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Biomedical subjects

G L Knatterud

Publications and source records attributed to G L Knatterud.

At least 73 records · Page 4Linked to original sources

Persantine-Aspirin Reinfarction Study. Part II. Secondary coronary prevention with persantine and aspirin.

In the Persantine-Aspirin Reinfarction Study, Part II (PARIS II), 3,128 persons who had recovered from myocardial infarction, suffered from 4 weeks to 4 months previously, were randomized into two groups: dipyridamole (Persantine) plus aspirin (n = 1,563) and placebo (n = 1,565). The average length of follow-up was 23.4 months. Prespecified primary end points were coronary incidence (definite nonfatal myocardial infarction plus death due to recent or acute cardiac event), coronary mortality (death due to recent or acute cardiac event) and total mortality, each at 1 year of patient follow-up and at the end of the study. Coronary incidence in the Persantine plus aspirin group was significantly lower than in the placebo group, both at 1 year (30% reduction) and at the end of the study (24% reduction). The statistically significant differences in coronary incidence, at 1 year and at the end of the study, in favor of the combination treatment remained after adjustment for multiple baseline variables and adjustment for multiple testing (three end points for two time periods). Although there were reductions for other end points, these differences were not statistically significant. Coronary mortality was 20% lower in the Persantine plus aspirin group compared with the placebo group at 1 year, and 6% lower overall. Total mortality in the treated group compared with the placebo group was 11% lower at 1 year and 3% lower overall. The reduced rates of coronary incidence largely reflected lower rates of definite nonfatal myocardial infarction in the Persantine plus aspirin group. Several subgroups were defined a priori and at the end of the study. The beneficial effect of Persantine plus aspirin compared with placebo for coronary incidence tended to be greater for the following groups of patients: those who had a non-Q wave infarct; those who were not taking digitalis; those who were receiving beta-receptor blocking drugs at baseline; those who were in New York Heart Association functional class I; those who had had only one myocardial infarction; or those who were enrolled in the study early, that is within 85 days of the qualifying myocardial infarction.

Actuarial Analysis↗

Mortality experience in the diabetic retinopathy study.

The mortality experience of patients enrolled in the Diabetic Retinopathy Study is compared with that observed in other prospective studies of patients with diabetic retinopathy, as well as those in other clinical trial populations such as the University Group Diabetes Program and the Coronary Drug Project. Patients were eligible to participate in the Diabetic Retinopathy Study if they had proliferative retinopathy in at least one eye or severe nonproliferative retinopathy in each eye, and had visual acuity of 20/100 or better in each eye and had not had previous photocoagulation treatment. Of the 1,742 patients enrolled either in the argon or xenon treatment group, 409 died. The 1-yr and 5-yr cumulative mortality rates were 3.0 and 22.6, respectively. The mortality rates observed for patients with different levels of severity of retinopathy and baseline abnormalities are examined by type of diabetes. The mortality experience of patients with severe visual loss is also presented.

Actuarial Analysis↗

The use of factor eight inhibitor by-passing activity (FEIBA immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors.

FEIBA (factor eight inhibitor by-passing activity) Immuno was used to achieve hemostasis in 46 patients with factor VIII inhibitors with titers greater than 4 Bethesda units, and 3 patients with factor IX inhibitors. One-hundred and sixty-five bleeding episodes were treated with 50-70 U/kg; 102 of these episodes occurred in joints. 20 in mucous membranes, 33 muscle and soft tissue, and 10 were emergency episodes including 3 central nervous system and 4 surgical procedures. Ninety-three percent of the bleeding episodes were controlled, while 7% were not controlled: 36% were controlled by one infusion in 12 hr, another 42% with 1 or more infusions in 36 hrs and an additional 14% were controlled in more than 36 hr. There were no serious side effects, and while the inhibitor titer rose in 10 of the patients, the product continued to be efficacious.

Clinical Trials as Topic↗

Methods of quality control and of continuous audit procedures for controlled clinical trials.

The success of any cooperative clinical trial is dependent on assuring that the data collected are of good quality. This requires that an extensive and detailed program be developed for assuring good quality performance of all participating centers. Procedures for monitoring the clinical centers and procedures for monitoring or assuring quality of data handling and processing in the coordinating center, i.e., procedures for monitoring the coordinating center, are discussed. The procedures described are based on experience in the Diabetic Retinopathy Study, which is completing data collection, and a new study, the Early Treatment for Diabetic Retinopathy Study, which is in the planning phase. Some of the principles will apply to any participating unit. As in all aspects of clinical trials, a quality control program requires attention to detail and careful planning and vigilance on the part of all participants.

Clinical Trials as Topic↗

Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. VII. Mortality and selected nonfatal events with insulin treatment.

The University Group Diabetes Program is a long-term prospective clinical trial designed to evaluate the effects of various hypoglycemic agents on vascular complications in patients with asymptomatic adult-onset diabetes. Mortality and blood glucose levels were determined as well as certain nonfatal events for patients assigned to diet alone or to either of two insulin treatment regimens. Lower levels of blood glucose with mean values close to normoglycemia were achieved in the treatment group in which the insulin dosage was adjusted to achieve normoglycemia compared with the levels achieved in patients treated with diet alone or with a fixed dose of insulin. In spite of differences in blood glucose levels among the treatment groups, there were only minor differences in the occurrence of fatal or nonfatal events.

Blood Glucose↗