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Introduction: Overview of the 2013 Statin Guidelines

Rob Orman, MD
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The decision to start a statin isn’t always clear choice.

  • 25% of adults over age 45 in the USA are treated with statins, and most do not have heart disease.  The 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults has the potential to put even more people on statins.   Whether statins have played a role in the continued decline in the rate of deaths from heart disease is unclear.  Even before statins were being prescribed, the percent of people with high cholesterol and the death rate from heart disease were going down.  The rate of decline of deaths from heart disease has not changed since statins came on the scene.  Stone, Neil J., et al. "2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults." Journal of the American College of Cardiology (2013).

  • The purpose of the 2013 guidelines is to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) events.  A heart-healthy lifestyle is on the top of the pyramid.  This includes quitting smoking, exercising, maintaining a healthy weights, controlling blood pressure and eating a healthy diet.

  • The guideline recommendations for statin use.  The target groups are patients in whom they feel that benefit outweighs harm.  

    • Strong evidence supports their use in the following patients:

      • Those with clinical ASCVD

      • Those who have an LDL ≥ 190 mg/dL

      • Diabetics age 40 to 75 and an LDL 70-189 mg/dL

      • Non-diabetics age 40 to 75 with an LDL 70-189 mg/dL who have an estimated 10-year ASCVD risk of ≥7.4%

    • Moderate evidence supports their use in patients who are:

      • Age 40 to 75 with year ASCVD risk of 5-7.5% and an LDL of 70 to 189

Case:  52 year old male patient who is a smoker and a jogger.  He has a BMI of 25.  His total cholesterol is 180 mg/dL, HDL is 35, LDL is 115 and triglycerides are 150.  His blood pressure is 130/85 and his family history is notable for a father with diabetes and blindness due to diabetic complications. The patient is especially worried about becoming diabetic and blind like his father.  

  • This patient’s 10-year ASCVD risk is 10.9%.  Although his LDL is only 115, the 2013 ACC/AHA guidelines would advise that he start a statin.

  • The older ATP III guidelines calculate his risk at 13%, but for his level of LDL do not recommend starting a statin.

  • What should this patient do?  Three different expert opinions were given in an April 2014 NEJM article titled “The Guidelines Battle on Starting Statins”.  http://www.nejm.org/doi/pdf/10.1056/NEJMclde1314766

    • Option 1:  Do not begin statin therapy and encourage smoking cessation.  If this patient stopped smoking, his 10-year risk would be reduced to 5.4% which puts him below the risk level recommended for starting a statin.  The patient’s main concern is getting diabetes and a statin may increase this risk.  The Air Force Texas Coronary Atherosclerosis Prevention Trial (AFCAPS/TexCAPS) looked at coronary prevention in patients with low LDL.  They found that lovastatin given to patients with an average LDL (130-190) had a 25% risk reduction in cardiovascular events, but this benefit did not extend to those with an LDL below 149.  Downs, John R., et al. "Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS." Jama 279.20 (1998): 1615-1622.

    • Option 2:  Begin a statin and monitor LDL.  This patient has risk factors for coronary artery disease and meets criteria for metabolic syndrome.  With his 10-year atherosclerotic risk of 7.5 or greater and an LDL between 70 and 189, the 2013 guidelines recommend moderate to high intensity statin therapy. This expert presumes the patient has an elevated CRP, given his cigarette use and metabolic syndrome.  According to the JUPITER Trial (Justification for the Use of Statin in Prevention), patients with a CRP of greater than 2 mg/L and LDL under 130 benefit from statin therapy.  Patients randomized to statin versus placebo therapy had a 44% reduction of all vascular events, 54% reduction in MI, 48% reduction in stroke and 20% reduction in all-cause mortality.  This expert recommends a low to moderate intensity statin, titrating the dose to achieve a 20-30% reduction in LDL.  A lower dose should reduce the risk of diabetes for this patient.   Ridker, Paul M., et al. "Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial." The Lancet380.9841 (2012): 565-571.

    • Option 3:  Begin a statin, but do not monitor LDL.  This expert states that overall risk rather than LDL determines the statin benefit.  For this patient, the NNT is 50 -- 50 patients treated with statins for 10 years for one benefit.  He adds that if the patient quits smoking, the NNT would nearly double. This patient has a 1 in 10 chance of heart disease or stroke in the next 10 years and statins can improve the odds.  The expert does not see a need for regular cholesterol testing because this was not done in the major studies.

  • There is clearly lack of consensus among experts about the appropriate management of the above patient.  There is no doubt, however, that if the 2013 guidelines are followed, the percentage of people treated with statins will increase.  A 2014 NEJM analysis of the new guideline states that the percentage of people age 60-75 eligible for statin therapy will increase from 30 to 87% among men and from 21 to 54% among women.  The effect is largely driven by an increased number of adults classified solely on the basis of their 10-year risk of a cardiovascular event.  As compared to the ATP III recommendations, the new guidelines recommend statin therapy for more adults who would be expected to have future cardiovascular events, but it also means that many who will never have future events will also be treated.  The potential cost of following the 2013 guidelines is $6.6 billion dollars per year.  Pencina, Michael J., et al. "Application of new cholesterol guidelines to a population-based sample." New England Journal of Medicine 370.15 (2014): 1422-1431.

The new guidelines are controversial and have not been embraced with open arms by everyone.   As commonly occurs, guidelines may make recommendations that are contrary to how one thinks medicine should be practiced.

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These Statins Are Giving Me a Headache! Full episode audio for MD edition 185:03 min - 87 MB - M4AHippo Primary Care RAP January 2015 Summary 397 KB - PDF

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