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Biomedical subjects

G Tognoni

Publications and source records attributed to G Tognoni.

At least 127 records · Page 7Linked to original sources
PubMed1995

[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↗
PubMed1995

[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↗
PubMed1994

Misoprostol: the experience of women in Fortaleza, Brazil.

Misoprostol is used by women in Brazil in case of unwanted pregnancy to attempt abortion. This paper reports the characteristics, pattern of misoprostol use and opinions of a group of 102 women (median age 25 years, range 16-49 years), from Fortaleza, capital of Ceará state, who had used misoprostol to attempt abortion. Seventy-five percent were women of lower social class, 58% had less than 8 years of education and 46% were never married. Misoprostol was used for the first induced abortion by 65 women. Modal dose was 4 tablets--200 micrograms of misoprostol each--most frequently 2 tablets by oral route and 2 tablets by intravaginal route. This pattern of use was associated with the highest rate of abortion, mainly at 9-12 weeks of amenorrhea. Fifty-five percent of women had no pregnancy test; 41% had 8 weeks or less of amenorrhea. Curettage was performed in 49 of 84 women who reported abortion and in 41 of 43 women who entered the hospital. Infection and uterine perforation were the complications described. Seventy-two percent of women were in favor of legalization of abortion, but 52% were also in favor of the prohibition of misoprostol sales; 66% would not repeat misoprostol use and 53% would not suggest it to a friend. The poorest women were less favorable to misoprostol ban. Despite the current lack of safer alternatives, misoprostol does not seem a satisfactory solution to illegal abortion in Brazil.

Abortion, Induced↗
PubMed1994

Consequences of mental distress recognition in general practice in Italy: a follow-up study. Italian Cooperative Group on Mental Distress in General Practice.

Many reports have been recently published on the accuracy of mental distress detection by general practitioners. Recognition of 'caseness', irrespective of its accuracy, nevertheless determines the implementation of therapeutic interventions. This paper reports the results of a naturalistic study describing the consequences for the patients of being identified as 'cases' in the general practice (in terms of referral strategies at recruitment and outcome 3 months and 1 year later), in the context of care provision generated by the 1978 Italian psychiatric reform. Sixty-eight GPs recruited 878 'cases' according to implicit criteria. Overall 20% of the patients were referred the psychiatric setting; only half of these for psychiatric care. After 3 months and 1 year from recruitment respectively 12% and 23% of the subjects were no longer 'cases'. The factors contributing to predict the outcome at three months were age, symptom duration, comorbidity, presence of social context risk factors and prior psychiatric history (or presence of 'major' symptoms); after one year the predictors of caseness were caseness status at 3 months, and clinical severity, symptom duration and presence of somatization at recruitment. GPs remain the main care providers in the short- and long-term. The results of the study indicate the need for a reappraisal of the emphasis to be put on caseness recognition and on the development of standardized instruments for the identification of mental distress. Non-clinical variables concurring in the definition of caseness in general practice, and the factors influencing physicians' decision-making in the implementation of alternative intervention strategies should be further clarified by ad hoc studies.

Adult↗
PubMed1994

A simple electrocardiographic predictor of the outcome of patients with acute myocardial infarction treated with a thrombolytic agent. A Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2)-Derived Analysis.

OBJECTIVES: This analysis aimed to evaluate in a large patient cohort the relation between ST segment alterations after fibrinolytic therapy for acute myocardial infarction and 1) the combined end point of in-hospital mortality plus clinical congestive heart failure or extensive left ventricular damage, and 2) mortality 30 and 180 days after randomization. BACKGROUND: Angina relief, enzyme release acceleration and ST segment normalization are related to coronary artery reperfusion and prognosis. Electrocardiographic (ECG) evaluation before and after fibrinolytic drug administration has been used to predict short- and long-term clinical outcome in acute myocardial infarction. METHODS: Patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2) trial underwent a standard ECG on admission and after 4 h of alteplase or streptokinase therapy; 7,426 recordings were suitable for ST segment analysis. A decrease > or = 50% in the sum of ST segment elevation in all ECG leads was adopted as the cutoff for predicting coronary artery patency. Recanalization was deemed to have occurred in 4,951 patients (group A) versus 2,475 patients without reperfusion (group B). RESULTS: Group A patients experienced a lower incidence of the combined end point than did group B patients (16.2% vs. 22.9%, respectively), as well as of all its components (death, clinical heart failure, ejection fraction < 35%, injured myocardial segment > 45%, QRS score > 10). Thirty- and 180-day mortality rates were lower in group A than group B (3.5% and 5.7% vs. 7.4% and 9.9%, respectively); relative risk (Cox) was 0.46 (95% confidence interval [CI] 0.37 to 0.57) for 30-day and 0.58 (95% CI 0.48 to 0.70) for 180-day mortality. Patients in group A had significantly less ventricular fibrillation and sustained ventricular tachycardia but more ischemic episodes (early recurrent angina plus myocardial infarction recurrence). CONCLUSIONS: A simple, inexpensive instrumental evaluation, unaffected by different epidemiologic and clinical characteristics of the population analyzed, can allow early assessment of the effectiveness of fibrinolytic treatment with respect to the main clinical outcomes.

Aged↗
PubMed1994

Predictors of nonfatal reinfarction in survivors of myocardial infarction after thrombolysis. Results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2) Data Base.

OBJECTIVES: This study was designed to reassess the prediction of recurrent nonfatal myocardial infarction in patients recovering from acute myocardial infarction after thrombolysis. BACKGROUND: Recurrent nonfatal myocardial infarction is a strong and independent predictor of subsequent mortality. Current knowledge of risk factors for nonfatal reinfarction is still largely based on data gathered before the advent of thrombolysis. Thus, this prospective study was planned to identify harbinger of nonfatal reinfarction in the postinfarction patients of the multicenter Grouppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2) trial. METHODS: Predictors of nonfatal reinfarction at 6 months were analyzed by multivariate technique (Cox model) in 8,907 GISSI-2 survivors of myocardial infarction with clinical follow-up, relying on a set of prespecified variables reflecting residual ischemia, left ventricular failure or dysfunction, complex ventricular arrhythmias, comorbidity as well as demographic and historical factors. RESULTS: The postdischarge to 6-month incidence rate of nonfatal reinfarction was 2.5%. Independent predictors of nonfatal reinfarction were cardiac ineligibility for exercise test (relative risk 2.97, 95% confidence interval [CI] 1.98 to 4.45), previous myocardial infarction (relative risk 1.70, 95% CI 1.22 to 2.36) and angina at follow-up (relative risk 1.50, 95% CI 1.10 to 2.04). On further multivariate analysis, performed in 6,580 patients with both echocardiographic and electrocardiographic monitoring data available, a history of angina emerged as an additional risk predictor (relative risk 1.58, 95% CI 1.10 to 2.25). CONCLUSIONS: The 6-month incidence of nonfatal reinfarction is rather low in survivors of myocardial infarction after thrombolysis. Cardiac ineligibility for exercise testing and a history of coronary artery disease are risk predictors. Recurrent nonfatal infarction is not predictable by qualitative variables reflecting residual ischemia, except by postdischarge angina. Prediction of nonfatal reinfarction appears less accurate than prediction of mortality, as almost 50% of reinfarctions occur in patients without any of the identified risk factors.

Analysis of Variance↗
PubMed1994

Antihypertensive efficacy and tolerability of different drug regimens in isolated systolic hypertension in the elderly.

The pharmacological treatment, mainly based on diuretics, of isolated systolic hypertension (ISH) has recently been shown to reduce the risk of stroke and coronary heart disease in the elderly. The purpose of this study was to compare the antihypertensive effect and tolerability of different drug regimens in elderly subjects with ISH (systolic blood pressure--SBP-- > or = 160 mmHg and diastolic blood pressure--DBP-- < 90 mmHg). A multicentre, randomized, controlled open trial was planned in the general practice setting. Four widely used treatment schedules were tested: hydrochlorothiazide 25 mg plus amiloride 2.5 mg (H+Am), nifedipine slow release 20 mg (N), atenolol 50 mg (At) and atenolol 25 mg plus chlorthalidone 6.25 mg (At+C). After a baseline evaluation, 308 patients (76.3% female, mean age 75.3 +/- 7.1 years) were randomized and followed up for 6 months. After 3 months the drug dosage was doubled if the systolic blood pressure goal (SBP < 160 mmHg and SBP reduction of at least 20 mmHg) had not been reached. Ninety-four subjects (30.5%) presented contraindications to beta-blockers. At the 3rd- and 6th-month visits all treatment groups, except At, showed a significant reduction in SBP compared to the control group; DBP showed no significant reduction in any group at any time. At the end of the follow-up the percentage of hypertensives who had reached the BP goal was 14.6% in the control group, 52.9% in H+Am, 54.8% in N, 28.6% in At and 52.2% in At+C.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1994

Analytic epidemiology in psoriasis.

The cause of psoriasis has only recently been subject to structured epidemiologic research approach. This is reflected in the scarcity of quantitative knowledge about etiologic factors for psoriasis other than genetics. A schematic model suggests that susceptibility to develop psoriatic lesions includes both genetic and extragenetic predisposing factors. Expression in terms of visible lesions is modulated by precipitating or trigger factors. Unlike many chronic diseases, psoriasis spontaneously waxes and wanes. When assessing factors that trigger the onset of the disease, one must also consider factors that lead to recurrence or exacerbation. Cohort and case-control studies are the main methodologic options for risk assessment. Combination of these techniques and the merging of an epidemiologic approach with basic biologic research are suggested routes to valuable results in this area.

Case-Control Studies↗
PubMed1994

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↗
PubMed1994

From pharmacological promises to controlled clinical trials to meta-analysis and back: the case of nimodipine in cerebrovascular disorders.

On the basis of their promising experimental evidence, calcium channel blockers are today largely used in clinical practice for treatment of patients with cerebrovascular disorders. We propose a meta-analytical evaluation of published clinical trials on nimodipine, a dihydropiridin calcium antagonist, in subarachnoid hemorrhage and in ischemic stroke. In seven trials of subarachnoid hemorrhage, 112 deaths occurred among 682 patients randomized to active treatment compared with 154 deaths among 689 control patients (odds ratio of 0.68, 95% confidence interval of 0.52 to 0.90). Poor outcome due to delayed cerebral ischemia following subarachnoid hemorrhage was also lower in the group allocated to receive nimodipine (odds ratio of 0.47, 95% confidence interval of 0.36 to 0.62). In 12 trials of ischemic stroke, 382 deaths occurred among 2056 patients allocated to receive nimodipine compared to 288 deaths among 1462 control patients (odds ratio of 0.98, 95% confidence interval of 0.82 to 1.18). Pooled results strongly suggest a protective effect of nimodipine in delayed cerebral ischemia following subarachnoid hemorrhage and no effect in ischemic stroke, but the direction and the significance of these results are due to the contribution of a single large trial on subarachnoid hemorrhage and of two trials on ischemic stroke, which account respectively for 40% and 65% of randomized patients. The dissociated effect of nimodipine on these similar conditions could be related to its preventive role in ischemic damage, resembling animal models of ischemic stroke where a beneficial effect of calcium antagonists was clearly shown only when treatment was started before experimental cerebral artery occlusion. In this view, the negative results obtained from the clinical setting of ischemic stroke seem to indicate nimodipine as an aspecific neuroprotective agent without a curative effect.

Animals↗
PubMed1994

Surrogate end-points: the case of trials on coronary atherosclerotic plaque regression.

The experimental progression-regression human model offers an excellent opportunity for testing the pathophysiological hypotheses that have arisen in the study of atherosclerosis. Nevertheless, it is still necessary to demonstrate that the modifications of angiographic patterns are strictly related to changes in coronary events, and this evidence is not yet supported to date by performed trials. Ten randomized controlled trials designed with the aim of angiographically evaluating the evolution of coronary lesions in patients with coronary heart disease made over the past 13 years were reviewed to perform a meta-analysis. Quality of design and execution of the trials, and the analysis of the primary and secondary end-points chosen for each trial, as well as the methods used to measure the changes in atherosclerotic plaques were also assessed. The phenomenon of plaque regression in human beings seems to occur, but clinical, methodological and physiopathologic heterogeneity between examined trials made it unfeasible to perform a meta-analysis. Coronary events are the consequence of the interaction of known and unknown factors, and coronary arterial narrowing from a mild to moderate degree is only one of these factors. The choice of the regression of atherosclerotic plaques as the primary end-point of a trial should probably be confined to phase 2 studies, while proof of clinical efficacy should be based on harder end-points that are representative of the very objective of medical interventions: amelioration and/or prolongation of a patient's life.

Calcium Channel Blockers↗
PubMed1994

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↗
PubMed1993

Age-related increase in mortality among patients with first myocardial infarctions treated with thrombolysis. The Investigators of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2).

BACKGROUND: The overall rate of mortality due to ischemic heart disease is known to increase progressively with age. We evaluated the relation between the mortality rate and age in patients with first myocardial infarctions treated with thrombolytic therapy. METHODS: We studied 9720 patients with first infarctions who had been enrolled in the GISSI-2 trial. (This trial compared the efficacy of tissue plasminogen activator with that of streptokinase in patients with myocardial infarction.) Of these, only 35 percent had a history of angina. The relation between age and mortality during hospitalization and during the six months after discharge was determined by unadjusted and adjusted analyses. RESULTS: The in-hospital mortality rate was 1.9 percent among patients 40 years old or younger, but it increased to 31.9 percent among those more than 80 years old; however, values for indicators of infarct size did not increase with age. Autopsies were performed in 20 percent of the 772 patients who died in the hospital; the findings showed that the frequency of cardiac rupture increased from 19 percent among patients 60 years old or younger to 86 percent among those more than 70 years old. The mortality rate for the first six months after hospital discharge also increased significantly with age. After adjustment for confounding variables, older age continued to be significantly associated with a higher risk of in-hospital and post-discharge death. When age was introduced into a multivariate model as a continuous variable, the risk of death was estimated to increase by about 6 percent per year for both in-hospital and six-month mortality rates. CONCLUSIONS: In patients with first myocardial infarctions who received thrombolytic therapy, age was a powerful independent predictor of both in-hospital and post-discharge mortality rates. The exponential, age-related increase in the mortality rate did not appear to be explained by larger infarcts.

Adult↗
PubMed1993

Comparison of frequency, diagnostic and prognostic significance of pericardial involvement in acute myocardial infarction treated with and without thrombolytics. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI).

Data from the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI) trial were reviewed to describe the epidemiology of pericardial involvement in patients treated with or without thrombolysis, and to establish its role as a marker of the extent of myocardial infarction and its prognostic value. In both GISSI-1 (n = 11,806) and 2 (n = 12,381), a specific item regarding presence/absence of clinically detected pericardial involvement was included in the study forms. In GISSI-1, patients with ST elevation and depression at the onset of myocardial infarction were admitted, whereas GISSI-2 included only those with ST elevation. Results of univariate analysis are presented as Mantel-Haenszel-Peto odds ratios with 95% confidence intervals. Cox proportional hazards models were used to assess the independent prognostic significance of pericardial involvement for in-hospital and long-term mortality. The main results indicate that: (1) the incidence of pericardial involvement in patients treated with thrombolytic agents is approximately half of that in the control group (6.7 vs 12.0%); (2) the earlier is the treatment, the lower is the incidence of pericardial involvement; (3) pericardial involvement is strongly associated with infarction size, evaluated by electrocardiograms, creatine kinase peak and echo assessments; and (4) pericardial involvement is associated with a higher long-term mortality, but is not an independent prognostic factor (RR 1.02; 95% confidence interval 0.82-1.26). Pericardial involvement is a reliable bedside, cost-free marker of myocardial infarction size and poorer outcome. Because it may elude detection owing to its transitory and often short duration, it should be given greater attention.

Heparin↗
PubMed1993

Tar yield of cigarettes and risk of acute myocardial infarction. GISSI-EFRIM Investigators.

OBJECTIVE: To analyse the relation between tar and nicotine yield of cigarettes smoked in the recent past and the risk of myocardial infarction. DESIGN: Multicentre case-control study conducted between September 1988 and June 1989. SETTING: Over 80 coronary care units in various Italian regions. SUBJECTS: 916 patients with acute myocardial infarction without history of ischaemic heart disease and 1106 controls admitted to hospital for acute conditions not related to known or suspected risk factors for ischaemic heart disease. MAIN OUTCOME MEASURES: Relative risk of myocardial infarction according to type of cigarette smoked adjusted for identified potential confounding factors. Brands of cigarettes classified according to yield of tar and nicotine. RESULTS: Patients with acute myocardial infarction were more often smokers and among smokers they tended to smoke more cigarettes. Compared with non-smokers their estimated relative risks were 3.8, 4.3, 3.2, and 3.7 in the four categories of tar yield (< 10, 10-15, > 15-20, and > 20 mg, respectively). No trend in risk across yields was evident when analysis was restricted to smokers and allowance was made for number of cigarettes. Compared with risks in subjects in the lowest category of tar yield the relative risks were 1.2, 0.8, and 1.0 for the subsequent yields. Compared with risks in non-smokers the relative risks ranged from 9.3 to 12.6 below the age of 50 but no trend was observed with increasing yield. CONCLUSIONS: Changing to cigarettes with a lower tar yield is not an effective means of reducing tobacco related morbidity from myocardial infarction.

Adult↗