Francesco Bamfi

Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age.

A combined DTPa-HBV-IPV/Hib vaccine containing diphtheria (D), tetanus (T), acellular pertussis (Pa), hepatitis B (HBV) and types 1, 2 and 3 inactivated polioviruses (IPV) extemporaneously mixed with a conjugated Haemophilus influenzae type b (Hib) vaccine (Group 1) was compared to the DTPa-HBV-IPV and Hib vaccines (Group 2) administered separately at 3, 5 and 11 months of age (n=440). A microneutralization assay was used to detect antibodies against the 3 polio virus types (cut-off 1:8 dil), RIA for anti-HBs antibodies (cut-off 10 mIU/ml) and ELISA for antibodies against all other vaccine antigens (cut-off: 0.1 IU/ml for anti-tetanus and anti-diphtheria antibodies; 5 El.U/ml for antibodies against each of the 3 acellular pertussis antigens and 0.15 μg/ml for anti-PRP antibodies). Similar immune responses were observed in both groups 1 month after dose 2 as well as after dose 3. Six months after dose 2 however, the proportion of subjects maintaining an anti-tetanus antibody concentration ≥0.1 IU/ml was lower in Group 2 and a slight group difference in favour of Group 1 was also observed for anti-PRP, anti-diphtheria and anti-polio type 1 antibody persistence prior to the third dose. The overall incidence of local and general solicited symptoms was similar in both groups. One subject discontinued study vaccination following an SAE considered to be related to vaccination. The DTPa-HBV-IPV/Hib combined vaccine is immunogenic and well tolerated when administered according to a 3, 5 and 11 month vaccination schedule and can therefore be considered as a feasible alternative to the separate administration of the pentavalent DTPa-HBV-IPV and the monovalent Hib vaccines.

Asthma mortality and long-acting beta2-agonists in five major European countries, 1994-2004

Objectives. Over the last few decades, important changes occurred in the pharmacological approach to asthma control. However, the possible link between pharmacologic treatment and asthma death remains controversial. Study Design and Setting. Age-standardized asthma mortality rates were computed over the 1994–2004 period for France, Germany, Spain, the UK, and Italy. Rates for children and young adults 5 to 34 years of age, middle age adults 35 to 64 years of age, and elderly adults ≥ 65 years. Joinpoint regression was performed to identify years where significant changes in mortality trends occurred. Consumption of inhaled long-acting beta-2-agonists (LABA), including inhaled corticosteroids (ICS) when combined with LABAs in a single inhaler, derived from sales estimates. Results. In 1994, the highest asthma mortality rates were in Germany (4.7/100,000), and the lowest ones were in Italy and Spain (0.5/100,000). Steady downward trends were observed in all the countries considered. The largest decline was registered in Germany and the smallest one was in the UK. LABA sales increased steadily since 1994, particularly in France, Spain, and the UK, reaching values around 14 Defined Daily Doses (DDD)/1,000 inhabitants in 2004. Conclusion. While the use of LABAs (with or without ICS) increased over the last decade, asthma mortality declined in major western European countries.

Knowledge and opinion on prostate and prevalence of self-reported BPH and prostate-related events. A cross-sectional survey in Italy.

Benign prostatic hyperplasia (BPH) is a very common condition in ageing men and causes considerable morbidity. Although great strides have been made recently, important issues remain under-researched and poorly understood. We have conducted a survey on a representative sample of Italian males to investigate the knowledge and opinion on prostate, to estimate the self-reported prevalence and intensity of BPH and LUTS (low urinary tract symptoms) and to evaluate the performance of the International Prostate Symptom Score (I-PSS) in a population-based sample. Trained interviewers administered a standardized questionnaire to a representative random sample of 671 Italian men aged 50 years and over, between May and June 2000. Univariate and multivariate statistical techniques were used to estimate the prevalence of relevant events, and the associations with selected variables. Only half of responders were able to identify the reason for prostate enlargement, less than one-third recently had spoken with a doctor, and only 8.6% had had a rectal examination. Further, 13.7% (95% confidence interval (CI) 11.1–16.3%) had ever been told they had BPH, with less than half of them receiving surgery for BPH. About 19% reported moderate-severe I-PSS. Both self-reported BPH and severe–moderate LUTS increased significantly with age (P-value <0.01). As to the I-PSS performance, we documented in a community-based sample that it is reliable and valid. Results of the multivariate analysis suggest that, in addition to age, a persons knowledge that they have BPH and a poor perception of health status are the main variables associated with the probability of moderate–severe LUTS. In conclusion, this community-based survey documents that Italian males have a poor knowledge and perception of prostate-related conditions and do not adequately care about them and, thus, do not seek medical attention. These facts notwithstanding, urological conditions such as BPH are common and may largely affect an individuals life. Our findings might help in the design and implementation of effective interventions to improve peoples knowledge and understanding of prostate and change their attitudes towards medical care.

Immunogenicity and Reactogenicity following Primary Immunisation with a Combined DTaP-HBV Vaccine and a Haemophilus influenzae Type B Vaccine Administered by Separate or Mixed Injection.

AbstractObjectives: The aim of this open, randomised, multicentre trial was to evaluate the immunogenicity and reactogenicity of the tetravalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTaP-HBV) vaccine when given either as a mixed or as a separate concomitant injection with the Haemophilus influenzae type b (Hib) vaccine at 3, 5 and 11 months of age. Methods: Antibody against diphtheria, tetanus, pertussis (ELISA), hepatitis B (radioimmunoassay) and Hib polyribosylribitol phosphate (PRP) [radiolabeled antigen binding assay] was determined. Solicited local and systemic adverse events were evaluated on the day of each vaccination and for three subsequent days. Follow-up of unsolicited and serious adverse events was conducted for 30 days following each vaccination. Results: A total of 360 subjects were enrolled in the study. After completion of the three-dose vaccination course, seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, together with a pertussis vaccine response, were seen in almost all subjects with immunogenicity results (n = 336). All subjects had post-vaccination Hib anti-PRP antibody concentrations of at least 0.15 μg/mL, and 97.0% and 99.4%, respectively, of the subjects receiving a single or separate injections had Hib anti-PRP antibody concentrations ≥1.0 μg/mL. Addition of the Hib vaccine to the tetravalent DTaP-HBV vaccine did not increase the incidence of local or systemic reactions. Conclusions: Combination of DTaP-HBV and Hib vaccines in a single injection is safe, immunogenic and well tolerated, and thus has the potential to simplify the childhood immunisation schedule in Italy.

Estimation of economic consequences of GOLD guidelines adoption in the Italian clinical practice

Background: Chronic Obstructive Pulmonary Disease (COPD) affects about 4.5% of the Italian population, representing one of most burdensome public health problems. Literature data report an annual health care expenditure ranging between € 1,300 and € 4,500 per patient, of which drug costs are a limited share. In 1998 the WHO started GOLD program in order to ameliorate COPD patient management. As a part of his program, periodically updated guidelines are produced with the aim of defining an efficient diagnostic-therapeutic pathway managed by a multidisciplinary team and based on the optimization of the use of drugs and diagnostic tests and the reduction of exposure to risk factors. Objective: to estimate the economic consequences of GOLD guidelines adoption in the Italian clinical practice. Methods: a decision analytic model capable of calculating the impact on the National Health Service budget of an ameliorated adherence to GOLD guidelines (GOLD GL strategy), basing on the needed variations in health care strategies on a defined patient cohort treated with the current approach (CURRENT strategy). The simulation runs on a cohort representing Italian COPD patients over 45 years who transit through 5 Markov health states (4 GOLD stages and death), according to patient characteristics (age, gender, FEV1), with a time horizon of 3 years. Stage-specific drug consumption of the CURRENT strategy is based on data of 3,113 patients collected by three Health Local Units involved in a larger clinical audit project. The consumption of other health resources, i.e. medical visits and inpatient care, is estimated based on a multicentre observational Italian study. The GOLD GL strategy includes spirometry-based staging on the totality of the simulated patients, the development of a therapeutic strategy including the redefinition of pharmacological therapy based on guideline recommendations and experts opinion, and variation of other health resources consumption based on observational data. Costs of health care resources are calculated based on published micro-costing analysis and current prices and tariffs. Results: the model estimates an adjunctive cost of about 19 million of Euros with the GOLD GL strategy, just for the the spirometry-based restaging of about 40% of the over 1 million and 250 thousand prevalent Italian COPD patients. Furthermore, in the first year of the analysis, the redefinition of the best clinical management strategy for all patients would cost about 100 million Euros, which are to be added to the more than 320 million Euros associated with adaptation of the GOLD stage specific pharmacological therapy, consisting mainly in a higher usage of long-acting beta agonist/corticosteroid combinations, only partially offset by the lower prescription of corticosteroid alone. Based on Italian observational data, the consumption of other health care resources with the GOLD GL strategy is reduced by about 44%, reflected in an estimated cost saving of more than 850 millions of Euros. For the first analysis year, the net cost saving associated with full GOLD guideline adoption is estimated equal to 410 millions of Euros; this value decreases by 11% and 21% respectively in the second and third years. Conclusion: our model estimates that the adoption of GOLD guidelines in the Italian clinical practice is associated to an average cost saving of about 300 Euros per patient/year.

EE7 ECONOMIC ANALYSIS OF PROPHYLACTIC CERVICAL CANCERVACCINATION IN ITALY: THE NATIONAL AND REGIONAL LEVEL

over 5 years. The use of ivabradine also leads to a higher effectiveness, as it reduces the average number of revascularisation procedures from 1.100 to 0.143, including the initial revascularisation procedures for the standard care arm of the model. The number of revascularisations during the 5-year period is about similar, when excluding the initial revascularisation procedure (0.100 to 0.143). Sensitivity analyses show that ivabradine remains cost saving over the complete range of the input variables. CONCLUSIONS: Ivabradine is a cost-effective treatment and, in fact, a dominant treatment: Ivabradine yields to a higher effectiveness as standard treatment with respect to number of revascularisations, but leads to substantial overall cost savings.