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G Tognoni

Publications and source records attributed to G Tognoni.

At least 19 recordsLinked to original sources

A trial of goal-oriented hemodynamic therapy in critically ill patients. SvO2 Collaborative Group.

BACKGROUND: Hemodynamic therapy to raise the cardiac index and oxygen delivery to supranormal may improve outcomes in critically ill patients. We studied whether increasing the cardiac index to a supranormal level (cardiac-index group) or increasing mixed venous oxygen saturation to a normal level (oxygen-saturation group) would decrease morbidity and mortality among critically ill patients, as compared with a control group in which the target was a normal cardiac index. METHODS: A total of 10,726 patients in 56 intensive care units were screened, among whom 762 patients belonging to predefined diagnostic categories with acute physiology scores of 11 or higher were randomly assigned to the three groups (252 to the control group, 253 to the cardiac-index group, and 257 to the oxygen-saturation group). RESULTS: The hemodynamic targets were reached by 94.3 percent of the control group, 44.9 percent of the cardiac-index group, and 66.7 percent of the oxygen-saturation group (P < 0.001). Mortality was 48.4, 48.6, and 52.1 percent, respectively (P = 0.638), up to the time of discharge from the intensive care unit and 62.3, 61.7, and 63.8 percent (P = 0.875) at six months. Among patients who survived, the number of dysfunctional organs and the length of the stay in the intensive care unit were similar in the three groups. No differences in mortality among the three groups were found for any diagnostic category. A subgroup analysis of the patients in whom hemodynamic targets were reached revealed similar mortality rates: 44.8, 40.4, and 39.0 percent, respectively (P = 0.478). CONCLUSIONS: Hemodynamic therapy aimed at achieving supranormal values for the cardiac index or normal values for mixed venous oxygen saturation does not reduce morbidity or mortality among critically ill patients.

Adult

Antiarrhythmic drug prescription in patients after myocardial infarction in the last decade. Experience of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI).

BACKGROUND: Recent clinical trials have shown increased, rather than decreased, mortality in patients treated with antiarrhythmic drugs after acute myocardial infarction. OBJECTIVE: To determine whether these findings had an impact on prescription of antiarrhythmic drugs after acute myocardial infarction. METHODS: We retrospectively analyzed the class I and III antiarrhythmic prescription data of 38,072 patients with acute myocardial infarction enrolled in three large randomized clinical trials endorsed by a highly representative sample (about 75%) of Italian coronary care units during the last 10 years. The first study was conducted in 1984 to 1985; the second, in 1988 to 1989; the pilot for the third, in 1991; and the third, in 1991 to 1994. RESULTS: Total class I and III antiarrhythmic prescriptions after acute myocardial infarction was halved during the last decade, from 11.9% at discharge and 14.4% at follow-up in 1984 to 1985 to 5.8% and 5.8%, respectively, in 1991 to 1994. The trend was independent of the different distributions in the three studies of the patients' characteristics associated with antiarrhythmic use (ie, age > or = 70 years, anterior acute myocardial infarction, ventricular fibrillation during hospitalization, and Killip class > or = 2 at randomization). The same decreasing trend was observed for each antiarrhythmic drug. The drug most widely used was amiodarone, accounting for about half of the antiarrhythmic prescriptions, followed by mexiletine hydrochloride and propafenone hydrochloride; flecainide acetate was dropped from the prescription list after the publication of the Cardiac Arrhythmia Suppression Trial results. CONCLUSION: The negative results of the recent clinical trials on class I antiarrhythmic drug use after acute myocardial infarction have been rapidly transferred into routine clinical practice in Italy, since the proportion of patients who received class I and III antiarrhythmic drugs after acute myocardial infarction was halved from the early 1980s to the early 1990s.

Aged

Serum cholesterol and risk of ischemic stroke: results of a case-control study. On behalf of PROGETTO 3A Investigators.

BACKGROUND: While a positive relation between serum cholesterol and the risk of myocardial infarction has been consistently reported, the association between serum cholesterol and the risk of ischemic stroke lacks consistency. To further investigate the strength of cholesterol as a risk factor for myocardial infarction and stroke we conducted a comparative study. METHODS: A case-control study was conducted from 1990 to 1992. A network of 21 hospitals in Abruzzo, southern Italy, was created. First, computerized tomography scans confirmed ischemic stroke patients (230 with median age: 64; range: 31-69 years) and 230 sex- and age-matched controls with acute disorders unrelated to known cardiovascular risk factors. Acute myocardial infarction patients (513) and 513 matched controls were simultaneously recruited for a parallel study comparison. Total serum cholesterol concentration was measured within the first 48 hr following admission and the response to a structured questionnaire was evaluated. RESULTS: The mean (standard deviation) serum cholesterol level was 220.7 mg/dl (50.9) among stroke patients and 201.5 mg/dl (41.6) among controls (P < 0.0001). Compared with the lowest quintile (< 160 mg/dl), the odds ratio of ischemic stroke for patients in the highest quintile (> 240 mg/dl), after simultaneous adjustment for other potentially confounding covariates, was 2.6 (95% confidence interval: 1.4-4.8). A significant linear trend in risk was found (chi 2 1 df = 7.27, P < 0.01). Within each total serum cholesterol quintile, adjusted odds ratios for myocardial infarction were higher than that for ischemic stroke, and a stronger linear trend in risk was found (chi 2 1 df = 21.3, P < 0.0001). CONCLUSIONS: Our data confirm the strong linear relationship between total serum cholesterol and the risk of myocardial infarction and suggest that, at least in our population, cholesterol seems to be an indicator of ischemic stroke risk.

Adult

[Lisinopril: myocardial infarction, the first 24 hours, in patients with stable hemodynamic status. The GISSI-3 study; results at 6 weeks].

The GISSI-3 study is a multicentre randomised trial, the aim of which is to assess the efficacy of lisinopril, of transdermic glyceryl trinitrate and their association on survival and left ventricular function after acute myocardial infarction. Between June 1991 and July 1993, 19,394 patients were randomised in 200 Italian coronary care units. The patients were eligible if admitted within 24 hours of the onset of symptoms, if they had a stable haemodynamic status and in the absence of contraindications to the study drugs. Using a factorial protocol, these patients were randomised to receive either oral lisinopril (5 mg/day as a starting dose followed by 5 mg at the 24th hour and then 10 mg/day) glyceryl trinitrate alone (intravenously for 24 hours followed by 10 mg by transdermic patch) or the association of the two drugs or neither (control group). The principal criteria were global mortality and a parameter of combined events. The combined parameter was defined as the number of deaths plus the number of late (after the 4th day of hospital admission) cases of clinical cardiac failure or of severe left ventricular dysfunction without clinical signs of cardiac failure. Complete clinical information and a six-week follow-up were obtained in 18,895 (97.4%) of randomised patients. The global mortality at 6 weeks was 6.7%. The results of GISSI-3 show that treatment with lisinopril started (in addition to conventional therapy) in clinically stable patients during the first 24 hours of myocardial infarction and continued for 6 weeks significantly reduces (p = 0.03) global mortality at 6 weeks (6.3% in the lisinopril group versus 7.1% in the group without lisinopril), which results in 8 lives saved for every 1,000 patients treated. This "gain in lives" is observed from the first day of treatment. At 6 weeks, the combined morbidity-mortality was 15.6% in the lisinopril group, compared with 17% in the group without lisinopril, a significant reduction of 8%. In patients receiving glyceryl trinitrate, the 6 week mortality was 6.5% (617/9,453) compared with 6.9% (653/9,442) in the group not receiving this treatment; this difference was not significant. There was no significant difference in combined morbidity-mortality between these two groups (15.9 vs 16.7% respectively). The beneficial effect of lisinopril alone or associated with glyceryl trinitrate was also demonstrated on the combined parameter in high risk subgroups (elderly patients and women).(ABSTRACT TRUNCATED AT 400 WORDS)

Aged

[Hemostatic factors and family history of thrombosis in patients with a myocardial infarct: a case-control study. The participants in GISSI-2-Efrim. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico].

We studied a series of hemostasis factors in a group of patients selected from a cohort of 916 patients affected by MI from the GISSI-2 study population. Following a case-control design, 73 patients with a family history of thrombosis (the presence of at least two first degree relatives affected by MI and/or stroke before 65 years) were matched with MI patients with no family history of thrombosis. Blood collection could be performed 6 +/- 1 months after the acute phase following MI in 53 pairs of such patients. The presence of mixed disulphides (MDS) was significantly higher in patients with family history than in controls; MDS were detected in 7 cases and only in 1 control. No difference was found in contrast in the distribution of fibrinogen, factor VII, factor VIII, vWF, protein C, protein S, AT III, HC II, PAI-1, lipoprotein (a). Nevertheless, independently from the family history, in the whole population of MI patients studied, 21 cases of suspected deficiency of protein C were found. Sixteen out of 53 patients with family history of MI and/or stroke had a family history of MI only. In patients with family history of MI the t-PA antigen levels were significantly lower than in the control group (7.5 +/- 4.4 vs 11.1 +/- 3.5 ng/ml, t = -2.6, p < 0.02). In the whole population of MI patients and in patients with a family history of thrombosis t-PA antigen was positively correlated with PAI-1 antigen and vWF. The correlation with PAI-1 was lost in patients with family history of MI.(ABSTRACT TRUNCATED AT 250 WORDS)

Analysis of Variance

Use and abuse of clinical trials. Is the timing of treatment critical?

The timing of treatment for any condition is dependent on the underlying pathophysiology. One of the issues to consider is whether decreasing the time to intervention can be translated into recognisable benefits. Key data have been generated over the last 10 years which are relevant to the treatment of acute myocardial infarction (MI), including results of the large-scale 'mega-trials' in broad population groups. The therapeutic interventions which will be considered here are beta blockers, aspirin, thrombolytics and angiotensin-converting enzyme (ACE) inhibitors. Of these, aspirin seems to be the least time-dependent, provided it is administered within 12-24 h of symptom onset. Mortality benefits associated with beta blocker therapy increase as the time of administration from symptom onset is reduced and the extent to which thrombolytic therapy is beneficial is also clearly time dependent. The results from GISSI-3 and ISIS-4, which recruited a broader patient population than in previous trials, were concordant, showing a significant improvement in survival after five to six weeks' treatment. The message from GISSI-3 was that administration of ACE inhibitors within 24 h of symptom onset will improve survival and left ventricular function provided patients are hemodynamically stable, are not hypotensive and have no renal dysfunction; 76 lives were saved (representing an 11% risk reduction in mortality) after six weeks' lisinopril treatment, 54 of which were saved in the first five days.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists

The open infarct-related artery theory: a critical view.

Early reopening of the infarct-related artery salvages myocardium and, consequently, preserves left ventricular function, which results in an improved survival rate (the early open infarct-related artery theory). Nevertheless, late patency of the infarct-related artery is also important, because it prevents ventricular remodeling (the late-open infarct-related theory). A comprehensive view of the importance of both conditions is presented.

Coronary Vessels

The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico II (GISSI-2), and The International Study Group.

BACKGROUND: Many trials in patients with acute myocardial infarction have demonstrated that thrombolytic therapy is not associated with an excessive risk of stroke, as compared with conventional treatment. However, the incidence of various forms of stroke in patients treated with different thrombolytic and antithrombotic regimens and the associated effect of risk factors for stroke are largely unknown. METHODS: Strokes occurring in patients hospitalized with acute myocardial infarction who were enrolled in either of two large trials were analyzed. The patients were randomly assigned to receive streptokinase (1.5 million units) or recombinant tissue plasminogen activator (t-PA) (100 mg) and also randomly assigned to receive subcutaneous heparin or no heparin. Ninety-one percent of the patients also received aspirin. RESULTS: Complete data were available on 20,768 patients. A total of 236 (1.14 percent) had strokes in the hospital; 0.36 percent had hemorrhagic strokes, 0.48 percent ischemic strokes, and 0.30 percent strokes of undefined cause. Patients treated with t-PA had a small but significant excess of stroke as compared with those who received streptokinase (1.33 vs. 0.94 percent; adjusted odds ratio, 1.42; 95 percent confidence interval, 1.09 to 1.84). The administration of subcutaneous heparin in addition to a thrombolytic agent did not increase the risk of stroke (risk with heparin, 1.13 percent; without heparin, 1.14 percent). Older age, a higher Killip class, and the occurrence of anterior infarction significantly increased the risk of stroke, whereas a higher body-mass index or a history of hypertension, diabetes, or smoking did not. CONCLUSIONS: Patients with acute myocardial infarction who receive thrombolytic therapy have a small risk of stroke. Treatment with t-PA as compared with streptokinase resulted in a small but significant excess of stroke. Subcutaneous heparin, given together with t-PA or streptokinase and aspirin, did not result in an increased risk of stroke.

Aged

Patterns of aftercare for psychiatric patients discharged after short inpatient treatment. An Italian collaborative study.

This is the first of a series of papers presenting the results of an Italian collaborative study on psychiatric inpatient service utilisation. Patterns of care of a large sample of patients discharged after short inpatient treatment are discussed in the light of the changes introduced by the 1978 Mental Health Act in the Italian psychiatric care delivery system. Three closely related issues are considered: a) use of psychiatric hospitalisation, b) relationships between inpatient and community treatment before and after an admission episode, c) continuity of care. The main findings are: 1) great variability between services suggests that local factors play an important role in determining the contents of care in Italian post-reform psychiatry. 2) The relationship between inpatient and community services is complex, partial integration being the most common picture. 3) Psychiatric hospitalisation is the entry point into the care system for a sizeable group of patients. 4) Continuity of care is achieved for half the patients, mostly with diagnoses of severe mental disorders. 5) Subjects with a recent history of revolving door behaviour or a past history of mental hospital admission show the highest likelihood of remaining in community care following discharge.

Adult

Outcome of discharged psychiatric patients after short inpatient treatment: an Italian collaborative study.

This paper presents the results of an Italian multicentre study on the 6-month outcome of psychiatric patients discharged after short-term in-patient treatment from 21 general hospital psychiatric units. Two outcome measures were used: relapses (defined as readmissions for psychiatric treatment or suicide) and community tenure. The data showed, on average, a fairly high relapse rate (43% in 6 months) combined with a good community tenure. The findings are discussed in the light of the heterogeneity in patterns of care provision observed in Italian psychiatric services after the changes introduced by the 1978 Mental Health Act, reported in a previous paper.

Activities of Daily Living

Use of plasma levels for antiepileptic drug monitoring in clinical practice. Gruppo Collaborativo per lo Studio dell'Epilessia.

A multi-center survey of antiepileptic treatment was conducted in Italy on 245 previously untreated ("new") patients with epilepsy and 355 patients treated for more than three months ("old" patients). Therapeutic drug monitoring (TDM) of antiepileptic drugs was evaluated in the context of routine clinical conditions, in relation to individual therapeutic problems and mode of treatment. Plasma levels (PL) were determined in 75% of "new" patients and 78% of "old" patients, with wide intercenter variability. TDM was done at 69% of the follow-up attendences for "new" patients and at 34% for "old" patients, but was apparently unrelated to specific therapeutic problems, such as poor disease control or adverse drug reactions. Plasma drug concentration measurements were made more often among patients on polytherapy. The age of the patient and the time elapsing since diagnosis did not seem to affect request patterns significantly. From these findings it appears that TDM is largely influenced by factors unrelated to the common recommendations in the literature. In addition, the use of TDM in clinical practice reflects the limitations of the available techniques.

Adolescent

GISSI update. Which patients with myocardial infarction should receive thrombolysis?

Large-scale, randomized clinical trials have produced over the last few years a wide consensus about the role of thrombolysis in the treatment of acute myocardial infarction (AMI). It has been estimated from the trials with broader inclusion criteria that about 40% of the patients admitted to coronary care units with AMI are eligible for fibrinolytic therapy and can benefit from it. On the other hand, drug utilization data suggest that only a fraction of eligible patients actually receive thrombolysis. A reason for this dissociation between knowledge and practice lies in the widespread assumption that thrombolysis is inefficacious in particular population subsets, as well as in the setting of a number of contraindications based on controversial evidence. Age per se does not represent a contraindication to thrombolysis, which could display a lifesaving potential two or three times that estimated for the general population of patients with AMI. Although it has been shown that the sooner thrombolytic treatment is provided after the onset of symptoms the more effective it is, the available evidence seems to indicate that the effect could well extend up to 12 h from the onset of symptoms. Patients with an inferior myocardial infarction should also receive thrombolytic treatment on the basis of the results of a meta-analysis carried out on 12,000 patients. Very misleading recommendations for practice can be produced by adjusting the main results so as to conveniently allow for subgroup findings, regardless of their degree of epidemiologic, biologic, and pathophysiologic consistency. For all categories of patients included in the population trials (with the exception of those with ST depression), thrombolysis should be considered a recommended treatment. From an epidemiologic perspective, the extension of the benefits of thrombolytic therapy to all AMI patients for whom the drug is not clearly contraindicated is a goal of primary importance.

Adult

Cerebrovascular events after myocardial infarction: analysis of the GISSI trial. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI).

OBJECTIVES: To describe the epidemiology of cerebrovascular events in patients given or not given fibrinolytic treatment and to assess the prognostic implications and risk factors. DESIGN: Case series derived from the GISSI randomised trial. SETTING: 176 coronary care units in Italy giving various levels of care. PATIENTS: 5860 patients with acute myocardial infarction treated with 1.5 million units of intravenous streptokinase and 5852 patients not given fibrinolytic treatment. MAIN OUTCOME MEASURES: Cerebrovascular event, sex, age, blood pressure, history of previous infarct, site of infarction, and Killip class. RESULTS: 99 of 11,712 patients (0.84%) had a cerebrovascular event. Older age, worse Killip class, and anterior location of infarction seemed to be risk factors for cerebrovascular events (40/3201 aged 65-75 v 42/7295 aged less than 65, odds ratio 2.18; 9/437 class 3 v 55/8277 class 1, 1.81; and 57/4878 anterior v 24/4013 posterior, 1.96). No significant difference was found in the rate of cerebrovascular events between patients treated with streptokinase and controls (45/5852 (0.92%) streptokinase v 54/5860 (0.77) control). More patients in the streptokinase group than in the control group had cerebrovascular events (especially haemorrhagic strokes) on day 0-1 after randomisation (27 streptokinase v 7, control), although this was balanced by late events in control patients (54 streptokinase v 45 control at one year). The mortality of patients who had a cerebrovascular event was higher than that of those who did not (47% (47/99) v 11.6% (1350/11,613]. CONCLUSIONS: Although the incidence of cerebrovascular events complicating myocardial infarction was low, they increased morbidity and mortality. Treatment with streptokinase did not significantly alter the incidence, but age and poor haemodynamic state were associated with an increased risk.

Aged