- A case of figurate urticaria by etanercept. [Journal Article]
- J Pharmacol Pharmacother 2016 Apr-Jun; 7(2):106-8.
Etanercept is a competitive inhibitor of tumor necrosis factor-alpha (TNF-α) a polypeptide hormone, involved in the development of the immune system, in host defense and immune surveillance. Even if the etanercept mechanism of action is not completely understood, it is supposed that it negatively modulates biological responses mediated by molecules (cytokines, adhesion molecules, or proteinases) induced or regulated by TNF. For this reason, it is widely used in the treatment of immunologicals diseases, such as rheumatoid and psoriatic arthritis, polyarticular juvenile idiopathic active, ankylosing spondylitis, and plaque psoriasis. Etanercept has a good tolerability profile. Adverse events related to skin are rare, arising usually in about 5% of patients treated with anti-TNF α. In this scenario, we describe a case of figurate urticaria arose after the re-administration of etanercept in a patient affected by psoriasis and hepatitis B. A 65-year-old man, affected by psoriasis, was hospitalized in September 2014 to the Regional Center for the treatment of psoriasis and Biological Drugs of Second University of Naples for progressive extension of psoriatic skin lesions. The laboratory analysis detected positivity for hepatitis B virus (HBV) antigens. For this reason, it was administered to him lamivudine 100 mg/die about 30 days before to start etanercept treatment. The etanercept therapy has resulted in a progressive improving of skin manifestations, and the patient decided individually to stop the therapy. Afterwards, for worsening of the psoriatic lesions, he was again hospitalized and treated with the same therapeutic schedule (lamivudine followed by etanercept). Ten days after the start of therapy, the patient showed the onset of urticarial rash. Due to this, the treatment with lamivudine and etanercept was suspended and the patient's clinical conditions improved. It is probably that immunological disorders due to etanercept therapy and HBV infection could explain the onset of figurate urticaria in our patient. In this contest, the post-marketing surveillance confirms its important role in the monitoring of drugs tolerability and effectiveness.
- Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial. [JOURNAL ARTICLE]
- Qual Life Res 2016 Jul 20.
Cardiac cell therapy is a promising treatment for acute myocardial infarction (AMI), leading to cardiac function improvement. However, whether it translates into quality of life (QoL) improvement is unclear. We hypothesized that administration of bone marrow cells (BMC) to patients with AMI improves QoL.In the multicenter BONAMI trial (NCT00200707), patients with reperfused AMI and decreased myocardial viability were randomized to intracoronary autologous BMC infusion (n = 52) or state-of-the-art therapy (n = 49). QoL data, derived from the Minnesota Living with Heart Failure questionnaire (MLHFQ), were obtained 1, 3, and 12 months after AMI and analyzed using a Rasch-family model.Using this model, QoL improved over time in the BMC group (p = 0.025) but not in the control group. Furthermore, the BMC-group patients displayed a better QoL than the control-group patients at 3 and 12 months post-AMI (p = 0.034 and p = 0.003, respectively). These findings were not detected when analyzing MLHFQ data using a standard method. Cardiac function, myocardial viability, mortality, and number of major adverse cardiac events did not differ between treatment groups.Our results suggest that BMC therapy can improve QoL, stressing the need for confirmation trials and for systematic QoL assessment in cardiac cell therapy trials .
- Geographic Clusters of Basal Cell Carcinoma in a Northern California Health Plan Population. [JOURNAL ARTICLE]
- JAMA Dermatol 2016 Jul 20.
Rates of skin cancer, including basal cell carcinoma (BCC), the most common cancer, have been increasing over the past 3 decades. A better understanding of geographic clustering of BCCs can help target screening and prevention efforts.Present a methodology to identify spatial clusters of BCC and identify such clusters in a northern California population.This retrospective study used a BCC registry to determine rates of BCC by census block group, and used spatial scan statistics to identify statistically significant geographic clusters of BCCs, adjusting for age, sex, and socioeconomic status. The study population consisted of white, non-Hispanic members of Kaiser Permanente Northern California during years 2011 and 2012.Statistically significant geographic clusters of BCC as determined by spatial scan statistics.Spatial analysis of 28 408 individuals who received a diagnosis of at least 1 BCC in 2011 or 2012 revealed distinct geographic areas with elevated BCC rates. Among the 14 counties studied, BCC incidence ranged from 661 to 1598 per 100 000 person-years. After adjustment for age, sex, and neighborhood socioeconomic status, a pattern of 5 discrete geographic clusters emerged, with a relative risk ranging from 1.12 (95% CI, 1.03-1.21; P = .006) for a cluster in eastern Sonoma and northern Napa Counties to 1.40 (95% CI, 1.15-1.71; P < .001) for a cluster in east Contra Costa and west San Joaquin Counties, compared with persons residing outside that cluster.In this study of a northern California population, we identified several geographic clusters with modestly elevated incidence of BCC. Knowledge of geographic clusters can help inform future research on the underlying etiology of the clustering including factors related to the environment, health care access, or other characteristics of the resident population, and can help target screening efforts to areas of highest yield.
- Psychotropic drug initiation during the first diagnosis and the active treatment phase of B cell non-Hodgkin's lymphoma: a cohort study of the French national health insurance database. [JOURNAL ARTICLE]
- Support Care Cancer 2016 Jul 19.
Patients with B cell non-Hodgkin's lymphomas (B-NHLs) are known to be at risk of developing psychological disorders. The aims of this study were to measure the incidence of psychotropic drug use during the diagnosis and the active treatment phase in comparison with controls from the general population, and to identify factors associated with this use.B-NHL patients were selected through the French national health insurance database in the Midi-Pyrénées region (southwestern France) from January 1, 2011, to April 31, 2013. Patients with a previous history of B-NHL and/or psychotropic drug treatment were excluded.Among 745 newly diagnosed B-NHL patients, psychotropic treatment was initiated in 31.5 % (95 % CI [28.1-34.9]), compared to 7.6 % (95 % CI [7.57-7.64]) in the general population during the same period. This incidence was comparable in colorectal cancer patients (33.5 %) but higher than that in patients with myocardial infarction (23.5 %) or with a first knee replacement surgery (22.4 %). Anxiolytics and hypnotics were the most frequently used drugs. Median duration of treatment was 37 days for anxiolytics and 58 days for hypnotics, with 20.8 % of patients remaining under treatment at 8 months. Factors associated with psychotropic drug initiation were young age, health care consumption in the year before diagnosis, and initial care at a university hospital.The high rate of psychotropic drug initiation reflects a high level of anxiety at the initial phase of B-NHL patients' trajectory. This pharmacoepidemiological study reveals inappropriate use in some patients, which should now be investigated in lymphoma survivorship.
- Top-down, Bottom-up and Middle-out Strategies for Drug Cardiac Safety Assessment via Modeling and Simulations. [REVIEW, JOURNAL ARTICLE]
- Curr Pharmacol Rep 2016.:171-177.
Cardiac safety is an issue causing early terminations at various stages of drug development. Efforts are put into the elimination of false negatives as well as false positives resulting from the current testing paradigm. In silico approaches offer mathematical system and data description from the ion current, through cardiomyocytes level, up to incorporation of inter-individual variability at the population level. The article aims to review three main modelling and simulation approaches, i.e. "top-down" which refers to models built on the observed data, "bottom-up", which stands for a mechanistic description of human physiology, and "middle-out" which combines both strategies. Modelling and simulation is a well-established tool in the assessment of drug proarrhythmic potency with an impact on research and development as well as on regulatory decisions, and it is certainly here to stay. What is more, the shift to systems biology and physiology-based models makes the cardiac effect more predictable.
- Pharmacists counselling of pregnant women: Web-based, comparative study between Serbia and Norway. [JOURNAL ARTICLE]
- Midwifery 2016 Jun 10.:79-86.
To describe, compare and evaluate whether pharmacists in two European countries, Serbia and Norway, give appropriate counselling for common ailments in pregnancy.A cross sectional, web-based study.A study was conducted among Serbian and Norwegian pharmacists during two four-month study periods in 2012 respectively 2014. Participants were recruited through postal and electronic invitation facilitated by several pharmacy chains. Participation in the study was anonymous and voluntary.Pharmacists were presented with the questionnaire that included five scenarios (back pain, heavy legs, nausea, cold and constipation in pregnancy) and were asked to give their advice about use of medicines, supplements (e.g. herbal products, vitamins, minerals), non-pharmacological treatment and referral to physician in each condition.In total, 276 pharmacists, 119 in Serbia and 157 in Norway, accepted to participate in the study. Recommendation about medicines use ranged from 32% (heavy legs) to 71% (back pain) in Serbia and from 3% (heavy legs) to 92% (constipation) in Norway. Several pharmacists' recommendations on medicines and supplements use were inappropriate. Recommendation about non-pharmacological treatments ranged from 11% (nausea) to 50% (heavy legs) in Serbia and from 12% (constipation) to 63% (cold) in Norway. Approximately 12% of the Norwegian and Serbian pharmacists offered referral to a physician as only advice for nausea in pregnancy, indicating a lack of confidence in or knowledge about this common ailment in pregnancy.Large differences in counselling of pregnant women by pharmacists in Serbia and Norway were observed. Enhancement of pharmacists' knowledge about treatment of common ailments in pregnancy is needed and will enhance pharmacists' role in improving maternal health.
- Generic Drug Approvals Since the 1984 Hatch-Waxman Act. [JOURNAL ARTICLE]
- JAMA Intern Med 2016 Jul 18.