CLINICAL TRIALS PROFILE FOR LOPRESSOR

All Clinical Trials for LOPRESSOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00246519 ↗	Pharmacogenomic Evaluation of Antihypertensive Responses	Completed	University of Florida	Phase 4	2005-10-01	There are many medications available for the treatment of high blood pressure (hypertension), but finding the right one for a specific patient can be challenging. In fact, it is estimated that only 34% of people with hypertension have their blood pressure under control. The hypothesis is that genetic differences between individuals influence their response to antihypertensive medications. This study is aimed at determining the genetic factors that may influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their blood pressure medicine, leading to better control of blood pressure, and less need for the current trial and error process.
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	GlaxoSmithKline	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	St. Paul Heart Clinic	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
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.

Clinical Trial Conditions for LOPRESSOR

Condition Name

Condition Name for LOPRESSOR
Intervention	Trials
Hypertension	11
Healthy	6
Atrial Fibrillation	5
Atrial Flutter	2

Condition MeSH

Condition MeSH for LOPRESSOR
Intervention	Trials
Hypertension	10
Atrial Fibrillation	5
Atrial Flutter	2
Pure Autonomic Failure	2

Clinical Trial Locations for LOPRESSOR

Trials by Country

+

−

Trials by Country for LOPRESSOR
Location	Trials
United States	31
Canada	4
France	1

Trials by US State

+

−

Trials by US State for LOPRESSOR
Location	Trials
Minnesota	4
West Virginia	3
Florida	3
Tennessee	3
Nebraska	2

Clinical Trial Progress for LOPRESSOR

Clinical Trial Phase

Clinical Trial Phase for LOPRESSOR
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LOPRESSOR
Clinical Trial Phase	Trials
Completed	19
Terminated	3
Unknown status	2

Clinical Trial Sponsors for LOPRESSOR

Sponsor Name

Sponsor Name for LOPRESSOR
Sponsor	Trials
Mylan Pharmaceuticals	4
Forest Laboratories	4
Vanderbilt University	3

Sponsor Type

Sponsor Type for LOPRESSOR
Sponsor	Trials
Other	26
Industry	13
NIH	3

LOPRESSOR (Metoprolol Tartrate): Clinical Trials, Market Analysis, and Projections

Introduction

LOPRESSOR, also known as metoprolol tartrate, is a beta-adrenergic receptor blocking agent widely used in the treatment of various cardiovascular conditions. This article will delve into the clinical trials, market analysis, and future projections for this drug.

Mechanism of Action and Clinical Pharmacology

LOPRESSOR works by selectively blocking beta1 adrenoreceptors, primarily located in the cardiac muscle. This action reduces heart rate, cardiac output, and systolic blood pressure, especially during exercise. It also inhibits isoproterenol-induced tachycardia and reflex orthostatic tachycardia. While it has preferential beta1 selectivity, at higher doses, it can also affect beta2 adrenoreceptors in the bronchial and vascular musculature[1].

Clinical Trials

Antianginal and Antihypertensive Effects

In controlled clinical trials, LOPRESSOR has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. These trials involved dosages ranging from 100-400 mg daily, administered two or four times a day[1].

Post-Myocardial Infarction Treatment

A significant double-blind, placebo-controlled clinical study demonstrated that LOPRESSOR reduced 3-month mortality by 36% in patients with suspected or definite myocardial infarction. This study involved early intravenous followed by oral administration of LOPRESSOR, showing significant reductions in ventricular fibrillation and chest pain[1].

Lopressor Intervention Trial (LIT)

The LIT was a multicentre study designed to evaluate the effect of oral metoprolol on overall mortality in patients surviving a recent acute myocardial infarction. Although the study was prematurely terminated due to low patient enrollment, it showed a trend towards reduced mortality in the metoprolol group compared to the placebo group[3].

Obstructive Hypertrophic Cardiomyopathy (HCM)

A randomized, double-blind, placebo-controlled crossover trial (TEMPO) investigated the effects of metoprolol in patients with obstructive HCM. The study found that metoprolol reduced left ventricular outflow tract (LVOT) obstruction at rest and during exercise, provided symptom relief, and improved quality of life without affecting maximum exercise capacity[4].

Market Analysis

Global Market Size and Growth

The global metoprolol tartrate market was valued at approximately $6,101.4 million in 2022 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 3.3% over the forecast period. This growth is driven by increasing prevalence of cardiovascular diseases, such as hypertension, angina, and heart failure[2].

Market Segmentation

The market is segmented by mode of administration, with oral and injectable forms being the primary categories. The oral form is more commonly used due to its ease of administration and patient compliance. Geographically, the Asia-Pacific region is expected to account for the largest share of the market due to a large patient population and increasing healthcare expenditure[5].

Competitive Landscape

The metoprolol tartrate market is highly competitive, with several generic and branded versions available. Key players in the market focus on improving formulation, enhancing patient compliance, and expanding their distribution networks to capture a larger market share.

Future Projections

Increasing Demand for Cardiovascular Treatments

The growing prevalence of cardiovascular diseases, coupled with an aging population and lifestyle changes, is expected to drive the demand for metoprolol tartrate. Advances in healthcare infrastructure and increased access to medications in developing countries will also contribute to market growth.

Innovations in Formulations

Future innovations in drug formulations, such as extended-release versions and combination therapies, are likely to enhance the market. These advancements can improve patient compliance and efficacy, further boosting the market size.

Regulatory Environment

Regulatory approvals and guidelines will continue to play a crucial role in shaping the market. Stringent regulatory standards ensure the safety and efficacy of metoprolol tartrate, which is essential for maintaining public trust and driving market growth.

Key Takeaways

• Clinical Efficacy: LOPRESSOR has been proven effective in reducing angina attacks, improving exercise tolerance, and lowering mortality in post-myocardial infarction patients.
• Market Growth: The global metoprolol tartrate market is expected to grow at a CAGR of 3.3%, driven by increasing demand for cardiovascular treatments.
• Market Segmentation: Oral forms dominate the market, with the Asia-Pacific region expected to be the largest market segment.
• Future Innovations: Advances in formulations and combination therapies are anticipated to enhance patient compliance and efficacy.

FAQs

What is the primary mechanism of action of LOPRESSOR?

LOPRESSOR works by selectively blocking beta1 adrenoreceptors, primarily located in the cardiac muscle, reducing heart rate, cardiac output, and systolic blood pressure[1].

What are the key clinical trials that have demonstrated the efficacy of LOPRESSOR?

Key trials include studies showing its effectiveness as an antianginal agent, its role in reducing mortality post-myocardial infarction, and its benefits in patients with obstructive hypertrophic cardiomyopathy[1][3][4].

What is the current market size and growth rate of the metoprolol tartrate market?

The global metoprolol tartrate market was valued at approximately $6,101.4 million in 2022 and is expected to grow at a CAGR of 3.3%[2].

Which region is expected to dominate the metoprolol tartrate market?

The Asia-Pacific region is expected to account for the largest share of the market due to a large patient population and increasing healthcare expenditure[5].

What are the potential future innovations in the metoprolol tartrate market?

Future innovations include extended-release versions, combination therapies, and improvements in patient compliance and efficacy[5].

Sources

1. LOPRESSOR (metoprolol tartrate) tablet - FDA Label.
2. Metoprolol Tartrate Market Size, Share, Technological - OpenPR.
3. The Lopressor Intervention Trial: multicentre study of metoprolol in - PubMed.
4. Randomized Trial of Metoprolol in Patients With Obstructive - PubMed.
5. Metoprolol Tartrate Market Generated Opportunities, Future - OpenPR.