Elisa Rossi

Massive Pulmonary Embolism

Background— Acute massive pulmonary embolism (PE) carries an exceptionally high mortality rate. We explored how often adjunctive therapies, particularly thrombolysis and inferior vena caval (IVC) filter placement, were performed and how these therapies affected the clinical outcome of patients with massive PE. Methods and Results— Among 2392 patients with acute PE and known systolic arterial blood pressure at presentation, from the International Cooperative Pulmonary Embolism Registry (ICOPER), 108 (4.5%) had massive PE, defined as a systolic arterial pressure <90 mm Hg, and 2284 (95.5%) had non–massive PE with a systolic arterial pressure ≥90 mm Hg. PE was first diagnosed at autopsy in 16 patients (15%) with massive PE and in 29 patients (1%) with non–massive PE (P<0.001). The 90-day mortality rates were 52.4% (95% CI, 43.3% to 62.1%) and 14.7% (95% CI, 13.3% to 16.2%), respectively. In-hospital bleeding complications occurred in 17.6% versus 9.7% and recurrent PE within 90 days in 12.6% and 7.6%, respectively (P<0.001). In patients with massive PE, thrombolysis, surgical embolectomy, or catheter embolectomy were withheld in 73 (68%). Thrombolysis was performed in 33 patients, surgical embolectomy in 3, and catheter embolectomy in 1. Thrombolytic therapy did not reduce 90-day mortality (thrombolysis, 46.3%; 95% CI, 31.0% to 64.8%; no thrombolysis, 55.1%; 95% CI, 44.3% to 66.7%; hazard ratio, 0.79; 95% CI, 0.44 to 1.43). Recurrent PE rates at 90 days were similar in patients with and without thrombolytic therapy (12% for both; P=0.99). None of the 11 patients who received an IVC filter developed recurrent PE within 90 days, and 10 (90.9%) survived at least 90 days. IVC filters were associated with a reduction in 90-day mortality (hazard ratio, 0.12; 95% CI, 0.02 to 0.85). Conclusions— In ICOPER, two thirds of the patients with massive PE did not receive thrombolysis or embolectomy. Counterintuitively, thrombolysis did not reduce mortality or recurrent PE at 90 days. The observed reduction in mortality from IVC filters requires further investigation.

Right heart thrombi in pulmonary embolism: Results from the international cooperative pulmonary embolism registry

OBJECTIVESnThis study was designed to investigate the prevalence and prognostic significance of right heart thrombi (RHTh) in pulmonary embolism.nnnBACKGROUNDnMost reports about patients with RHTh are small case series. We analyzed data referring to RHTh among 2,454 consecutive pulmonary embolism patients enrolled in the International Cooperative Pulmonary Embolism Registry.nnnMETHODSnOf the 2,454 patients, 1,113 had results available from baseline echocardiography. We compared the 42 patients with RHTh versus 1,071 without RHTh.nnnRESULTSnPatients with RHTh had shorter duration of symptoms (2.2 +/- 2.9 days vs. 4.3 +/- 6.0 days, p = 0.013), lower systolic blood pressure (BP) (116.0 +/- 28.8 vs. 125.7 +/- 25.0 mm Hg, p = 0.008), and more frequent right ventricular hypokinesis (64% vs. 40%, p = 0.002) and congestive heart failure (26% vs. 13%, p = 0.024); but they had similar age (62.9 vs. 62.5 years), arterial oxygen pressure (71.3 +/- 26.0 vs. 69.5 +/- 30.5 mm Hg), and prevalence of cancer (14% vs. 19%). The overall mortality rate at 14 days and at three months was higher in patients with RHTh (21% vs. 11%, p = 0.032, and 29% vs. 16%, p = 0.036). The difference in early mortality was observed almost entirely within the subgroup of patients treated with heparin alone (23.5% vs. 8%, p = 0.02), despite similar clinical severity at presentation (systolic BP 122.2 +/- 24.2 vs. 127.8 +/- 24.1 mm Hg, hypotension in 5.9% vs. 3.4% patients).nnnCONCLUSIONSnAmong patients with acute pulmonary embolism, RHTh is usually found in those more hemodynamically compromised but is also a marker of worse prognosis in initially apparently stable patients treated with heparin alone.

MET increased gene copy number and primary resistance to gefitinib therapy in non-small-cell lung cancer patients

BACKGROUNDnMET amplification has been detected in approximately 20% of non-small-cell lung cancer patients (NSCLC) with epidermal growth factor receptor (EGFR) mutations progressing after an initial response to tyrosine kinase inhibitor (TKI) therapy.nnnPATIENTS AND METHODSnWe analyzed MET gene copy number using FISH in two related NSCLC cell lines, one sensitive (HCC827) and one resistant (HCC827 GR6) to gefitinib therapy and in two different NSCLC patient populations: 24 never smokers or EGFR FISH-positive patients treated with gefitinib (ONCOBELL cohort) and 182 surgically resected NSCLC not exposed to anti-EGFR agents.nnnRESULTSnHCC827 GR6-resistant cell line displayed MET amplification, with a mean MET copy number >12, while sensitive HCC827 cell line had a mean MET copy number of 4. In the ONCOBELL cohort, no patient had gene amplification and MET gene copy number was not associated with outcome to gefitinib therapy. Among the surgically resected patients, MET was amplified in 12 cases (7.3%) and only four (2.4%) had a higher MET copy number than the resistant HCC827 GR6 cell line.nnnCONCLUSIONSnMET gene amplification is a rare event in patients with advanced NSCLC. The development of anti-MET therapeutic strategies should be focused on patients with acquired EGFR-TKI resistance.

Gefitinib in Pretreated Non–Small-Cell Lung Cancer (NSCLC): Analysis of Efficacy and Correlation With HER2 and Epidermal Growth Factor Receptor Expression in Locally Advanced or Metastatic NSCLC

PURPOSEnTo evaluate the correlation between HER2 expression and gefitinib (ZD 1839, Iressa; AstraZeneca, London, United Kingdom) efficacy in terms of response rate, time to progression (TTP), and overall survival (OS) time.nnnPATIENTS AND METHODSnPatients with pretreated advanced non-small-cell lung cancer (NSCLC) received gefitinib at a daily dose of 250 mg until disease progression. Tumor tissue specimens obtained at the time of primary diagnosis were collected to determine HER2/epidermal growth factor receptor (EGFR) status by immunohistochemistry.nnnRESULTSnFrom February 2001 to June 2002, 63 consecutive patients were enrolled onto the study. The overall disease control rate was 58.7% (partial response [PR], 15.9%; stable disease [SD], 42.8%), median TTP was 3.3 months, and median OS was 4.1 months. Among the 43 patients in whom EGFR/HER2 status was determined, we observed six PRs (14%) and 18 SDs (42%). Disease control, including PR and SD, was 40% in the 15 patients overexpressing HER2 and 64.3% in the 28 patients not overexpressing HER2 (P =.126). No difference was found between the two groups in terms of TTP (3.5 v 3.7 months, respectively) and OS (5.7 v 6.8 months, respectively). In addition, we did not find any difference in TTP, OS, toxicity, and symptom outcome in the group of patients overexpressing both HER2 and EGFR compared with patients who had no overexpression of HER2nnnCONCLUSIONnAccording to these data, efficacy, toxicity, and symptom outcome in patients with NSCLC treated with gefitinib do not seem to be related to HER2 expression.

Drug utilisation profile in the Italian paediatric population.

ObjectiveIn order to evaluate the prescribing pattern in the Italian paediatric population, prescriptions involving 923,353 children under 14xa0years old and dispensed during 2006 by the retail pharmacies of 22 Italian local health units were analysed.Materials and methodsA total of 561,237 children (61%) received at least one drug prescription. The prescription prevalence rate was highest in children 3xa0years of age (78%), decreased with increasing age and was higher in boys than in girls (χ2u2009=u2009655; pu2009<<u20090.001). Each treated child received an average of 3.2 prescriptions and 4.8 boxes.ResultsAntibiotics and anti-asthmatics were the more prescribed therapeutic classes and represented 80% of prescriptions. Amoxicillin+clavulanic acid was the most prescribed drug (24% of the overall population; 17% of all boxes), followed by inhaled beclometasone and amoxicillin. A total of 620 different drugs were prescribed and the ten leading drugs represented 64% of the prescribed boxes. Six of the ten most prescribed drugs were the same in all age groups. Wide differences were found in the prevalence rate between the different local health units; these ranged between 50.1 and 68.4% (pu2009<<u20090.001). The prescription prevalence increased in the 2000–2002 period (from 62.2 to 68.3%) and slightly decreased afterwards.ConclusionDespite some limitations, the systematic monitoring of prescriptions is a valuable tool for evaluating the appropriateness of the care.

Use of psychotropic medications in Italian children and adolescents

IntroductionThe evidence of psychotropic drug safety and efficacy in the pediatric population is scant and widely debated. Yet, the prescription prevalence and incidence are increasing. A drug utilization study, based on a multiregional prescription database was therefore carried out in a sample of 1,484,770 Italian children and adolescents younger than 18xa0years during the year 2004. Furthermore, the trend of psychotropic prescription prevalence was evaluated from 1998 to 2004. During 2004, 4,316 children and adolescents received psychotropic drugs (2.91‰ youths). Antidepressants were prescribed to 3,503 youths (2.36‰), antipsychotics to 1,005 (0.68‰), and lithium to 73 (0.05‰). A total of 265 youths received drugs from more than one psychotropic class. The prevalence rate of psychotropic drug prescriptions increased with increasing age, with a statistically significant trend (

The Direct Economic Cost of Pharmacologically-Treated Diabetes in Italy-2006. The ARNO Observatory

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Inappropriate use of anti-asthmatic drugs in the Italian paediatric population.

; p<0.0001), and it increased in the period 1998–2004 with a statistically significant trend (