibitor also indicated for hypercholesterolemia.11,12 Coformulated statin and niacin products (niacin/lovastatin and niacin/simvastatin) were removed from the market in 2016 based on a lack of evidence that adding niacin in statin-treated patients further reduces cardiovascular (CV) outcomes beyond what is seen with statins alone.13, Statins have repeatedly been proven effective for reducing LDL-cholesterol (LDL-C) and triglyceride levels while raising HDL-cholesterol (HDL-C) levels.14 Additionally, they have been shown to improve meaningful patient-oriented outcomes, such as major CV events (CVEs), in both primary and secondary prevention.15-19. 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. Life expectancy at all ages is also increasing. 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 effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Sabatine MS, Giugliano RP, Keech AC, et al. Blood thinners sometimes cause anemia (low red blood cell count), because they can make people prone to have small — or occasionally bigger — bleeds in their stomach or bowels. Statins have some important drug interactions.The first type of interaction involves the enzymes responsible for the elimination of statins by the liver. 2007;147:1-9.23. www.federalregister.gov/documents/2016/04/18/2016-08894/abbvie-inc-withdrawal-of-approval-of-new-drug-applications-for-advicor-and-simcor. Recently, my mom has been awaken up by excruciating pain in her legs in the middle of the night. Patients with no history of an ASCVD event who have an LDL-C level of 190 mg/dL or higher. 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. Copher HR, Stewart RD. Whitehouse Station, NJ: Merck & Co, Inc; February 2015.8. Eur Heart J. All rights reserved. This online tool takes into account the patient’s age, sex, race, systolic blood pressure, total cholesterol, HDL-C, and past medical history significant for hypertension treatment, diabetes, or smoking.21 Once all inputs have been entered, the patient’s 10-year risk of experiencing an ASCVD event is calculated. Kjekshus J, Apetrei E, Barrios V, et al. Kastelein JJ, Akdim F, Stroes ES, et al. Statin-induced myopathies. Pri-Med Institute is the accredited provider for this activity. Pacerone (amiodarone) package insert. Although statin use for secondary prevention in elderly patients confers significant benefit, its use for primary prevention is unclear. 2021 marks a change in the editorial team at the Journal of Clinical Epidemiology with the appointment of David I. Tovey to succeed André Knottnerus as Co-Editor-in-Chief of the Journal. 2017;26:45-55.45. Daily dosing versus alternate-day dosing of simvastatin in patients with hypercholesterolemia. Sydney cardiologist Dr Ross Walker says that common health checks for blood pressure and cholesterol were not the best predictors of heart attacks. Balancing primary prevention and statin-induced diabetes mellitus prevention. Cerebrovascular disease or multi infarct dementia is the second leading cause of dementiiig illness among Caucasians, preceded only by Alzheimer's disease. "Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review". Although most statins may be taken without regard to meals, immediate-release (IR) lovastatin should be taken with the evening meal because of increased bioavailability.4 However, the opposite is true for extended-release lovastatin, which should not be taken with food owing to decreased bioavailability.8 Further, although all statins may be dosed once daily, IR fluvastatin and lovastatin may require twice-daily dosing.3,4 Finally, whereas atorvastatin, pravastatin, and rosuvastatin may be administered at any time of day, fluvastatin, lovastatin, and simvastatin should be taken in the evening.3,4,7 Simvastatin, in particular, was shown to have significantly different efficacy when taken in the evening as opposed to the morning.32. Pri-Med Institute designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit™. UMass Medical School/Baystate, The following financial relationships have been disclosed by faculty. Princeton, NJ: Bristol-Myers Squibb Company; July 2016.6. Has disclosed no relevant financial relationships. 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. 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. 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. Risk factors for statin-associated muscle damage, e.g. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 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. During the day, her legs seem fine for the most part. Jellinger PS, Handelsman Y, Rosenblit PD, et al. Laufs U, Filipiak KJ, Gouni-Berthold I, et al. Abstract Background Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. Pravachol (pravastatin) package insert. New York, NY: Pfizer Inc; October 2017.36. Banach M, Serban C, Sahebkar A, et al. With a variety of generic options on the market and strong evidence backing their use, statins are some of the most widely prescribed medications in the world.1 However, frequent use of these agents has led to continual scrutiny of their safety and ongoing debate about their role in therapy. 2017;23(suppl 2):1-87.15. Rhus Tox is a top grade medicine for treating back pain. American College of Cardiology. Pri-Med Institute Accredited Provider In addition, specific slides will include notation of the off-label use or investigational agent being discussed. Goldberg AS, DeGorter MK, Ban MR, et al. 1. Financial disclosures are listed in the activity syllabus and will also be printed on the slides and announced at the start of each presentation. 2015;32:649-661.25. Rosuvastatin in older patients with systolic heart failure. 2002;360:1623-1630.24. 2005;352:1425-1435.16. Accessed June 20, 2018.32. Effects of coenzyme Q10 on statin-induced myopathy: a meta-analysis of randomized controlled trials. Cannon CP, Braunwald E, McCabe CH, et al. Statin Use in the Elderly – Start or Stop? Accessed March 18, 2018.46. What Are CKD Risks With Intensive Blood-Pressure Lowering? It is likely that other therapies such as the appropriate use of statin medications , more intensive blood pressure control and smoking cessation are more important measures for prevention than taking aspirin.” N Engl J Med. 2002;22:1110-1116.50. Baigent C, Landray MJ, Reith C, et al. 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. 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. Professor, Family Medicine and Community Health, Wallace A, Chinn D, Rubin G. Taking simvastatin in the morning compared with in the evening: randomised controlled trial. Cardizem (diltiazem) package insert. The cornerstone of dyslipidemia treatment involves the use of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, more commonly known as statins. It is also the most frequently diagnosed sexual dysfunction in the older male population. Dementia is a major illness and cause of disability among the elderly. Ginsberg HN, Elam MB, Lovato LC, et al. Several other strategies exist for managing and preventing these symptoms. Tomaszewski M, Stepien KM, Tomaszewska J, Czuczwar SJ. For instance, the use of statins in older adults should be approached cautiously. A number of different diseases potentially worsening sexual function may occur in elderly people, together with polypharmacy. 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. ASCVD Risk Estimator Plus. Medicines use and spending in the U.S.: a review of 2015 and outlook to 2020. https://morningconsult.com/wp-content/uploads/2016/04/IMS-Institute-US-Drug-Spending-2015.pdf. The last step is to determine whether a causal relationship between symptoms and statin use exists. Clinical judgment must guide each clinician in weighing the possible risks, benefits, or contraindications of any diagnostics, interventions or treatments discussed. Mayo Clin Proc. 22-24 Additionally, patients with heart failure have not been found to experience the same benefits from statin therapy as those without heart failure. ↑ "Study says there's no link between cholesterol and heart disease" IMS Institute for Healthcare Informatics. 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. University of Massachusetts Medical School, Worcester, MA, Professor and Chairman, Dept of Family Medicine Endocr Pract. Am J Cardiol. Ezetimibe added to statin therapy after acute coronary syndromes. http://tools.acc.org/ASCVD-Risk-Estimator. 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. 2014;235:644-648.53. Each statin has different concerns regarding drug-drug and drug-food interactions because of the specific pathways through which each is metabolized (TABLE 5). 2008;358:1431-1443.28. An interesting question is whether widespread statin-induced neuropathy makes our elderly drivers (and even not-so-elderly drivers) more accident prone? Patients with prior atherosclerotic CVD (ASCVD), including those with a prior event (i.e., acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease of presumed atherosclerotic origin).2. Atherosclerosis. Effects of combination lipid therapy in type 2 diabetes mellitus. To comment on this article, contact rdavidson@uspharmacist.com. Accessed March 18, 2018.22. Erectile dysfunction (ED) is one of the most common chronic diseases affecting men and its prevalence increases with aging. The Alternate Day Versus Daily Dosing of Atorvastatin Study (ADDAS). F1000Res. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. 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). It is the mission of Pri-Med Institute to develop and present educational activities that are timely, fair-balanced, scientifically rigorous, and that serve to improve patient outcomes. Whitehouse Station, NJ: Merck & Co, Inc; February 2014.5. Zocor (simvastatin) package insert. Continued statin prescriptions after adverse reactions and patient outcomes: a cohort study. 2017;167:221-227.40. Statins for primary prevention of cardiovascular disease in elderly patients: systematic review and meta-analysis. Montgomery, AL: Kowa Pharmaceuticals America, Inc; November 2016.11. We are an aging population. Some people treated for hypothyroidism may still experience symptoms even if blood tests show that their thyroid stimulating hormone (TSH) levels are well within the normal range.The reasons for this are complex, but the bottom line is that having a normal TSH value doesn't necessarily mean that all of your symptoms will go away.
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