Nebivolol withdrawal results in blood pressure returning toward pretreatment levels, but without rebound symptoms: phase IV randomized trial
Journal of the American Society of Hypertension, 04/24/2012
Lewin A et al. – Nebivolol withdrawal resulted in a mean blood pressure (BP) increase near pretreatment levels and was not associated with rebound hypertension.Methods
- Rapid withdrawal of antihypertensive drugs may lead to blood pressure (BP) increase above pretreatment values or symptoms such as palpitations, chest pain, and tremor.
- This phase IV trial assessed the consequences of abrupt and stepwise withdrawal of nebivolol, a β1–selective blocker, in individuals with stage I–II hypertension.
- After a 4– to 5–week placebo washout phase and 12–week single–blind nebivolol treatment (10–40 mg/day, titrated based on BP response), participants achieving BP control (systolic BP [SBP]/diastolic BP [DBP] <140/90 mm Hg) or response (SBP decrease ≥10 mm Hg or DBP decrease ≥5 mm Hg) entered a 4–week, randomized, double–blind phase of continued nebivolol treatment (n = 102) or withdrawal to placebo (n = 105).
- Primary and secondary efficacy measures were changes in mean sitting DBP and SBP, respectively, analyzed using an analysis of covariance model.
- Safety and tolerability were also assessed..
- In the withdrawal phase, nebivolol and placebo groups demonstrated mean DBP increases of 1.8 and 7.7 mm Hg, respectively (P < .001), and SBP increases of 3.5 and 7.6 mm Hg (P = .011).
- 23 (22.5%) nebivolol–treated and 18 (17.1%) placebo–treated participants experienced a treatment–emergent adverse event.
- No adverse events associated with β–blocker withdrawal and considered causally related to nebivolol were reported.