Sabrina Trippoli

Bleeding and pneumonia in intensive care patients given ranitidine and sucralfate for prevention of stress ulcer: meta-analysis of randomised controlled trials

Abstract Objectives: To determine the effectiveness of ranitidine and sucralfate in the prevention of stress ulcer in critical patients and to assess if these treatments affect the risk of nosocomial pneumonia. Design: Published studies retrieved through Medline and other databases. Five meta-analyses evaluated effectiveness in terms of bleeding rates (A: ranitidine v placebo; B: sucralfate v placebo) and infectious complications in terms of incidence of nosocomial pneumonia (C: ranitidine v placebo; D: sucralfate v placebo; E: ranitidine v sucralfate). Trial quality was determined with an empirical ad hoc procedure. Main outcome measures: Rates of clinically important gastrointestinal bleeding and nosocomial pneumonia (compared between the two study arms and expressed with odds ratios specific for individual studies and meta-analytic summary odds ratios). Results: Meta-analysis A (five studies) comprised 398 patients; meta-analysis C (three studies) comprised 311 patients; meta-analysis D (two studies) comprised 226 patients: and meta-analysis E (eight studies) comprised 1825 patients. Meta-analysis B was not carried out as the literature search selected only one clinical trial. In meta-analysis A ranitidine was found to have the same effectiveness as placebo (odds ratio of bleeding 0.72, 95% confidence interval 0.30 to 1.70, P=0.46). In placebo controlled studies (meta-analyses C and D) ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine significantly increased the incidence of nosocomial pneumonia (meta-analysis E: 1.35, 1.07 to 1.70, P=0.012). The mean quality score in the four analyses (on a 0 to 10 scale) ranged from 5.6 in meta-analysis E to 6.6 in meta-analysis A. Conclusions: Ranitidine is ineffective in the prevention of gastrointestinal bleeding in patients in intensive care and might increase the risk of pneumonia. Studies on sucralfate do not provide conclusive results. These findings are based on small numbers of patients, and firm conclusions cannot presently be proposed.

Quality of Life and Utility in Patients with Non-Small Cell Lung Cancer

AbstractBackground: Although several studies have determined quality of life in patients with lung cancer, there is still little information about the use of generic questionnaires [e.g. the 36-item Short Form health survey (SF-36)] and utility questionnaires [e.g. the EuroQOL instrument (EQ-5D)] in this disease. Objectives: To (i) measure quality of life and utility in patients with non-small cell lung cancer (NSCLC) using the SF-36 and the EuroQOL questionnaires; (ii) to evaluate the impact of some clinical variables on quality of life and utility; (iii) to assess the correlation between the measurements produced by the 2 questionnaires. Study design: Cross-sectional study. Participants: 95 patients from15 Italian hospitals with NSCLC (93% male, mean age 62 years) completed both questionnaires. Results: The mean scores for the 8 domains of the SF-36 ranged from 20.8 (physical role) to 63.0 (social functioning). The mean physical and mental summed scores of the SF-36 were 36.8 [standard deviation (SD) 9.8] and 43.0 (SD 11.5), respectively. The EuroQOL mean score was 0.58 (SD 0.32) in the self-classifier (SC) version and 0.58 (SD 0.20) in the visual analogue scale (VAS) version. Among the clinical variables that affected quality of life and utility, the presence of metastasis had the greatest impact: patients with metastasis had statistically significantly lower scores for 2 domains of the SF-36 (physical functioning, p = 0.009; bodily pain, p = 0.016), for the physical component summed score of the SF-36 (p = 0.015) and for both utility estimates (EuroQOL-SC, p = 0.027; EuroQOL-VAS, p = 0.038) than patients without metastasis. Both the SC and VAS EuroQOL scores showed a statistically significant correlation with each of the 8 domains of the SF-36. The scores for both the SF-36 and the EuroQOL in patients with NSCLC were considerably worse (relative differences ranging from −8 to −73%) than the corresponding values (normative data) previously reported for healthy individuals. Conclusions: Our study quantified the degree to which quality of life is impaired in patients with NSCLC, showed that the presence of metastasis had an important role, and indicated a strong correlation between the measurements produced by the 2 questionnaires. The EuroQOL measurements obtained from these patients will aid evaluation of the cost-utility ratio for NSCLC therapies.

Adjunctive lamotrigine therapy in patients with refractory seizures: a lifetime cost–utility analysis

AbstractObjective: Lamotrigine as add-on treatment (500 mg per day) is effective in patients with refractory epilepsy, but its high cost requires a pharmacoeconomic analysis. We conducted a retrospective lifetime cost–utility study in which clinical data were derived from a recent placebo-controlled clinical trial, cost-of-illness data were drawn from a previous ad-hoc study, and quality-of-life values were obtained by prospectively interviewing a separate group of 81 patients referred to our institution with epilepsy. Results: Our analysis showed that chronic lamotrigine treatment implies an incremental lifetime cost of about

Controvalore economico del farmaco e beneficio clinico: stato dell’arte della metodologia e applicazione di un algoritmo farmacoeconomico

1 600 000 for every 100 patients. Incremental lifetime utility was around 40 quality-adjusted life-years (QALYs) for every 100 patients. On the basis of these data, adjunctive lamotrigine was estimated to cost approximately

Cost-effectiveness of adjuvant chemotherapy with cyclophosphamide + methotrexate + fluorouracil in patients with node-positive breast cancer

41 000 per QALY gained. Sensitivity testing suggested a range of

Pharmacoeconomic profile of paclitaxel as a first-line treatment for patients with advanced ovarian carcinoma. A lifetime cost-effectiveness analysis.

25 000–

Results can be summarised in a simple figure

85 000 per QALY gained. Conclusion: Adjunctive lamotrigine (500 mg per day) in refractory epilepsy seems to have a worse pharmacoeconomic profile than many pharmacological treatments commonly used in areas other than epilepsy. Further data are needed to determine if lamotrigine can be equally effective at lower (and less costly) daily doses which could markedly improve its pharmacoeconomic characteristics.

Antithrombin III in patients admitted to intensive care units: a multicenter observational study

SummaryObjectiveThe aim of this article was to present an algorithm that, on the basis of parameters as objective as possible, converts the clinical benefit of an innovative drug into an economic figure that can be helpful in determining the price of the drug.MethodsOutcomes considered by the algorithm include prolongation in survival, avoidance of disease-related events, savings in the use of health-care resources; the algorithm is unable to handle quality of life expressed as utility. Each month of survival gained is valued from € 1000 to € 5000; cost-of-illness data are used to convert the avoidance of unfavourable disease-specific events into economic figures; when present, documented savings in direct costs are in part incorporated in the drug price.SettingThe algorithm is designed to be used by national regulatory agencies and, in some cases, by hospital pharmacies that produce orphan drugs.ResultsThree examples of application of the algorithm are presented, concerning drotrecogin, fondaparinux, and oral fludarabine, respectively. A fourth example refers to an orphan drug (copper hystidinate) manufactured by a hospital pharmacy.ConclusionsBeing aware of the strengths and weaknesses of the method, as discussed in the article, our conclusion is that our algorithm can prove a useful starting point in determining the price of drugs. Moreover, it can be modified in the future, introducing the evaluation of further parameters in order to reflect the complexity of clinical practice, “real” patients management and possible outcomes. Quality of life is one of such parameters (endpoint), becoming increasingly important.

Cost Effectiveness of Riluzole in Amyotrophic Lateral Sclerosis

Background: The analysis of published survival curves can be used as the basis for incremental cost-effectiveness analyses in which two treatments are compared with each other in terms of cost per life year saved. In patients with node-positive breast cancer adjuvant chemotherapy with cyclophosphamide + methotrexate + fluorouracil has been reported to improve survival in comparison with patients who are not given this treatment. Methods:To assess the pharmacoeconomic profile of this adjuvant chemotherapeutic regimen in terms of cost per life-year gained, we conducted an incremental cost-effectiveness analysis in which the Gompertz model was used to calculate the lifetime estimate of the patient-years gained by treated subjects compared to controls.Results:Using data from a published, controlled long-term trial involving 207 patients treated with cyclophosphamide + methotrexate + fluorouracil and 179 controls, we estimated that this adjuvant chemotherapy improved life expectancy by 357 patient-years per 100 subjects. Direct costs, which were almost exclusively related to the administration of chemotherapy, were estimated to be US

Survival in patients with metastatic breast cancer: analysis of randomized studies comparing oral aromatase inhibitors versus megestrol.

159,516 per 100 patients. On the basis of these data, adjuvant chemotherapy was found to imply an incremental cost of US