Minerva Medica Research Articles

The efficacy and tolerability of the new micronized purified flavonoid fraction (MPFF) 1000 mg once-daily chewable formulation in comparison with the established MPFF 500 mg conventional tablet at the same daily dose are unknown. CHEWY was an international, multicenter, double-blind, double-dummy, randomized, parallel group, non-inferiority phase III study conducted in adult patients with symptomatic chronic venous disease (CVD). Patients were randomly allocated to MPFF 1000 mg chewable or MPFF 2x500 mg daily treatment. The primary efficacy endpoint for clinical non-inferiority (non-inferiority margin predefined at 1 cm) was lower limb discomfort (LLD) assessed by a 10 cm electronic visual analog scale (eVAS) at 8 weeks. Secondary endpoints included leg pain (LP), leg heaviness (LH), and quality of life (QoL) measured by the eCIVIQ-14 questionnaire. Overall acceptability was assessed at each visit by patient and investigator. Three hundred and nine patients were randomized to MPFF 1000 mg chewable and 302 to MPFF 2x500 mg. After 8 weeks, LLD decreased from baseline by -3.6±2.4 cm and -3.6±2.5 cm in the MPFF chewable and 2x500 mg groups, respectively. Non-inferiority of the once-daily chewable formulation compared with twice daily tablets on improving LLD was demonstrated (adjusted between-group difference [Standard Error]) (E [SE]) = 0.00 (0.18) cm, 95%CI -0.35; 0.35, non-inferiority P value <0.0001. Decreases of similar magnitude were observed at 8 weeks for LP and LH in both treatment arms: -3.4±2.3 cm and -3.5±2.5 cm, respectively for LP, and -3.5±2.5 cm and -3.5±2.6 cm, respectively for LH. QoL (global score) improved by -21.0±17.2 and -22.5±20.1 in the MPFF 1000 mg chewable group and 2x500 mg groups, respectively (E [SE]=1.03 [1.20], 95%CI [-1.32; 3.38]), with similar improvements in the QoL subscore components in both groups. Treatment acceptability was high for both patients and physicians and tolerability similar to the tablet formulation. MPFF 1000 mg chewable was non-inferior to MPFF 2x500 mg tablets with respect to its effect on LLD. Both formulations were associated with improvements of similar magnitude in lower limb symptoms and QoL. The chewable formulation was observed to be well tolerated and well accepted. Once-daily MPFF chewable tablet offers patients with CVD a good alternative treatment regimen.

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Endarterectomy with prosthetic patch angioplasty is the preferred treatment for common femoral artery occlusive disease. Eversion endarterectomy was described as a promising alternative. the aim of this study was to compare the eversion endarterectomy and patch angioplasty outcomes for patients with de novo femoral bifurcation atherosclerotic lesions. this study was a single-center, retrospective analysis of prospectively collected registry data, non-randomized cohort. Patients treated by eversion endarterectomy and patch angioplasty for de novo femoral bifurcation atheromatous lesions were evaluated. Between January 2016 and June 2019, all patients with de novo femoral bifurcation atheromatous lesions with a stenosis ≥70% were included in a prospective single-center database. Patients undergoing eversion endarterectomy and patch angioplasty were propensity-matched by age, sex, preexisting comorbidities, and lesion characteristics. There were 51 eversion endarterectomy and 137 patch angioplasty cases. One-to-one propensity matching yielded 51 pairs of patients. In the matched population, intermittent claudication was the most common clinical presentation (68% for both groups; P=0.83). There was no difference in femoral bifurcation lesion types between the two groups (P=0.11). Univariate analysis found no significant difference between the groups in terms of 30-d morbidity and mortality (10% and 16%; P=0.55). At 24 months, there was no significant difference in primary sustained clinical improvement (72% and 86%; P=0.22), primary patency rate (90% and 98%; P=0.48), and freedom from target lesion revascularization (100% and 98%; P=0.31) between the groups. This propensity-score analysis did not show any advantage for the EE. The EPPA should be the first line treatment of de novo femoral tripod occlusive disease. Results show that patch angioplasty treatment for de novo femoral bifurcation atheromatous could improve the daily practice with a good clinical improvement and primary patency.

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Minerva Medica Research Articles

Articles published on Minerva Medica

Are there preoperative factors associated with negative long-term results after standard lumbar microdiscectomy? A retrospective study of 97 cases at 5 years follow-up

Effects of a combination of Bromelain and Boswellia Serrata Casperome® on swelling, pain, stiffness and complications in ankle fracture

Effects of hand joints protection on pain, motor performance, and function in patients with hand osteoarthritis: a literature review

The effect of 12 weeks of Baduanjin exercise on cognitive function, lower limb balance and quality of life of the elderly with mild cognitive impairment: a randomized controlled trial

MPFF 1000 mg chewable once daily vs. MPFF 500 mg twice daily in chronic venous disease: the double-blind, randomized, non-inferiority CHEWY trial.

Early electroencephalogram and somatosensory evoked potentials as prognostic bedside tools in the pediatric cardiac intensive care.

Nursing study on promoting the recovery of gastrointestinal peristalsis after laparoscopy in Obstetrics and Gynecology Department.

Direct oral anticoagulants versus vitamin K antagonists in the treatment of left ventricular thrombosis: when off label becomes routine.

Time has come for interventional cardiologists to be fully involved in peripheral vascular interventions.

Fitness for surgery: is early ETCO2 production during (standardized) exercise instead of carrying grocery bags on flight(s) of stairs the next scalable step?

Time to replace the inappropriate old name of Physiotherapy for the medical specialty of Physical and Rehabilitation Medicine in official EU documents.

Study on the clinical efficacy of wipe cupping traditional Chinese medicine therapy on patients with pulmonary interstitial fibrosis and lung cancer.

Correlation between the position of double-lumen catheter tip with the incidence of recirculation among patients who undergo hemodialysis: a literature review

Hard-to-treat wound due to trabectidine extravasation: first case successfully treated with human lyophilized acellular dermis.

Influence of stent-graft fabrics on aortic stiffness after EVAR: preliminary results of a prospective cohort-study

Iron deficiency anemia and HbA1c levels: a wake-up call for health policy planners in low- and middle-income countries.

The effects of training with unstable surfaces on the strength and inter-limb asymmetry values in young soccer players

Application software for managing reservations and optimizing resources in interventional radiology rooms: from creation to clinical practice

Common femoral artery endarterectomy by eversion versus prosthetic patch angioplasty: a propensity-matched study.

Comment on: "Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi Consensus from the Focal Therapy Society".

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Minerva Medica Research Articles

Articles published on Minerva Medica

Are there preoperative factors associated with negative long-term results after standard lumbar microdiscectomy? A retrospective study of 97 cases at 5 years follow-up

Effects of a combination of Bromelain and Boswellia Serrata Casperome® on swelling, pain, stiffness and complications in ankle fracture

Effects of hand joints protection on pain, motor performance, and function in patients with hand osteoarthritis: a literature review

The effect of 12 weeks of Baduanjin exercise on cognitive function, lower limb balance and quality of life of the elderly with mild cognitive impairment: a randomized controlled trial

MPFF 1000 mg chewable once daily vs. MPFF 500 mg twice daily in chronic venous disease: the double-blind, randomized, non-inferiority CHEWY trial.

Early electroencephalogram and somatosensory evoked potentials as prognostic bedside tools in the pediatric cardiac intensive care.

Nursing study on promoting the recovery of gastrointestinal peristalsis after laparoscopy in Obstetrics and Gynecology Department.

Direct oral anticoagulants versus vitamin K antagonists in the treatment of left ventricular thrombosis: when off label becomes routine.

Time has come for interventional cardiologists to be fully involved in peripheral vascular interventions.

Fitness for surgery: is early ETCO2 production during (standardized) exercise instead of carrying grocery bags on flight(s) of stairs the next scalable step?

Time to replace the inappropriate old name of Physiotherapy for the medical specialty of Physical and Rehabilitation Medicine in official EU documents.

Study on the clinical efficacy of wipe cupping traditional Chinese medicine therapy on patients with pulmonary interstitial fibrosis and lung cancer.

Correlation between the position of double-lumen catheter tip with the incidence of recirculation among patients who undergo hemodialysis: a literature review

Hard-to-treat wound due to trabectidine extravasation: first case successfully treated with human lyophilized acellular dermis.

Influence of stent-graft fabrics on aortic stiffness after EVAR: preliminary results of a prospective cohort-study

Iron deficiency anemia and HbA1c levels: a wake-up call for health policy planners in low- and middle-income countries.

The effects of training with unstable surfaces on the strength and inter-limb asymmetry values in young soccer players

Application software for managing reservations and optimizing resources in interventional radiology rooms: from creation to clinical practice

Common femoral artery endarterectomy by eversion versus prosthetic patch angioplasty: a propensity-matched study.

Comment on: "Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi Consensus from the Focal Therapy Society".