Download Update: Lipid Guidelines - American College of Physicians

Update: Lipid Guidelines
DO NOT BURN THE COOKIES
Amy R. Woods, M.D.
a common goal
a common goal
“These guidelines are meant to define practices that
meet the needs of patients in most circumstances and are
not a replacement for clinical judgment. The ultimate
decision about care of a particular patient must be made
by the healthcare provider and patient in light of the
circumstances presented by that patient. As a result,
situations might arise in which deviations from these
guidelines may be appropriate. These considerations
notwithstanding, in caring for most patients, clinicians
can employ the recommendations confidently to reduce
the risks of atherosclerotic cardiovascular disease
(ASCVD) events.”
a little background
2002
ATP III
2004
2008
NHLBI
2011
IOM
Report
JUNE 2013
NHLBI
ACC AHA
4 guidelines published
Assessment
of CV risk
Lifestyle
Modifications
to reduce CV
risk
Management
of Blood
Cholesterol in
Adults
Management
of
Overweight
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 guideline development
• Reviewed best available RCT, meta-analyses, and
observational 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 a
comprehensive approach to lipid management
• Focus on selected CQs
• Recommendations were mapped using the
NHLBI 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-S45
Copyright © American Heart Association, Inc. All rights reserved.
public service announcement
RECOMMENDATIONS WERE NOT MADE WHEN
SUFFICIENT EVIDENCE WAS NOT AVAILABLE
Age
Early Fhx CVD
HTN
Low HDL (<40)
tobacco
our happy place
RISK FACTORS & GOALS
CHD or RE
LDL goal < 100
≥ 2 RF
LDL goal < 130
0 - 1 RF
LDL goal < 160
ATP IV: a little more abstract
ATP III
• RISK FACTOR COUNTING
• TREAT TO LDL GOAL
• ADDRESS NON-HDL TARGET
ATP IV
• THERE IS NO TARGET
INTENSITY
• THE
OF
STATIN THERAPY IS THE
FOCUS OF TREATMENT
so what do the guidelines say?
• Identify 4 major statin benefit groups for
whom ASCVD risk reduction clearly outweighs
the risk of adverse events based on a strong
body of evidence
the 4 statin benefit groups
1) Secondary Prevention in those with clinical
ASCVD
2) Primary Prevention in those with LDL ≥ 190
3) Primary Prevention in those with DM, age 4075, with LDL 70-189
4) Primary Prevention in those without DM, age
40-75, 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 for
secondary prevention of ASCVD?
• Critical Question 2:
– What is the evidence for LDL and non-HDL goals for
primary prevention of ASCVD?
• Critical Question 3:
– For primary and secondary prevention of ASCVD, what
is the impact on lipid levels, effectiveness, and safety
of specific cholesterol modifying drugs?
clinical vignette # 1
A 63 yo WM smoker with HTN comes to see you for
a post 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
PCP had prescribed simvastatin 80 mg years ago
and he stopped it secondary to leg cramps. He
recalls he was on amlodipine for his HTN at that
time as well. He is worried he will have leg cramps
and wants to stop the atorvastatin or at least
decrease the dosage. What do you tell him?
clinical vignette # 1
A: Let him decrease to atorvastatin 20 mg since
patients seem to better tolerate this dosage
B: Tell him to have a consultation with his
chiropractor and get his advice on lipid
management
C: Check his CK, lipid profile, and liver enzymes now
(& at every subsequent visit), then decide
D: Explain to him the proven benefit of aggressive
secondary 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 low
intensity statin therapy results in an LDL < 100, the evidence
suggests that higher intensity statin therapy provides a
greater risk reduction in ASCVD events
• There was NO DATA to support treating to
specific non-HDL targets either
moderate vs high
MODERATE INTENSITY
STATIN THERAPY
MODERATE intensity lowers
LDL by 30-49%
• Atorvastatin 10 or 20 mg
• Rosuvastatin 5 or 10 mg
•
•
•
•
Simvastatin 20 or 40 mg
Pravastatin 40 or 80 mg
Lovastatin 40 mg
Fluvastatin 40 mg BID
HIGH INTENSITY
STATIN THERAPY
HIGH intensity lowers LDL by ≥
50%
• Atorvastatin 40* or 80 mg
• Rosuvastatin 20 or 40 mg
*IDEAL down-titrated
to 40 mg when 80
was not tolerated
even though we don’t treat to target…
Most RCTs showed that HIGH intensity statin
therapy brings most individuals to an LDL < 100
tidbits
• In those patients > 75 years old, MODERATE
intensity statin therapy showed a better RR in
secondary prevention
• The evidence supports continuation of statins
in those > 75 in persons already on them and
tolerating them well
• Routine CK and ALT monitoring not necessary
the dreaded PA
PLEASE COMPLETE CORRESPONDING SECTION FOR THESE SPECIFIC DRUGS/CLASSES LISTED BELOW AND CIRCLE THE APPROPRIATE ANSWER OR SUPPLY RESPONSE.
ANTIFUNGALS: LAMISIL, SPORANOX, PENLAC, DIFLUCAN
Does the patient have secondary medical risk factors? Please specify which risk factor(s): ________________________________________________________________________
Formulary Exception/Prior Authorization Request Form
Please return completed form to: 1-888-836-0730
Patient Information
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 circle
If the diagnosis is Tinea corporis or Tinea cruris, does the patient require systemic therapy or have more extensive superficial infections? Yes or No
ANTIEMETIC (5-HT3) AGENTS:
Prescriber Information
Patient Name:
Prescriber Name:
Is the patient receiving moderate to highly emetogenic chemotherapy or receiving radiation therapy? Yes or No
If 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:
-
City:
State:
City:
Home Phone:
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Office Phone #:
DOB:
Contact Person at Doctor's Office:
Gender:
M or F
State:
Office Fax #:
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vitamin B6, doxylamine, promethazine (Phenergan), trimethobenzamide (Tigan) or metoclopramide (Reglan)? Yes or No
CELEBREX:
Is the patient at risk for a severe NSAID-related gastrointestinal (GI) adverse event (e.g., NSAID associated gastric ulcer, GI bleed)? Yes or No
Is the patient being treated for post-operative pain following CABG surgery or have active GI bleeding? Yes or No
Has the patient received a 30 days supply of an anticoagulant, antiplatelet, an oral corticosteroid or a gastrointestinal medication? Yes or No
Has the patient had intolerance to or an inadequate treatment response to a traditional NSAID or NSAID/GI combination product? Yes or No
Medication:
Diagnosis and Medical Information
Strength:
Expected Length of Therapy:
Qty:
Frequency:
Is the drug being prescribed for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain , primary dysmenorrheal, or juvenile rheumatoid arthritis? Please circle
ERECTILE DYSFUNCTION: CIALIS, LEVITRA, VIAGRA, ALPROSTADIL
Diagnosis:
Day Supply:
If this is a continuation of therapy,
how long has the patient been on the
medication?
Diagnosis (ICD) Code(s):
Does the patient require nitrate therapy on a regular OR on an intermittent basis? Yes or No
Is it being prescribed for erectile dysfunction ?, Yes or No
Is the patient using other pharmacological treatments for erectile dysfunction? Yes or No
Is the drug being prescribed for Pulmonary Arterial Hypertension (PAH)? Yes or No
Is the drug being prescribed for symptomatic Benign Prostatic Hyperplasia (BPH)? Yes or No
FORM CANNOT BE EVALUATED WITHOUT REQUIRED CLINICAL INFORMATION
INSOMNIA AGENTS:
PLEASE CHECK ALL BOXES THAT APPLY:
Have other treatable medical/psychological causes of chronic insomnia been considered and/or addressed? Yes or No
Please list all medications and dates of therapy the patient has tried specific to the diagnosis and specify below:
Reason for failure, including date of therapy, for each drug: ______________________________________________________________
Have appropriate sleep hygiene and sleep environment issues been addressed? Yes or No
PROTON PUMP INHIBITORS:
Does the patient have frequent and severe symptoms of chronic GERD (e.g., heartburn, regurgitation)? Yes or No
Drugs contraindicated (Include rationale): _____________________________________________________________________________
Adverse event (e.g. toxicity, allergy) for each drug:________________________________________________________________________
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 risk
for a significant adverse event with a medication change? Specify anticipated significant adverse event: ____________________________________________________
Does that patient have a chronic condition confirmed by diagnostic testing? If so, please provide diagnostic test and date: _____________________________________
Does the patient have a clinical condition for which other alternatives are not recommended based on published guidelines or clinical literature? If so, please provide
documentation: ___________________________________________________________________________________________________________________________
Does the patient require a specific dosage form (e.g., suspension, solution, injection)? If so, please provide dosage form: _____________________________________
Are additional risk factors (e.g., GI risk, cardiovascular risk, age) present? If so, please provide risk factors: ___________________________________________________
Other: Please provide additional relevant information: ____________________________________________________________________________________________
PLEASE COMPLETE CORRESPONDING SECTION ON PAGE 2 FOR THE SPECIFIC DRUG/CLASS LISTED BELOW.
Antifungals/Antiemetic (5-HT3) Agents/Celebrex/Erectile Dysfunction Agents/Insomnia Agents/Proton Pump Inhibitors
Provigil/Nuvigil/Stimulants/Tazorac/Tretinoin Products/Testosterone Products/Triptans
**FOR ANY DRUG/CLASS NOT LISTED ON PAGE 2, PLEASE ATTACH RELEVANT CLINICAL DOCUMENTATION TO SUPPORT USE OF THIS MEDICATION**
PRESCRIPTION BENEFIT PLAN MAY REQUEST ADDITIONAL INFORMATION OR CLARIFICATION, IF NEEDED, TO EVALUATE REQUESTS
I 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
available for review if requested by CVS Caremark, the health plan sponsor, or, if applicable, a state or federal regulatory agency. I understand that any person who knowingly makes or causes to be
made a false record or statement that is material to a claim ultimately paid by the United States government or any state government may be subject to civil penalties and treble damages under both
the federal and state False Claims Acts. See, e.g., 31 U.S.C. §§ 3729-3733.
Does the patient have atypical symptoms or complications of GERD (e.g., dysphagia, hoarseness, erosive esophagitis)? Yes or No
Were the symptoms inadequately controlled with the histamine2-receptor antagonist (H2RA)? Yes or No
Is the patient at high risk for GI adverse events? Yes or No If Yes, why__________________________________________________________________________________
PROVIGIL/NUVIGIL:
Does the patient have a diagnosis of Shift Work Sleep Disorder AND experience excessive sleepiness while working? Yes or No
Does the patient have a diagnosis of Obstructive Sleep Apnea confirmed by polysomnography? Yes or No
Is the patient currently using continuous positive airway pressure (CPAP) therapy OR is CPAP therapy contraindicated or ineffective for the patient? Yes or No
Does the patient have a diagnosis of Narcolepsy, and if so, has the diagnosis been confirmed by sleep lab evaluation? Yes or No
STIMULANTS: AMPHETAMINES, METHYLPHENIDATES, STRATTERA
Will the patient be monitored closely for suicidal thinking or behavior, clinical worsening, and unusual changes in behavior? Yes or No
Does the patient have a diagnosis of ADHD or ADD? Yes or No
Does the patient have a diagnosis of Narcolepsy, and if so, has the diagnosis been confirmed by sleep lab evaluation? Yes or No
TAZORAC/ TRETINOIN PRODUCTS:
Does the patient have a diagnosis of
u Acne V lgaris or
e K ratosis Follicularis (Darier’s disease, Darier-White disease)? Yes or No
Has the patient tried and failed products from the following categories: Salicylic Acid Products OR Benzoyl Peroxide products? Yes or No
If the patient is female, has the physician discussed with the patient the potential risks of fetal harm and importance of birth control while using Tazorac? Yes or No
Has the pregnancy status of the patient been evaluated? Yes or No
Will the patient be applying Tazorac to less than 20 percent of body surface area? Yes or No
TESTOSTERONE PRODUCTS:
Is the patient being treated for Hypogonadism? Yes or No
Did the patient have or does the patient currently have confirmed low testosterone level according to your standard lab reference values? Yes or No
Prescriber Signature: ________________________________________________________________________
Date: ______________________________
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TRIPTANS:
Does the patient have confirmed or suspected cardiovascular or cerebrovascular disease, or uncontrolled hypertension? Yes or No
Does the patient have a diagnosis of migraine headache? Yes or No
Does the patient have a diagnosis of cluster headache? Yes or No
Is the patient currently using migraine prophylactic therapy or unable to take prophylactic therapy due to inadequate response, intolerance or contraindication? Yes or No
Has medication overuse headache been considered and ruled out? Yes or No
clinical vignette # 2
A 60 BF presents to you for follow up. At her last visit you
mentioned that you wanted to talk to her about statin
therapy to decrease her risk of stroke & MI. She is very
concerned because she has been seeing the ads on TV
asking patients to call 1800-SUE-DOCS if you developed
diabetes while taking statin therapy.
The patient does not smoke, she is treated with 2 antihypertensives (treated BP 142/88), her BMI is 31. Her
mother was diabetic and had CVA at age 62. The patient’s
lipid profile shows TC 200, LDL 125, HDL 55, TG 130.
Fasting glucose is 109, A1c is 5.9%. Using the risk
calculator, her 10 year estimated risk of ASCVD is 8.7%. So
what do you advise?
clinical vignette # 2
A: She should focus only on LSM because LSM
reduce ASCVD more than any statin could dream of,
and you don’t want to get sued
B: Go ahead and put her on Bydureon to help
cancel out the risk of diabetes development then
add pravastatin 10 mg daily
C: Measure carotid intima media thickness & obtain
a BOSTON advanced lipid profile, then decide
D: Have a RISK DISCUSSION and recommend that
she start a moderate or high intensity statin
Stone N J et al. Circulation. 2014;129:S1-S45
Copyright © American Heart Association, Inc. All rights reserved.
CQ 2: Is there evidence to treat to specific LDL and nonHDL targets in primary prevention?
• There was NO DATA to treat to specific LDL
targets
• There was NO DATA to treat to specific nonHDL targets
– RCTs used FIXED DOSE statin therapy
AFCAPS/TEXCAPS
MEGA
JUPITER
the risk calculator
the risk calculator
• Use it to calculate a 10 year risk of first ASCVD
event in those without ASCVD, ages 40-75,
with an LDL 70-189. Can be used in those
WITH DM or those WITHOUT DM
• If the 10 year risk is > 7.5%, the benefit of
statin therapy clearly outweighs the risk
• Those with a 10 year risk of 5 – 7.5% showed a
similar RR however the potential for AE > RR
the risk calculator
• Based on pooled cohort equations for RCTs
– ARIC, CHS, CARDIA, Framingham & Offspring Cohorts
• Variables that met inclusion criteria:
– Age, TC, HDL, systolic BP, DM smoking status
• Applicable to non-Hispanic whites and AA
• Admittedly OVER-estimates for Hispanic &
Asian American populations
• Admittedly UNDER-estimates for American
Indian populations
the risk calculator
• Recommendation for use of the risk calculator in
AA and whites:
– NHLBI: Grade = B recommendation (moderate)
– ACC/AHA COR: Class = I (benefit > risk)
– Level of Evidence = B (limited populations)
• Recommendation for use of the risk calculator in
other populations:
– NHLBI: Grade = E recommendation
– ACC/AHA COR: Class = IIb (benefit ≥ risk)
– Level of Evidence = C (expert opinion)
the risk discussion
•
•
•
•
ATP III goal
LDL < 130
due to
age, HTN,
neutral HDL
Shared decision making
A time to revisit LSM and address other RF
Discuss potential for ASCVD risk reduction
Discuss adverse effects
– New onset DM (dose dependent)
• 1 per 1000 in moderate intensity (prevention of 5.4 ASCVD
events)
• 3 per 1000 in high intensity (5.9 ASCVD events)
– Myopathy & Hemorrhagic CVA
• Discuss drug – drug interactions
• Discuss patient preferences
if you like ordering more tests..
• In primary prevention, if the risk-based
decision is unclear, consider:
– Family hx of premature CVD
– Hs CRP
– CAC
– ABIs
doc, can you explain this to me?
clinical vignette # 3
A 58 yo WM with hx of 3 v CABG about 2 years ago
comes in to see you for follow up. He is not
smoking. He is taking his meds as prescribed. He
exercises regularly. BP is well controlled and BMI is
24. On rosuvastatin 40 mg his LDL is 116, HDL is 32,
TG 145.
Should you add more medications to his regimen of
asa, BB, statin, long acting nitrate, and diuretic/ACE
in order to get his lipid profile in better standing?
clinical vignette # 3
A: Add VASCEPA – EPA all the way baby
B: Add ezetimibe because he remembers being
on it once but stopped it due to $$$
C: Add NIACIN to get his HDL out of the red
zone and back into the black zone
D: Let him ride
CQ 3: For primary and secondary prevention, what is
the impact on lipids levels, effectiveness, and safety of
specific cholesterol modifying drugs?
• NO DATA to support routine use of non-statin
drugs combined with statin therapy to further
reduce ASCVD events
– Review included statins, fibrates, niacin, bile acid
sequestrants, ezetimibe, O-3 fatty acids
– AIM-HIGH: adding NIACIN to achieve non-HDL
targets did NOT reduce ASCVD risk
• NO DATA for ASCVD outcomes in statin
intolerant patients
a public service announcement
worth repeating
RECOMMENDATIONS WERE NOT MADE WHEN
SUFFICIENT EVIDENCE WAS NOT AVAILABLE
but
• When treating high risk patients who have a
less than anticipated response to statins, or
who are unable to tolerate less than
recommended intensity of statin therapy, or
who are completely statin intolerant, one may
consider a non-statin cholesterol lowering
therapy
inhibition of
CETP=increases
HDL
new drugs & other targets
ILLUMINATE
OUTCOMES
new drugs & other targets
GAUSS-2
LAPLACE-2
DESCARTES
FOURIER
Summary of Statin Initiation Recommendations for the Treatment of Blood Cholesterol to
Reduce ASCVD Risk in Adults (See Figures 3, 4, and 5 for More Detailed Management
Information).
Stone N J et al. Circulation. 2014;129:S1-S45
Copyright © American Heart Association, Inc. All rights reserved.
ATP IV strengths to consider
• Encourages a “risk discussion” with patients in
regards to primary prevention
• Strictly evidence based
• The bulk of the content is undisputed
• 10 year risk of ASCVD includes CHD & stroke
• More relevant for women and AA populations
ATP IV weaknesses to consider
• Strictly evidence based
– Limited or NO DATA for > 75 and < 40
• The risk calculator is controversial* and may
significantly overestimate risk
• Forgotten populations: diabetics < 40 y/o and
other high risk groups
• Younger patients often have a high lifetime
risk and a low short term (10 year) risk
afterthoughts
• RCT consider defined populations
• Risk estimation is based on group averages
which are then applied to individual patients
in practice
• Guidelines are made to inform us, rather to
replace clinical judgment
• Anticipate an update forthcoming….
afterthoughts
Individual with the SAME estimated risk WILL
either have, or not have, the event of interest
and only those patients who are destined to
have an event can have their risk prevented by
therapy
so what do we do now?
DO NOT BURN THE COOKIES
references
•
•
•
•
•
http://www.nhlbi.nih.gov/guidelines/cvd_adult/risk_assessment
http://my.americanheart.org/cvriskcalculator
http://www.medscape.com
Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D’Agostino RB Sr, Gibbons R,
Greenland P, Lackland DT, Levy D, O’Donnell CJ, Robinson JG, Schwartz JS,
Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline
on the assessment of cardiovascular risk: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines.
Circulation. 2014;129(suppl 2):S49-S73.
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH,
Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero
ST, Smith SC Jr, Watson K, Wilson PWF. 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. Circulation. 2014;129(suppl
2):S1–S45.