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CHOLIB (simvastatin, fenofibrate), statin in combination with other lipid-lowering agent
CARDIOLOGY - New medicinal product
Opinions on drugs -
Posted on
May 04 2016
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
No clinical benefit when compared with separate administration of both active ingredients in patients stabilised by a free combination of simvastatin and fenofibrate
- CHOLIB has Marketing Authorisation, as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
- Given the profile of patients treated and the risks associated with concomitant use of statin and fibrates (increased risk of muscle toxicity), this combination must be used with caution and under strict monitoring for signs of muscle toxicity.
- Treatment should be initiated by starting to combine simvastatin with the lowest effective dose of fenofibrate, to ensure good tolerance of the combination.
- CHOLIB can be proposed in patients stabilised by a well-tolerated free combination of simvastatin and fenofibrate at the same doses.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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