CLINICAL TRIALS PROFILE FOR BYSTOLIC

All Clinical Trials for BYSTOLIC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00673075 ↗	The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease	Completed	Forest Laboratories	Phase 4	2008-05-01	This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
NCT00829296 ↗	Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries	Completed	Forest Laboratories	Phase 2/Phase 3	2009-01-01	The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00829296 ↗	Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries	Completed	University of Chicago	Phase 2/Phase 3	2009-01-01	The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00893984 ↗	Alternative in Beta Blocker Intolerance: The ABBI Trial	Terminated	Forest Laboratories	Phase 4	2009-05-01	In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use. The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.
NCT00893984 ↗	Alternative in Beta Blocker Intolerance: The ABBI Trial	Terminated	Minneapolis Heart Institute Foundation	Phase 4	2009-05-01	In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use. The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.

Clinical Trial Conditions for BYSTOLIC

Condition Name

Condition Name for BYSTOLIC
Intervention	Trials
Hypertension	23
Coronary Artery Disease	2
Prehypertension	2
Healthy Subjects	2

Condition MeSH

Condition MeSH for BYSTOLIC
Intervention	Trials
Hypertension	21
Prehypertension	3
Myocardial Ischemia	2
Coronary Disease	2

Clinical Trial Locations for BYSTOLIC

Trials by Country

Trials by Country for BYSTOLIC
Location	Trials
United States	62

Trials by US State

Trials by US State for BYSTOLIC
Location	Trials
Florida	5
California	4
Tennessee	4
Georgia	4
Texas	4

Clinical Trial Progress for BYSTOLIC

Clinical Trial Phase

Clinical Trial Phase for BYSTOLIC
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for BYSTOLIC
Clinical Trial Phase	Trials
Completed	25
Terminated	4
Unknown status	1

Clinical Trial Sponsors for BYSTOLIC

Sponsor Name

Sponsor Name for BYSTOLIC
Sponsor	Trials
Forest Laboratories	23
University of Chicago	2
Torrent Pharmaceuticals Limited	2

Sponsor Type

Sponsor Type for BYSTOLIC
Sponsor	Trials
Other	30
Industry	26

BYSTOLIC Market Analysis and Financial Projection

Bystolic (Nebivolol): Clinical Trials, Market Analysis, and Projections

Introduction

Bystolic, also known as nebivolol, is a beta blocker approved for the treatment of hypertension. Here, we will delve into the clinical trials that have shaped its approval, analyze its market position, and project its future in the pharmaceutical landscape.

Clinical Trials and Efficacy

Monotherapy Studies

Bystolic has been extensively evaluated in several clinical trials to assess its efficacy and safety. Three pivotal Phase III studies involved 2016 patients with mild to moderate essential hypertension. These studies demonstrated that Bystolic, at doses ranging from 1.25 mg to 40 mg, significantly reduced both systolic and diastolic blood pressure compared to placebo. The antihypertensive effect was observed within two weeks of treatment and was maintained over the 24-hour dosing interval[3].

Combination Therapy

In addition to monotherapy, Bystolic has been studied in combination with other antihypertensive agents. A Phase 3 study combining Bystolic with lisinopril (an ACE inhibitor) showed a favorable benefit/risk profile, indicating that Bystolic can be effectively used in combination with ACE inhibitors[3].

Safety Profile

The safety profile of Bystolic has been well-documented. Common adverse reactions include headache, fatigue, nasopharyngitis, dizziness, diarrhea, and upper respiratory tract infections. These reactions were generally similar in frequency to those observed in placebo-treated patients, with some reactions like bradycardia and dizziness more likely at higher doses or shortly after initiating treatment[3].

Market Analysis

Market Players

The market for Bystolic is dominated by several key players, including Allergan plc (AbbVie Inc.), Mylan Laboratories, Actavis Generics (Teva), Zydus Healthcare Ltd, Eris lifesciences, Cipla ltd, Lupin ltd, Abbott, and Cadila Pharmaceuticals. These companies play a crucial role in the manufacturing, distribution, and marketing of Bystolic[2].

Market Trends

Bystolic was introduced to the market in January 2008 by Forest Laboratories, which had licensed the product from Mylan in 2006. Despite entering a crowded market with many generic beta blockers, Bystolic has carved out a niche due to its unique properties, such as greater tolerability and vasodilating qualities. This differentiation is expected to drive its use, particularly among patients who experience side effects like fatigue with traditional beta blockers[5].

Sales and Projections

The beta blocker market in the US has seen significant sales over the years. While Bystolic faces competition from established brands like Toprol-XL and Metoprolol, its unique features and targeted marketing strategies are expected to contribute to its growth. The North American market for Bystolic is projected to increase from its current value to a higher figure by 2030, at a compound annual growth rate (CAGR) during the forecast period[2].

Marketing Strategy

Forest Laboratories, the initial marketer of Bystolic, has adopted a distinct marketing approach. Instead of direct-to-consumer advertising, the company focuses heavily on physician education and outreach. This includes detailed interactions with prescribers through a large sales force, speaker programs, and journal advertising. This strategy aims to educate healthcare professionals about the benefits of Bystolic, particularly its low sedation level and efficacy in a broader patient population, including African Americans[5].

Competitive Landscape

Unique Selling Points

Bystolic stands out in the beta blocker market due to several unique features:

• Vasodilating Properties: Unlike traditional beta blockers, Bystolic has vasodilating effects, which contribute to its antihypertensive efficacy.
• Tolerability: It is known for its low sedation level, making it a preferred option for patients who experience fatigue with other beta blockers.
• Efficacy in Diverse Populations: Bystolic has shown efficacy in a broader group of patients, including African Americans, which is a significant advantage in a diverse patient population[5].

Comparison with Other Beta Blockers

Clinical trials have compared Bystolic with other antihypertensive agents like losartan, lisinopril, amlodipine, and nifedipine. These studies have shown that Bystolic is not inferior in terms of reducing both systolic and diastolic blood pressure. Its neutral metabolic effects and ability to maintain cardiac output also make it a favorable option for certain patient groups[4].

Future Projections

Market Growth

The global market for Bystolic is expected to grow, driven by increasing awareness of hypertension and the need for effective antihypertensive treatments. The North American market, in particular, is projected to see significant growth, with Bystolic expected to capture a substantial share due to its unique features and targeted marketing strategies[2].

Potential Indications

Bystolic is also being researched for the treatment of heart failure. While it has shown promise in this area, further studies are needed to fully establish its efficacy and safety in heart failure patients. If approved for this indication, it could significantly expand the market for Bystolic[5].

Key Takeaways

• Efficacy: Bystolic has been shown to be effective in reducing blood pressure in patients with mild to moderate hypertension.
• Safety: It has a favorable safety profile, with common adverse reactions similar to those of other beta blockers.
• Market Position: Bystolic differentiates itself through its vasodilating properties and low sedation level, making it a preferred option for certain patient groups.
• Growth Projections: The market for Bystolic is expected to grow, driven by its unique features and targeted marketing strategies.

FAQs

What is Bystolic used for?

Bystolic (nebivolol) is used for the treatment of hypertension to lower blood pressure.

What are the common side effects of Bystolic?

Common side effects include headache, fatigue, nasopharyngitis, dizziness, diarrhea, and upper respiratory tract infections.

Can Bystolic be used in combination with other antihypertensive agents?

Yes, Bystolic can be used alone or in combination with other antihypertensive agents, including ACE inhibitors and thiazide diuretics.

What makes Bystolic different from other beta blockers?

Bystolic has vasodilating properties and a low sedation level, making it more tolerable for some patients.

Is Bystolic being researched for other indications?

Yes, Bystolic is being researched for the treatment of heart failure, although further studies are needed to establish its efficacy and safety in this area.

Sources

1. Drugs.com: Bystolic: Package Insert / Prescribing Information.
2. Valuates Reports: Global Bystolic (Nebivolol) Market Research Report 2024.
3. Health Canada: Summary Basis of Decision for Bystolic.
4. European Society of Cardiology: Preferred beta-blockers for the treatment of heart failure.
5. MM+M: Bystolic - MM+M - Medical Marketing and Media.