Introduction:Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems.Materials and Methods:We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions.Results:First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution.Discussion and Conclusion:Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.
Background Most studies focused on the benefits of lycopene on serum lipids but no studies have been specifically designed to assess the role of a tomato sauce from vine-ripened tomatoes on patients affected by polygenic hypercholesterolemia. The aim of this study was to compare the lipid-lowering effect of a novel functional tomato sauce with a well-known functional food with a lipid-lowering effect, i.e. a sterol-enriched yogurt. Methods In this cross-over study, we evaluated a population of 108 ambulatory patients affected by polygenic hypercholesterolemia of both gender, who were allocated to a tomato sauce (namely OsteoCol) 150 ml/day or a sterol-enriched yogurt (containing sterols 1.6 g/die) treatment, for 6 weeks. Carotenoids content was 3.5 mg per gram of product. We measured serum lipids and creatinine and transaminases at basal and follow-up visit. Results A total of 91 subjects completed the protocol. A significant difference in LDL-cholesterol change was found between participants taking yogurt, tomato sauce (high adherence) and tomato sauce (low adherence) (− 16; − 12; + 8 mg/dl respectively; p < 0.001). We found a greater LDL-cholesterol reduction in the participants with a basal LDL-cholesterol more than 152 mg/dl (15% for sterol-enriched yogurt and 12% for tomato sauce at high adherence). Conclusion A novel functional tomato sauce from vine-ripened tomatoes compares favourably with a commercialised sterol-enriched yogurt in term of absolute LDL-cholesterol change. Intake of a tomato sauce with a high carotenoid content may support treatment of patients affected by common hypercholesterolemia. The present study has various limitations. The presence of other dietary components, which may have influenced the results, cannot be ruled out. Of course, these results cannot be extrapolated to other populations. Furthermore, there was a low adherence rate in the tomato sauce group. Moreover, we did not report serum carotenoids data. Trial registration: ID: 13244115 on the ISRCTN registry, retrospectively registered in 2019-5-14. URL: http://www.isrctn.com/ISRCTN13244115
ResumenObjetivo. Obtener datos actuales de la angioplastia coronaria (ATC) en la Argentina y factores asociados a morbimortalidad hospitalaria, en pacientes con infarto agudo de miocardio (IAM) incluidos en el registro RAdAC (Registro Argentino de Angioplastia Coronaria). Material y métodos. Desde mayo de 2010 a noviembre de 2010, 67 centros incluyeron 1.905 pacientes tratados con ATC; de éstos, 752 presentaban IAM. Todos los pacientes fueron enrolados en forma consecutiva, previa fi rma del consentimiento informado, y los datos demográfi cos, clínicos y angiográfi cos recolectados en un formulario electrónico online.
Aims: Herein we evaluated the association between the use of Hydrochlorothiazide (HCTZ) and the risk of NMSC both, basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Background: Even if the use of HCTZ is not related with the development of serious adverse drug reactions, in the last years, has been recorded the development of non-melanoma skin cancer (NMSC) in patients treated HCTZ, probably due to its photosensitizing capability. Objective: To evaluate the statistically significant difference (P<0.05) in the development of NMSC between HCTZ users and non-users, and the correlation (P<0.05) between HCTZ use and NMSC. Methods: We performed a retrospective study, in patients referred to general practitioners that, treated or not with antihypertensive drugs, developed or not skin cancer or NMSC. Controls were matched with test by age and sex. Using conditional logistic regression, we calculated odds ratios (ORs) for both skin cancer and NMSC associated with hydrochlorothiazide use. Results : In the present study, we enrolled 19,320 patients of these 10,110 (52.3%) received treatment with antihypertensive drugs. Of 10,110 patients, 3,870 were treated with HCTZ (38.3%). During the study, we failed to report an increased risk of NMSC in HCTZ-treated vs untreated patients. Gender stratification revealed an OR for NMSC of 1.36 for men and 0.56 for women. We did not find a dose-response relationship between HCTZ use and NMSC. Conclusions: In the present study we failed to report an association between the use of HCTZ and the development of NMSC.
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