Ever since in the year 2013, American guidelines focused on atherosclerotic cardiovascular disease as a prime focus for treating lipids. Measuring lipids in patients became a less important. More than that clinicians had only statins at their disposal for treating lipids. Treatment of lipid was grouped into high intensity and moderate and low-intensity groups, depending mostly on atherosclerotic risk and disease evidence. Check this article to know more on this1 click here.
I and most of my interventional cardiology friends would just prescribe high-intensity statins following the acute coronary event and their ends the matter. This was because that’s all we could do for these patients. There was no clear cut evidence and recommendation with respect nonstatins drugs showing benefit in reduction cardiovascular end points. But, in the year 2015 things started changing, IMPROVE-IT a landmark trial showed benefit2. In this study simvastatin versus simvastatin with ezetimibe was compared. LDL-C level was 69.9 mg/dl and 53.2mg/dl simvastatin and simvastatin with ezetimibe respectively. primary endpoint comprising CV death, MI, hospitalization for unstable angina, coronary revascularization (>-30days), or stroke occurred in 34.7% of the simvastatin group versus 32.7% of the simvastatin plus ezetimibe group, representing an absolute risk reduction of 2% (numbers needed to treat- 50) and 6.4% relative risk reduction (hazard ratio 0.936, CI 0.887-0.988, p=0.016).
In individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L (38.7mg/dl) reduction in LDL cholesterol, produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years3. Reduction in CV events with reduction of LDL level lasts up to 50mg/dl2.
These new trials lead to the formation of new recommendation from ACC in the year 20164, Along with ezetimibe, PCSK-9 inhibitors are recommended. Although we do not have clinical end points studies in regard to PCSK-9 yet. We need to wait up to the year 2018 for results of Alirocumab—ODYSSEY Outcomes , Evolocumab—FOURIER and Bococizumab—SPIRE I. Major concern in regard to PCSK-9 is cost effectiveness5 . These drugs are very expensive.
ACC has recommended ezetimibe along with statins in all four groups of patients i.e. groups created in 2013 guidelines. Although IMPROVE-IT trial was done in ACS patients.
In 2013 guidelines there were no targets for treating lipids. But in 2016 ACC has created a kind of targets i.e. 30 to 50% reduction LDL-C or less than 100mg/dl. Clear recommendation to add nonstatin drugs in case of the target not achieved even after intensive or maximally tolerated statin dose is already given6. These make clinician’s checking lipids, more relevant now.
1. Bilagi U. Lipid and hypertensive guidelines of 2013. | LearnOnly Heart [Internet]. Available from: http://bilagi.org/blog/2014/05/31/lipid-and-hypertensive-guidelines-of-2013/
2. Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med [Internet]. 2015;372(25):2387–97. Available from: http://dx.doi.org/10.1056/NEJMoa1410489
3. Collaborators CTT (CTT). 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. Lancet [Internet]. 2016 Sep 1;380(9841):581–90. Available from: http://dx.doi.org/10.1016/S0140-6736(12)60367-5
4. Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly DD, DePalma SM, et al. 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 Clinical Expert Cons. J Am Coll Cardiol [Internet]. 2016;68(1):92–125. Available from: http://www.sciencedirect.com/science/article/pii/S0735109716323981
5. Kazi DS, Moran AE, Coxson PG, Penko J, Ollendorf DA, Pearson SD, et al. Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease. JAMA. 2016 Aug;316(7):743–53.
6. Guo Y. What do we learn from the 2016 ACC Expert Consensus Decision Pathway on Non-Statin Therapies for LDL-C Lowering in the Management of Atherosclerotic Cardio- vascular Disease Risk ? Cardiol Plus. 2016;1(2):5–7.