GISSI trial: early results and late follow-up. Gruppo Italiano per la Sperimentazione della Streptochinasi nell'Infarto Miocardico.

In the GISSI trial, 11,712 patients with acute myocardial infarction were randomized to receive either standard care or standard care with 1.5 million units streptokinase intravenously. A highly significant reduction in mortality during hospitalization in streptokinase-treated patients was observed. The mortality at 1 year was determined in 98.3% of the patients who had been originally randomized; the 1 year mortality of patients discharged alive was similar in those patients treated with streptokinase and those who were not; that is, the beneficial effects of streptokinase treatment on survival that were observed in the hospital phase of the study persisted unchanged and with comparable statistical significance for 1 year. However, a higher incidence of reinfarction occurred in the treated versus the control groups both during the hospital phase and at the 6 month follow-up. Streptokinase treatment had no detectable effect in patients with a history of previous infarction.

Effects of moderate salt restriction in hypertensive patients treated with oxprenolol or chlorthalidone.

Ninety-five hypertensive out-patients, whose lying diastolic blood pressure was still greater than or equal to 95 mm Hg after a 4-week treatment with oxprenolol slow release 160 mg/day or chlorthalidone 25 mg/day, restricted their daily sodium intake for a 4-week period, while continuing to receive the previous pharmacological therapy. The dietary intervention, appositely formulated to moderately restrict sodium intake, resulted in a high patient compliance as assessed by the significant (p less than 0.01) reduction in the 24-hour urinary sodium excretion. At the end of the 4-week dietary period, a significant (p less than 0.01) decrease in lying and standing systolic and diastolic blood pressure was observed in both the oxprenolol and chlorthalidone treated groups. These results suggest that a moderate reduction in sodium intake, obtained from a low sodium diet characterized by high patient compliance and easily followed in everyday life, is effective in lowering blood pressure in hypertensive patients who don't respond satisfactorily to pharmacological therapy alone.

Comparison of three different methods of monitoring unwanted effects during antihypertensive therapy.

In a double-blind, randomized, crossover, multicenter study performed in 227 hypertensive outpatients, two antihypertensive drugs, oxprenolol and chlorthalidone, were investigated to determine unwanted effects. Three main methodologic procedures were applied: the conventional evaluation of unwanted effects by the physician and involving the whole patient population, the checklist, and the free questionnaire. The latter two were assigned by randomization to the patients themselves. The study showed that unwanted effects seem to be frequently overreported when a checklist is used, whereas the free questionnaire gives more information about the symptoms of the disease than about the tolerance of the drug. The conventional method, when physicians are well-informed and sensitized to the problem, seems to provide more reliable information about unwanted effects of a drug.

[Ulterior observations on the use of C3 in acute myocardial infarction: 105 patients were treated within the 1st 6 hours after the symptoms started]. / Observaciones ulteriores sobre el uso del C3 en el infarto miocárdico agudo: 105 pacientes tratados a las seis horas del comienzo de los sintomas

Two homogeneous groups of patients with acute myocardial infarction were observed within the first six hours from the coronary attack. On admittance and for ten days, 105 patients were treated with C3: the mortality rate resulted in 13.3%. The control group of 108 patients showed a mortality of 18.5%. Strict criteria of randomization were followed in allocating patients to the two groups. Although the difference is not statistically significant it is however interesting since it confirms a previous research. Statistically significant differences between the two groups were observed in all surviving patients in the injury signs regression time and in the cardiac volume in favour of the group treated with C3.

Antidepressant treatment with maprotiline in the management of emotional disturbances in patients with acute myocardial infarction: a controlled study.

In coronary artery disease the patients usually manifest both anxiety and depression disturbances. A controlled clinical study was conducted to test the efficacy of a new antidepressant agent, maprotiline, in the early stages of acute myocardial infarction. The sample consisted of 126 patients, sixty-three receiving orally 25 mg of maprotiline twice daily and the remainder 5 mg of diazepam twice daily. Treatment lasted on an average two weeks (ten days to eight weeks). The depressive and/or anxiety conditions were rated on the basis of a questionnaire administered before and after treatment. Depression improved markedly in patients receiving maprotiline, while the two drugs developed a comparable anxiolytic action. Tolerability was good. No clinical or ECG evidence of cardiotoxic signs was detected. The importance of a drug with these characteristics in the management of emotional disturbances in the early stages of coronary artery disease is emphasized.

[A correlative study of the evolution of myocardial infarction using 131Cs scintigraphy and ecocardiography (author's transl)]. / Studio correlativo dell'evoluzione dell'infarto miocardico mediante la scintigrafia con 131Cs e l'ecocardiografia

21 patients with acute myocardial infarction (A.M.I.) were studied by echocardiography (Echo) and 131CS myocardial scintigraphy (M.S.). Some months after discharge from Hospital (mean value = 10 months), the echocardiograms and myocardial scintigrams were taken again. M.S. resulted modified in 13 patients (62%); in 7 of these there was a reduction of the "cold" area due to M.I.; in 6 an extension with scintigraphic pattern of left ventricular aneurysm was shown. Echo showed in the first group of 7, with normal ventricular cavity (L.V.C.), dimension and good movement of the walls affected by A.M.I. In the second group of 6, L.V.C. dilatation (mean value = 5,6 cm) and reduction of L.V. walls movements gave noticeable results. In the patients (8 = 38%) with unchanged M.S., Echo showed an L.V.C. dimensions increase and L.V. wall movement reduction. The most important results of the present study is the sensitivity of the M.S. and Echo to picking up left ventricular aneurysm by means of non-invasive techniques. The Authors emphasize the availability of Echo and M.S. in the follow up of M.I.

[On the use of an anabolic hormone in the acute myocardial infarction. Experimental trial on 486 patients (author's transl)]. / Sull'impeigo di un anabolizzante nella fase acuta dell'infarto miocardico. Sperimentazione clinica controllata su 486 pazienti

An anabolic hormone, methandrostenolone, was shown to be able to decrease significantly the cicatrization-time on animals with induced sperimental acute myocardial infarction (AMI). A controlled clinical trial was performed on group of 246 patients affected by AMI, giving them methandrostenolone at dose of 25 mg im.m. per day, for the first ten days from the beginning of symptoms. An omogeneous group of 240 patients with AMI was used as control. The mortality rate resulted 13,4% in the treated group 18,7% in the control's. 10 patients in the treated group (4,2%) died of cardiac failure versus 17 (7,1%) in the control group, 9 (3,7%) of cardiac rupture in the former versus 6 (2,4%) in the latter. As far as these differences are concerned statistical significance was not reached. A larger number of patients would be requested.

[Prognostic value of serial determination of CPK in acute myocardial infarction (author's transl)]. / Valore prognostico della determinazione seriata della CPK nell'infarto miocardico acuto

Serial determinations of CPK enzyme were performed every 4 hours during a 72 hour period in 40 patients with acute myocardial infarction (AMI) admitted to the Coronary Care Unit in the first 6 hours (average 2.6) from the appearance of symptoms. The peak ratio of activity of CPK was 708 mU/ml +/- 48 E.S. as medium value in the whole group was reached in a medium period of 21,1 +/- 0,74 E.S. hours from the attack. Half value of the peak ratio activity was reached after a medium time of 19,1 +/- 1,0 E.S. hours. A significant statistical correlation between the CPK peak ratio and the prognostic index of Selvini et al. was found. The peak ratio resulted in 571 +/- 41 E.S. in patients with uncomplicated AMI, whereas in those with complications such as arrhythmias and heart failure the average value was 901 +/- 136 E.S. No significant correlation between CPK values and ST wave evolution of the ECG peak ratio of 1638 mU/ml was found; however, one patient who died of cardiac rupture showed a low level of 395 mU/ml. The diagnostic and prognostic value of the serial determination of CPK during the first 48 hours of a coronary attack is emphasized.