The GISSI Story (1983–1996): A Comprehensive Review

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[Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]

BACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in addition to traditionally-used vitamin K antagonists (VKA). Idarucizumab is a monoclonal antibody that binds to dabigatran, neutralizing its anticoagulant effect.OBJECTIVE: To assess the economic effect of idarucizumab in patients treated with dabigatran when the rapid reversal of its anticoagulant effect is required.METHODS: The analysis was carried over through the development of a budget impact model specifically adapted to the context of Italian care. The analysis was conducted along a time horizon of five years. The target population was defined by those patients on dabigatran treatment presenting uncontrolled and life-threatening bleedings (gastro-intestinal, intracranial or other) or requiring emergency surgery or urgent procedures. The estimation of healthcare resources (i.e. diagnostic procedures, medications, and other in-hospital services) needed for the management of uncontrolled bleeding and emergency surgery in patients treated with dabigatran was obtained from a panel of five Italian Clinical Experts. Unit costs were derived from current prices and tariffs.RESULTS: The total cost of management with the current therapeutic modalities ranged from € 16.5 million in year 1 to € 20.1 million in year 5. In the scenario with idarucizumab the total cost ranged from € 15.4 million in year 1 to € 18.7 million in year 5. The adoption of idarucizumab resulted in a cumulative 5-year savings of 6.5 million euro corresponding to 7.1% of the total expense.CONCLUSION: Idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations has the potential for substantial savings, compared to treatments currently available. This preliminary assessment will require further confirmatory evidence when the product will become available in Italian healthcare setting.[Article in Italian

Are Hospitalizations for Percutaneous Coronary Procedures Missed Opportunities for Teaching Rules of Secondary Prevention?

Background and aims: Percutaneous coronary intervention (PCI) is the most frequently used revascularization approach, often repeatedly applied. The quest for the ultimate revascularization procedure however may capture cardiologist’s attention and lead them to minimize the issue of secondary prevention in their patients. Aims of this study were to assess: 1. The individual risk factor profile, 2. The relation between the risk factors correction and the number of hospital admissions for elective procedures, 3. The appropriateness of medical treatment in patients admitted for elective coronary invasive procedures (diagnostic and interventional). 4. The patients knowledge of threshold values for cardiovascular risk factors. Patients and Methods: 100 patients (71% males, mean age 68 years) consecutively admitted for elective coronary angiography or PCI. They underwent a classical risk factors assessment and were divided in three groups according to the number of admissions for coronary angiography and in two groups according to the number of PCIs. Results: Fifty-seven % of patients had been previously admitted for invasive examination at least three times and 58% had already been treated with at least one PCI. Seventyone % were treated with beta-blockers but only 25% of them received a dosage found effective in RCTs (randomized clinical trials). Sixty % were treated with ACE-inhibitors and 83% received the dosage found effective in RCTs. Fifty-two % were treated with statins and 95% received a dosage found effective in RCTs. Nine % were still active smokers. Fourtynine % had a LDL cholesterol level above 100 mg/dL. The percentage of patients not on target was unrelated to the number of hospital admissions for invasive procedures. Conclusions: Modern cardiology is quickly embracing high tech procedures and trials results but often fails to spend enough time teaching how to control risk factors according to the recommendations of the evidence-based guidelines, even independently of the number of hospitalizations for invasive cardiovascular procedures

Budget impact analysis of dabigatran compared with rivaroxaban in the prevention of the thromboembolic risk in patients with non-valvular atrial fibrillation

BACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events.OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy.METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis.RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%.CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS

A Qualitative Exploration of the Use of Contraband Cell Phones in Secured Facilities

Offenders accepting contraband cell phones in secured facilities violate state corrections law, and the possession of these cell phones is a form of risk taking behavior. When offenders continue this risky behavior, it affects their decision making in other domains where they are challenging authorities; and may impact the length of their incarceration. This qualitative phenomenological study examined the lived experience of ex-offenders who had contraband cell phones in secured correctional facilities in order to better understand their reasons for taking risks with contraband cell phones. The theoretical foundation for this study was Trimpop\u27s risk-homeostasis and risk-motivation theories that suggest an individual\u27s behaviors adapt to negotiate between perceived risk and desired risk in order to achieve satisfaction. The research question explored beliefs and perceptions of ex-offenders who chose to accept the risk of using contraband cell phones during their time in secured facilities. Data were collected anonymously through recorded telephone interviews with 8 male adult ex-offenders and analyzed using thematic content analysis. Findings indicated participants felt empowered by possession of cell phones in prison, and it was an acceptable risk to stay connected to family out of concern for loved ones. The study contributes to social change by providing those justice system administrators, and prison managers responsible for prison cell phone policies with more detailed information about the motivations and perspectives of offenders in respect to using contraband cell phones while imprisoned in secured facilities

Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

Are Hospitalizations for Percutaneous Coronary Procedures Missed Opportunities for Teaching Rules of Secondary Prevention?

Background and aims: Percutaneous coronary intervention (PCI) is the most frequently used revascularization approach, often repeatedly applied. The quest for the ultimate revascularization procedure however may capture cardiologist’s attention and lead them to minimize the issue of secondary prevention in their patients. Aims of this study were to assess: 1. The individual risk factor profile, 2. The relation between the risk factors correction and the number of hospital admissions for elective procedures, 3. The appropriateness of medical treatment in patients admitted for elective coronary invasive procedures (diagnostic and interventional). 4. The patients knowledge of threshold values for cardiovascular risk factors. Patients and Methods: 100 patients (71% males, mean age 68 years) consecutively admitted for elective coronary angiography or PCI. They underwent a classical risk factors assessment and were divided in three groups according to the number of admissions for coronary angiography and in two groups according to the number of PCIs. Results: Fifty-seven % of patients had been previously admitted for invasive examination at least three times and 58% had already been treated with at least one PCI. Seventyone % were treated with beta-blockers but only 25% of them received a dosage found effective in RCTs (randomized clinical trials). Sixty % were treated with ACE-inhibitors and 83% received the dosage found effective in RCTs. Fifty-two % were treated with statins and 95% received a dosage found effective in RCTs. Nine % were still active smokers. Fourtynine % had a LDL cholesterol level above 100 mg/dL. The percentage of patients not on target was unrelated to the number of hospital admissions for invasive procedures. Conclusions: Modern cardiology is quickly embracing high tech procedures and trials results but often fails to spend enough time teaching how to control risk factors according to the recommendations of the evidence-based guidelines, even independently of the number of hospitalizations for invasive cardiovascular procedures

How lower doses of direct oral anticoagulants are interpreted in clinical practice

To evaluate the current interpretation of the lower doses of direct oral anticoagulants (DOAC) dabigatran, apixaban, edoxaban and rivaroxaban in nonvalvular atrial fibrillation