The Biosulin equivalence in standard therapy (BEST) study - a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus.

INTRODUCTION: The need for more cost-effective insulin therapy is critical in reducing the burden on patients and health systems. Biosimilar insulins have the potential to dramatically lower healthcare costs by delivering insulin with a similar anti-glycaemic effect and adverse reaction profile. OBJECTIVES: The purpose of this study was to confirm equivalence in glycaemic outcomes and side-effect profiles between Biosulin 30/70 and other human premixed insulin preparations on the South African market in a clinical practice setting. METHODS: Subjects in this interventional, observational, multicentre, open-label, prospective study were switched from their existing human premix insulin (Actraphane, Humulin 30/70 or Insuman) to the study insulin Biosulin 30/70. The primary endpoint was the change in HbA1c from baseline to 6 months. RESULTS: Seventy-seven adult patients with type 1(n=18) or type 2 (n=59) diabetes were enrolled. The baseline HbA1c in the overall cohort was 7.9%, 8.0% at 3 months (p=0.50) and 7.6% at 6 months (p=0.14).There was a small increase in the total daily dose of insulin used in both the type 1 and type 2 cohort, from 0.62 to 0.65 units/kg/day (p=0.0004). There was no significant difference in weight in the study subjects during the 6-month period on Biosulin 30/70 (p=0.67). CONCLUSION: Biosulin 30/70 achieved at least equivalent glycaemic control to existing human premix insulins, with no reported new or severe adverse events. Increased use of biosimilar insulins has the potential for significant cost savings.

Exposure of professional pesticide applicators to carbaryl.

Dermal and respiratory exposure, and erythrocyte and serum acetylcholinesterase activity were monitored on two groups of professional pesticide applicators spraying trees with carbaryl. The mean dermal exposure to the first group was 128 mg hr-1 of carbaryl and the mean respiratory exposure was 0.1 mg hr-1. The maximum percent (%) toxic dose received by the applicators was 0.12% hr-1. The mean exposure to the second group of applicators was 59.4 mg hr-1 dermal and 0.1 mg hr-1 respiratory, for a total of 0.02% toxic dose per hr. It was estimated that 86.9% of the dermal exposure was to the forearms and hands. The rate of exposure to pads placed under the applicators clothing was approximately 1/20 that of pads on the outside of the clothing. Of the body areas monitored, the back received the least rate of exposure. It was determined, in vitro, that 10(-3) M carbaryl would inhibit human serum (pseudocholinesterase) and erythrocyte acetylcholinesterase for at least 72 hr. There was no overall inhibition of acetylcholinesterase activity in the applicators.

Exposure of urban applicators to carbaryl.

Thirty-eight urban volunteers from the Lincoln and Omaha, Nebraska areas were monitored for carbaryl exposure during the summer of 1979. All volunteers were involved in the application of carbaryl incidental to their employment or leisure activities. The investigators made no attempt to affect the method of carbaryl application. The mean rates of carbaryl exposure were 3.85 and 0.26 microgram cm-2 hr-1, respectively, for the outside of the clothing and the skin beneath the clothing; clothing apparently provided an effective barrier to carbaryl penetration. The rate of carbaryl exposure to the hands of applicators was 2.36 and 24.96 micrograms cm-21 hr-1, respectively, for applicators with and without gloves. The maximum dermal exposure recorded in this study was 2.86 mg kg-1 hr-1 which is significantly less than the stimated dermal LD50 value for carbaryl (4000 mg kg-1). The maximum air concentration of carbaryl was 0.28 microgram L-1. Only a small mean decrease was found in the applicators serum (-1.01%) or erythrocyte (-1.39%) acetylcholinesterase activity. Although some applicators had decreases in either serum or erythrocyte acetylcholinesterase activity greater than 20%, an equal number had increases of the same magnitude. The mean total carbaryl exposure to the applicators, expressed as a percent of toxic dose per hr, was 0.01%, with a maximum estimated exposure of 0.08%.