Fenofibrate 160mg Can Be Safely Combined with Pravastatin 10mg
Yes, fenofibrate 160mg can be safely combined with pravastatin 10mg when clinically indicated for mixed dyslipidemia. 1 This combination is considered reasonable and effective for patients who need both LDL-cholesterol and triglyceride reduction.
Safety Profile of This Combination
The combination of fenofibrate with pravastatin has several advantages over other statin-fibrate combinations:
- Fenofibrate is the preferred fibrate when combining with any statin due to a reduced incidence of drug-drug interactions compared to gemfibrozil 1
- Pravastatin is specifically identified as one of the preferred statins when combination therapy with fibrates is needed 1
- The combination of pravastatin and fenofibrate has been shown to be safe in clinical studies 1
- No cases of rhabdomyolysis were reported in studies examining this specific combination 2, 3
Pharmacological Rationale
This combination works well together because:
- Pravastatin is not extensively metabolized by CYP3A4, unlike some other statins, making it less prone to drug interactions 1
- Fenofibrate has minimal effects on pravastatin metabolism, with studies showing only a 1% decrease in fenofibric acid exposure when combined with pravastatin 4
- The combination provides complementary lipid-lowering effects - statins primarily lower LDL-C while fibrates primarily lower triglycerides and raise HDL-C 1
Monitoring Recommendations
When using this combination, implement the following monitoring protocol:
- Baseline liver function tests (ALT/AST) and creatine kinase (CK) levels
- Follow-up liver function tests at approximately 12 weeks after starting therapy, then annually 1
- Monitor for muscle symptoms (soreness, tenderness, pain) at 6-12 weeks and each follow-up visit 1
- Obtain CK measurement if muscle symptoms develop 1
- Monitor renal function, particularly in patients with pre-existing kidney disease 1, 4
Important Cautions
While the combination is generally safe, be aware of these potential issues:
- Increased risk of myopathy compared to monotherapy, though still relatively low with this specific combination 1
- Potential for modest increases in serum creatinine, which is a known effect of fenofibrate 5
- Use caution in patients with severe renal impairment (eGFR <30 mL/min/1.73m²) 4
- Consider dose reduction of fenofibrate in patients with moderate renal impairment (eGFR 30-59 mL/min/1.73m²) 1, 4
- Elderly patients and those with multisystem disease may require more careful monitoring 1
Clinical Evidence
The safety of this combination is supported by multiple studies:
- A preliminary report showed the combination of pravastatin and fenofibrate was safe 1
- Long-term studies (average 2.06 years per patient) showed the combination of fenofibrate with low-dose pravastatin was generally safe and effective for combined hyperlipidemia 6
- A fixed-dose combination of fenofibrate/pravastatin 160/40 mg demonstrated good tolerability in patients with type 2 diabetes and mixed hyperlipidemia 5
In conclusion, the combination of fenofibrate 160mg with pravastatin 10mg represents a safe and effective approach for treating patients with mixed dyslipidemia when monotherapy is insufficient to reach lipid goals.