NicOx' presents naproxcinod ABPM data
The presentation included line graphs displaying the hourly mean blood pressure measurements over 24 hours following a two week treatment period, during which naproxcinod or naproxen were administered twice daily. These graphs showed that the hourly systolic blood pressure (SBP) and diastolic blood pressure (DBP) values for naproxcinod were consistently below those observed in the naproxen group. In addition, the data suggest that the blood pressure effect of naproxcinod lasts for 7 to 8 hours after each administration.
Considering the average of the ABPM measurements over 24 hours the results showed an almost 2 mmHg reduction in SBP and DBP for naproxcinod compared to naproxen, in terms of the mean change from baseline, after a 2 week active treatment period. This difference did not reach statistical significance for SBP (p=0.101), the primary endpoint of the study, but did achieve statistical significance for DBP (p=0.007).
Blood pressure data were collected in the first phase 3 trial for naproxcinod (the 301 study) using Office Blood Pressure Measurements (OBPM) up to 13 weeks. The top-line results of this trial revealed a sustained reduction in blood pressure for naproxcinod, compared to baseline and naproxen.
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