ABSTRACT
The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic, full thickness, lower extremity diabetic ulcers are presented. The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks' duration. Following initial complete sharp debridement of the ulcer, patients were randomized to receive a standardized regimen of good ulcer care alone, good ulcer care plus placebo gel, or good ulcer care plus becaplermin gel-30 microg/g, or good ulcer care plus becaplermin gel-100 microg/g, with various combinations of regimens used in the four studies. Safety was assessed by monitoring adverse events and by clinical laboratory evaluations. Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies. Based on an analysis of patients with baseline ulcer area common to all trials (
Subject(s)
Foot Ulcer/drug therapy , Platelet-Derived Growth Factor/therapeutic use , Recombinant Proteins/therapeutic use , Administration, Topical , Adult , Aged , Aged, 80 and over , Becaplermin , Female , Gels , Humans , Male , Middle Aged , Multicenter Studies as Topic , Platelet-Derived Growth Factor/administration & dosage , Proto-Oncogene Proteins c-sis , Randomized Controlled Trials as Topic , Recombinant Proteins/administration & dosage , Treatment OutcomeABSTRACT
A survey was conducted through the Virginia Tumor Registry to ascertain whether there was a higher-than-expected rate of second primary breast cancers among women having a first primary tumor (benign or malignant) of the salivary glands. The population included 372 patients (182 men and 190 women) diagnosed between January 1, 1960 and December 31, 1979. Second primary breast cancer occurrence among women in this group was 4.8 times the expected number (P = 0.0102). Ages of those developing a second primary fell between 37 and 79 years. No racial prevalence was observed. The time of diagnosis of the first and second primary tumors was more than 6 years in 75% of the cases. It was concluded that women in our population incurred a fourfold-to-fivefold increased risk of a second primary breast cancer subsequent to the first primary salivary gland tumor. Consideration of this observation should be in the minds of clinicians seeing patients for follow-up.
