The reality is that most of the studies, the clinical trials, that have run, several clinical trials have been run with carfilzomib and most of them systematically excluded patients with prior history of cardiovascular issues or ongoing non-stabilised cardiovascular issues. Therefore all these patients, often represented in the elderly population indeed, we had no data. The reality is that these patients develop myeloma and when they develop myeloma if we have no data we can’t use carfilzomib and we can’t propose carfilzomib and we don’t know how to safely propose carfilzomib to these patients while carfilzomib is one of the best five drugs in myeloma. So it’s very sad that we would have no data.
This study was able to capture data looking at patients that had a prior history of cardiovascular issues or ongoing cardiovascular issues. These patients were exposed to carfilzomib and we were able to demonstrate that there were some increased issues, however nothing major, nothing detrimental, nothing that impaired the patients from receiving carfilzomib and benefitting from carfilzomib.
So the idea is that upon cardiovascular monitoring, very reasonable but a strong one if needed, particularly if patients have ongoing cardiovascular issues, it’s safe to give carfilzomib to patients independently of age and independently of prior history of cardiovascular issues. I want to take this opportunity here to remember to people that the number one cardiovascular issue that you have that my colleagues, the community, has to be very careful with when it comes to carfilzomib is the hypertension which is probably one of the easiest cardiovascular diseases that you can treat these days in 2019. All you have to do is monitor it properly, follow the recommendations and treat hypertension when it comes, continue carfilzomib. Most of the patients can handle and manage carfilzomib in this respect.
When the patients have a severe cardiovascular issue stop carfilzomib, ask your cardiologist to treat the patient, improve the cardiovascular condition and then question the reintroduction of carfilzomib, possibly at a lower dose and to get back at full dose if the patient can have his cardiovascular condition improving and fixed.
So there is no contraindication of giving carfilzomib to patients with a prior history of cardiovascular issues. We know that now and it’s great information for the patients.