Clinical efficacy and safety of a new 1000-mg suspension versus twice-daily 500-mg tablets of MPFF in patients with symptomatic chronic venous disorders

A randomized controlled trial

Patrick Carpentier, Bonno Van Bellen, Debora Karetova, Hanafiah Haruna Rashid, Elizabeth Enriquez-Vega, Alexander Kirienko, Andrej Dzupina, Miso Sabovic, Lourdes Reinag Utierrez, Somboom Subwongcharoen, Hasan Tüzün, Arnaud Maggioli

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. 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.

Original languageEnglish
Pages (from-to)402-409
Number of pages8
JournalInternational Angiology
Volume36
Issue number5
DOIs
Publication statusPublished - 1 Oct 2017

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Flavonoids
Tablets
Suspensions
Randomized Controlled Trials
Safety
Lower Extremity
Quality of Life
Leg
Pain
Therapeutics
Patient Compliance
Quality Improvement
Visual Analog Scale
Arm

Keywords

  • Flavonoids
  • Lower extremity
  • Quality of life
  • Signs and symptoms
  • Suspensions
  • Vascular diseases

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Clinical efficacy and safety of a new 1000-mg suspension versus twice-daily 500-mg tablets of MPFF in patients with symptomatic chronic venous disorders : A randomized controlled trial. / Carpentier, Patrick; Van Bellen, Bonno; Karetova, Debora; Haruna Rashid, Hanafiah; Enriquez-Vega, Elizabeth; Kirienko, Alexander; Dzupina, Andrej; Sabovic, Miso; Reinag Utierrez, Lourdes; Subwongcharoen, Somboom; Tüzün, Hasan; Maggioli, Arnaud.

In: International Angiology, Vol. 36, No. 5, 01.10.2017, p. 402-409.

Research output: Contribution to journalArticle

Carpentier, P, Van Bellen, B, Karetova, D, Haruna Rashid, H, Enriquez-Vega, E, Kirienko, A, Dzupina, A, Sabovic, M, Reinag Utierrez, L, Subwongcharoen, S, Tüzün, H & Maggioli, A 2017, 'Clinical efficacy and safety of a new 1000-mg suspension versus twice-daily 500-mg tablets of MPFF in patients with symptomatic chronic venous disorders: A randomized controlled trial', International Angiology, vol. 36, no. 5, pp. 402-409. https://doi.org/10.23736/S0392-9590.17.03801-9
Carpentier, Patrick ; Van Bellen, Bonno ; Karetova, Debora ; Haruna Rashid, Hanafiah ; Enriquez-Vega, Elizabeth ; Kirienko, Alexander ; Dzupina, Andrej ; Sabovic, Miso ; Reinag Utierrez, Lourdes ; Subwongcharoen, Somboom ; Tüzün, Hasan ; Maggioli, Arnaud. / Clinical efficacy and safety of a new 1000-mg suspension versus twice-daily 500-mg tablets of MPFF in patients with symptomatic chronic venous disorders : A randomized controlled trial. In: International Angiology. 2017 ; Vol. 36, No. 5. pp. 402-409.
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T2 - A randomized controlled trial

AU - Carpentier, Patrick

AU - Van Bellen, Bonno

AU - Karetova, Debora

AU - Haruna Rashid, Hanafiah

AU - Enriquez-Vega, Elizabeth

AU - Kirienko, Alexander

AU - Dzupina, Andrej

AU - Sabovic, Miso

AU - Reinag Utierrez, Lourdes

AU - Subwongcharoen, Somboom

AU - Tüzün, Hasan

AU - Maggioli, Arnaud

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N2 - BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. 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.

AB - BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. 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.

KW - Flavonoids

KW - Lower extremity

KW - Quality of life

KW - Signs and symptoms

KW - Suspensions

KW - Vascular diseases

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