A new cholesterol-lowering agent that does not cause muscle pain as a side effect. That seems like good news for the many people who can’t tolerate a statin because of muscle pain. But the research on the new drug has been criticized.
Almost two million Dutch people use a statin to lower cholesterol, such as simvastatin or rosuvastatin. That could have been even more, because many people (an estimated 10 to 30 percent) stop taking statins because of muscle pain as a side effect. The new drug bempedoic acid (Nilemdo®) works in a different way than the statins. In theory it wouldn’t cause muscle pain. It is not yet available because the compensation has not yet been finalized. But it has already been registered in 2020 if LDL cholesterol concentrations are too high, in addition to, among other things, a statin. In addition, bempedoic acid is registered for people with high-risk cholesterol levels who should not have a statin or who cannot tolerate it. The latter group consists mainly of people who have stopped because of muscle pain. But is it a solution for them? According to the critical medical journal Drug Bulletin not.
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More research needed
The Medicines Bulletin points out that although the drug lowers cholesterol, it has still been proven to work on the ‘hard endpoints’. In other words, we do not know whether bempedoic acid reduces the risk of heart disease. That is to be expected, says the Zorginstituut, but the Medicines Bulletin prefers to stop at ‘measuring is knowing’.
Second criticism: the research into the side effects is faltering. The side effects have only been measured properly in 1 of the 3 studies. In that study, people were also given a statin, so it is not easy to see whether the new drug bempedoic acid causes less muscle pain than a statin. Because side effects to the muscles were indeed reported in the test group. People who received the drug quit more often than people who received a placebo, during the study. So more research is really needed before you swap a statin for this new drug because of side effects, according to the Medicines Bulletin.
Compensation
With the registration, the medicine is admitted to the market, step two is that the Zorginstituut advises on the required reimbursement. That has already happened, the National Health Care Institute has given the green light on 5 July. The green light applies to a small group of people. Specific: patients who maintain high LDL cholesterol despite diet and maximum doses of statins and ezetimibe, or people who cannot tolerate or cannot tolerate statins. Two requirement: they should not be eligible for a PCSK-9 inhibitor, another group of new injections of cholesterol-lowering drugs. It is also very expensive, so the Zorginstituut advises the minister to negotiate the price before it is reimbursed. The decision on the compensation is now up to the minister.
