Introduction
Brevibloc, also known as esmolol hydrochloride, is a beta blocker used primarily to manage supraventricular tachycardia, noncompensatory sinus tachycardia, and perioperative tachycardia and hypertension. The Double Strength Premixed Injection is a formulation that offers a concentrated solution, making it a preferred option in clinical settings.
Clinical Trials Overview
Efficacy in Supraventricular Tachycardia
Clinical trials have demonstrated the efficacy of Brevibloc in managing supraventricular tachycardia. Studies showed that approximately 60-70% of patients treated with Brevibloc achieved a desired therapeutic effect, such as a 20% reduction in heart rate, a decrease in heart rate to less than 100 bpm, or conversion to normal sinus rhythm (NSR). The average effective dosage was around 100-115 mcg/kg/min[1][4].
Perioperative Tachycardia and Hypertension
In the perioperative setting, Brevibloc has been shown to effectively manage tachycardia and hypertension. In clinical trials involving 763 patients, Brevibloc was administered as a bolus or infusion, resulting in significant reductions in heart rate, rate pressure product, and cardiac index. Hypotension was the most commonly observed side effect, occurring in about 16% of patients receiving the bolus and 5% of those on infusion[2][4].
Comparison with Other Beta Blockers
Studies comparing Brevibloc with propranolol indicated similar effects on heart rate and blood pressure. However, Brevibloc produced a larger fall in systolic blood pressure during exercise. This suggests that Brevibloc is as effective as, if not more so than, other beta blockers in certain clinical scenarios[1].
Adverse Effects and Safety Profile
Common Adverse Reactions
The most common adverse effects associated with Brevibloc include hypotension, bradycardia, and infusion site reactions. Hypotension, both symptomatic and asymptomatic, was reported in a significant number of patients, with symptomatic hypotension occurring in about 12% of cases. However, hypotension resolved in 63% of patients during the infusion and in 80% of the remaining patients within 30 minutes after discontinuation[1][4].
Special Considerations
Brevibloc should be used with caution in patients with certain conditions, such as myasthenia gravis, where it can exacerbate muscle weakness. In patients with renal impairment, the excretion of the acid metabolite of esmolol is significantly decreased, which may affect the drug's efficacy and safety profile[2].
Market Analysis
Market Size and Revenue
As of 2013, the US market for Brevibloc was approximately $43 million. This figure indicates a significant market presence for the drug, particularly in the critical care and perioperative settings[5].
Competitive Landscape
The approval of generic versions of esmolol hydrochloride, such as the tentative approval of HQ Specialty Pharma's 505(b)(2) application, may impact the market share of Brevibloc. However, the unique formulation and stability of Brevibloc, as highlighted in Baxter's patents, continue to make it a preferred choice for many clinicians[3][5].
Projections and Future Outlook
Market Growth
Given the consistent demand for effective beta blockers in critical care and perioperative settings, the market for Brevibloc and its generic counterparts is expected to grow. The convenience and stability of the premixed injection formulations are likely to maintain a strong market presence.
Regulatory and Competitive Factors
The ongoing development and approval of generic esmolol hydrochloride products may introduce competition, but the established brand reputation and clinical efficacy of Brevibloc are expected to sustain its market position. Regulatory approvals and patent protections will continue to play a crucial role in shaping the market landscape[3][5].
Key Takeaways
- Clinical Efficacy: Brevibloc Double Strength Premixed Injection is highly effective in managing supraventricular tachycardia and perioperative tachycardia and hypertension.
- Safety Profile: Common adverse effects include hypotension and bradycardia, but these are generally transient and manageable.
- Market Presence: The US market for Brevibloc is substantial, with a revenue of approximately $43 million as of 2013.
- Future Outlook: The market is expected to grow, with Brevibloc maintaining a strong position due to its unique formulation and clinical efficacy.
FAQs
What is Brevibloc used for?
Brevibloc (esmolol hydrochloride) is used to manage supraventricular tachycardia, noncompensatory sinus tachycardia, and perioperative tachycardia and hypertension.
What are the common adverse effects of Brevibloc?
The most common adverse effects include hypotension, bradycardia, and infusion site reactions.
How does Brevibloc compare to other beta blockers?
Brevibloc has been shown to be as effective as, if not more so than, other beta blockers like propranolol in certain clinical scenarios.
What are the contraindications for Brevibloc?
Brevibloc is contraindicated in patients with severe sinus bradycardia, heart block greater than first degree, cardiogenic shock, and severe hypotension.
How is Brevibloc administered?
Brevibloc is administered intravenously, either as a bolus or continuous infusion, and is available in premixed injection formulations.
What is the impact of generic versions on the market for Brevibloc?
The approval of generic versions may introduce competition, but Brevibloc's established brand reputation and clinical efficacy are expected to sustain its market position.
Sources
- Brevibloc Premixed Injection Label - FDA.
- PRODUCT MONOGRAPH - BREVIBLOC Injection esmolol hydrochloride - Baxter.
- Baxter Healthcare Corp. v. Mylan Labs. Ltd. - Casetext.
- BREVIBLOC injection - FDA.
- Esmolol Hydrochloride Premixed Injection Tentatively Approved - WG Critical Care.
