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Single-dose cefotetan vs. multiple-dose cefoxitin--antimicrobial prophylaxis in colorectal surgery. Results of a prospective, multicenter, randomized study.

This multicenter, prospective, randomized trial of short-term antimicrobial prophylaxis in colorectal surgery was designed to compare the efficacy of a single dose of cefotetan vs. multiple doses of cefoxitin. Of the 403 evaluable patients, 206 received cefoxitin (1 gm intravenously at the beginning of surgery and after 3, 6, and 12 hours, group A) and 197 cefotetan (2 gm intravenously at the beginning of surgery, group B). The two groups of patients were similar in respect to age, sex, obesity, preoperative weight loss, diabetes, type of disease, type, and mean duration of surgery. The abdominal wound infection rate was 11.2 percent in group A and 9.1 percent in group B (difference not significant). The number of patients with infections at nonsurgical sites (respiratory and urinary tract, phlebitis, and septicemia) was significantly greater in group A than in group B (17 vs. 9.1 percent, P less than .05). The mean postoperative hospital stay was similar in both the cefoxitin and cefotetan groups (15.1 vs. 15.9 days). Both regimens were inadequate in preventing infections in the presence of severe contamination of the operative field.

Adult↗

A multicenter trial of the use of the proteolytic enzyme inhibitor aprotinin in colorectal surgery.

Animal studies have demonstrated the value of the proteolytic enzyme inhibitor, aprotinin, in reducing collagen breakdown and improving the healing of experimental colonic anastomoses. A double-blind, multicenter, prospective trial has evaluated the use of aprotinin in the prevention of anastomotic leakage in patients. Two hundred sixteen patients undergoing colonic resection and anastomosis were studied. Patients were randomized to receive either aprotinin or placebo intravenously, peroperatively, and for the first three postoperative days. Anastomotic integrity was assessed clinically and by Hypaque enema on the tenth postoperative day. Although the use of aprotinin was not associated with a significant overall decrease in anastomotic leakage rates, in 95 patients undergoing anterior resection, leakage rates in those receiving aprotinin (clinical 10.8 percent; radiologic 32.4 percent) were lower than in those receiving placebo (17.2 percent and 43.1 percent, respectively). An apparent adverse association was noted, however, in patients undergoing left hemicolectomy or sigmoid colectomy who received aprotinin.

Anastomosis, Surgical↗

Cefoxitin for one day vs. ampicillin and metronidazole for three days in elective colorectal surgery. A prospective, randomized, multicenter study.

In a multicenter study the prophylactic efficacy of two antibiotic regimens was tested against postoperative septic complications following elective colorectal surgery. The study was conducted in a prospective block-randomized design. Patients were preoperatively allocated to either ampicillin, 1 gm, four times daily, and metronidazole, 0.5 gm, three times daily, for 72 hours, or to cefoxitin, 2 gm, given three times in a period of 10 hours. Both regimens were initiated immediately before surgery. Forty-five patients were withdrawn from the study after randomization. Three hundred fifty two patients (175 receiving ampicillin and metronidazole and 177 receiving cefoxitin) completed the study and were followed for one month postoperatively. The frequency of septic and nonseptic complications was not statistically significant different between the two regimens. About one third of all septic complications appeared more than two weeks after surgery. It is concluded that short-term treatment with cefoxitin is at least as efficient as a three-day treatment with ampicillin and metronidazole.

Aged↗

The effect of gender on the probability of myocardial infarction among emergency department patients with acute chest pain: a report from the Multicenter Chest Pain Study Group.

OBJECTIVE: To identify differences in the incidences of myocardial infarction in women and men with chest pain. DESIGN: Prospective multicenter cohort study. SETTING: Emergency rooms of three university and four community hospitals. PATIENTS: 7,734 emergency room patients with acute chest pain. MEASUREMENTS AND MAIN RESULTS: Myocardial infarction was diagnosed in 10% of the 3,896 women, compared with 19% of the 3,838 men, yielding an age-adjusted relative risk of myocardial infarction for women of 0.54 (95% confidence interval 0.48, 0.60). Physicians were equally adept at admitting women and men with myocardial infarctions, but men without myocardial infarction or unstable angina were significantly more likely to be admitted than were women without these diagnoses. Most clinical and electrocardiographic features indicating a risk of myocardial infarction were present in both women and men, but several high-risk features were less commonly present in women. After adjusting for the other factors that correlate with each patient's probability of having acute myocardial infarction, the relative risk of myocardial infarction was the same in women as men when the emergency department electrocardiogram showed the classic changes associated with acute myocardial infarction, but the risk was 40% lower in women when such electrocardiographic changes were not present. CONCLUSIONS: Clinical features that predict myocardial infarction in men predict myocardial infarction in women to a similar extent. However, female gender is associated with about a 40% lower rate of myocardial infarction except when classic electrocardiographic evidence is present on the emergency department electrocardiogram.

Adult↗

Multicenter 1-year trial on formoterol, a new long-acting beta 2-agonist, in chronic obstructive airway disease.

An open multicenter trial was performed in 242 subjects with chronic obstructive airways disease between August 1987 and April 1989. Two hundred thirty-six subjects were evaluated with regard to safety (m 137, f 99, mean age 49.4 (18-77) years) and 204 subjects with regard to therapeutic efficacy (m 120, f 84, mean age 49.2 (18-77) years). Twelve micrograms (one puff) formoterol was given by metered-dose inhaler twice daily. Investigations were performed at days 0, 14, and subsequently in monthly intervals. Twenty-one patients (10.3%) were sufficiently treated by formoterol alone. One hundred and eighty-three (89.7%) required additional medication, which could be reduced in 90 cases (45.6%). Initially symptoms were present in 201 of 204 patients. At 1 year, 43 patients (21.1%) were symptom-free. At day 0 32.4% of the patients felt "very good" or "good." At 1 year the rate increased to 68.1%. Raw decreased from 0.52 +/- 0.26 (0.06-2.11) kPa.L-1.S at day 0 to 0.33 +/- 0.14 (0.06-0.88) kPa.L-1.S (= -43.5%) at 1 year. FEV1 increased from 1.90 +/- 0.80 to 2.54 +/- 0.97 L (33.7%). The global assessment of therapeutic efficacy was classified as "very good" in 51% (patients) and 47% (doctors), respectively, and as "good" in 38.7% and 42.0%, respectively. Tolerability was "very good" in 82.3% (patients, doctors), and "good" in 12.7% (patients) or 13.7% (doctors). The treatment did not influence blood pressure or heart rate. Twenty-nine patients (12.3% of 236) reported unwanted 39 side effects, such as tremor (6.36%), headache (2.54%), dryness of the mouth (1.27%), cough (0.85%), and dizziness (0.85%).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗

European multicenter trials of curosurf for treatment of neonatal respiratory distress syndrome.

Curosurf, a preparation of polar lipids and hydrophobic proteins isolated from porcine lungs by liquid-gel chromatography, is currently used in European multicenter trials for prevention and treatment of neonatal respiratory distress syndrome (RDS). In babies requiring artificial ventilation with 60-100% oxygen, tracheal instillation of a single dose of Curosurf (200 mg/kg) leads to a dramatic improvement of gas exchange and reduced mortality, without increasing the incidence of neurodevelopmental handicap among survivors. Several factors, including high ventilator pressure and oxygen requirements, have a negative impact on the therapeutic response, suggesting that the patients should be treated at a comparatively early stage of the disease. Clinical trials testing this hypothesis, as well as the effect of multiple treatment doses, are in progress.

Europe↗

A multicenter randomized controlled clinical trial of Shosaiko-to in chronic active hepatitis.

The efficacy of Shosaiko-to (SST) on 222 patients with chronic active hepatitis was studied in a double-blind multicenter clinical study. One hundred and sixteen patients received SST in a daily oral dose of 5.4 g for 12 weeks, followed by the same dose for a further 12 weeks. One hundred and six patients received a placebo containing 0.5 g of SST for 12 weeks, followed by a cross-over to SST for a further 12 weeks. Among the liver tests, serum AST and ALT values decreased significantly with the administration of SST. The difference of the mean value between the SST group and the placebo group was significant after 12 weeks. In patients with chronic active type B hepatitis, a tendency towards a decrease of HBeAg and an increase of Anti-HBe antibodies was also observed. No remarkable side effects were noticed.

Adult↗

Transcutaneous PCO2 and PO2: a multicenter study of accuracy.

A multicenter study used 756 samples from 251 patients in 12 institutions to compare arterial (PaO2, PaCO2) with transcutaneous (PsO2, PsCO2) oxygen and carbon dioxide tensions, measured usually at 44 degrees C. Of these samples, 336 were obtained from 116 neonates, 27 from 25 children with cystic fibrosis, and 140 from 40 patients under general anesthesia. Ninety-one patients were between 4 weeks and 18 years of age, 32 were between 18 and 60 years, and 12 were over 60. The ratio of transcutaneous to arterial P(s/a)CO2 was 1.01 +/- 0.11 with PaCO2 less than 30 mm Hg, increasing to 1.04 +/- 0.08 at PaCO2 greater than 40 mm Hg. Mean bias and its standard deviation (PsCO2 - PaCO2) were + 1.3 +/- 3.9 mm Hg in the entire group, + 1.8 +/- 4.2 mm Hg in neonates (NS). Bias was + 0.2 +/- 2.7 mm Hg when PaCO2 was less than 30 mm Hg (N = 175, NS), 1.0 +/- 3.4 with 30 less than PaCO2 less than 40 (n = 329, p less than 0.001), and + 2.04 +/- 4.00 mm Hg with 40 less than PaCO2 less than 70 (n = 229, p less than 0.001). These data suggest that, using transcutaneous PCO2 monitors with inbuilt temperature correction of 4.5%/degrees C, the skin metabolic offset should be set to 6 mm Hg. The linear regression was PsCO2 = 1.052(PaCO2) - 0.56, Sy.x = 3.92, R = 0.929 (n = 756); and PsCO2 = 1.09(PaCO2) - 1.57, Sy.x = 4.17, R = 0.928 in neonates (n = 336).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results.

PURPOSE: There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States. METHODS: Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery. RESULTS: A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery. CONCLUSIONS: These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.

Analysis of Variance↗

Favorable early and long-term prognosis following coronary bypass surgery therapy for myocardial infarction: results of a multicenter trial. TAMI Study Group.

Coronary bypass surgery was performed before hospital discharge on 82 (21%) of 386 consecutive patients enrolled in the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) multicenter trial of intravenous tissue plasminogen activator and coronary angioplasty for acute myocardial infarction. Time from infarct symptom onset to coronary bypass surgery was 7.3 +/- 1.9 hours for 24 patients operated upon on an emergency basis and 9.3 +/- 5.2 days for 58 patients having late in-hospital surgery. There were no operative deaths and five in-hospital deaths in the surgical group, all of which occurred in patients with preoperative cardiogenic shock. Although patients in the surgical group were older (59.7 +/- 10.4 years versus 54.9 +/- 10.2 years; p = 0.03), had more extensive coronary artery disease (42% three-vessel disease versus 11%; p = 0.001), and had a higher incidence of anterior wall myocardial infarction (48% versus 39%; p = 0.02), in-hospital mortality for the surgical group (6%) was similar to that in 301 patients not undergoing surgery (7%) in this trial. For patients discharged from the hospital, mortality at 1 year was 2.5% in the surgical group and 1.8% in patients not having coronary bypass surgery before hospital discharge. At a 1 year follow-up, there were no significant differences in the frequency of cardiac or noncardiac-related hospitalizations or in event-free survival between surgical and nonsurgical groups. The majority of patients in both groups considered themselves to be in excellent or good condition. Coronary bypass surgery can be performed with low morbidity and mortality rates in close temporal association to acute myocardial infarction.(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon↗

Ventricular septal and free wall rupture complicating acute myocardial infarction: experience in the Multicenter Investigation of Limitation of Infarct Size.

Left ventricular rupture was studied in 849 patients enrolled in the Multicenter Investigation of Limitation of Infarct Size. Although documented rupture occurred in only 14 cases (1.7%), it accounted for 14% of in-hospital mortality. Seven of the 14 ruptures occurred within 2 days and 10 within 4 days of the MB-creatine kinase-determined onset of infarction. Three easily determined baseline characteristics defined a set of patients with a markedly increased risk of myocardial rupture. Rupture was 9.2 times more likely to occur in patients with all of the following characteristics than in the remaining patients: (1) no history of previous angina or myocardial infarction, (2) ST segment elevation or signs of Q wave development on the initial ECG, and (3) peak MB-creatine kinase value (greater than or equal to 150 IU/L). The risk of myocardial rupture with these three characteristics was 5.5%. Although these predictors are likely to be of little therapeutic value for free wall rupture, since most patients with that complication die within minutes of its onset, they may aid in alerting physicians to the early diagnosis and timely surgical correction of ventricular septal rupture.

Creatine Kinase↗

Clinical characteristics and natural history of survivors of pulmonary congestion during acute myocardial infarction. The Multicenter Postinfarction Research Group.

Although pulmonary congestion during acute myocardial infarction (AMI) is recognized as an important adverse event, the detailed clinical features, natural history and predictive value of standard diagnostic tests in such patients have not been well characterized. As part of a multicenter prospective postinfarction trial, 123 patients with pulmonary congestion during AMI, who survived and were discharged from the coronary care unit, were studied. These patients were compared with similar patients who did not develop pulmonary congestion. Patients with pulmonary congestion had a significantly higher 1-year mortality rate compared with 744 patients without pulmonary congestion during AMI (28 vs 5.5%). Patients with pulmonary congestion were characterized by a lower ejection fraction, more frequent anterior infarction, diminished ability to perform exercise testing and higher incidence of subsequent cardiac events. Even without these variables, pulmonary congestion was associated with increased mortality. In patients with pulmonary congestion, ejection fraction (dichotomized at 30%) and exercise testing were the most discriminating tests in risk stratification. An ejection fraction greater than 30% and completion of the exercise test was associated with a 7% mortality while an ejection fraction less than 30% and inability to take or complete the exercise test was associated with a 44% 1-year mortality. A greater incidence of reinfarction, ischemia during exercise and ischemic events at the time of death in the pulmonary congestion group suggests that ischemia may be an important factor in this high risk category.

Aged↗

Influence of beta 2 agonism and beta 1 and beta 2 antagonism on adverse effects and plasma lipoproteins: results of a multicenter comparison of dilevalol and metoprolol.

Dilevalol combines vasodilation due to selective beta 2 agonism and nonselective beta antagonism. We studied 311 patients randomized to dilevalol and 138 to metoprolol in a multicenter trial. After a 4-week placebo washout, dilevalol was titrated from 200 to 1,600 mg once daily and metoprolol from 100 to 400 mg to a goal supine diastolic blood pressure less than 90 and greater than or equal to 10 mm Hg decrease from baseline. Responders were followed for 1 year. The average age of patients was 51 years; 72% were men and 54% were white. Both drugs reduced blood pressure effectively to a similar level. Fewer patients discontinued dilevalol than did those taking metoprolol (9 vs 16%; p less than 0.03). More metoprolol-treated patients withdrew because of depression (6 vs less than 1%; p = 0.03) and impotence (5 vs less than 1%; p = 0.03). Lipoprotein levels before and after treatment were measured in 99 patients treated for 53.5 weeks with dilevalol (mean dose 438 mg). Dilevalol increased high-density lipoprotein (HDL) cholesterol by 2.5 mg/dl to 47.2 (p = 0.05), reduced low-density lipoprotein (LDL) cholesterol by 2.5 mg/dl, increased HDL/LDL by 0.03, and decreased total cholesterol/HDL cholesterol by 0.18. Triglycerides increased by 21 mg/dl (p = 0.06). In patients with an initial HDL cholesterol less than 35 mg/dl, dilevalol increased it by 9 mg/dl. In patients treated with metoprolol, the only significant change (p = 0.02) was a 41.9-mg/dl increase in triglyceride levels.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Agonists↗

Effects of simvastatin and probucol in hypercholesterolemia (Simvastatin Multicenter Study Group II).

This 12-week, randomized, double-blind, multicenter study compared the efficacy, tolerability and safety of simvastatin (a potent HMG-CoA reductase inhibitor) and probucol. Two doses of simvastatin, 20 or 40 mg once daily, were compared to probucol, 500 mg twice daily. Both simvastatin doses were significantly more effective than probucol in improving the plasma lipid profile. Mean reduction in low density lipoprotein (LDL) cholesterol was 34% with 20-mg simvastatin and 40% with the 40-mg dosage, compared to a mean reduction of 8% with probucol. Simvastatin significantly decreased total cholesterol, triglycerides and apolipo-protein B, and increased high density lipoprotein (HDL) cholesterol and apolipoprotein A-I. Probucol caused some reduction in LDL cholesterol but significantly decreased HDL cholesterol. Both simvastatin and probucol were well tolerated and no serious drug-related events occurred. Simvastatin appears to be a well-tolerated and effective new agent used once-a-day as an adjunct to diet in the management of patients with hypercholesterolemia.

Adult↗

Multicenter long-term results of antitachycardia pacing for supraventricular tachycardias.

This report describes the multicenter experience of the Tachylog antitachycardia pacemaker (Siemens-Elema) in the treatment of drug-refractory, recurrent supraventricular arrhythmias. The device has been implanted in 63 patients (mean age 47 years). The arrhythmias were atrial tachycardia in 4 patients (6%), atrioventricular nodal reentry tachycardia in 23 patients (37%), circus movement tachycardia via an overt bypass tract in 17 patients (27%) and via a concealed bypass tract in 19 patients (30%). The mean follow-up period was 30 months. In 28 patients (44%) arrhythmia control was achieved with the pacemaker therapy alone. In 31 patients (49%) drug therapy had to be reintroduced to obtain control of recurrent arrhythmias. Four patients (6%) were definite nonresponders. In 4 patients (6%) the pulse generator was explanted either because it was not tolerated or because of tachycardia-sensing failure. No syncope or death was observed during follow-up. Thus, antitachycardia pacing gives satisfactory results in selected patients with drug-refractory supraventricular tachycardias.

Cardiac Pacing, Artificial↗

Clinical characteristics and outcome of acute myocardial infarction in patients with initially normal or nonspecific electrocardiograms (a report from the Multicenter Chest Pain Study).

To determine the prevalence and characteristics of acute myocardial infarction (AMI) patients who present to emergency departments with normal or nonspecific electrocardiograms (ECGs), data were analyzed from 7,115 consecutive patients in the Multicenter Chest Pain Study. AMI patients with normal or nonspecific initial ECGs (n = 107) were less likely to have a past history of coronary artery disease or to be diaphoretic on presentation (p less than 0.01) than AMI patients with initial ECGs highly suggestive of AMI (n = 811). The overall probability of AMI among patients with chest pain and initially normal or nonspecific ECGs was 3%, but ranged from less than 1 to 17% depending on the patient's age and sex and whether the patient had pressure-type pain or pain radiating to the shoulder, neck or arms. Among initially admitted patients, the time elapsed between onset of pain and presentation was similar in both groups. However, the time between onset of pain and definitive diagnosis of AMI by enzymes or clinical course was longer in patients with initially normal or nonspecific electrocardiograms (8.3 vs 7.5 hours, p less than 0.05), their peak creatine kinase levels were lower (mean 643 vs 1,032 mg/dl, p less than 0.001) and their mortality was slightly lower (6 vs 12%, p = 0.10). These findings suggest that AMI patients with initially normal or nonspecific ECGs may have a less severe short-term clinical outcome.

Adult↗

A multicenter comparison of lovastatin and probucol for treatment of severe primary hypercholesterolemia. The Lovastatin Study Group IV.

A multicenter study was undertaken to compare the effects of lovastatin (given in 4 different dosage regimens) and probucol in patients with severe primary hypercholesterolemia. The subjects were 290 patients taking lipid-lowering diets who were randomly assigned to 1 of the following treatment regimens for 14 weeks: lovastatin, 40 mg once a day with the morning meal (qam); lovastatin, 40 mg once a day with the evening meal (qpm); lovastatin 80 mg qpm; lovastatin, 40 mg twice daily, or probucol, 500 mg twice daily. One-third of the patients received probucol, and the other two-thirds were equally divided between the 4 lovastatin treatment groups. The mean reductions in total cholesterol in the 5 groups were, respectively, 20, 25, 30, 33 and 10%. The corresponding values for low-density lipoprotein cholesterol were 25, 32, 37, 40 and 8%. High-density lipoprotein cholesterol increased by 9 to 12% in all the lovastatin groups, but decreased by 23% in the probucol group. Triglycerides were reduced by 17 to 25% in all the lovastatin groups, but did not change significantly in the probucol group. Both drugs were well tolerated; no serious adverse events could be attributed to either agent. It is concluded that lovastatin is a considerably more effective lipid-lowering agent than probucol. In addition, lovastatin is almost as effective when given in a single daily dose as when given in a divided dose. When a once-a-day regimen is used, lovastatin is more effective if taken in the evening rather than the morning.

Adult↗

Effect of diltiazem on cardiac rate and rhythm after myocardial infarction. Multicenter Diltiazem Postinfarction Trial Investigators.

The a priori hypothesis that diltiazem would reduce the frequency and repetitiveness of ventricular arrhythmias was tested 3 months after myocardial infarction in patients participating in the Multicenter Diltiazem Postinfarction Trial. After 3 months of follow-up, 1,546 of the 2,466 patients enrolled had a 24-hour continuous electrocardiographic recording that contained greater than or equal to 12 hours of analyzable data. They were similar to the patients who survived 3 months but chose not to have a 24-hour electrocardiographic recording (i.e., they were representative of the entire group that survived 3 months). After 3 months of follow-up, there were no significant differences between the diltiazem and placebo groups in the prevalence of atrioventricular block, the frequency of atrial arrhythmias or the frequency or repetitiveness of ventricular arrhythmias. Heart rate was significantly lower (67 +/- 12 vs 71 +/- 12 beats/min) and there was a significantly greater proportion of patients with sinus pauses greater than or equal to 2 seconds in duration in the diltiazem group (6%) than in the placebo group (3%). Comparison with placebo revealed no evidence either for an anti- or proarrhythmic effect of diltiazem. There was no reduction in sudden or arrhythmic death attributable to diltiazem treatment; the fraction of total deaths that were arrhythmic by the Hinkle classification was 41% in the placebo group and 42% in the diltiazem group. It may be that the lack of effect of diltiazem on ventricular arrhythmias is partially responsible for its lack of effect on mortality after myocardial infarction.

Adult↗