22 research outputs found

    Additional file 3: Figures S2. of Italian program for independent research on drugs: 10 year follow-up of funded studies in the area of rare diseases

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    Kaplan-Meier curve of cumulative probability of publication by time (months) since funding agreement by impact factor of the journal in the sub-group of published studies (p = 0.0849). (DOCX 35 kb

    Additional file 2: Figures S1. of Italian program for independent research on drugs: 10 year follow-up of funded studies in the area of rare diseases

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    Kaplan-Meier curve of cumulative probability of publication by time (months) since funding agreement by robustness of outcome in the sub-group of published studies (p = 0.5862). (DOCX 36 kb

    Data_Sheet_1_Dynamics of price competition in Italian pharmaceutical off-patent market.docx

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    IntroductionThe aim of the study was to evaluate, in a regulated generics market, the effect of the number of manufacturers of generic drugs on the amplitude of off-patent products price reduction and the price evolution of originators and generics after the patent expiry of pharmaceuticals dispensed by community pharmacies and reimbursed by the Italian National Health Service (INHS).MethodsThe AIFA “transparency list” was utilized to select unbranded and branded off-patent drug dispensed by community pharmacies and reimbursed by the Italian National Health Service between 2012 and 2018. The unbranded drug entry in the transparency list database was considered as a proxy of its patent expiry.ResultsA total of 42 different active ingredients were included in the analysis. The relative price per dose at time t of unbranded and branded drugs, considering as common denominator the price per dose a year before the patent expiry, (t-1) decreased with the increase of unbranded manufacturers. At the time of the patent expiry, the price of unbranded drugs was almost 50% less than that of branded drugs at t-1 and the price of branded drugs started to decrease before the first unbranded entry.ConclusionAn inverse relation between the number of generic drug entrants and the price of generics and originators was detected. The patent expiry determines a price decline, more concentrated in the first year of patent expiry.</p

    Cardiovascular safety of tiotropium Respimat vs HandiHaler in the routine clinical practice: A population-based cohort study

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    <div><p>The cardiovascular safety of tiotropium Respimat formulation in the routine clinical practice is still an open issue. Our aim was to compare the risk of acute myocardial infarction and heart rhythm disorders in incident users of either tiotropium Respimat or HandiHaler. The study population comprises patients aged ≥45 years, resident in two Italian regions with a first prescription of tiotropium (HandiHaler or Respimat) between 01/07/2011-30/11/2013. The cohort was identified through the database of prescriptions reimbursed by the Italian National Health Service. Comorbidities and clinical outcomes were obtained from hospital records. The primary outcome was the first hospitalization for acute myocardial infarction and/or for heart rhythm disorders during the exposure period. Hazard ratios were estimated in the propensity score-matched groups through Cox regression. After matching, 31,334 patients with incident prescription of tiotropium were included. The two groups were balanced with regard to baseline characteristics. Similar incidence rates of the primary outcome between Respimat and HandiHaler users were identified (adjusted hazard ratio 1.02, 95% CI 0.82–1.28). No risk difference between Respimat and HandiHaler emerged when considering clinical events separately. This large cohort study showed a comparable acute cardiovascular safety profile of the two tiotropium formulations.</p></div

    Rate ratio of sudden unexpected deaths in infants of age 31–729 days by risk period (following any vaccination) and dose, Italy 1999–2004.

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    <p>N: Number of deaths; RR adj: adjusted Rate Ratio; CI: Confidence Interval.</p>1<p>RRs are estimated according to the self controlled case-series method for censoring, perturbed or curtailed post-event exposures <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0016363#pone.0016363-Farrington3" target="_blank">[19]</a> and adjusted by age group (31–80; 81–100; 101–120; 121–180; 181–360; 361–729).</p

    Rate ratio of sudden unexpected deaths in infants of age 31–729 days by risk period and type of vaccine, Italy 1999–2004.

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    <p>N: Number of deaths; P-d: Person-days at risk; RR adj: adjusted Rate Ratio; CI: Confidence Interval.</p>1<p>RRs are estimated by the Poisson regression model and adjusted by age group (31–80; 81–100; 101–120; 121–180; 181–360; 361–729).</p>2<p>The information of the brand name of the hexavalent product was missing for 1 infant (the event occurred in the control period).</p
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