A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort.

BACKGROUND AND AIMS: ODYSSEY APPRISE trial evaluated efficacy and safety of alirocumab in 994 patients with hypercholesterolemia and high CV risk in a real-life setting. The aim of the present report is to detail on the Italian cohort enrolled and treated in the trial. METHODS AND RESULTS: The methodology of the of the multinational, single-arm, Phase 3b open-label ODYSSEY APPRISE (Clinicaltrials.gov: NCT02476006) has been previously reported. 255 Italian patients were enrolled and treated according to the trial protocol. Overall mean exposure to alirocumab was 83.3 ± 27.7 weeks. At week 12, LDL-C decreased by 51.3 ± 23.1% and this reduction was overall maintained for the duration of the study. A similar reduction was observed in patients with and without heterozygous familial hypercholesterolemia (HeFH 50.7% ± 23.9 vs. non-FH, 53.6% ± 19.6). LDL-C was reduced below 1.8 mmol/L and/or by ≥ 50% reduction from baseline in 62% of patients overall (61% in HeFH and 67% in non-FH). Alirocumab was similarly well tolerated in the Italian cohort as in the entire study population and the more common treatment emergent adverse events (TEAEs) were influenza, myalgia and nasopharyngitis. The incidence LDL-C levels <25 mg/dl and <15 mg/dl, was 8.2% and 2.9% respectively. CONCLUSION: The efficacy and safety of alirocumab in a real-life setting, in the Italian subgroup of patients are consistent with findings in the entire study population and confirm that alirocumab is a beneficial approach to further reduce LDL-C levels in patients at high CV risk on maximally tolerated conventional lipid lowering treatment. GOV IDENTIFIER: NCT02476006.

Living with Chronic Spontaneous Urticaria in Italy: A Narrative Medicine Project to Improve the Pathway of Patient Care.

Chronic spontaneous urticaria (CSU) is perceived as a difficult to manage disease with negative impact on quality of life. The aim of this study was to highlight how to improve the care of people with CSU, using the methodology of narrative medicine. From June 2014 to March 2015, CSU-diagnosed patients and their physicians were asked to record their experiences of the condition in writing. Fourteen healthcare teams participated: 41% considered CSU as a challenge to overcome, while 22% experienced CSU as a big commitment. The number of professional involved was evaluated as insufficient in 11 hospitals. Seventy-five percent of the 190 Italian patients had visited 3 or more physicians before receiving a final diagnosis, with a perceived waste of time and resources. The therapeutic pathways were described as unsatisfactory in 83% of cases. As a result, anger and frustration were life-dominant emotions in 92% of patients. The critical points of the care pathway are related to organizational issues and lack of awareness.

[Streptococcus bovis infectious endocarditis: clinical and epidemiological characteristics]. / Le endocarditi infettive da Streptococcus bovis: caratteristiche cliniche ed epidemiologiche.

This paper shows our experience concerning the study of Streptococcus bovis infectious endocarditis (EI): 47 patients, with no prior history of IV drug abuse (NTD), who suffered EI caused by Streptococcus bovis were excerpted from a case record of 1053 cases with diagnosis of EI defined in accordance with Duke's Hospital criteria. For each patient we considered age, sex, complications, echocardiographic findings, antibiotic therapy, eventual heart-surgery and final outcome of the disease. We then compared the parameters of our patients, with the ones of 216 NTD patients suffering non Streptococcus bovis EI, selected according to age correspondence and concomitant onset of the disease. The characteristics of Streptococcus bovis EI are analogous to the ones of EIs caused by other micro-organisms in NTD patients, except for a non statistically significant trend of higher frequency in old age and in males. Concerning possible predisposing conditions, we considered the association extensively described in the literature between Streptococcus bovis EI and gastroenteric pathology (above all colon neoplasms): this association was not frequently observed in our study because appropriate instrumental investigations of the digestive tract were carried out only in a minority of patients.

[Polymicrobial infective endocarditis in Italy]. / Endocarditi infettive polimicrobiche in Italia.

In our series, including 1053 cases of infective endocarditis (IE) collected from 86 Infectious Diseases Centres in Italy between 1984 and 1999, we identified 34 cases (3.2%) with a polymicrobial etiology. Intravenous drug abuse was the most important risk factor for the development of polymicrobial IE. Twenty three patients had a left sided-IE and 6 patients had a right-sided IE. The most commonly encountered microorganisms were Staphylococci and Streptococci and the most frequently observed associations of microorganisms were those between Staphylococci and Gram-negative bacteria and between Staphylococci and fungi. Twelve patients (35.3%) underwent surgery, and 5 patients (16.7%) died. Polymicrobial endocarditis did not differ clinically from IE caused by a single microorganism, and the prognosis seems to be related to the site of infection and to some specific pathogens.

[Infective endocarditis as predisposing factor to recurrence]. / Le endocarditi infettive come fattore predisponente a successive recidive.

In this paper we communicate our experience with 60 patients who suffered two or more episodes of infectious endocarditis (IE), selected from 1053 cases of IE defined in accordance with Duke's Hospital criteria. Relapsing IE was diagnosed when episodes occurred with at least a 6 month interval between them or when, even if the time distance was shorter, they were caused by different microorganisms. Sixty-four cases of relapsing IE were observed. In each patient we considered age, sex, presence of risk-factors for IE, time laps from the onset of symptomatic disease to diagnosis, time interval between the two or more IE episodes, aetiology, endocarditic location, echocardiographic elements, therapy, complications and final outcome were considered. We conclude, agreeing with other authors, that infectious endocarditis may rightfully be considered a risk factor for further IE episodes and that, for this reason, an adequate prophylactic therapy must be given.