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Showing record 1 from the 1 matches found.
Article Reference No 059766
Author
Sculpher M J, Lozano-Ortega G, Sambrook J, Palmer S,
Ormanidhi O, Bakhai A, Flather M, Steg G, Mehta S R,
Weintraub W.
Fondaparinux versus enoxaparin in non-ST-elevation acute coronary
Article Title
syndromes: short-term cost and long-term cost-effectiveness using
data from the Fifth Organization to Assess Strategies in Acute
Ischemic Syndromes Investigators (OASIS-5) trial
Americal Heart Journal
Journal Name
2009
Journal Date
157:845-852
Journal Reference
Published in a peer reviewed journal
Publication Status
Availability Details Correspondence to: Mark J. Sculpher, PhD, Centre for Health
Economics, University of York, Heslington, York, YO10 5DD,
United Kingdom. E-mail: [email protected].
2003
First Year Clinical
Data
2005
Last Year Clinical
Data
First Year Cost Data 2003
Last Year Cost Data 2005
2006
Cost Base Year
O
Source Of Article
UK, France, Canada, USA
Countries Of
Authors
Countries Applicable USA
Applied study
Type Of Article
Type Of Econ Eval Cost effectiveness analysis;Cost utility analysis
Technology Assessed Pharmaceutical
B01A
ATC Codes
411; 433; 434; 435; 436; 437; 438
ICD-9 Codes
FONDAPARINUX; ENOXAPARIN
Drug Names
Randomised clinical trial;Judgement;Modelling
Prob. of Main
Clinical Events
Randomised clinical trial;Modelling
Quantities of
Resources Used
'Ad Hoc' Estimation;Local Standard Prices
Prices or Costs of
Resources
Randomised clinical trial;Modelling
Outcomes
Values Of Outcomes Previously Published Values
Major bleeding rate, death, myocardial infarction, stroke, QualityOutcome Measure
Qual Of Life Index
Source Of Data
Costs Included
Costs Discounted
Benefits Discounted
Sensitivity Tested
Quantitatively
Reported
Study Question
Key Results
adjusted life years (QALY)
Generic;Utility assessment;EQ-5D
Incorporated from another study
Hospital costs;Direct provider/purchaser costs
3%
3%
Sensitivity tested
Quantitatively reported
Based on a randomized control trial (Fifth Organization to Assess
Strategies in Acute Ischemic Syndromes Investigators [OASIS-5]) the
aim of the study was to compare the short-term costs and long-term
cost-effectiveness of 2 antithrombotics, fondaparinux (2.5 mg daily)
and enoxaparin (1 mg per kg twice daily), for nonûST-elevation acute
coronary syndrome. Treatment was administered for a mean of 5
days. The rationale of the study was that in OASIS-5 trial,
fondaparinux patients were found to have about half the rate of major
bleeding 9 days after randomization and at least as good clinical
outcomes (death, myocardial infarction, major bleeding and stroke)
after 6 months of follow-up. To undertake the economic evaluation,
health care resource use and clinical efficacy data from the trial were
incorporated into a cost-effectiveness model as applied to both for the
time horizon of the trial (6 months) and over the longer term (life
time). A societal perspective was adopted and the setting of the study
was secondary care in the United States.
The effectiveness results showed that for each type of event over the
180-day follow-up period, fondaparinux is protective compared with
enoxaparin, although this is not significant with nonfatal MI. For
death, nonfatal MI and nonfatal stroke, increasing age, being male, a
history of heart failure, and diabetes increase the event risk. ST
depression and high creatinine at baseline increase mortality risk.
Increased serum creatinine was the only predictive covariate for
bleeds. The 180-day cost analysis indicated that fondaparinux would
generate a cost saving of US$547 per patient (95% CI US$207US$924). Sensitivity analysis suggested that savings could vary
between US$494 and US$733. As well as mean (expected) costeffectiveness, the probability of each therapy being the least costly
and the more cost-effective assuming a cost-effectiveness threshold
of US$50,000 per QALY gained was presented using probabilistic
sensitivity analysis. Fondaparinux was predicted to generate a $188
saving and 0.04 additional QALYs in the ôaverageö OASIS-5 patient.
However, when 180-day cost and clinical results were extrapolated to
long-term cost-effectiveness, fondaparinux was dominant (less costly
and more effective in terms of quality-adjusted life-years) under most
scenarios. The authors concluded that fondaparinux is a more costeffective antithrombotic agent than enoxaparin in nonûST-elevation
acute coronary syndrome. This is true across the range of event risks
seen in the OASIS-5 trial, which informed the present modelling
Patient Group
Sponsor
Keywords
study.
The patient group comprised of 20,078 male and female patients with
nonûST-elevation acute coronary syndrome. Patients participated in
the Fifth Organization to Assess Strategies in Acute Ischemic
Syndromes Investigators [OASIS-5] trial. The economic analysis was
based on a sub-sample of 759 trial patients.
Pharmaceutical industry
Coronary Heart Disease;Coronary - Artery Disease;Acute Care;Cost
Effectiveness;Cost Effectiveness Analysis (CEA);Cost Utility;Cost
Utility Analysis;QALYs;Quality Adjusted Life Years;Thrombolytic
Agents - Medications;Thrombosis