The economics of TRACE. A cost-effectiveness analysis of trandolapril in postinfarction patients with left ventricular dysfunction.

OBJECTIVE: The objective of the study was to compute a cost-effectiveness ratio relating the economic cost of trandolapril to the number of effectiveness units (i.e. life-years) gained. DESIGN AND SETTING: The trandolapril cardiac evaluation (TRACE) study was a prospective placebo-controlled clinical trial designed to determine the long term effect of the oral angiotensin-converting enzyme (ACE) inhibitor trandolapril in postinfarction patients with left ventricular dysfunction. We used the individual data of the TRACE trial to compute a cost-effectiveness ratio relating the economic cost of trandolapril to the number of life-years saved. The analysis was differential and was conducted from a payer perspective in a French setting. Costs were computed from individual data related to the use of resources during the TRACE trial. For drug treatments, we chose French public prices, and for hospitalisations, we used the mean cost as determined by the diagnosis related group (DRG) from the 1996 Programme de Médicalisation des Systémes d'Information (PMSI) database from the French Ministry of Health. Life expectancy was estimated through an accelerated failure-time model with an exponential distribution specification; we made the conservative hypothesis that the effect of trandolapril on mortality after the end of the trial was nil. We assessed the standard deviation and the 95% confidence interval (CI) of the ratio through its bootstrap distribution. RESULTS: The incremental cost-effectiveness ratio of treating patients with trandolapril rather than with placebo was estimated as 4910 French francs (FF) per life-year saved. Discounting both costs and health effects led to ratio of FF6950 per life-year saved. The bootstrap estimate of the ratio reached FF5950 and the 95% CI was FF5650 to FF6250 per life-year saved. CONCLUSIONS: These results could be considered as highly cost effective, even though our estimation was very close to the design and the conditions of the TRACE trial. Nevertheless, we showed that this trial constitutes a favourable case for economic evaluation.

Cost saving of 5-day therapy with cefpodoxime proxetil versus standard 10-day beta-lactam therapy for recurrent pharyngotonsillitis in adults. A prospective general practice study.

A prospective economic evaluation was undertaken as part of a randomised clinical trial conducted in French general practice. Its aim was to compare the costs and therapeutic outcomes of a 5-day course of cefpodoxime proxetil 100 mg twice daily with 10-day courses of phenoxymethylpenicillin (penicillin V) 1 MIU 3 times daily and amoxicillin-clavulanic acid 500/125 mg 3 times daily for the treatment of recurrent pharyngotonsillitis in 575 adults. Over the 6-month study period, the total cost to society per patient treated with cefpodoxime proxetil was 123 French francs (FF; 1993 values) lower than that for patients treated with phenoxymethylpenicillin and FF227 lower than that for patients treated with amoxicillin-clavulanic acid. This cost saving was primarily attributable to a lower initial drug acquisition cost, and a reduction in the cost associated with lost productivity and general practitioner consultations. Furthermore, as a consequence of a lower relapse rate, the cost-saving ratio for cefpodoxime proxetil, expressed as FF per month free of recurrence, was FF50 less than for phenoxymethylpenicillin and FF60 less than for amoxicillin-clavulanic acid. Thus, a 5-day course of cefpodoxime proxetil is likely to be less costly for treatment of pharyngotonsillitis in the general practice setting than standard 10-day courses of phenoxymethylpenicillin and amoxicillin-clavulanic acid.

An evaluation of tolerance of roxithromycin in adults.

This review deals with tolerance of a new macrolide, roxithromycin from data collected from a number of studies in adults. A total of 2917 adults, 2519 given roxithromycin 150 mg bid, were recruited into 17 multicentre comparative or non-comparative studies. Nine studies were double-blind, against doxycycline, erythromycin estolate (EES), lymecycline or cephradine. Overall the drug was well tolerated: side-effects possibly or probably related to roxithromycin were noted in only 4.1% (120/2917) of all patients, and in 3.1% (15/480) of elderly subjects. The gastrointestinal tolerance of roxithromycin was significantly better than that of doxycycline in four trials, and better than that of erythromycin ethylsuccinate in one study. The incidence of drug-related liver function test abnormalities following roxithromycin therapy was low and compared favourably with data published on erythromycin. Roxithromycin shows a satisfactory safety profile at the recommended daily dosage of 150 mg bid in adults.