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Efficacy of MPFF 1000 mg oral suspension on CVD C0s-C1-related symptoms and quality of life.
Int Angiol. 2019 Apr; 38(2):83-89.IA

Abstract

BACKGROUND

To show the efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg in the mild cases of chronic venous disorders (CVD), i.e. in C0s-C1 patients according to the CEAP classification.

METHODS

In an international, randomized, double-blind, parallel-group study, symptomatic C0s to C4 patients according to the Clinical Etiological Anatomic Pathophysiologic (CEAP) were treated for 8 weeks by either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis is focused on the efficacy of MPFF at the daily doses of 1000 mg in the population of mild cases of the CVD (C0s-C1 patients) on lower limb discomfort, leg pain and leg heaviness using a 10-cm Visual Analog Scale (VAS), and on quality of life (QoL) using CIVIQ-20.

RESULTS

In the 256 patients of the C0s-C1 subset of the study patients, lower limb discomfort improvement measured on VAS was clinically and statistically significant: -2.87±2.38 cm in the MPFF 1000 mg group and -3.30±2.36 cm in the MPFF 500 mg group (P<0.001 in both groups). Leg pain and leg heaviness VAS improved similarly: -2.77±2.58 cm in the MPFF 1000 mg group and -3.45±2.38 cm in the MPFF 500 mg group (P<0.001 in both groups), and -2.91±2.47 cm in the MPFF 1000 mg group and -3.47±2.33 cm in the MPFF 500 mg group (P<0.001 in both groups). The quality of life assessed by the CIVIQ-20 questionnaire improved significantly in both treatment groups from baseline to W8 with a mean changes of global index score of -16.53±14.18 in the MPFF 1000 mg group and -18.78±18.14 in the MPFF 500 mg group (P<0.001).

CONCLUSIONS

MPFF at the daily dose of 1000 mg was shown to have a similar efficacy in mild CVD cases (C0s-C1 patients) as in the whole spectrum of patients from the main study, with a very good safety profile. These result further illustrates the interest of MPFF in the management of the mild cases of the disease at a daily dose of 1000 mg.

Authors+Show Affiliations

Laboratoires Servier, Nevilly sur Seine, France - arnaud.maggioli@servier.com.Grenoble University Hospital, Grenoble cedex, France.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31056892

Citation

Maggioli, Arnaud, and Patrick Carpentier. "Efficacy of MPFF 1000 Mg Oral Suspension On CVD C0s-C1-related Symptoms and Quality of Life." International Angiology : a Journal of the International Union of Angiology, vol. 38, no. 2, 2019, pp. 83-89.
Maggioli A, Carpentier P. Efficacy of MPFF 1000 mg oral suspension on CVD C0s-C1-related symptoms and quality of life. Int Angiol. 2019;38(2):83-89.
Maggioli, A., & Carpentier, P. (2019). Efficacy of MPFF 1000 mg oral suspension on CVD C0s-C1-related symptoms and quality of life. International Angiology : a Journal of the International Union of Angiology, 38(2), 83-89. https://doi.org/10.23736/S0392-9590.18.04054-3
Maggioli A, Carpentier P. Efficacy of MPFF 1000 Mg Oral Suspension On CVD C0s-C1-related Symptoms and Quality of Life. Int Angiol. 2019;38(2):83-89. PubMed PMID: 31056892.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of MPFF 1000 mg oral suspension on CVD C0s-C1-related symptoms and quality of life. AU - Maggioli,Arnaud, AU - Carpentier,Patrick, PY - 2019/5/7/entrez PY - 2019/5/7/pubmed PY - 2019/9/19/medline SP - 83 EP - 89 JF - International angiology : a journal of the International Union of Angiology JO - Int Angiol VL - 38 IS - 2 N2 - BACKGROUND: To show the efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg in the mild cases of chronic venous disorders (CVD), i.e. in C0s-C1 patients according to the CEAP classification. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic C0s to C4 patients according to the Clinical Etiological Anatomic Pathophysiologic (CEAP) were treated for 8 weeks by either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis is focused on the efficacy of MPFF at the daily doses of 1000 mg in the population of mild cases of the CVD (C0s-C1 patients) on lower limb discomfort, leg pain and leg heaviness using a 10-cm Visual Analog Scale (VAS), and on quality of life (QoL) using CIVIQ-20. RESULTS: In the 256 patients of the C0s-C1 subset of the study patients, lower limb discomfort improvement measured on VAS was clinically and statistically significant: -2.87±2.38 cm in the MPFF 1000 mg group and -3.30±2.36 cm in the MPFF 500 mg group (P<0.001 in both groups). Leg pain and leg heaviness VAS improved similarly: -2.77±2.58 cm in the MPFF 1000 mg group and -3.45±2.38 cm in the MPFF 500 mg group (P<0.001 in both groups), and -2.91±2.47 cm in the MPFF 1000 mg group and -3.47±2.33 cm in the MPFF 500 mg group (P<0.001 in both groups). The quality of life assessed by the CIVIQ-20 questionnaire improved significantly in both treatment groups from baseline to W8 with a mean changes of global index score of -16.53±14.18 in the MPFF 1000 mg group and -18.78±18.14 in the MPFF 500 mg group (P<0.001). CONCLUSIONS: MPFF at the daily dose of 1000 mg was shown to have a similar efficacy in mild CVD cases (C0s-C1 patients) as in the whole spectrum of patients from the main study, with a very good safety profile. These result further illustrates the interest of MPFF in the management of the mild cases of the disease at a daily dose of 1000 mg. SN - 1827-1839 UR - https://www.unboundmedicine.com/medline/citation/31056892/Efficacy_of_MPFF_1000_mg_oral_suspension_on_CVD_C0s_C1_related_symptoms_and_quality_of_life_ L2 - https://www.minervamedica.it/index2.t?show=R34Y2019N02A0083 DB - PRIME DP - Unbound Medicine ER -