Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy.

OBJECTIVE: To compare health-related quality of life (HRQOL) in patients with diabetes receiving insulin lispro with patients receiving regular human insulin (Humulin R). RESEARCH DESIGN AND METHODS: We performed two randomized comparative studies over a 6-month period (3 months per treatment). Primary analyses used crossover baseline to 3-month changes in HRQOL scores. Ninety-three principal investigators in Canada, France, Germany, and the U.S. participated in these studies. One HRQOL crossover study included 468 patients with type I diabetes; the other HRQOL crossover study included 474 patients with type II diabetes. In both studies, patients were taking insulin at least 2 months before enrollment. Primary outcomes included two generic HRQOL domains, energy/fatigue and health distress, and two diabetes-specific domains, treatment satisfaction and treatment flexibility. Thirty secondary outcomes included both generic and diabetes-specific measures. Secondary outcome domains were controlled for multiplicity in the analyses. RESULTS: Primary analyses showed that treatment satisfaction scores (P < 0.001) and treatment flexibility scores (P = 0.001) were higher for insulin lispro in type I diabetic patients. No other significant treatment differences were detected using the data from these 6-month crossover studies. CONCLUSIONS: Treatment satisfaction and treatment flexibility were significantly improved in patients with type I diabetes using insulin lispro. Other HRQOL findings were comparable for insulin lispro and regular human insulin. Insulin lispro appears to have a measurable impact on lifestyle benefits in patients with type I diabetes, as demonstrated by increased treatment satisfaction and treatment flexibility.

Human growth hormone and Creutzfeldt-Jakob disease.

For more than 20 years cadaver-derived human growth hormone (HGH) was used successfully to enhance linear growth in short children. In 1985 the US Food and Drug Administration (FDA) stopped use of the hormone in response to reported deaths due to Creutzfeldt-Jakob (CJD) agent in 3 former HGH recipients. To date, a total of 9 patients have been identified who both received HGH and became infected with CJD agent (7 in the United States, 1 in Britain, and 1 in New Zealand). Circumstances make it likely that HGH contaminated with a slow growing, viral-like particle may have been responsible for these fatalities. In Oklahoma at least 60 children and adolescents previously received HGH and are potentially at risk of developing CJD. It is important that health care providers responsible for the care of these individuals be aware of this fatal illness and remain informed of new developments in the field.

Comparison of postoperative intraocular pressures after use of Miochol and Miostat.

Over 100 cases of standard extracapsular cataract extraction with intraocular lens implantation were reviewed and the effects of two commercially available pharmacological agents were compared. The treatment groups received either acetylcholine chloride (Miochol) or carbachol (Miostat). Intraocular pressures were measured preoperatively and 20 to 24 hours postoperatively. The difference in mean pressures between the treatment groups was statistically significant. The results of the study showed Miostat to be the better pharmacological agent for controlling intraocular pressure 20 to 24 hours later. Since the majority of surgeons use Miochol rather than Miostat, the conclusions of this study appear to be significant.