A randomized, double-blind, placebo-controlled, clinical study on the efficacy and safety of calcium dobesilate in the treatment of chronic venous insufficiency

Phlebology

Volumn 31, Issue 4, 2016, Pages 264-274

  Rabe, Eberhard ^a   Ballarini, Stefania ^b   Lehr, Lorenz ^b  

^a UNIVERSITY OF BONN   (Germany)

^b Vifor (International) Inc   (Switzerland)

Author keywords

calcium dobesilate; CEAP; Chronic venous insufficiency; CIVIQ score; leg volume

Indexed keywords

DOBESILATE CALCIUM; GAMMA GLUTAMYLTRANSFERASE; PLACEBO;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; CHRONIC VEIN INSUFFICIENCY; CLINICAL STUDY; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DIARRHEA; DISEASE ASSESSMENT; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EAR DISEASE; ECZEMA; FEMALE; FOLLOW UP; HEADACHE; HEART DISEASE; HUMAN; HYPERTENSION; INFLUENZA; LEG PAIN; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MUSCLE SPASM; NAUSEA; NEOPLASM; NUTRITIONAL DISORDER; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VOLUMETRY; WATER DISPLACEMENT VOLUMETRY; CHRONIC DISEASE; CLINICAL TRIAL; LEG; MIDDLE AGED; MULTICENTER STUDY; PATHOPHYSIOLOGY; PHASE 4 CLINICAL TRIAL; VASCULARIZATION; VEIN INSUFFICIENCY;

ADULT; AGED; CALCIUM DOBESILATE; CHRONIC DISEASE; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEG; MALE; MIDDLE AGED; VENOUS INSUFFICIENCY;

EID: 84964194578     PISSN: 02683555     EISSN: 14333031     Source Type: Journal    
DOI: 10.1177/0268355515586097     Document Type: Article

References (34)

1. J.J.BerganG.W.Schmid-SchonbeinP.D.Smith. Chronic venous disease. N Engl J Med2006; 355: 488–498.
2. R.T.EberhardtJ.D.Raffetto. Chronic venous insufficiency. Circulation2005; 111: 2398–2409.
3. B.EklofR.B.RutherfordJ.J.Bergan. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg2004; 40: 1248–1252.
4. A.BollingerG.PfisterU.Hoffmann. Fluorescence microlymphography in chronic venous incompetence. Int Angiol1989; 8: 23–26.
5. A.BollingerI.HerrigM.Fischer. Intravital capillaroscopy in patients with chronic venous insufficiency and lymphoedema: relevance to Daflon 500 mg. Int J Microcirc Clin Exp1995; 15(Suppl 1): 41–44.
6. J.L.Beebe-DimmerJ.R.PfeiferJ.S.Engle. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol2005; 15: 175–184.
7. E.RabeF.Pannier-FischerK.Bromen. Bonner venenstudie der deutschen gesellschaft für phlebologie – Epidemiologische untersuchung zur frage der häufigkeit und ausprägung von chronischen venenkrankheiten in der städtischen und ländlichen wohnbevölkerung. Phlebologie2003; 32: 1–14.
8. E.RabeJ.J.GuexA.Puskas. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol2012; 31: 105–115.
9. F.G.FowkesC.J.EvansA.J.Lee. Prevalence and risk factors of chronic venous insufficiency. Angiology2001; 52(Suppl 1): S5–15.
10. A.N.NicolaidesC.AllegraJ.Bergan. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol2008; 27: 1–59.
11. No authors listed. Management of chronic venous disorders of the lower limbs – guidelines according to scientific evidence. Int Angiol 2014; 33: 87–208
12. A.CiapponiE.LaffaireM.Roque. Calcium dobesilate for chronic venous insufficiency: a systematic review. Angiology2004; 55: 147–154.
13. T.TejerinaE.Ruiz. Calcium dobesilate: pharmacology and future approaches. Gen Pharmacol1998; 31: 357–360.
14. J.BrunetJ.C.FarineR.P.Garay. Angioprotective action of calcium dobesilate against reactive oxygen species-induced capillary permeability in the rat. Eur J Pharmacol1998; 358: 213–220.
15. G.FalkayL.Kovacs. Calcium dobesilate (Doxium) as a prostaglandin synthetase inhibitor in pregnant human myometrium in vitro. Experientia1984; 40: 190–191.
16. C.SuschekH.KolbV.Kolb-Bachofen. Dobesilate enhances endothelial nitric oxide synthase-activity in macro- and microvascular endothelial cells. Br J Pharmacol1997; 122: 1502–1508.
17. J.R.Casley-SmithJ.R.Casley-Smith. The effects of calcium dobesilate on acute lymphedema (with and without macrophages), and on burn edema. Lymphology1985; 18: 37–45.
18. J.R.Casley-Smith. The influence of tissue hydrostatic pressure and protein concentration on fluid and protein uptake by diaphragmatic initial lymphatics; effect of calcium dobesilate. Microcirc Endothelium Lymphatics1985; 2: 385–415.
19. N.B.Piller. The lymphogogue action of calcium dobesilate on the flow of lymph from the thoracic duct of anesthetized and mobile guinea pigs. Lymphology1988; 21: 124–127.
20. S.LameynardieC.ChiavaroliP.Travo. Inhibition of choroidal angiogenesis by calcium dobesilate in normal Wistar and diabetic GK rats. Eur J Pharmacol2005; 510: 149–156.
21. R.RotaC.ChiavaroliR.P.Garay. Reduction of retinal albumin leakage by the antioxidant calcium dobesilate in streptozotocin-diabetic rats. Eur J Pharmacol2004; 495: 217–224.
22. S.PecchiV.De FrancoP.Damiani. Calcium dobesilate in the treatment of primary venous insufficiency of the lower limbs. A controlled clinical study. Clin Ter1990; 132: 409–417.
23. L.WidmerL.BilandJ.P.Barras. Doxium 500 in chronic venous insufficiency: a double-blind placebo controlled multicentre study. Int Angiol1990; 9: 105–110.
24. K.H.LabsS.DegischerG.Gamba. Effectiveness and safety of calcium dobesilate in treating chronic venous insufficiency: randomized, double-blind, placebo-controlled trial. Phlebology2004; 19: 123–130.
25. E.RabeK.,.Jaeger. on behalf of the study working group. Multicentre, double-blind, placebo-controlled, randomised clinical study to assess the efficacy and safety of Doxium® 500 three times daily in patients suffering from chronic venous insufficiency (CVI) CEAP Class C3, 4 or 5. Phlebologie2006; 35: A37–A37.
26. E.RabeK.A.JaegerM.Bulitta. Calcium dobesilate in patients suffering from chronic venous insufficiency: a double-blind, placebo-controlled, clinical trial. Phlebology2011; 26: 162–168.
27. M.PerrinJ.J.Guex. Edema and leg volume: methods of assessment. Angiology2000; 51: 9–12.
28. K.;.Jaeger. the CVI Study Group. Efficacy and safety of Doxium in chronic venous insufficiency: double-blind, placebo-controlled multicenter study. Int Angiol2001; 20: 239–239.
29. F.Flota-CerveraC.Flota-RuizC.Trevino. Randomized, double blind, placebo-controlled clinical trial to evaluate the lymphagogue effect and clinical efficacy of calcium dobesilate in chronic venous disease. Angiology2008; 59: 352–356.
30. M.J.Martinez-ZapataR.M.MorenoI.Gich. A randomized, double-blind multicentre clinical trial comparing the efficacy of calcium dobesilate with placebo in the treatment of chronic venous disease. Eur J Vasc Endovasc Surg2008; 35: 358–365.
31. O.AldaM.S.ValeroD.Pereboom. In vitro effect of calcium dobesilate on oxidative/inflammatory stress in human varicose veins. Phlebology2011; 26: 332–337.
32. N.B.Piller. Assessment of the anti-inflammatory action of calcium dobesilate. Effect on macrophages attaching to subcutaneously implanted coverslips in guinea pigs. Arzneimittelforschung1990; 40: 698–700.
33. B.EklofM.PerrinK.T.Delis. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg2009; 49: 498–501.
34. H.AllainA.A.RameletE.Polard. Safety of calcium dobesilate in chronic venous disease, diabetic retinopathy and haemorrhoids. Drug Saf2004; 27: 649–660.