From the Guidelines
Hyperlipidemia medications can cause various side effects, but statins, as the first-line treatment, have an acceptable safety profile, with the most common side effects being muscle-related, affecting 5-10% of patients, and liver enzyme elevations, as reported in the 2012 European guidelines on cardiovascular disease prevention in clinical practice 1.
Common Side Effects of Hyperlipidemia Medications
- Statins: muscle pain or weakness (myalgia), liver enzyme elevations, digestive issues like constipation or diarrhea, and slightly increased risk of developing diabetes
- Fibrates: gastrointestinal disturbances and increased risk of gallstones
- PCSK9 inhibitors: injection site reactions and flu-like symptoms
- Bile acid sequestrants: constipation, bloating, and interference with absorption of other medications
- Ezetimibe: minimal side effects, but may cause diarrhea or joint pain in some patients
- Niacin: flushing, itching, and gastrointestinal upset
Management of Side Effects
Regular monitoring through blood tests and reporting any unusual symptoms to healthcare providers is essential for managing potential side effects while effectively treating hyperlipidemia, as emphasized in the 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk 1.
Recent Guidelines and Recommendations
The most recent guidelines, such as the 2022 ACC expert consensus decision pathway, provide recommendations for the use of nonstatin therapies, including ezetimibe and PCSK9 inhibitors, in the management of atherosclerotic cardiovascular disease risk, highlighting their efficacy and safety profiles 1.
From the FDA Drug Label
In clinical studies with a median follow-up of at least 4 years, in which 24,747 patients received simvastatin, the incidence of myopathy (defined as unexplained muscle weakness, pain, or tenderness accompanied by CK increases greater than 10xULN) was approximately 0.03%, 0.08%, and 0.61% for the simvastatin 20 mg, 40 mg, and 80 mg daily groups, respectively.
Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.
The incidence of myopathy and rhabdomyolysis were highest during the first year and then decreased during the subsequent years of treatment.
Moderate (less than 3xULN) elevations of serum transaminases have been reported with use of simvastatin.
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including atorvastatin.
Common side effects of hyperlipidemia drugs include:
- Myopathy
- Rhabdomyolysis
- Elevated liver enzymes
- Increased risk of hemorrhagic stroke
- Increases in HbA1c and fasting serum glucose levels
Key considerations:
- Monitor patients for signs of myopathy and rhabdomyolysis, particularly during the first year of treatment 2.
- Discontinue treatment if markedly elevated CK levels occur or if myopathy is suspected 2.
- Consider the risk/benefit of use of atorvastatin calcium 80 mg in patients with recent hemorrhagic stroke 2.
- Optimize lifestyle measures to minimize the risk of increased HbA1c and fasting serum glucose levels 2.
From the Research
Hyperlipidemia Drug Side Effects
- The most common side effects of statins, a first-line treatment for hyperlipidemia, include myopathies and an increased risk of diabetes mellitus 3.
- Statin-related myopathies can be predicted through gene analysis, allowing for personalized treatment with minimal risk of side effects, with the most convincing data available for simvastatin 3.
- Other lipid-lowering drugs, such as ezetimibe, bile acid sequestrants, and fibrates, may have different side effect profiles, but the evidence is less clear 4, 5.
- The combination of simvastatin and ezetimibe has been shown to be effective in reducing cardiovascular events in patients with severe renal insufficiency, with minimal side effects reported 3, 6.
- Atorvastatin-ezetimibe combinations have been found to be generally well-tolerated, with previous concerns about an increased incidence of cancer with ezetimibe dismissed in large trials with long follow-up periods 6.
- New treatment options are being developed to manage hypercholesterolemia, with a focus on minimizing side effects and improving patient compliance 7.
Specific Side Effects
- Myopathies: a common side effect of statins, which can be predicted through gene analysis 3.
- Increased risk of diabetes mellitus: a potential side effect of statin therapy, particularly with long-term use 3.
- Liver transaminase elevations: a potential side effect of statin therapy, which should be monitored through regular blood tests 5.
- Cancer: previously a concern with ezetimibe, but dismissed in large trials with long follow-up periods 6.