EXPERT ADVICE
Order and Features of Prescribing Statins in the Treatment of Acute Ischemic Syndromes
Today, society, health policymakers, and doctors pay a lot of attention to acute cerebrovascular and cardiovascular disorders, their early diagnosis, and treatment. Although the treatment of acute ischemic syndromes - myocardial infarction and unstable angina - is regulated by the orders issued by the State Medicines Control Agency in 2010 and 2011, in everyday clinical practice, doctors face various questions, especially regarding the long-term treatment with antilipidemic drugs. We discuss the peculiarities of interpreting the diagnosis of acute ischemic syndromes and the order of prescribing statins with the cardiologist Dr. Jolita Badarienė at VUL Santaros Clinic Center.
What is unstable angina, and how does it differ from stable angina?
Stable angina (SA) - these are typical symptoms of angina that occur with a certain intensity of physical exertion that the patient usually recognizes and adapts to in order to avoid symptoms. This type of angina is usually associated with stable plaques in the coronary arteries. These are patients in stable condition for whom diagnostic and interventional procedures can be performed on a routine basis.
Unstable angina (UA) - one of the types of acute ischemic syndromes, where there are unstable plaques in the coronary arteries that can rupture or erode, leading to the formation of a clot at that site. This term is usually used to describe either rapidly progressing previously diagnosed angina (more frequent or severe attacks that occur after less physical exertion) or recently manifested angina, regardless of severity. This type of angina is treated more intensively, usually in the hospital, as the symptoms may herald a myocardial infarction.
Remind what are the peculiarities of prescribing statins for patients with acute ischemic syndromes (unstable angina, acute myocardial infarction)?
According to the procedure established by the Lithuanian Minister of Health, statins are reimbursed for patients with an episode of unstable angina (UA) or for long-term treatment after an acute myocardial infarction (MI) if, based on a lipid profile, total cholesterol concentration is >5 mmol/l, LDL cholesterol >3 mmol/l, triglycerides >2 mmol/l. Statins are prescribed by a cardiologist, and then reimbursable statins can be prescribed by an internist or family doctor. It is important to emphasize that statin therapy is prescribed continuously, regardless of the date of the myocardial infarction or the onset of unstable angina attack.
Are reimbursable lipid-lowering drugs prescribed based on the disease or only based on changes in the lipid profile?
Reimbursable drugs are prescribed to patients based on the disease: after an acute MI (ICD-10 codes: I21, I22, later - I25.2) or unstable angina (ICD-10 I 20.0), when abnormal blood lipid concentration is detected, i.e., when total cholesterol concentration is >5 mmol/l, LDL cholesterol >3 mmol/l, triglycerides >2 mmol/l.
I would say that the sizes of lipid concentration for compensatory drugs are already outdated, as the European Society of Cardiology recommends prescribing statins in the early period (1-4 days after admission) of acute coronary syndrome (ACS, MI), regardless of the size of cholesterol concentration. According to the "Description of the Diagnosis and Treatment of Acute Ischemic Syndromes without ST Segment Elevation (Unstable Angina (ICD-10 I20.0) and Myocardial Infarction (ICD-10 I21, I22))" published by the Lithuanian Minister of Health in 2011, statins are also prescribed regardless of the initial cholesterol concentration if there are no contraindications. In the guidelines for the diagnosis and treatment of acute myocardial infarction with ST segment elevation published by the European Society of Cardiology in 2012, it is recommended to prescribe high doses of statins to patients being treated for acute ischemic syndrome in the hospital, regardless of the initial cholesterol concentration.
For a patient suffering from acute myocardial infarction, intensive treatment with high doses of statins is prescribed, and during the second month of treatment when lipid levels are found to have normalized. Can compensatory statins continue to be prescribed to him? How should they be dosed?
Continuing statin therapy without reducing the dose is simply mandatory. When the LDL cholesterol concentration is reduced to the target level (<1.8 mmol/l) after acute ischemic syndrome, the statin dose is not changed - the treatment is continued with the same dose of the drug. This is similar to treating arterial hypertension: doctors know very well that after regulating blood pressure (<140/90 mm Hg, for patients with CVD <130/85 mm Hg), treatment with antihypertensive drugs must be continued without reducing their dose.
A patient from a district hospital, who was hospitalized for unstable angina (low risk) and received optimal drug treatment, is discharged home. How long can the family doctor rely on the hospital discharge summary and continue compensatory drugs based on the diagnosis of unstable angina? Is this a lifelong diagnosis?
According to the order No. V-615 of the Lithuanian Minister of Health issued on June 17, 2011, "Description of the Diagnosis and Treatment of Acute Ischemic Syndromes without ST Segment Elevation (Unstable Angina (ICD-10-AM I 20.0) and Myocardial Infarction (ICD-10-AM I 21, I 22)," it is stated that statins are used for an unlimited period and the goal is to keep the LDL cholesterol concentration below 1.8 mmol/l. After all, unstable angina is an acute ischemic syndrome that can recur and lead to a threatening myocardial infarction. Treating patients with statins reduces the risk of recurrent acute ischemic syndrome. The European Society of Cardiology also recommends prescribing statins for an unlimited time after acute ischemic syndrome.
How are patients with cerebral ischemia and peripheral artery disease treated with statins
Cerebral ischemia is the same cardiovascular disease as heart and vascular system disease, so statins are recommended for its treatment. The latest edition of the guidelines for the diagnosis, treatment, prevention, and rehabilitation of cerebral stroke, published in May 2012 and endorsed by the Lithuanian Stroke Association, provides recommendations for statin therapy.
Statin therapy for stroke prevention is recommended for these patients: those with a high overall cardiovascular disease (CVD) risk, diagnosed with other CVD (excluding stroke).
High LDL Risk Group
Patients who have had an ischemic stroke or a transient ischemic attack (TIA) are classified into the very high risk group for cardiovascular events. Therefore, it is recommended for them to lower their LDL cholesterol concentration below the threshold of 1.8 mmol/l and/or by more than 50% from baseline if the target level is unattainable. Patients with peripheral arterial disease are also classified into the very high risk group and are treated with statins to reduce LDL cholesterol concentration (concentration) (<1.8 mmol/l).
Myths About Statins
Various myths circulate in society regarding the adverse effects of lipid-lowering drugs, such as toxic effects on the liver. How is this perceived in scientific literature and expert consensus?
According to the recommendations of the European Society of Cardiology, statin therapy is safe, and the drugs can be safely used at the maximum recommended or maximum tolerated dose.
In Lithuania, there is a widespread fear that statins can harm the liver. Many patients say they do not want to take statins because they are afraid of "damaging" their liver. This fear is completely unfounded. Liver damage is indicated by elevated liver transaminase (AST and ALT enzymes) levels, which can be easily detected by performing a liver enzyme test. Furthermore, the effect of statins on the liver has been studied. Liver enzyme tests were conducted in all clinical trials, and it was found that liver enzyme concentration increases by 0.5–2% in patients treated with statins, and the effect on the liver is directly related to the statin dose. Interestingly, in 2012, the Food and Drug Administration (FDA) withdrew the recommendation to regularly monitor liver enzymes when using statins because it is uninformative, not useful, and even harmful. The FDA statement said that severe liver damage from taking statins is rare and unpredictable, and periodic liver enzyme tests do not effectively detect and prevent severe liver damage.
According to the recommendations of the European Society of Cardiology, before prescribing a statin, liver enzymes (usually ALT) concentration must be examined. If it exceeds the norm by more than three times, statins should not be prescribed, and further testing for possible liver disease is necessary. If transaminase concentration in the blood has not increased, it is recommended to repeat the test after 8 weeks from the start of treatment or change of treatment (i.e., after 2 months), and then once a year. If during the treatment period, it is found that liver enzyme concentration exceeds the norm by less than three times, statin therapy should be continued, and transaminase testing should be repeated after 4–6 weeks. If while taking statins, liver enzyme concentration in the blood exceeds the norm by more than three times, the statin dose should be reduced or its use discontinued, and enzymes should be tested after 4–6 weeks. Once the liver enzymes have normalized, statin therapy should be gradually resumed.
Can the Cardioprotective Effect of High Omega Fatty Acid Doses and Various Dietary Supplements Be Equivalent to the Effect of Statins?
No, only the cardioprotective effect of statins has been proven.
Interview with Ramutė Pečeliūnienė
"Lithuanian Doctor's Journal"
