title: Clinical improvement in chronic venous insufficiency signs and symptoms with Venoruton® (HR): an 8-month, open-registry, cost-efficacy study.
abstract: OBJECTIVE
  This study evaluated the clinical efficacy of Venoruton (O-(beta-hydroxyethyl)-rutosides) (HR) (Novartis Consumer Healthcare) in subjects with severe chronic venous insufficiency (CVI).
  
  
  METHODS
  Patients were included in an average 8-month follow-up registry. At the end of the study 3 spontaneous groups emerged: a group treated with HR 2 g/day, a second group with HR 1 g/day and elastic stockings, and another group with stockings only. The age range was between 45 and 55. The 3 resulting groups were comparable clinically and for age/sex distribution. There were no differences in ambulatory venous pressure (AVP) at inclusion; microcirculatory and clinical evaluations were comparable.
  
  
  RESULTS
  At 8 months there was a decrease in skin resting flux in all groups. Better results (P<0.05) were obtained in the group using the higher dosage and the associated treatment. Stockings alone were less effective (P<0.05). There was significant decrease (P<0.05) in capillary filtration (RAS) in all groups with an advantage in the combination group (P<0.021). HR alone was more effective (P<0.05) than compression alone. There was an improvement in the symptomatic score in all groups with better results (P<0.5) in the combined group; HR alone was more effective (P<0.025) than compression alone. The clinical severity score was reduced (P<0.05) in all groups with better results in the combined group. HR alone was more effective (P<0.05) than compression alone. The venous disability score indicated that HR alone was more effective (P<0.025) than compression. No side effects or tolerability problems were observed with HR. Compliance of HR was also very good. A cost comparison was made considering a comparable control groups (cost of best standard management=100%). Cost in group A was 44% of standard costs; cost in group B (HR+stockings) was 48% of standard costs, and cost in group C (stockings only) was 67% (P<0.05).
  
  
  CONCLUSIONS
  The study confirms the long-term efficacy of HR in CVI patients. Controlling signs/symptoms and edema in CVI with HR also prevents the most severe complications of CVI.
authors.affiliation: Irvine3 Labs, Department of Biomedical Sciences, Chieti-Pescara Univeristy, Pescara, Italy.
authors.forename: M R
authors.initials: MR
authors.lastname: Cesarone
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: E
authors.initials: E
authors.lastname: Ippolito
authors.forename: L
authors.initials: L
authors.lastname: Pellegrini
authors.forename: A
authors.initials: A
authors.lastname: Ledda
authors.forename: R
authors.initials: R
authors.lastname: Luzzi
authors.forename: A
authors.initials: A
authors.lastname: Ricci
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: P
authors.initials: P
authors.lastname: Bavera
authors.forename: M
authors.initials: M
authors.lastname: Hosoi
authors.forename: S
authors.initials: S
authors.lastname: Stuard
authors.forename: M
authors.initials: M
authors.lastname: Corsi
mesh_terms: D000328:Adult; D000368:Aged; D018660:Blood Pressure Monitoring, Ambulatory; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D006896:Hydroxyethylrutoside / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D017078:Laser-Doppler Flowmetry; D008297:Male; D008833:Microcirculation; D008875:Middle Aged; D012042:Registries; D053828:Stockings, Compression / Q000191:economics; D014689:Venous Insufficiency / Q000188:drug therapy* / Q000628:therapy
chemical_list: D006896:Hydroxyethylrutoside; C005865:troxerutin