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Expert opinion on the definition of "not responding to PCSK9 inhibitor therapy"

Welcome

Monoclonal antibodies directed against PCSK9 (evolocumab and alirocumab) are registered therapies for LDL-C reduction. Anecdotal data suggest that in some patients, prescription of these agents does not result in the anticipated LDL-C level reductions and/or generates adverse effects. Yet, a uniform definition of this “non-responding” is lacking.
With the help of Medcon, and in collaboration with the EAS and NLA we aim to define a 'working' definition for non-responders on PCSK9 inhibitors.

The purpose of this survey is:
  • To assess the view of experts prescribing PCSK9 inhibitors on the definition of “non-response” to PCSK9 inhibitors.
  • To estimate the prevalence of patients not-responding to PCSK9 inhibitors in real clinical practice (according to the personal judgement of the experts surveyed).
While acknowledging time constraints, we minimized the number of questions to be answered, and the total survey with a maximum of 19 questions is likely to take less than five minutes of your time. Please try to be as precise as possible when writing down any numbers. Your response will be analyzed anonymously.

We thank you for your time.

Arjen Cupido, MD
Rens Reeskamp, MD
Prof. dr. Erik Stroes, MD
Prof. dr. Kees Hovingh, MD

Amsterdam University Medical Centers - Location AMC
Amsterdam, The Netherlands


The first few questions will address general characteristics and prescription behavior of our colleagues prescribing PCSK9 inhibitor therapy.
2. What is your specialty? *This question is required.
This question requires a valid number format.
patients.
This question requires a valid number format.
patients.
5. How many of these prescriptions were approximately granted by health insurance companies? (Scale in percentage)
0 percent
50 percent
100 percent
6. What is your most frequent indication to prescribe a PCSK9 inhibitor?
  *This question is required.


The following questions address the non-response to PCSK9 inhibitor therapy due to insufficient reductions in cholesterol levels. 
7. Have you ever stopped treatment with PCSK9 inhibitors in (a) patient(s) due to insufficient relative reduction of his/her LDL-C level? *This question is required.
This question requires a valid number format.
patients.
8. What do you consider the minimal relative reduction in LDL-C to continue treatment with a PCSK9 inhibitor (percentage)?  *This question is required.
0 percent
50 percent
100 percent
9. In your opinion, What minimum relative reduction in LDL-C levels can be considered a normal response to treatment with a PCSK9 inhibitor (percentage)?
  *This question is required.
0 percent
50 percent
100 percent
10. How many times do you normally measure LDL-C levels in order to confirm the unresponsiveness of the patient to the PCSK9 inhibitor? *This question is required.
0
5 times
10 times


The following questions will adress adverse effects probably due to PCSK9 inhibitor therapy. 
This question requires a valid number format.
patients.
12. Have any of your patients discontinued PCSK9 inhibitor treatment due to adverse effects?
  *This question is required.
This question requires a valid number format.
patients.
What adverse effects made your patients discontinue therapy with PCSK9 inhibitors? You can check multiple options.
  *This question is required.


The last questions address switching between PCSK9 inhibitor therapeutics, e.g. from evolocumab to alirocumab or from alirocumab to evolocumab.
13. Have you ever started treatment with the alternative PCSK9 inhibitor when the first PCSK9 inhibitor was ineffective and/or resulted in adverse effects that made the patient discontinue treatment? *This question is required.
This question requires a valid number format.
patients.
In your experience, what percentage of patients where you have switched treatment responded sufficiently to the second PCSK9 inhibitor? *This question is required.
0 percent
50 percent
100 percent