Key result
Concurrent administration of exenatide with lisinopril did not significantly alter 24-hour mean systolic (MD +1.38 mmHg; 95% CI -1.95 to 4.71) or diastolic blood pressure.
Why the study?
Does exenatide alter the pharmacodynamics and pharmacokinetics of lisinopril in patients with mild-to-moderate hypertension?
RCT (n=22)
Double-blind
randomized
Does exenatide alter the pharmacodynamics and pharmacokinetics of lisinopril in patients with mild-to-moderate hypertension?
Mean Difference: 1.38 (95% CI -1.95–4.71)
Concurrent administration of exenatide does not produce clinically relevant changes in blood pressure or significantly alter lisinopril pharmacokinetics in patients with mild-to-moderate hypertension.
No BP interaction supports safe exenatide-lisinopril coadministration; confirms absence of clinically relevant pharmacodynamic effects in hypertension.
OBJECTIVES: This study evaluated the potential effect of exenatide on the pharmacokinetics and pharmacodynamics of lisinopril in patients with mild-to-moderate hypertension. METHODS: 22 patients with mild-to-moderate primary hypertension participated in a double-blind, randomized, placebo-controlled, 2-period, 2-sequence crossover study. Patients on stable lisinopril therapy were randomly assigned to receive subcutaneous exenatide (10 microg b.i.d.) and placebo b.i.d. separated by at least 2 days washout period. The primary pharmacodynamic parameters were baseline-adjusted 24-hour mean systolic and diastolic blood pressure. Steady state plasma lisinopril concentration-time profiles were also assessed. RESULTS: Mean blood pressure changes were not significantly different between exenatide and placebo coadministered with lisinopril. The least squares mean differences (95% CI) between treatments were +1.38 mmHg (-1.41, 4.17) for diastolic and +1.38 mmHg (-1.95, 4.71) for systolic blood pressure. Exenatide delayed the time to attain maximum lisinopril concentration (tmax,ss) by 2 hours but did not significantly alter maximum lisinopril concentration (Cmax,ss) or area under the concentration-time profile (AUCtau,ss) over the 24-hour steady-state dosing interval. CONCLUSIONS: This study demonstrated that concurrent administration of exenatide did not produce clinically relevant changes in blood pressure and did not significantly alter lisinopril pharmacokinetics in patients with mild-to-moderate hypertension.
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Linnebjerg et al. (2009) conducted an RCT in mild-to-moderate primary hypertension (n=22). exenatide vs. placebo was evaluated on baseline-adjusted 24-hour mean systolic and diastolic blood pressure (MD +1.38 mmHg, 95% CI -1.95, 4.71). Concurrent administration of exenatide with lisinopril did not significantly alter 24-hour mean systolic (MD +1.38 mmHg; 95% CI -1.95 to 4.71) or diastolic blood pressure.
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