Exenatide in acutefor stroke fails to improve neurological outcomes but helps manage blood sugar safely

In the treatment of patients with acute ischaemic stroke, treatment with exenatide does not appear to have any beneficial effect on neurological function at 7 days but is safe and substantially decreases the frequency of hyperglycaemic events, without leading to hypoglycaemia, according to the results of the phase II TEXAIS trial.

In TEXAIS, 350 adult patients (median age 71 years) with acute ischaemic stroke were randomly assigned to receive exenatide (5 µg subcutaneous injection twice a day; n=177) or standard care (n=173). Treatment was administered ≤9 hours of stroke onset and given for 5 days or until hospital discharge.

The primary endpoint was the proportion of patients achieving ≥8-point improvement in National Institutes of Health Stroke Scale score (NIHSS scores 0–1) at 7 days poststroke. Death, episodes of hyperglycaemia and hypoglycaemia, and adverse events were also assessed as safety endpoints.

The median NIHSS score at baseline was 4. In the intention-to-treat analysis, 104 of 170 (61.2 percent) patients in the exenatide group and 97 of 171 (56.7 percent) in the standard care group achieved the primary outcome, but the difference did not reach significance (adjusted odds ratio, 1.22, 95 percent confidence interval [CI], 0.79–1.88; p=0.38).

However, exenatide was associated with significantly lower per-patient mean daily frequency of hyperglycaemia across all quartiles compared with standard care. None of the patients had hypoglycaemic episodes during the treatment period.

Adverse events included nausea and vomiting (3.5 percent with exenatide vs 0 percent with standard care), both being mild and not resulting in treatment withdrawal.