Document Detail


Impact of a 4-week treatment with prostaglandin E1 on health-related quality of life of patients with intermittent claudication.
MedLine Citation:
PMID:  10870853     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Intermittent claudication impairs functional status and quality of life in many patients by limiting walking capacity. The aim of this study was to evaluate the effects of a 4-week treatment with prostaglandin E1 (PGE1), a drug inducing vasodilation and inhibiting platelet aggregation, on improving functional status and health-related quality of life in patients with disabling intermittent claudication. Forty-two untrained outpatients (37 men and five women, mean age 64 +/- 8 years) with intermittent claudication,and maximum walking distance (MWD) of at least 50 and no more than 200 m on treadmill test (5% slope, 3 km/hr) were randomized to 4 weeks of double-blind treatment either with 60 mcg PGE1 daily given IV in 250 mL saline over a period of 2 hours (21 patients) or placebo (250 mL saline, 21 patients). Treatment-free follow-up was completed 8 weeks after the final infusion. Pain free walking distance (PFWD), MWD, and questionnaire evaluation were determined at baseline, after the 4-week treatment period, and at the end of the 8 weeks of the treatment-free follow-up period. After 4 weeks of treatment with PGE1 PFWD and MWD increased from 72 +/- 16 m to 135 +/- 33 m (+87%, p<0.001)and from 140 +/- 30 m to 266 +/- 62 m (+90%, p<0.001), respectively. Analysis of the Walking Impairment Questionnaire responses in the PGE1 group at 4 weeks demonstrated significant improvements in the walking impairment score (+19 percentage points, p<0.001), in the distance score (+25 percentage points, p<0.001), in the speed score (+24 percentage points, p<0.001), in the stair climbing score (+20 percentage points, p<0.001). The RAND survey responses showed improvements in physical function and bodily pain scores (+14 percentage points, p<0.001, and +15 percentage points, p<0.01, respectively). After the treatment-free follow-up period of 8 weeks, increases in PFWD and MWD were maintained (113 +/- 26 m, +57%, p<0.001, and 229 +/- 55 m, +63%, p<0.001, respectively). Similarly, at the end of the treatment-free follow-up, the walking impairment score (+16 percentage points, p<0.001), the distance score (+23 percentage points, p<0.001), the speed score (+22 percentage points, p<0.001), the stair climbing score (+18 percentage points, p<0.001) as well as the RAND physical function and bodily pain scores (+10 percentage points, p<0.001, and +13 percentage points, p<0.01, respectively) were still increased compared with baseline. No change from baseline was found in all the target parameters in the placebo group after 4 weeks of treatment and at the end of the treatment-free follow-up period. These data show that a 4-week treatment with PGE1 improves functional status and quality of life as well as treadmill performance in patients with disabling intermittent claudication as compared with placebo-treated patients. The improvements are also maintained for a period of 8 weeks beyond the end of the treatment. Additional studies are needed to determine the duration of functional benefits after the end of treatment.
Authors:
R A Mangiafico; R Messina; T Attinà; S Dell'Arte; L Giuliano; L S Malatino
Related Documents :
23556123 - New treatments in hemophilia: insights for the clinician.
11956273 - Association of depressive syndrome and early deaths among patients after stem-cell tran...
23556123 - New treatments in hemophilia: insights for the clinician.
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Angiology     Volume:  51     ISSN:  0003-3197     ISO Abbreviation:  Angiology     Publication Date:  2000 Jun 
Date Detail:
Created Date:  2000-07-13     Completed Date:  2000-07-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0203706     Medline TA:  Angiology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  441-9     Citation Subset:  IM    
Affiliation:
Institute of Internal Medicine L. Condorelli, University of Catania, Italy.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Aged
Alprostadil / administration & dosage*
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Health Status
Humans
Intermittent Claudication / drug therapy*
Male
Middle Aged
Pilot Projects
Platelet Aggregation Inhibitors / administration & dosage*
Quality of Life*
Time Factors
Vasodilator Agents / administration & dosage*
Chemical
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 0/Vasodilator Agents; 745-65-3/Alprostadil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Fructose-1,6-diphosphatase deficiency and glyceroluria: one possible etiology for GIS.
Next Document:  Isolated nonfilling of contrast in deep leg vein segments seen on phlebography, and a comparison wit...