• Je něco špatně v tomto záznamu ?

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

P. Carpentier, B. van Bellen, D. Karetova, H. Hanafiah, E. Enriquez-Vega, A. Kirienko, A. Dzupina, M. Sabovic, L. Reina Gutierrez, S. Subwongcharoen, H. Tüzün, A. Maggioli,

. 2017 ; 36 (5) : 402-409. [pub] 20170215

Jazyk angličtina Země Itálie

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc18025155

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.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc18025155
003      
CZ-PrNML
005      
20180716120426.0
007      
ta
008      
180709s2017 it f 000 0|eng||
009      
AR
024    7_
$a 10.23736/S0392-9590.17.03801-9 $2 doi
035    __
$a (PubMed)28206732
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a it
100    1_
$a Carpentier, Patrick $u Grenoble University Hospital, Grenoble, France - pcarpentier@chu-grenoble.fr.
245    10
$a 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 / $c P. Carpentier, B. van Bellen, D. Karetova, H. Hanafiah, E. Enriquez-Vega, A. Kirienko, A. Dzupina, M. Sabovic, L. Reina Gutierrez, S. Subwongcharoen, H. Tüzün, A. Maggioli,
520    9_
$a 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.
650    _2
$a aplikace orální $7 D000284
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a chronická nemoc $7 D002908
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a flavonoidy $x aplikace a dávkování $x škodlivé účinky $7 D005419
650    _2
$a lidé $7 D006801
650    _2
$a mezinárodní spolupráce $7 D007391
650    _2
$a dolní končetina $x krevní zásobení $x patofyziologie $7 D035002
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a management bolesti $7 D059408
650    _2
$a měření bolesti $7 D010147
650    _2
$a kvalita života $7 D011788
650    _2
$a průzkumy a dotazníky $7 D011795
650    _2
$a výsledek terapie $7 D016896
650    _2
$a nemoci cév $x farmakoterapie $x patofyziologie $7 D014652
650    _2
$a mladý dospělý $7 D055815
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a van Bellen, Bonno $u Service of Vascular Surgery and Angiology, Real e Benemérita Associação Portuguesa de Beneficência, São Paulo, Brazil.
700    1_
$a Karetova, Debora $u Department for Cardiology and Angiology, General Faculty Hospital.
700    1_
$a Hanafiah, Harunarashid $u st Faculty of Medicine, Charles University, Prague, Czech Republic.
700    1_
$a Enriquez-Vega, Elizabeth $u National University of Malaysia, Kuala Lumpur, Malaysia.
700    1_
$a Kirienko, Alexander $u National Autonomous University of Mexico, Mexico City, Mexico.
700    1_
$a Dzupina, Andrej $u Department of Surgery, Faculty of Medicine, Pirogov Russian National Research Medical University, Moscow, Russia.
700    1_
$a Sabovic, Miso $u Angiologická Ambulancia Alian, Bardejov, Slovakia.
700    1_
$a Reina Gutierrez, Lourdes $u Department of Vascular Diseases, University Clinical Center of Ljubljana, Ljubljana, Slovenia.
700    1_
$a Subwongcharoen, Somboom $u Department of Angiology and Vascular Surgery, Hospital de la Cruz Roja, Madrid, Spain.
700    1_
$a Tüzün, Hasan $u Rajavithi Hospital, Bangkok, Thailand.
700    1_
$a Maggioli, Arnaud $u Cerrahpaşa Faculty of Medicine, Istanbul University, Istanbul, Turkey.
773    0_
$w MED00002267 $t International angiology a journal of the International Union of Angiology $x 1827-1839 $g Roč. 36, č. 5 (2017), s. 402-409
856    41
$u https://pubmed.ncbi.nlm.nih.gov/28206732 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20180709 $b ABA008
991    __
$a 20180716120724 $b ABA008
999    __
$a ok $b bmc $g 1317286 $s 1022076
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 36 $c 5 $d 402-409 $e 20170215 $i 1827-1839 $m International angiology $n Int Angiol $x MED00002267
LZP    __
$a Pubmed-20180709

Najít záznam

Citační ukazatele

Možnosti archivace