METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire.
RESULTS: A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P<0.0001) was found for lower limb discomfort (-3.33 cm for MPFF 1000 mg and -3.37 cm for MPFF 500 mg), leg pain (-3.27 cm for MPFF 1000 mg and -3.31 cm for MPFF 500 mg) and leg heaviness (-3.41 cm for MPFF 1000 mg and -3.46 cm for MPFF 500 mg). The patients' QoL was improved by about 20 points on the CIVIQ scale in both groups (19.33 points for MPFF 1000 mg and 20.28 points for MPFF 500 mg).
CONCLUSIONS: MPFF 1000-mg oral suspension and MPFF 500-mg tablets treatments were associated with similar reductions in lower limb symptoms and QoL improvement. The new once daily MPFF1000-mg oral suspension has a similar safety profile to two tablets of MPFF 500 mg, with the advantage of one daily intake, potentially associated with improved patient adherence and easier CVD management.
METHODS: The system typically consists of segmenting the calcium region from the CT scan into slices based on Hounsfield Unit-based threshold, and subsequently computing the summation of the calcium areas in each slice. However, when the carotid volume has intermittently higher concentration of contrast agent, a dependable approach is adapted to correct the calcium region using the neighboring slices, thereby estimating the correct volume. Furthermore, mitigation is provided following the regulatory constraints by changing the system to semi-automated criteria as a fall back solution. We evaluate the automated and semi-automated techniques using completely manual calcium volumes computed based on the manual tracings by the neuroradiologist.
RESULTS: A total of 64 patients with calcified plaque in the internal carotid artery were analyzed. Using the above algorithm, our automated and semi-automated system yields correlation coefficients (CC) of 0.89 and 0.96 against first manual readings and 0.90 and 0.96 against second manual readings, respectively. Using the t-test, there was no significant difference between the automated and semi-automated methods against manual. The intra-observer reliability was excellent with CC 0.98.
CONCLUSIONS: Compared to automated method, the semi-automated method for calcium volume is acceptable and closer to manual strategy for calcium volume. Further work evaluating and confirming the performance of our semi-automated protocol is now warranted.