GOLD severity stratification and risk of hospitalisation for COPD exacerbations.

BACKGROUND AND AIM: The Italian Costs for Exacerbations in COPD ("ICE") study, following a pharmacoeconomic assessment of costs due to COPD exacerbations (primary endpoint), aimed also at evaluating (secondary endpoint) which clinical factors, among those considered for cost-analysis, may, at follow up, present a risk of new exacerbations and re-admission to hospital. MATERIALS AND METHODS: A prospective, multicentre study was carried out on COPD patients admitted to 25 Hospital Centres as a result of an exacerbation from October-December 2002. Following discharge, a 6-month follow-up was performed in each patient via three bi-monthly telephone interviews with a questionnaire administered by an investigator clinician. RESULTS: 570 patients were eligible for data processing, mean age 70.6 years (+/- 9.5 standard deviation, SD), males 69.2%. According to GOLD, severity stratification was as follows: moderate 36.4%; severe 31.3%; very severe 32.3%. 282 patients experienced at least one exacerbation at follow up, 42% of exacerbations requiring hospitalisation. No significant association was seen between exacerbations and GOLD stage or co-morbidities or treatments except LTOT. Conversely, COPD functional severity influenced hospitalisations very significantly, with relative risks 2.6 (95% Confidence Interval, CI 1.8-3.8) and 2.0 (CI 1.3-2.8) (GOLD very severe versus moderate and severe, respectively), and 1.3 (CI 0.85-2.1) (GOLD severe versus moderate). Hospitalisations were also significantly associated with treatments denoting more severe conditions (oral corticosteroids, oral theophylline, and LTOT). CONCLUSIONS: Severity stratification of COPD patients according to respiratory function classes as outlined in GOLD guidelines and need for LTOT are confirmed as important predictors of hospitalisation for an exacerbation.

Proton pump inhibitors in acute treatment of reflux oesophagitis : a cost-effectiveness analysis.

BACKGROUND AND AIM: Gastro-oesophageal reflux disease is a common medical problem that places a significant financial burden on outpatient pharmaceutical expenditure. A substantial proportion of this expenditure can be attributed to the use of proton pump inhibitors (PPIs). The aim of this analysis was to evaluate the cost-effectiveness of PPIs currently licensed in Italy in the acute treatment of reflux oesophagitis. METHODS: A decision analysis model that simulated the sequential management of reflux oesophagitis over the course of 8 weeks was constructed. Healing rates were derived from a published meta-analysis of PPIs for reflux oesophagitis. Costs of PPIs were based on retail prices in Italy, endoscopies and specialist (outpatient) visits were costed on the basis of public tariffs, and opportunity costs were calculated for general practitioner visits. The clinical effectiveness of a PPI was measured in terms of the proportion of patients healed at 8 weeks. An incremental cost-effectiveness analysis was performed, using omeprazole, the recognised 'gold standard' PPI in Italy, as the common comparator. The perspective of the analysis was the Italian National Health System (NHS). A sensitivity analysis was conducted in which the key parameters in the model were varied according to a Monte Carlo simulation of 1000 patients. RESULTS: Esomeprazole 40 mg/day was a dominant treatment option compared with omeprazole 20 mg/day (88.8% patients healed vs 82.2%, respectively; total treatment cost euro164.85 vs euro169.56, respectively (year of costing, 2002). Furthermore, on the basis of the 95% CIs generated by the Monte Carlo simulation, esomeprazole 40 mg/day appears to be more cost-effective than both lansoprazole 30 mg/day and pantoprazole 40 mg/day. CONCLUSIONS: Esomeprazole 40 mg/day can be considered a cost-effective treatment option for the acute treatment of reflux oesophagitis in Italy.

Utilisation Pattern of Nonspecific Nonsteroidal Anti-Inflammatory Drugs and COX-2 Inhibitors in a Local Health Service Unit in Northeast Italy.

BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed widely in Italy. They include nonspecific NSAIDs (NS-NSAIDs) and the newly marketed cyclo-oxygenase (COX)-2 specific inhibitors (COXIBs) celecoxib and rofecoxib. The objective of this study was to describe the prescribing patterns for NS-NSAIDs and COXIBs in a local Italian area, analysing an administrative database. PATIENTS AND METHODS: We extracted from the database information on subjects who had received at least one reimbursed prescription of an NSAID during the period between 1 January 2001 and 31 December 2001, including age, sex, patient identification code, Anatomical Therapeutic Chemical (ATC) classification system code, strength, formulation, number of packs prescribed, prescription date, and prescription of gastroprotective agents (GPAs) on the same day as the prescription of the NSAID. On the basis of the type of NSAID received, we divided the patients into five cohorts: oral NS-NSAIDs only during the observed year, injectable NS-NSAIDs only, celecoxib only, rofecoxib only, and a combination. For descriptive purposes, we defined three age groups: <40 years, 40-64 years, and >64 years. The duration of exposure to NSAID therapy was calculated using the most commonly prescribed dose for the different drugs. Subjects receiving >/=30 doses per year were defined as "regular users". Analyses included mean age, mean duration of exposure, percentage of regular users, and percentage of GPAs co-prescribed in the different cohorts. RESULTS: NSAIDs were prescribed to 62 059 subjects from a resident population of 365 321 inhabitants; 43.8% received oral NS-NSAIDs only, 22.6% injectable NS-NSAIDs only, 7.2% celecoxib only, 5.2% rofecoxib only, and 22% different regimens of different types of NSAIDs. The mean duration of treatment increased with age in all cohorts; the mean age was 56 years in the NS-NSAID cohort, 61 years in the celecoxib cohort, and 62 years in the rofecoxib cohort (p = 0.01, COXIBs vs NS-NSAIDs). The mean duration of therapy was 11.4 days/year for injectable NS-NSAIDs, 43.8 days/year for rofecoxib, 50.5 days/year for oral NS-NSAIDs, and 53.7 days/year for celecoxib. Fifty-four percent of subjects in the oral NS-NSAID cohort were regular users versus 64% in the rofecoxib and 70% in the celecoxib groups (p = 0.001, COXIBs vs NS-NSAIDs). Co-prescription with GPAs was 9.5% for NS-NSAIDs, 8.4% for rofecoxib, and 7.7% for celecoxib. CONCLUSIONS: Analysis of an administrative database in Italy showed a trend suggesting that COXIBs are prescribed to an older population and for a longer period of time than NS-NSAIDs, and that their use is less frequently associated with GPAs.

Epidemiology and cost analysis of varicella in Italy: results of a sentinel study in the pediatric practice. Italian Sentinel Group on Pediatric Infectious Diseases.

BACKGROUND: Describing the epidemiology of varicella is relevant to the development of specific prevention strategies and to building up of economic models evaluating the cost:efficiency ratios of these strategies. AIM: Our study was designed to describe the epidemiology of chickenpox among Italian children and to assess the resulting economic and health burden on the country. METHODS: Thirty-nine Italian pediatricians participated in a sentinel network on pediatric infectious diseases representing a total pediatric population of 30 168 children. Each case of varicella observed from January through December, 1997, was recorded. Economic analysis was conducted from the societal point of view. All costs were broken down into two groups: direct and indirect costs. RESULTS: A total of 1599 cases of varicella were reported among children 0 to 14 years old. There were 1266 primary cases (mean age, 4.5 +/- 2 years) and 333 secondary cases (mean age, 3.6 +/- 3.2 years). The global incidence of chickenpox was 51.01/1000/year. Complications were seen in 56 cases (3.5%). Drugs were prescribed in 672 cases. A group of adults (364 susceptible and 193 with uncertain status) were exposed to primary cases. Seventy (12.5%) were eventually infected among whom there were 4 pregnant women. For pediatric patients an average cost of $146.90 (250 400 lire) was estimated; this is largely accounted for by indirect costs. CONCLUSIONS: The epidemiology of varicella in Italy is consistent with that found in previous studies in industrialized countries. Severe complications did not occur in our population. We believe that the health arguments in favor of universal vaccination of children > 18 months of age do not differ in our own country from those of other industrialized nations. Our data could now be incorporated into pharmacoeconomic models to establish cost-efficient strategies for Italy.

Cost of an outbreak of hepatitis A in Puglia, Italy.

In total, 5889 cases of hepatitis A virus infection were reported during an outbreak in Puglia, a region of Southern Italy, in 1996. The primary cause of the outbreak was consumption of contaminated food (raw shellfish, vegetables, etc.), with a contributory risk factor of person-to-person transmission. A detailed questionnaire was completed by 250 randomly selected patients to obtain information sufficient to calculate the direct and indirect costs of the outbreak for the individual patient, the National Health Service (NHS) and society as a whole. A conversion rate of $US1 = 1530 Italian lire (L) has been used throughout the study since this was the average exchange rate in 1996. For the individual patient with hepatitis A virus infection, the mean cost was L1.013 million ($US662), which was equivalent to 6.6% of the mean annual income of the employed patients. The total cost of the outbreak to the NHS was L23.98 billion ($US15.67 million), which was equivalent to 0.4% of the total public health expenditure in the region in 1996. The total cost of the outbreak to society (individual patient, NHS and third parties combined) was L37.406 billion ($US24.45 million), corresponding to 0.04% of the gross domestic product of the entire region in 1996, with a mean cost per patient of L6.35 million ($US4150) from a societal perspective. The majority of patients (86.3%) were 11 to 30 years of age, reflecting the increasing susceptibility of younger patients to hepatitis A virus infection in recent decades. These economic and demographic data provide important information for the evaluation of preventive strategies including public education, sanitation and immunisation, so as to optimise the use of local health resources.