A Double-Blind Randomized Controlled Trial Comparing Epidural Clonidine vs Bupivacaine for Pain Control During and After Lower Abdominal Surgery.

Background: Alpha-2 adrenergic agonists produce safe and effective analgesia, but most investigations studying the analgesic effect of alpha-2 adrenoceptor agonists postoperatively included previous or concomitant administration of other analgesics. Because clonidine potentiates the effect of these drugs, its own intrinsic analgesic effect has been difficult to establish. This study was designed to compare the intraoperative and postoperative effects of epidural clonidine vs bupivacaine for patients undergoing lower abdominal surgery.

Adenosine-induced flow arrest to facilitate intracranial aneurysm clip ligation does not worsen neurologic outcome.

Background: When temporary arterial occlusion of the parent artery is difficult for anatomical reasons, or when inadvertent aneurysmal rupture occurs during surgical dissection, adenosine administration can be used to produce flow arrest and brief, profound systemic hypotension that can facilitate intracranial aneurysm clip ligation. There is a concern, however, that the flow arrest and profound hypotension produced by adenosine, although brief, may cause cerebral ischemia and therefore worsen neurologic outcome compared with other techniques to facilitate aneurysm clip ligation. Therefore, we performed a retrospective, case-control study to determine whether adenosine-induced flow arrest had negative effects on the neurologic outcome of our patients.

A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain.

To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44).

Low-dose enoximone improves exercise capacity in chronic heart failure. Enoximone Study Group.

Objectives: This study was designed to evaluate the effects of low-dose enoximone on exercise capacity.

Background: At higher doses the phosphodiesterase inhibitor, enoximone, has been shown to increase exercise capacity and decrease symptoms in heart failure patients but also to increase mortality. The effects of lower doses of enoximone on exercise capacity and adverse events have not been evaluated.

Efficacy of Nicardipine for Long-Term Therapy of Chronic Stable Angina.

BACKGROUND: Although angina is a chronic disease, most clinical trials evaluating antianginal therapy are of a few weeks or months in duration. METHODS AND RESULTS: To evaluate the effects of nicardipine, a second-generation dihydro-pyridine calcium channel blocker, as long-term therapy, patients with chronic stable angina were treated for 1 year with open-label nicardipine. Anginal symptoms were controlled with 20 mg tid in 24%, 30 mg tid in 34%, and 40 mg tid in 42%.

Usefulness of technetium-99m sestamibi infarct size in predicting posthospital mortality following acute myocardial infarction.

In this multicenter study, 249 patients who underwent tomographic technetium-99m sestamibi infarct size measurement at hospital discharge were followed up for a median duration of 7 months. Infarct size was significantly associated with mortality (chi-square = 5.8, p = 0.

Intercenter variability in outcome for patients treated with direct coronary angioplasty during acute myocardial infarction.

Background: Direct coronary angioplasty is an effective therapy for acute myocardial infarction, but its success may be dependent on both ready availability and operator skill. The purpose of this study was to investigate the impact of the center performing direct coronary angioplasty for acute myocardial infarction while controlling for parameters known to affect outcome.

Methods And Results: The study group consisted of 99 patients with ST elevation who were treated with direct angioplasty in four high-volume centers.

Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review.

Objective: To provide a quantitative review of the treatment effects of primary coronary angioplasty vs intravenous thrombolysis for acute myocardial infarction.

Data Sources: Ten randomized trials were identified through computerized bibliographic search of MEDLINE from January 1985 through March 1996 and by queries of principal investigators.

Study Selection: Single-center and multicenter randomized trials comparing primary angioplasty with intravenous thrombolytic therapy among 2606 patients were included.

Poloxamer-188 as an adjunct to primary percutaneous transluminal coronary angioplasty for acute myocardial infarction.

Poloxamer-188 is a surfactant polymer with antithrombotic and hemorheologic properties that make it potentially useful as an adjunct to acute reperfusion strategies. Animal studies and early human studies have documented poloxamer-188 to be effective at improving myocardial salvage when used as an adjunct to intravenous thrombolytic therapy for acute myocardial infarction. The current trial was a prospective pilot study involving 150 patients who were randomized in a 2:1 fashion to a poloxamer-188 infusion for 48-hours versus placebo.

Comparative efficacy of short-term intravenous infusions of milrinone and dobutamine in acute congestive heart failure following acute myocardial infarction. Milrinone-Dobutamine Study Group.

The purpose of this study was to compare the hemodynamic and clinical effects of milrinone, a vasodilating and positive inotropic agent, with those of dobutamine in patients with congestive heart failure (CHF) following acute myocardial infarction (AMI). Thirty-three patients in Killip classification II or III within 12 h to 5 days after AMI were randomized in a multicenter, open-label clinical trial to receive a 24-h infusion of milrinone or dobutamine. Drugs were titrated to achieve at least a 30% increase in cardiac index (CI) from mean baseline or at least a 25% decrease in mean pulmonary capillary wedge pressure (MPCWP) from baseline.

Surgical intervention in acute myocardial infarction: an historical perspective.

Acute myocardial infarction is an evolving event that lends itself well to surgical intervention. An historical review of surgery of acute myocardial infarction, with specific emphasis on the Spokane data, shows that this can be done safely and efficiently with myocardial salvage. Those people who were operated on within 6 hours of the onset of symptoms of acute myocardial infarction had a clear reduction in hospital mortality incidence and a better long-term result.

Factors influencing myocardial salvage with primary angioplasty.

Background: The purpose of this study was to evaluate the factors influencing the salvage of jeopardized myocardium in patients treated with primary angioplasty for acute myocardial infarction.

Methods And Results: This multicenter study involved 59 patients with acute myocardial infarction who underwent primary angioplasty without antecedent thrombolytic therapy and paired baseline (before angioplasty) and predischarge tomographic perfusion imaging by quantitative 99mTc-labeled sestamibi techniques for assessing the initial area at risk and eventual infarct size. Of the 59 patients who underwent primary angioplasty, Thrombolysis In Myocardial Infarction (TIMI) level 3 perfusion was restored in the infarct vessel in 54 patients (92%).

Dose-ranging study with a new two-chain rt-PA in patients with acute myocardial infarction: a multicenter trial.

Tissue-type plasminogen activator (t-PA) derived from a melanoma cell line was first used in patients with acute myocardial infarction in the early 1980s. Recombinant DNA technology then allowed production of large amounts of t-PA. The TIMI-I trial used a two-chain recombinant (rt-PA) product.

Myocardial infarct artery patency and reocclusion rates after treatment with duteplase at the dose used in the International Study of Infarct Survival-3. Burroughs Wellcome Study Group.

Duteplase, 98% double-chain recombinant tissue-type plasminogen activator, was administered intravenously in 488 patients with acute myocardial infarction in a multicenter, open, safety and patency study. Duteplase dosing was based on body weight. Duteplase was administered as a bolus of 0.

Comparison of propranolol, diltiazem, and nifedipine in the treatment of ambulatory ischemia in patients with stable angina. Differential effects on ambulatory ischemia, exercise performance, and anginal symptoms. The ASIS Study Group.

Episodes of transient myocardial ischemia during ambulatory activities are common in patients with stable coronary artery disease and who are often asymptomatic. Selection of therapy for episodes of asymptomatic ischemia is limited by a lack of direct comparative studies. To determine the most effective monotherapy for patients with stable angina and a high frequency of asymptomatic ischemic episodes, propranolol-LA (mean daily dose, 293 mg), diltiazem-SR (mean daily dose, 350 mg), nifedipine (mean daily dose, 79 mg) were each compared with placebo, each for 2 weeks, in a randomized, double-blinded, crossover trial.

Randomized double-blind comparison of side effects of nicardipine and nifedipine in angina pectoris. The Nicardipine Investigators Group.

Nicardipine and nifedipine are structurally similar dihydropyridine calcium channel blockers with demonstrated efficacy in the treatment of stable angina pectoris. The present study was a prospective randomized trial designed to evaluate the relative incidence of dizziness, flushing, headache, pedal edema, and palpitations during use of these drugs in patients with angina pectoris. Of 250 patients who entered into the comparative treatment part of the study, 140 patients were susceptible to developing symptoms to nifedipine as identified during a 1-month open-label treatment with nifedipine.

Medical and surgical management of early Q wave myocardial infarction. II. Effects on mortality and global and regional left ventricular function at 10 or more years of follow-up.

To determine the long-term effect of surgical reperfusion on survival and left ventricular function of patients with anterior and inferior Q wave myocardial infarction, 387 patients were followed up for greater than or equal to 10 years after early Q wave infarction. In the anterior infarction group, 102 received conventional therapy and 101 underwent surgical reperfusion. The overall hospital mortality rate in the medically and surgically treated patients was different (16.

Medical and surgical management of early Q wave myocardial infarction. I. Effects of surgical reperfusion on survival, recurrent myocardial infarction, sudden death and functional class at 10 or more years of follow-up.

To define the outcome of patients given medical or surgical therapy for Q wave myocardial infarction, 387 patients were followed up for 10 to 13 years (mean 11.4). On study entry the groups had similar distributions for variables such as mean age, gender, previous myocardial infarction, abnormal creatine kinase activity, area of infarction, number of vessels diseased and clinical classification.

The efficacy of the addition of nifedipine in patients with mixed angina compared to patients with classic exertional angina: a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Episodes of myocardial ischemia in patients with coronary artery disease may be due to transient increases in coronary vasomotor tone superimposed on a fixed atherosclerotic obstruction. The purpose of this study was to determine whether identification of the clinical pattern of angina could predict the therapeutic response to the addition of nifedipine to a regimen of beta blockers and/or long-acting nitrates. Seventy-two patients with stable exertional angina were divided into two groups: "classic exertional angina" (17 patients), defined as exertional angina with a stable threshold; and "mixed angina" (55 patients), defined as exertional angina provoked by a variable threshold and/or at least two episodes of rest angina within the 3 months prior to screening.

Clinical implications of coronary arteriographic findings soon after non-Q-wave acute myocardial infarction.

A significant incidence of death and myocardial infarction after non-Q-wave infarction belies the earlier impression that it is less serious than Q-wave infarction. Coronary angiography in the early stages after non-Q-wave infarction shows a progressive increase in the number of totally occluded vessels. This is paralleled by an increase in number of collateral vessels.

Coronary arteriographic findings soon after non-Q-wave myocardial infarction.

Complete occlusion of the infarct-related coronary artery is a frequent finding soon after Q-wave (transmural) myocardial infarction. We performed coronary arteriography to study the frequency of total coronary occlusion and of angiographically visible collateral vessels in 341 patients within one week of non-Q-wave myocardial infarction. In this cross-sectional study, 192, 94, and 55 patients underwent coronary arteriography within 24 hours of peak symptoms, between 24 and 72 hours after peak symptoms, and between 72 hours and seven days after peak symptoms, respectively.

Value and limitations of thrombolytic therapy in early acute transmural myocardial infarction.

Since coronary thrombosis is the final common pathway by which acute transmural myocardial infarction occurs, intracoronary thrombolytic reperfusion has taken on new significance. The goals of early restoration of coronary blood flow are to reduce mortality as well as to demonstrate improvement of markers of success or failure associated with thrombolytic therapy relative to nonreperfused patients. This paper examines clinical studies from multiple centers and the results derived from these studies.