Summary Background Syndrome of inappropriate antidiuresis (SIAD) is the main cause of hyponatremia in cancer patients. International guidelines indicate urea as an interesting option for chronic SIAD. Nevertheless, strong data to support its use are lacking, and its role in oncologic patients has not been described so far. Material and Methods We retrospectively analysed 36 cancer patients affected by moderate or profound SIAD‐induced chronic hyponatremia, who started oral urea (initial daily dose 15 g or 30 g) without fluid restriction between July 2013 and July 2018. We analysed mean serum sodium (sNa) increase after 24 hours and percentages of patients who reached eunatremia within 14, 30 and 60 days of treatment, stratifying according to the degree of hyponatremia at diagnosis. Clinical evaluation and biochemical assessment were periodically performed. Results Mean sNa was 123 [±4] mmol/L at baseline; after 24 hours of treatment, a mean increase of 5 [±3] mmol/L was observed. Eunatremia was reached by 55.6%, 86.1% and 91.7% patients within 14, 30 and 60 days of treatment, respectively. Trends in sNa normalization were similar in patients with moderate and profound hyponatremia at diagnosis. Rapid sNa overcorrection was avoided in all cases. Urea was interrupted within the first 2 months of treatment in 10 patients, in half cases for rapid neoplastic progression and in the remaining patients for the drug taste. Conclusions In our study, urea was effective in correcting chronic hyponatremia among cancer patients with SIAD. Almost all patients reached eunatremia within the first month of therapy, and urea was globally well tolerated.
BackgroundAdverse drug reactions (ADRs) are a major burden in healthcare. The scientific literature indicates that women tend to have a higher risk of ADRs than men due to differences in pharmacokinetics, pharmacodynamics and drug use.PurposeThe aim of this study was to investigate the gender related differences in ADRs between the sexes in an Italian populations during a 15 year period of observation.Material and methodsData were obtained from the Italian National Network of Pharmacovigilance and we focused our attention on ADRs in the period between 2001 and 2016. We identified the ATC (Anatomic, Therapeutic, Chemical Classification) most reported ADRs, seriousness of ADRs and sex.ResultsDuring the observation period, we collected 341 599 ADRs: woman had a higher risk of ADRs, especially after the first 2 years (55.4%). Severe ADRs were more frequent in women than in men (54% versus 46%). In contrast, the frequency of death was higher in men than in women (54% versus 46%). Major toxicity was reported for this ATC: H03AA, thyroid hormones, women 80%-men 20%; J01CA, broad-spectrum penicillins, women 57%-men 43%; J01CR associations of penicillins, including beta-lactamase inhibitors, women 57%-men 43%; J05AE, protease inhibitors, women 26%-men 74%; J05AF reverse transcriptase inhibitors nucleoside, women 33%-men 67%; J07BB, flu vaccines, women 59%-men 41%; M01AB anti-inflammatory and antirheumatic drugs acetic acid derivatives and related substances, women 61%-men 39%; M01AC anti-inflammatory and antirheumatic drugs oxicam derivatives, women 64%-men 36%; M01AE anti-inflammatory and antirheumatic drugs propionic acid derivatives, women 58%-men 42%; M01AH anti-inflammatory and antirheumatic drugs coxibs, women 72%-men 28%; N05BA anxiolytic benzodiazepine derivatives, women 61%-men 39%; N06AB antidepressants selective serotonin reuptake inhibitors, women 64%-men 36%; P01BA antimalarials aminochinolines, women 58%-men 42%.ConclusionPrevious data suggested that ADRs are more frequent and severe in women than in men but death mainly occurred in men. These data indicate the need to include women in clinical studies and the importance of monitoring ADRs to ensure safer drug therapy.References and/or acknowledgementsStefano Stabile, et al. Gender difference as risk factor for adverse drug reactions: data analysis in salvini hospital.pharmacologyonline.silae.it Ferioli B, et al. A gender pharmacovigilance study in Tuscany Region.No conflict of interest
The aims of this observational “proof-of-concept” study were to analyze the clinical/psychological characteristics and gut microbiota/mycobiota composition of individuals with suspected non-celiac gluten/wheat sensitivity (NCGS/WS) according to responses to the double-blind-placebo-controlled (DBPC) crossover gluten challenge test. Fifty individuals with suspected NCGS/WS were subjected to the DBPC challenge test; anthropometric measurements, psychometric questionnaires, and fecal samples were collected. Twenty-seven (54%) participants were gluten responsive (NCGS), and 23 were placebo responsive, with an order effect. NCGS individuals displayed a significantly lower risk of eating disorders and a higher mental health score when compared to placebo-responsive participants, confirmed by multiple logistic regression analyses (OR = 0.87; 95% CI 0.76–0.98, p = 0.021, and OR = 1.30; 95% CI 1.06–1.59, p = 0.009, respectively). Principal coordinate analyses based on microbiota composition showed a separation by the DBPC response (p = 0.039). For Bacteroides (p = 0.05) and Parabacteroides (p = 0.007), the frequency of amplicon sequence variants was lower, and that for Blautia (p = 0.009) and Streptococcus (p = 0.004) was higher in NCGS individuals at multiple regression analyses. No difference in the mycobiota composition was detected between the groups. In conclusion, almost half of the individuals with suspected gluten sensitivity reported symptoms with placebo; they showed lower mental health scores, increased risk for eating disorders, and a different gut microbiota composition.
BackgroundInvasive fungal infections (IFIs) constitute a frequent and important complication in modern medicine and represent a relevant problem in the matter of the management of hospitalised and immunocompromised patients. The most common fungal infections, candidiasis and aspergillosis, are an important cause of morbidity and mortality in critically ill and immunocompromised patients: therefore, in spite of pharmacological development, they are still difficult to treat and to eradicate.PurposeBecause the pharmacist, as a member of the multidisciplinary team, can contribute by checking the treatment prescribed, to reduce medication related problems, we conducted an observational study of IFIs in two hospitals, one in Italy (Turin) and the other in France (Paris), to give a picture of the differences in their distribution and therapeutic approach in two hospital realities.Material and methodsThe study was conducted using a clinical database of patients between 2012 and 2013; patients were stratified according to infection, sex, age, wards and therapy.ResultsCandida or aspergillus related IFIs were detected in 213 men and 107 women. Candidiasis was higher in the critical care unit (Turin 40% vs Paris 48%), prevalent in men Turin 78%; Paris 65%) and older patients (61–90 years old), with a prevalence of 67% in Turin and 49% in Paris. In France, aspergillosis was highly distributed in the critical care unit (42%) and in the haematology ward (38%), was prevalent in men (68%) and, unlike candidiasis, in younger patients (47%; 31–60 years old). A comparable study was not possible for Turin where only one systemic aspergillosis was diagnosed. The most widely used drug in both hospitals was caspofungin, followed by fluconazole in Turin and voriconazole in Paris.ConclusionA similar trend in candidiasis related IFIs, with no significant differences between the two hospitals, was detected. Conversely, there were differences in the use of drugs. To reduce the incidence and mortality rate of IFI, the therapeutic approach should take account of the epidemiological picture but the hospital pharmacist’s role is also important. In fact, the hospital pharmacist together with the hospital infections committee, can monitor and analyse consumption, perform epidemiological statistics and choose the best therapy for patients in terms of cost and efficacy.No conflict of interest.
BackgroundThe syndrome of inappropriate antidiuretic hormone secretion (SIADH) is a frequent cause of hyponatraemia consisting of a reduction in plasma sodium concentration values below 135 mEq/L. This condition, reducing the survival of the patient, extends the duration of the hospital stay and therefore increases the cost for a given patient.PurposeTo provide an alternative treatment to the use of tolvaptan, either to enable cost savings and to maintain a good quality of life for patients by raising plasma sodium values, and consequently lowering the cost of hospitalisation.Material and methods3 patients were perorally administered urea and sodium chloride (NaCl) capsules to treat SIADH. All were affected by small cell lung cancer and were receiving chemotherapy (carboplatin). We speculated that NaCl and urea should be as effective as tolvaptan.1 We evaluated the patient’s natraemia four times, and the cost of the pharmacist’s performances for the preparation of 30 g of urea and 2 g of NaCl capsules.ResultsThe natraemia was normalised after treatment administration, as shown in table 1. With NaCl and urea treatment, effectiveness was achieved, despite carboplatin therapy and the patient’s medical condition which are both well known causes of SIADH.Abstract CP-106 Table 1Patient No 1Patient No 2Patient No 3Baseline (mEq/L)131131122Control 1 (mEq/L)138142136Control 2 (mEq/L)145140136Control 3 (mEq/L)135135137Control 4 (mEq/L)139139136Treatment with tolvaptan 15 g or 30 g costs 70€ per day, compared with 6.6€ for NaCl 2 g with 30 g of Urea. The patients did not need hospitalisation due to hyponatraemia.ConclusionThese preliminary data may indicate that therapy based on oral administration of urea and NaCl is as effective as tolvaptan in the treatment of SIADH. This new treatment approach being less aggressive and cheaper, may be interesting for further investigations regarding this therapeutic alternative.References and/or AcknowledgementsSoupart A, Coffernils M, Couturier B, et al. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADHNo conflict of interest.
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