Principal investigator of the PARALLAX trial discusses the results of the study and how use of sacubitril/valsartan impacted comorbidities and exercise capacity of patients with HFpEF.
In parallax we had two primary readouts we had the co-primary which was the change in anti-pro bnp from baseline to week 12 of therapy and we had the change in six minute walk distance from baseline to week 24 and we always assess the difference between the sacrament arm and the individualized medical therapy arm and yes we had a significant effect when we looked
Into anti-pro bnp there was a significant decline in nitratic peptides in the sacruptil valsartan arm at week four and that was already statistically significant the difference to the comparator and there was a statistical significant difference at week 12 and 12 with lower anti-pro-bnp values with sacrificial balsa time and this is consistent with previous
Data um for example from the phase two paramount study then we also looked into six minute walk distance and here we saw an improvement in six minute walk distance by roughly 10 meters in both groups in the sakurapatil valsartan group and in the comparator group this difference um at week 24 however between the two arms was not significant so no impact on six
Minute walk distance significant impact benefit reductions in anti-pro-bnp these are the key results from parallax so when we looked into quality of life parameters the measure was the kansas city cardiomyopathy questionnaire clinical summary score this was our key read out here kccq css and again we had several time points where we assess kccq baseline week
4 week 12 16 and 24 and we had an interesting finding we saw that quality of life significantly improved over time in both arms there was a significant difference in favor of sakurapatil valsartan after week four the difference between the two arms became smaller after at week 12 16 and 24 and at week 24 the significant the the difference was not significant
So early benefit on top of the overall improvement in this score and at the end of the study after week 24 no further significant difference um that is for kccq when we looked into new york heart association class changes one quarter of the patients in the overall cohort improved three quarters did not change a minority deteriorated but no significant difference between the two arms
Transcribed from video
Prof. Burkert Pieske, MD: Primary and Secondary Outcomes of PARALLAX By Practical Cardiology
