Replies to post #143726 on Biotech Values

[jq1234]

LLY/B-I’s LY2605541

Whatever potential improvement it might have, these are concerning to me in much longer trials:

Additional Safety Results

In both studies, following treatment with LY2605541, blood tests on liver function (as measured by mean ALT and AST levels) statistically significantly increased from baseline and were higher than with insulin glargine. The mean levels of both liver enzymes remained within the normal range during the study for glargine and LY2605541-treated patients.

In the type 1 study, patients treated with LY2605541 had a modest increase in triglycerides (91 mg/dL to 113 mg/dL) and LDL-C (96 mg/dL to 102 mg/dL), and HDL-C decreased modestly (60 mg/dL to 54 mg/dL) at the study's endpoint. These changes were statistically significant from baseline and compared to insulin glargine. In the type 2 study, triglyceride levels in patients treated with LY2605541 were not significantly different from baseline (163 mg/dL to 172 mg/dL), but statistically higher compared to insulin glargine (160 mg/dL vs. 147 mg/dL). There was no significant difference in LDL-C or HDL-C in patients treated with LY2605541 from baseline or compared with insulin glargine.

Adverse events in type 1 patients, including severe hypoglycemia, were similar in both treatment groups. Patients in the LY2605541 group had a statistically significant increase in gastrointestinal events (dyspepsia, nausea, abdominal distension) (15 percent vs. 4 percent). This observation was not noted in the type 2 patients, with 14 percent of glargine-treated patients reporting gastrointestinal events compared to 10 percent of LY2605541-treated patients. This was not statistically significant. Other adverse events were similar across treatments in type 2 patients.