Search results for " SURVEILLANCE"
showing 10 items of 388 documents
How increased pertussis vaccination coverage is changing the epidemiology of pertussis in Italy.
2005
Abstract The epidemiology of pertussis in Italy is described by using data from the statutory notification system and from seroepidemiology studies. Starting from the 1990s, the incidence of pertussis in Italy has shown a sharp decline and is now at the lowest level ever reached. During this time period vaccination coverage has increased from 88% in 1998 to 95% in 2003. In 1996–97, the prevalence of subjects with levels of IgG antibodies against PT greater than 2 EU/ml was 77.6%. The increase in vaccination coverage will probably change the pattern of disease transmission and increase the number of susceptible adults, unless administration of booster doses to adolescents and adults is consi…
Three years of experience : the Italian registry and safety data update
2011
At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability…
The pharmacovigilance program on natalizumab in Italy: 2 years of experience.
2009
At the end of 2006 a country-based surveillance program on natalizumab therapy in multiple sclerosis was settled in Italy by a collaborative effort of the Italian Drug Agency (AIFA) and a group of experts and neurologists appointed by the National Society of Neurology (SIN). After 2 years, 1,818 patients are registered in the database. The majority of cases (88.6%) failed the therapy with beta interferon or glatiramer acetate and had relapses or accumulated disability during immunomodulating treatment, while 11.4% of patients enrolled in the surveillance study were not previously treated with immunomodulating therapies and had a rapidly evolving clinical course. Almost 10% of the patients t…
ADMA, subclinical changes and atrial fibrillation in the general population.
2015
Abstract Background Pathways of oxidative stress, nitric oxide bioavailability and l-arginine derivatives are hypothesized to be related to atrial fibrillation (AF). Circulating methylated l-arginine metabolites can be assessed in the general population and may show an association with AF. Methods We determined l-arginine and its metabolites asymmetric dimethylarginine (ADMA), l-N ω -monomethylarginine (NMMA) and symmetric dimethylarginine (SDMA) in the population-based Gutenberg Health Study (n=5000), mean age 55±11years, 51% men, in association with clinical variables of AF such as electrocardiographic and echocardiographic measures and manifest AF. Results Individuals with AF (N=161), 71…
The P300 event-related potential and smoking--a population-based case-control study.
2009
A better understanding of the factors underlying habitual tobacco smoking may further new strategies to go about this major health problem. The P300 event-related potential (ERP) has emerged as a valuable (endo)phenotype in neuropsychiatric research. Previous studies suggested the P300 ERP to be reduced in smokers. The main purpose of the present study was to provide an in-depth description of smoking-related behavioral, biological and electrophysiological phenotypes with an emphasis on the P300 ERP and its mutual relationship with other smoking-related parameters. In this case-control study N=1318 participants (smokers and never-smoking controls) were investigated at 6 German academic inst…
The KARTAN study: a postmarketing assessment of Irbesartan in patients with hypertension.
2004
An important purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in the clinical setting. Another goal is to confirm the effectiveness of these drugs in patients who are candidates for antihypertensive therapy and who may have been excluded from Phase III studies. Irbesartan is a long-acting angiotensin II-receptor blocker specific for the angiotensin 1-receptor subtype that, in clinical trials in patients with hypertension, reduces blood pressure.The KARTAN (this word was derived from the first and last syllables of Karvea [trademark of Bristol-Myers Squibb Group, Madrid, Spain] and irbesartan) study was designed to confirm and extend…
Subtype-specific incidence of testicular cancer in Germany: a pooled analysis of nine population-based cancer registries.
2009
Summary Comparisons of incidence estimates of testicular cancer subtypes beyond seminoma and non-seminoma are virtually missing in the epidemiologic literature. We analysed incidence data from population-based German cancer registries to provide subtype-specific incidences of testicular cancer. We pooled data from nine cancer registries from 1998 to 2003. We estimated incidence and mortality time trends of West and East Germany. Incidence and mortality were standardized by the European standard population. The annual percentage incidence change from 1961 through 1989 was 4.9% in East Germany and 3.0% from 1970 through 2004 in Saarland. Incidence increases were the most pronounced among adol…
Invasive fungal disease in patients undergoing umbilical cord blood transplantation after myeloablative conditioning regimen
2018
OBJECTIVE Characteristics and risk factors (RFs) of invasive fungal disease (IFD) have been little studied in the setting of umbilical cord blood transplantation (UCBT). METHOD We retrospectively included 205 single-unit myeloablative UCBT recipients with a median follow-up of 64 months. RESULTS Fifty-six episodes of IFD were observed in 48 patients (23%) at a median time of 123 days after stem cell infusion. Invasive mold disease (IMD) occurred in 42 cases, 38 of them (90%) caused by invasive aspergillosis whereas invasive yeast disease (IYD) occurred in 14 cases, most of them due to candidemia (n = 12, 86%). The 5-year cumulative incidence of IFD, IMDs, and IYDs was 24% 19%, and 7%, respe…
First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.
2019
ObjectivesBrivaracetam (BRV) is the latest approved antiepileptic drug and acts as a synaptic vesicle protein 2A ligand. The aim of the present study was to evaluate the efficacy and tolerability of BRV in the clinical setting.DesignRetrospective, observational multicentre study.SettingWe retrospectively collected clinical data of patients who received BRV in 10 epilepsy centres using a questionnaire that was answered by the reporting neurologist.ParticipantsData of 615 epilepsy patients treated with BRV were included in the study.Primary and secondary outcome measuresEfficacy regarding seizure frequency and tolerability of BRV were evaluated. Descriptive statistics complemented by X2 conti…
Defining a reference population to determine the 99th percentile of a contemporary sensitive cardiac troponin I assay
2013
Abstract Background Diagnosis of acute myocardial infarction (AMI) according to the universal definition is based on ischemic symptoms, imaging findings and elevated myocardial necrosis markers, preferably cardiac troponin I/T with diagnostic threshold representing the 99th percentile of a reference population. It is not clearly defined if this should be an unselected population-based or a healthy cohort with respect to cardiac diseases. Aim of the current study was to describe the distribution of troponin I using a sensitive assay and to evaluate the impact of cardiac diseases and cardiovascular risk factors in apparently healthy individuals. Methods Troponin I was determined using a conte…