Safety of Antiplatelet Agents: Analysis of 'Real-World' Data from the Italian National Pharmacovigilance Network.

INTRODUCTION: According to the Italian National Report on drug use, thienopyridines (ticlopidine, clopidogrel and prasugrel) and ticagrelor represent the most prescribed antiplatelet agents, beside aspirin. The aim of this study was to analyse the safety profile of these drugs using data from spontaneous reporting of suspected adverse reactions (ADRs). METHODS: Suspected ADRs for ticlopidine, clopidogrel, prasugrel and ticagrelor, reported on the Italian National Pharmacovigilance Network between January 2009 and December 2016, were included in the analysis. All suspected ADRs were classified by frequency, seriousness, outcome, age and system organ class. RESULTS: Clopidogrel showed the highest absolute number of suspected ADRs, followed by ticlopidine. However, these data need to be contextualized in view of the differences in marketing authorization dates, prescription rates and a characterization of the relative seriousness of ADRs per each drug. After the correction for prescription rate, ticagrelor showed the highest reporting trend and ticlopidine the lowest. Most ADRs occurred in the elderly, in particular for ticlopidine. Bleeding represents one of the most reported events (ticlopidine 40%, clopidogrel 26%, prasugrel 42%, ticagrelor 30%) and aspirin was the most frequently associated suspected drug. The majority of ADRs had complete recovery and were non-serious, except for ticlopidine (serious ADRs 53%). Prasugrel showed the highest percentage of 'life-threatening' events and 'death'. CONCLUSIONS: Based on the analysis conducted on spontaneous ADRs reporting system in Italy, the safety profile of antiplatelet drugs seems favourable. However, the overall risk-benefit ratio of these drugs needs to be reassessed taking into account the appropriateness of use in particular populations at risk, such as the elderly. Based on this information, we believe that more attention from clinicians and/or an implementation of regulatory measures could be useful for clinical practice.

Losartan vs. amlodipine treatment in elderly oncologic hypertensive patients: a randomized clinical trial.

Elderly neoplastic patients frequently may show hypertension and hyperuricemia, before and after chemotherapeutic treatments. The purpose of this study was to evaluate the efficacy of losartan which is an antihypertensive drug with uricosuric properties vs. amlodipine in hypertensive neoplastic elderly patients. This was an open-labeled, randomized, comparative trial. The study was performed as a 30-day study. Seventy patients with cancer were randomly assigned to receive losartan or amlodipine. Blood pressure (BP), blood urea nitrogen (BUN) levels, creatinine, serum and urinary uric acid, creatinine and uric acid clearance were determined before and after chemotherapy. One day after chemotherapy in losartan group vs. amlodipine group we observed a significant difference in urinary uric acid (p<0.001) of 18 mg/24 h vs. 40 mg/24 h. Thirty days after chemotherapy we observed a significant difference in azotemia of 0.0 mg/dl vs. 3.8 mg/dl (p<0.001), serum uric acid of 0.05 mg/dl vs. 0.49 mg/dl (p<0.001), urinary uric acid (p<0.001) of 23 mg/24 h vs. 0.0 mg/24 h, GFR of 2 ml/min/1.73 m(2) vs. -8 ml/min/1.73 m(2) (p<0.05) and systolic BP (SBP) of 3.6 mmHg vs. 0.8 mmHg (p<0.05). The findings of the present study support the effective role of losartan compared to amlodipine in treating hypertension and hyperuricemia in elderly patients under chemotherapeutic treatment.

Managing patients with chronic severe asthma: rise to the challenge.

Most asthmatic patients with moderate to severe disease can be satisfactorily managed with a combination of inhaled corticosteroids and beta(2)-agonists. However, there are perhaps 10% of the asthmatic population with persistent symptoms, impaired quality of life and excessive health-care utilization, despite this management regime. These patients often require frequent and even occasionally regular oral corticosteroid use. Chronic, severe asthma is a heterogeneous disease with distinct sub-phenotypes. A systematic diagnostic work-up may help to identify these distinct sub-phenotypes and this may help guide treatment and may even provide information about prognosis. Optimal treatment of chronic severe asthma should achieve the best possible asthma control and quality of life with the least dose of systemic corticosteroids. The choice and formulation of therapeutic agent is dictated by the severity of disease and includes conventional, immunosuppressive/immunomodulating and biologic therapies. Unfortunately, current asthma management guidelines offer little contribution to the care of the challenging patient with chronic severe asthma. This review article aims at summarizing the evidence regarding various therapeutic modalities for chronic severe asthma and also aims to provide a practical approach to diagnosis and management for the benefit of those who have a specific interest in this problematic condition.

[Stromal tumors of the small intestine: personal experience and review of the literature]. / I tumori stromali dell'intestino tenue. Esperienza personale e revisione della letteratura.

Malignant gastointestinal stromal tumors (M-GIST) are rare mesenchymal tumors that arise in the wall of the gastrointestinal (GI) tract. Small intestinal GIST account for approximately 35% of all GIST the diagnosis of these tumors is difficult to establish, because the symptoms are vague and non-specific and traditional endoscopy is commonly unsatisfactory. Because of the infrequent nature of malignant small bowel tumors, the natural history and factors affecting outcome remain poorly defined; stage at presentation and complete surgical resection seem to be the main prognostic factors. For these rare tumors, surgery remains the treatment of choice, with little efficacy reported for irradiation, chemiotherapy, or both. Two cases of GIST of the jejunum, complicated by intestinal bleeding and intestinal obstruction respectively, are presented and a review of the literature is made.

[Acute postoperative acalculous cholecystitis]. / Colecistite acuta alitiasica postoperatoria.

After a brief review of acute postoperative acalculous cholecystitis, the Authors report their experience over the past 10 years consisting of 9 out of 520 cases (1.73%) of acute cholecystitis operated on in their department. They describe the surgical procedures after which acute cholecystitis developed, the diagnostic tools used, the laboratory test results and the types of cholecystitis encountered. Morbidity was 50% (4 cases) and mortality 11.1% (1 case). Acute postoperative acalculous cholecystitis obliges the surgeon to make an early diagnosis and intervene equally rapidly with treatment.

Drainage useful in the excision and closure "per primam" of pilonidal sinus: technical notes.

Pilonidal sinus treatment is still controversial, since all the most commonly used methods cause the patients considerable discomfort ("open" method) or increase the recurrence rate ("closed" method). In view of this, we reviewed our series of 52 patients treated by "en bloc" excision of all pathological tissue following closure "per primam" of the wound, after applying an aspirating drainage, which was then removed on day 2 or 3. Routine use of the drainage, antibiotic prophylaxis continued until postoperative day 6 or 7 and thorough daily disinfection of the wound and its neighbouring skin until removal of the suture, enabled us to achieve encouraging results (slight complications in 3 cases and only one recurrence).

Acute abdomen due to wandering spleen infarction: a case report.

We report a rare clinical case of acute abdomen due to partial infarction of a wandering spleen in the pelvis in a 60-year-old woman. The patient was suffering from stabbing pain in the external lower quadrant of the abdomen, irradiating back to the lumbosacral area, together with an unremitting feverish state (38 degrees C), sickness and constipation. After carrying out serological examinations, which revealed an increase in CPK and leukocytosis, ultrasonography and CT examinations were performed, revealing a mass in the left iliac cavity, which in all probability was a wandering spleen with an abnormally long pedicle and a dyshomogeneous lower area bearing witness to a splenic infarction. The patient was therefore submitted to surgery consisting in splenectomy after lysis of the adherences, which were plainly inflammatory. A wandering spleen, especially when infarcted, is a very rare clinical condition that may be congenital or acquired. Its presence can be confirmed by serological, ultrasonographical and CT examinations and must be suspected when there is no clearly defined acute abdomen.

[Polypoid lesions of the gallbladder: indications for surgical treatment]. / Le lesioni polipoidi della colecisti: indicazioni all'intervento chirurgico.

Through the study of a population of 176 patients with polypoid lesions of the gallbladder, our aim was to demonstrate the advantages of ultrasonography in the identification of those cases in which surgical intervention is indicated. From among our patients, specific criteria were used to select 92 patients to submit to cholecystectomy. These criteria were based on a thorough evaluation of the clinical data (patient's age, familiarity, presence of symptoms), and on careful examination of the ultrasonographic images (number and size of lesions, presence of associated cholelithiasis, state of the gallbladder wall). The histological results and the literature data confirmed the validity of our protocol. The risk factors for carcinoma are age (> 60 years), coexistence of gallstone disease, and the size of the lesions (> 10 mm). Therefore, when these risk factors are present, cholecystectomy is justified even in asymptomatic patients.