Does hypotension occur with bisoprolol (Beta blocker) 2.5mg?

From the Guidelines

Bisoprolol 2.5mg can cause hypotension in some patients, particularly those with pre-existing hypotension or those taking other medications that lower blood pressure 1.

Mechanism of Action

Bisoprolol is a cardioselective beta-blocker that works by blocking beta-1 receptors in the heart, reducing heart rate and cardiac output, which leads to lower blood pressure.

• The full antihypertensive effect usually develops over 1-2 weeks of regular use.
• For hypertension treatment, patients usually start with 2.5mg daily and may increase to 5-10mg daily if needed based on blood pressure response.

Administration and Monitoring

• Take bisoprolol at the same time each day, with or without food.
• Do not stop taking it suddenly as this can cause rebound hypertension; dosage should be gradually reduced over 1-2 weeks if discontinuation is necessary.
• Common side effects include fatigue, dizziness, and bradycardia.
• Blood pressure monitoring is recommended to assess effectiveness, with measurements taken at the same time of day for consistency.

Special Considerations

• Patients with pre-existing hypotension or those taking other medications that lower blood pressure should be closely monitored for signs of hypotension, such as dizziness or lightheadedness.
• Bisoprolol is generally well-tolerated, but patients should be aware of the potential for hypotension and take steps to manage it, such as rising slowly from a sitting or lying position.

From the FDA Drug Label

CLINICAL STUDIES In two randomized double-blind placebo-controlled trials conducted in the U.S., reductions in systolic and diastolic blood pressure and heart rate 24 hours after dosing in patients with mild-to-moderate hypertension are shown below. Study B Placebo Bisoprolol fumarate 2.5 mg 10 mg n = 56 59 62 Total Δ BP (mm Hg) 3.0/3.7 7.6/8.1 13.5/11.2 Drug Effect a - 4.6/4.4 10.5/7.5

The FDA drug label does not explicitly state that hypotension occurs with bisoprolol 2.5mg, it only reports the reduction in blood pressure.

• Blood pressure reduction is not the same as hypotension.
• The label does report a mean decrease in systolic and diastolic blood pressure of 7.6/8.1 mmHg with bisoprolol fumarate 2.5mg 2. However, this information does not directly answer the question of whether hypotension occurs.

From the Research

Hypotension with Bisoprolol 2.5mg

• The study 3 found that bisoprolol 2.5mg per day reduced systolic and diastolic pressures by 19.5/11.7 mm Hg, which is a significant reduction in blood pressure.
• Another study 4 investigated the effects of 2.5mg bisoprolol on home blood pressure and heart rate, and found that mean home systolic/diastolic BP and HR significantly decreased by 2.6/5.2 mm Hg and by 8.1 bpm, respectively.
• However, none of the studies directly reported hypotension (abnormally low blood pressure) as an adverse event with bisoprolol 2.5mg.
• A bioequivalence study 5 found that 2.5mg film-coated bisoprolol tablets were bioequivalent to the reference product, with no significant differences in pharmacokinetic parameters.
• Other studies 6, 7 investigated the efficacy of bisoprolol in patients with heart failure and essential hypertension, but did not specifically report on hypotension with bisoprolol 2.5mg.

Blood Pressure Reduction

• The studies 3, 4 consistently showed that bisoprolol 2.5mg reduces blood pressure, with significant decreases in systolic and diastolic pressures.
• The magnitude of blood pressure reduction was similar in both studies, with reductions ranging from 2.6 to 19.5 mm Hg for systolic pressure and 5.2 to 11.7 mm Hg for diastolic pressure.
• The reduction in blood pressure was accompanied by a decrease in heart rate, with significant reductions in heart rate observed in both studies 3, 4.