Corticosteroidi per via Intravitreale per il Trattamento Dell'edema Maculare: Revisione e Valutazione Della Qualità Dell'evidenza:

Intravitreal corticosteroids for the treatment of macular edema: review and assessment of quality of the evidenceIntroductionTreatment options for macular edema include intravitreal corticosteroids. Traditionally, an injectable suspension of triamcinolone acetonide (TA) had been employed off-label; in recent years, authorities have approved sustained-release drug delivery systems (DDSs) for corticosteroids. This review aims to compare the quality of the evidence on efficacy and safety of three different formulations of intravitreal corticosteroids: the dexamethasone (DEX) implant, the fluocinolone acetonide (FA) implant, and the preservative-free injectable suspensions of TA, in the management of two retinal pathologies: diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO).MethodsA search of clinical trials on MEDLINE from 01/01/2000 to 12/16/2015 was performed. Studies were included in the analysis if they met the following criteria: i) related to at least one of the preparations of interest in patients with DME or macular edema secondary to RVO; ii) included a control group treated with placebo, observation, sham procedures or conventional treatments; and iii) included visual acuity, retinal thickness and/or safety parameters as outcomes. Results were summarized in a narrative manner.ResultsTwenty-five publications from 19 RCTs were included. We observed increased attention of researchers towards TA compared to DEX and FA; however, studies for TA are less robust. Scientific publications related to DEX and FA implants are of higher quality, especially in terms of randomization and masking procedures.DiscussionAlthough trials on TA are numerous, evidence on DEX and FA implants is more robust. Since their introduction, these relatively new DDSs have been included in the main guidelines for the management of macular edema

[Organizational and financial aspects of the introduction of Botox® in the clinical diagnostic therapeutic process of chronic migraine at a Local Health Unit in Italy]

BACKGROUND: Existing literature shows that the use of Botox®/onabotulinumtoxinA (BT) in chronic migraine (CM) is promising from a cost-effectiveness standpoint and the use of a clinical diagnostic therapeutic process (CDTP) dedicated to CM allows a reduction of pathology costs. The inclusion of BT in chronic migraine therapy at a Roman ASL involves the need to investigate the real treatment costs of a CDTP and to measure how a targeted organizational CDTP strategy for CM allows insuring treatment accessibility, sustainability, and appropriateness.OBJECTIVE: To conduct a cost-effectiveness analysis of providing administration of BT in patients with CM using real world data from an ASL in Rome.METHODS: The real world cost data for approximately 215 anonymous patients were summarized. The cost data were extrapolated from the database of the ASL and they populated a Markov decision model developed by Allergan. The analysis is based on a decision model populated with real drug and service cost data, for the years 2010-2012. The financial assessment was conducted from the viewpoint of the Italian National Health Service.RESULTS: Over a 2 year temporal horizon, incremental BT costs, compared to a placebo, are equal to € 261 against an incremental gain of 0.0655 QALY in favor of BT. The ratio between costs and incremental QALY generates an ICER of 3,983 €/QALY, favorable and below the acceptability threshold used by many countries for reimbursement decisions (25,000-40,000 € per QALY gained).CONCLUSIONS: The inclusion of BT in the CDTP dedicated to CM of an Italian ASL improves both clinical outcomes of the patients and the allocation of the SSN available resources.[Article in Italian

Economic Evaluation of 5-Grass Pollen Tablets Versus Placebo in the Treatment of Allergic Rhinitis in Adults

Background Allergen immunotherapy (AIT) is aimed at modifying the immune response to a causative allergen, thereby reducing clinical symptoms and symptomatic medication intake and improving quality of life. Long-term AIT research has led to the development of 5-grass pollen tablets, currently indicated for the treatment of grass polleninduced allergic rhinitis (AR). Methods A post-hoc analysis was conducted using the Average Adjusted Symptom Score (AAdSS) to compare the effect of treatment of AR with 5-grass pollen tablets versus placebo treatment. Using the results of the VO34.04 and VO53.06 trials and economic data, cost-effectiveness analysis of 5-grass pollen tablet treatment was performed from the Italian third-party payer perspective with cost data derived from a study of 2008 updated to 2011. Also a societal perspective was considered by using the costs related to the losses of productivity by following the human capital approach. Using the results of the analysis, the estimated receiver-operating characteristic curve was plotted to evaluate medication effectiveness in terms of quality-adjusted life years (QALYs) and a decision tree constructed to model the possible outcomes and costs for adults and paediatric patients with a low, medium, and high AAdSS. Finally, probabilistic sensitivity analysis was conducted to test the robustness of the results as well as their consistency at an assumed cost-effectiveness threshold of € 30,000/QALY. Results The results indicate that compared to the placebo, the 5-grass pollen tablet treatment provides a benefit of 0.127 QALYs in medium AAdSS patients and of 0.143 QALYs in high AAdSS patients. The 5-grass pollen tablet treatment was found to cost € 1,024/QALY for patients with a medium AAdSS and € 1,035/QALY for patients with a high AAdSS. Of all the simulations performed in the probabilistic sensitivity analysis, 99 % indicated that the incremental cost-effectiveness ratio of the 5-grass pollen tablet treatment was below the threshold of € 30,000/ QALY in patients with medium and high AAdSS, whereas it was found to be dominated in 67 % of simulations related to patients with low AAdSS. Conclusion The 5-grass pollen tablet is a cost-effective treatment for adult AR patients with a medium or high AAdSS. This finding should be carefully considered when deciding the management strategy for these patients

Impact of drug policy on the use of parenteral cephalosporins in Italy

OBJECTIVE: To evaluate the effects of the 1998 revision of CUF Note 55 on doctors' prescribing behaviour and drug costs with regard to intramuscularly administered cephalosporins. METHOD: National data on drug use between January 1998 and June 2000 were provided by the Drug Utilisation Monitoring Centre of the Ministry of Health. The Anatomic Therapeutic Chemical classification and the Defined Daily Dose methodology, as well as population estimates obtained from the Italian National Statistics Institute were used to define consumption as the number of defined daily doses per 1000 inhabitants per day. The cost of these antibiotic medications was determined using the wholesale price reported in Informatore Farmaceutico. Italian inflation rates were used to annuitize the expenditure. "STATA 6.0" software was used for all statistical analyses. RESULTS: The use of cefonicid rose dramatically after the revision (+ 136.3%), whereas the utilisation of the other active ingredients decreased. A decrease of 5.6% in the expenditure for all parenteral cephalosporins was observed in this period while the same figure increased by 2.3% after one year. CONCLUSION: The exclusion of cefonicid from a restricted list appears to have significantly affected doctors' prescribing practices, while the effect on drug expenditure was contradictory

Cost effectiveness analysis of transnasal fentalyl citrate in the treatment of BTcP

HEALTH ECONOMIC EVALUATIO

Metabolic implications of coenzyme Q10 in red blood cells and plasma lipoproteins.

Plasma coenzyme Q10 (CoQ10) is currently assayed in our laboratory for its well-known diagnostic meaning; in fact plasma CoQ10 levels are inversely related to metabolic demand. Definite levels of CoQ10 are also found in white and red blood cell components, as well as in platelets. Plasma and erythrocyte CoQ10 has a well assessed antioxidant role, which was demonstrated through a series of experiments. Erythrocytes previously enriched with exogenous CoQ10 were found more resistant to a hemolysis induced by a free radical initiator. Several enzymatic activities of erythrocyte ghosts were also protected by different side chain CoQ homologues, both when reduced and, although at a lesser extent, in the oxidized state. CoQ was not effective in preventing metal-catalyzed oxidation of erythrocyte membrane enzymes, and this effect is likely to be due to lack of interaction of CoQ with the metal target. Moreover CoQ was able to protect isolated enzymes and erythrocyte membrane bound enzymes from the inactivating effect of free radicals generated by water sonolysis or radiolysis. As far as plasma lipoproteins are concerned it is well known that LDL isolated from healthy volunteers supplemented with CoQ10 are more resistant to peroxidation induced by an azoinitiator. We started to systematically investigate CoQ10 and vitamin E levels in isolated human LDL and HDL. Both CoQ10 and vitamin E concentrations, referred to protein, were found higher in LDL than in HDL. Susceptibility to exogenously applied peroxidation did not correlate with the endogeneous content of the two antioxidants, possibly on the basis of different lipid content of these lipoproteins