Dr. Jamshed Dalal answers some very pertinent questions related to PCSK9 inhibitors and statin intolerance and how to manage it. This Q&A transcript is an excerpt of the recent webinar by Dr. Dalal for M3 India.

Q-- Are PCSK9 inhibitors convenient for poor patients? What is the cost of the therapy?

Answer: The cost of the therapy is about INR 17000 per injection. Cost is an issue, if a patient cannot afford it, and there is very little we can do about it. Two things that can be done to help the patient:

1. Try speaking to the company, to help them avail some concession.
2. Patients sometimes take it once in 4 weeks instead of 2 weeks, though that is not officially recommended and that’s not a recommendation a physician should be giving. It’s just a practical option for patients who cannot afford it. But, it is important to understand that when a patient has a heart attack, he is going to go to the hospital, he is going to spend for that, he is going to have a stent, he is going to have angioplasty or bypass surgery, and all of those are expensive. Though the convenience of patients is important, heart disease is a problem and the treatment of heart disease is also a problem. So a better way would be to try and prevent it rather than having a problem, which will be much more expensive to deal with.

Q-- In chronic kidney disease (CKD) patients, up to what glomelular filtration rate (GFR) can PCSK9 inhibitor be given?

Answer: Usually, if it is found that there is no excretion of statins or PCSK9 through the renal tract, there is no need to reduce the dose. There has been some anxiety in the past about proteinuria with Rosuvastatin compared to Atorvastatin and many nephrologists prefer Atorvastatin over Rosuvastatin, but most of the recent trials say that there is no issue. So really, CKD is not an issue, neither with statins, nor with PCSK9 inhibitors.

Q-- Are there any drug interactions for PCSK9 inhibitors?

Answer: Yes, they are antibodies, so it is possible that there may be drug interactions. They haven't shown in trials at least any such interactions. It certainly doesn’t interact with the common drugs that one takesfor cardiac issues. It is unclear however on how it would react with anti-malignancy drugs or other more complicated drugs that one might take for arthritis or other health problems. So it is necessary to exercise caution and check a patient’s drug history when prescribing a PCSK9 inhibitor.

Q-- Why not use statins for primary prophylaxis?

Answer: We can use statins for primary prevention; not necessarily in very high doses, even in moderate doses of 10 mg of Rosuvastatin and 20 or 40 mg of Atorvastatin, we can significantly reduce a patient's problems.

Q-- Are intermittent statins harmful? How does one manage a patient who does not tolerate statins?

Answer: Intermittent statin can be used in patients who cannot tolerate statins. For managing a patient who doesn’t tolerate statins, it is necessary to first assess if it is absolute genuine intolerance. In order to find out if that's the case, one would have to stop the statin, the pain and side effects should go away, then restart statin to check if they happen again.

A study published in 2017 tested this in two groups of patients. A group of patients were divided into half. Half the group were given statins and the other half, placebo. It was a completely blind study, and both groups did not know what they were taking. The participants were told to return and report problems. One issue reported was muscle pain= 2% in the placebo group and 2% in the statin group.

Then, in the second half of the study, all participants were given statins and they were told that were given statins. There was a 42% increase in muscle pain from before. The same 2% people who had muscle pains when they didn’t know jumped to about 40 times more when they found out. Because everybody knows statins cause muscle pain, we may have so many patients who have osteoarthritis of one knee and think it is related to statins. Similarly, patients think that if they have a frozen shoulder and can’t lift their hand, it may be related to statin intolerance. Therefore, it is mandatory to first confirm a genuine intolerance.

Q-- If the statin intolerance is genuine, how do you deal with it?

Answer: You could reduce dosage to see if it helps. For example, a patient taking 20 mg of Rosuvastatin, could reduce it 10 mg, and see if it helps. It would also be helpful to check for vitamin D deficiency, correct it, and prescribe coenzyme Q10. This may help many patients.

The patient can be reassured that as they continue, muscle pain would become lesser. If the patient still cannot tolerate the dosage could be further reduced or the same dosage could be given every alternate day. It reduces the symptoms undoubtedly, at the same time, even 5 mg three times a day is better than 0 mg every day.

So any amount of statin is good, any lowering of cholesterol is good. There is a continuous benefit in LDL coming down from 100 or 90, all the way down to 20. Any lowering of LDL is beneficial. So if 5 mg lowers LDL by 10 mg, that much benefit to the patient.

This article is a transcript of the webinar by Dr. Jamshed Dalal, titled, 'How and when to consider PCSK9 inhibitors in practice'. Click here to watch.

To read the first part of the transcript, click Which patient populations should one target for PCSK9 Inhibitors?: Dr. Jamshed Dalal

To read the second part of the transcript, click Do PCSK9 inhibitors cause sugar to rise? When should they be prescribed?

To read Dr. Jamshed Dalal's article on PCSK9 inhibitors, click Role of PCSK9 inhibitors in the aggressive management of atherosclerotic vascular disease: Dr. Jamshed Dalal

Disclaimer

This document is a transcription of a portion of the webinar, produced for audience with bandwidth limitations that could possibly restrict them from viewing the video. While it is believed to be accurate, it is not warranted to be so. Divergence in format is to be expected.

The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.