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Update Lipid GuidelinesDO NOT BURN THE COOKIESAmy R Woods M D a common goal a common goal. These guidelines are meant to define practices that meetthe needs of patients in most circumstances and are not areplacement for clinical judgment The ultimate decisionabout care of a particular patient must be made by thehealthcare provider and patient in light of the circumstances.presented by that patient As a result situations might arisein which deviations from these guidelines may beappropriate These considerations notwithstanding incaring for most patients clinicians can employ therecommendations confidently to reduce the risks of.atherosclerotic cardiovascular disease ASCVD events a little background2002 2011 JUNE 2013ATP III IOM NHLBI2004 Report ACC AHA. 4 guidelines publishedAssessment Modificationof CV risk s to reduceManagemen Management of Blood t of.Cholesterol Overweightin Adults and Obesity who are these people ATP IV appointed by NHLBI 13 members plus 3 ex officio members. PCPs cardiologists endocrinologists experts in lipidology clinical trials CV epidemiology and nutrition and guidelinedevelopment Reviewed best available RCT meta analyses andobservational studies. Work Group determined CRITICAL QUESTIONS Formal peer review process Endorsed by many groups but not endo ATP III vs ATP IV differences to consider. Limited in scope not intended to be acomprehensive approach to lipid management Focus on selected CQs Recommendations were mapped using theNHLBI grading format and the ACC AHA level.of evidence construct alignment is imperfect Applying Classification of Recommendation and Level of Evidence Stone N J et al Circulation 2014 129 S1 S45Copyright American Heart Association Inc All rights reserved public service announcement.RECOMMENDATIONS WERE NOT MADE WHENSUFFICIENT EVIDENCE WAS NOT AVAILABLEEarly Fhx CVDLow HDL 40 our happy place.RISK FACTORS GOALSCHD or RE LDL goal 100 2 RF LDL goal 1300 1 RF LDL goal 160 ATP IV a little more abstract.ATP III ATP IV RISK FACTOR COUNTING THERE IS NO TARGET TREAT TO LDL GOAL ADDRESS NON HDL TARGET THE INTENSITY OF.STATIN THERAPY IS THEFOCUS OF TREATMENT so what do the guidelines say Identify 4 major statin benefit groups forwhom ASCVD risk reduction clearly outweighs.the risk of adverse events based on a strongbody of evidence the 4 statin benefit groups1 Secondary Prevention in those with clinical2 Primary Prevention in those with LDL 190.3 Primary Prevention in those with DM age 40 75 with LDL 70 1894 Primary Prevention in those without DM age40 75 with LDL 70 189 a 10 year ASCVD risk 7 5 using a new Risk Calculator . 3 critical questions Critical Question 1 What is the evidence for LDL and non HDL goals forsecondary prevention of ASCVD Critical Question 2 . What is the evidence for LDL and non HDL goals forprimary prevention of ASCVD Critical Question 3 For primary and secondary prevention of ASCVD whatis the impact on lipid levels effectiveness and safety of.specific cholesterol modifying drugs clinical vignette 1A 63 yo WM smoker with HTN comes to see you for apost hospital f u visit 1 week after suffering a STEMI He was discharged on atorvastatin 80 mg .antiplatelet BB and ACEI He recalls that his last PCPhad prescribed simvastatin 80 mg years ago and hestopped it secondary to leg cramps He recalls he wason amlodipine for his HTN at that time as well He isworried he will have leg cramps and wants to stop the.atorvastatin or at least decrease the dosage What doyou tell him clinical vignette 1A Let him decrease to atorvastatin 20 mg sincepatients seem to better tolerate this dosage.B Tell him to have a consultation with hischiropractor and get his advice on lipidmanagementC Check his CK lipid profile and liver enzymes now at every subsequent visit then decide.D Explain to him the proven benefit of aggressivesecondary prevention with high dose statin therapy CQ 1 Is there evidence to treat to specific LDL or non HDL targets in secondary prevention There was NO DATA identified to treat to a specific.LDL goal in those with clinical ASCVD 19 RCTs used FIXED DOSE statin therapy In patients with clinical ASCVD even if moderate or lowintensity statin therapy results in an LDL 100 the evidencesuggests that higher intensity statin therapy provides a.greater risk reduction in ASCVD events There was NO DATA to support treating tospecific non HDL targets either moderate vs highMODERATE INTENSITY HIGH INTENSITY.STATIN THERAPY STATIN THERAPYMODERATE intensity lowers HIGH intensity lowers LDL by LDL by 30 49 50 Atorvastatin 10 or 20 mg Atorvastatin 40 or 80 mg Rosuvastatin 5 or 10 mg Rosuvastatin 20 or 40 mg. Simvastatin 20 or 40 mg Pravastatin 40 or 80 mg IDEAL down titrated Lovastatin 40 mgto 40 mg when 80. Fluvastatin 40 mg BID was not tolerated even though we don t treat to target Most RCTs showed that HIGH intensity statintherapy brings most individuals to an LDL 100 In those patients 75 years old MODERATE.intensity statin therapy showed a better RR insecondary prevention The evidence supports continuation of statinsin those 75 in persons already on them andtolerating them well. Routine CK and ALT monitoring not necessary the dreaded PAPLEASE COMPLETECORRESPONDING SECTION FORTHESE SPECIFICDRUGS CLASSESLISTEDBEL... ANTIFUNGALS LAMISIL SPORANOX PENLAC DIFLUCANDoes the patient have secondary medical risk factors Please specify which risk factor s .Formulary Exception Prior Authorization Request Form Does the patient have a diagnosis of Onychomycosis confirmed with a fungal diagnostic test and does the infection involve the toenails fingernails or both Please circlePlease return completed formto 1 888 836 0730 If the diagnosis is Tinea corporis or Tinea cruris does the patient require systemic therapy or have more extensive superficial infections Yesor NoPatient Information Prescriber Information ANTIEMETIC 5 HT3 AGENTS Patient Name Prescriber Name Is the patient receiving moderate to highly emetogenic chemotherapy or receiving radiation therapy Yes or NoIf the patient has a diagnosis of Hyperemesis Gravidarum is the patient a documented risk for hospitalization for rehydration Yes or No.Patient ID If the patient has a diagnosis of Hyperemesis Gravidarum has the patient experienced an inadequate treatment response to two of the following medications Address Address vitamin B6 doxylamine promethazine Phenergan trimethobenzamide Tigan or metoclopramide Reglan Yesor NoCity State City State CELEBREX .Is the patient at risk for a severe NSAID related gastrointestinal GI adverse event e g NSAID associated gastric ulcer GI bleed Yesor NoHome Phone Zip Office Phone Office Fax Zip Is the patient being treated for post operative pain following CABG surgery or have active GI bleeding Yesor NoDOB Contact Person at Doctor s Office Has the patient received a 30 days supply of an anticoagulant antiplatelet an oral corticosteroid or a gastrointestinal medication Yesor NoGender M or F.Has the patient had intolerance to or an inadequate treatment response to a traditional NSAID or NSAID GI combination product Yesor NoDiagnosis andMedical InformationIs the drug being prescribed for osteoarthritis rheumatoid arthritis ankylosing spondylitis acute pain primary dysmenorrheal or juvenile rheumatoid arthritis Please circleMedication Strength Frequency ERECTILE DYSFUNCTION CIALIS LEVITRA VIAGRA ALPROSTADIL.Expected Length of Therapy Qty Day Supply If this is a continuation of therapy Does the patient require nitrate therapy on a regular OR on an intermittent basis Yes or Nohow long has the patient been on theIs it being prescribed for erectile dysfunction Yes or No Is the patient using other pharmacological treatments for erectile dysfunction Yesor Nomedication Diagnosis Diagnosis ICD Code s Is the drug being prescribed for Pulmonary Arterial Hypertension PAH Yesor No.Is the drug being prescribed for symptomatic Benign Prostatic Hyperplasia BPH Yesor NoFORM CANNOT BE EVALUATEDWITHOUT REQUIREDCLINICALINFORMATIONINSOMNIA AGENTS PLEASE CHECKALLBOXESTHATAPPLY Have other treatable medical psychological causes of chronic insomnia been considered and or addressed Yesor No.Please list all medications and datesof therapy the patient has tried specific to the diagnosis and specify below Have appropriate sleep hygiene and sleep environment issues been addressed Yes or NoReason for failure includingdate of therapy for each drug PROTON PUMP INHIBITORS Does the patient have frequent and severe symptoms of chronic GERD e g heartburn regurgitation Yesor NoDrugs contraindicated Include rationale Does the patient have atypical symptoms or complications of GERD e g dysphagia hoarseness erosive esophagitis Yesor No.Adverse event e g toxicity allergy for each drug Were the symptoms inadequately controlled with the histamine2 receptor antagonist H2RA Yesor NoIs the patient at high risk for GI adverse events Yes or No If Yes why Is the request for a patient with one or more chronic conditions e gl psychiatric condition diabetes who is stable on the current drug s and who might be at high riskfor a significant adverse event with a medication change Specify anticipated significant adverse event PROVIGIL NUVIGIL Does the patient have a diagnosis of Shift Work Sleep Disorder AND experience excessive sleepiness while working Yesor No.Does that patient have a chronic condition confirmed by diagnostic testing If so please provide diagnostic test and date Does the patient have a diagnosis of Obstructive Sleep Apnea confirmed by polysomnography Yesor NoDoes the patient have a clinical condition for which other alternatives are not recommended based on published guidelines or clinical literature If so please provide Is the patient currently using continuous positive airway pressure CPAP therapy OR is CPAP therapy contraindicated or ineffective for the patient Yesor Nodocumentation Does the patient have a diagnosis of Narcolepsy and if so has the diagnosis been confirmed by sleep lab evaluation Yes or No.Does the patient require a specific dosage form e g suspension solution injection If so please provide dosage form STIMULANTS AMPHETAMINES METHYLPHENIDATES STRATTERAAre additional risk factors e g GI risk cardiovascular risk age present If so please provide risk factors Will the patient be monitored closely for suicidal thinking or behavior clinical worsening and unusual changes in behavior Yesor NoDoes the patient have a diagnosis of ADHD or ADD Yesor NoOther Please provide additional relevant information Does the patient have a diagnosis of Narcolepsy and if so has the diagnosis been confirmed by sleep lab evaluation Yes or No.PLEASE COMPLETECORRESPONDING SECTION ON PAGE 2FORTHE SPECIFICDRUG CLASSLISTEDBELOW TAZORAC TRETINOIN PRODUCTS Antifungals Antiemetic 5 HT3 Agents Celebrex Erectile Dysfunction Agents Insomnia Agents ProtonPump Inhibitors of Acne V lgaris eor K ratosis Follicularis Darier s disease Darier White disease Yes or NoDoes the patient have a diagnosis uProvigil Nuvigil Stimulants Ta... Products Testosterone Products TriptansHas the patient tried and failed products from the following categories Salicylic Acid Products OR Benzoyl Peroxide products Yesor No. FOR ANYDRUG CLASSNOTLISTEDONPAGE 2 PLEASEATTACHRELEVANT CLINICALDOCUMENTATION TO SUPPORTUSE OFTHISMEDICATION If the patient isfemale has the physician discussed with the patient the potential risks of fetal harm and importance of birth control while using Tazorac Yesor NoPRESCRIPTION BENEFIT PLANMAYREQUESTADDITIONALINFORM... ORCLARIFICATION IFNEEDED TO EVALUATEREQUESTS Has the pregnancy status of the patient been evaluated Yesor NoWill the patient be applying Tazorac to less than 20 percent of body surface area Yesor NoI attest that the medication requested is medically necessary for this patient I further attest that the information provided is accurate and true and that documentation supporting this information is.The excess risk of diabetes is the main consideration in ~0.1 excess cases per 100 individuals treated with a moderate-intensity statin for 1 year and ~0.3 excess cases per 100 individuals treated with a high-intensity statin for 1 year. In RCTs, both statin-treated and placebo-treated participants experienced the same rate of muscle symptoms.