CLINICAL TRIALS PROFILE FOR LOPRESSOR HCT

All Clinical Trials for Lopressor Hct

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

Clinical Trial Conditions for Lopressor Hct

Condition Name

Condition Name for Lopressor Hct
Intervention	Trials
Hypertension	11
Healthy	6
Atrial Fibrillation	5

Condition MeSH

Condition MeSH for Lopressor Hct
Intervention	Trials
Hypertension	10
Atrial Fibrillation	5
Pure Autonomic Failure	2

Clinical Trial Locations for Lopressor Hct

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Lopressor Hct

Clinical Trial Phase

Clinical Trial Phase for Lopressor Hct
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

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

Clinical Trial Sponsors for Lopressor Hct

Sponsor Name

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

Sponsor Type

Sponsor Type for Lopressor Hct
Sponsor	Trials
Other	26
Industry	13
NIH	3

LOPRESSOR HCT: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to LOPRESSOR HCT

LOPRESSOR HCT is a fixed-dose combination drug that combines metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, and hydrochlorothiazide, a diuretic. This combination is used for the management of hypertension and offers the antihypertensive effects of both components[1][4].

Clinical Trials and Efficacy

Antihypertensive Effectiveness

In controlled clinical studies, LOPRESSOR HCT has been shown to be an effective antihypertensive agent when used alone or in conjunction with other therapies. The combination of metoprolol tartrate and hydrochlorothiazide has been demonstrated to reduce blood pressure effectively, with the onset of action of thiazides occurring within 2 hours and the peak effect at about 4 hours, persisting for approximately 6-12 hours[1].

Beta1 Selectivity and Safety

Metoprolol tartrate in LOPRESSOR HCT has been confirmed to have relative beta1 selectivity, which reduces the risk of adverse effects on beta2 receptors, such as those seen in asthmatic patients. This selectivity is crucial for minimizing the impact on respiratory function compared to nonselective beta blockers[1].

Pregnancy and Safety Concerns

There are no adequate and well-controlled studies of LOPRESSOR HCT in pregnant women. However, animal studies have shown increased postimplantation loss and decreased postnatal survival at high doses. Therefore, LOPRESSOR HCT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus[1].

Market Analysis

Market Size and Growth

The metoprolol tartrate market, which includes LOPRESSOR HCT, is projected to grow significantly. By 2027, the market size is estimated to reach $868.3 million, growing at a CAGR of 5.2% during the forecast period 2022-2027. This growth is driven by the increasing prevalence of cardiovascular diseases and the expanding elderly population[2].

Geographical Distribution

North America currently holds the highest revenue share in the metoprolol tartrate market and is expected to continue dominating the market over the forecast period. The Asia-Pacific region, however, is estimated to have the fastest CAGR due to the increasing application of metoprolol tartrate for treating hypertension and other cardiovascular conditions[2].

Competitive Landscape

The antihypertensive drugs market, which includes LOPRESSOR HCT, is highly competitive with various fixed-dose combinations available. Other notable combinations include olmesartan and amlodipine (Azor), valsartan and amlodipine (Exforge), and losartan and hydrochlorothiazide (Cozaar/Hyzaar)[5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Cardiovascular Diseases: The growing number of patients with hypertension and other cardiovascular conditions is a significant driver for the metoprolol tartrate market.
• Sedentary Lifestyle: The increasing sedentary lifestyle, particularly among the elderly, contributes to the rising demand for antihypertensive medications.
• Convenience of Fixed-Dose Combinations: Fixed-dose combinations like LOPRESSOR HCT offer reduced tablet burdens, simplified medication regimens, and improved adherence, which are attractive to both patients and healthcare providers[2][3].

Challenges

• Side Effects: The rising side effects associated with metoprolol tartrate, such as bradycardia, worsening cardiac failure, and bronchospastic disease, are major challenges.
• Regulatory Constraints: Binding government regulations on metoprolol tartrate also hamper the market growth[2].

Pharmacokinetics and Interactions

Distribution and Elimination

Hydrochlorothiazide in LOPRESSOR HCT has a volume of distribution of 3.6-7.8 L/kg and is 67.9% plasma protein bound. It is eliminated from plasma in a biphasic fashion with a terminal half-life of 10-17 hours[1][4].

Interactions

LOPRESSOR HCT can interact with various drugs, including catecholamine-depleting drugs, strong CYP2D6 inhibitors, digitalis, clonidine, and other antihypertensives. These interactions can potentiate the effects of LOPRESSOR HCT or increase the risk of adverse reactions[4].

Key Takeaways

• Efficacy: LOPRESSOR HCT is an effective antihypertensive agent with a combination of metoprolol tartrate and hydrochlorothiazide.
• Market Growth: The metoprolol tartrate market is projected to grow at a CAGR of 5.2% until 2027.
• Geographical Dominance: North America currently dominates the market, but the Asia-Pacific region is expected to grow rapidly.
• Drivers and Challenges: Increasing cardiovascular diseases and sedentary lifestyles drive the market, while side effects and regulatory constraints pose challenges.
• Pharmacokinetics and Interactions: Understanding the pharmacokinetics and potential interactions of LOPRESSOR HCT is crucial for safe and effective use.

Frequently Asked Questions (FAQs)

What is LOPRESSOR HCT used for?

LOPRESSOR HCT is used for the management of hypertension. It combines metoprolol tartrate, a beta blocker, and hydrochlorothiazide, a diuretic[1].

What are the benefits of fixed-dose combinations like LOPRESSOR HCT?

Fixed-dose combinations like LOPRESSOR HCT offer reduced tablet burdens, simplified medication regimens, and improved adherence[3].

What are the potential side effects of LOPRESSOR HCT?

Potential side effects include bradycardia, worsening cardiac failure, bronchospastic disease, and interactions with other medications[4].

Is LOPRESSOR HCT safe during pregnancy?

There are no adequate and well-controlled studies of LOPRESSOR HCT in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus[1].

How does the pharmacokinetics of hydrochlorothiazide in LOPRESSOR HCT affect its use?

Hydrochlorothiazide in LOPRESSOR HCT has a terminal half-life of 10-17 hours and is 67.9% plasma protein bound. Its pharmacokinetics can be affected by factors such as food intake and congestive heart failure[1][4].

Cited Sources

1. Lopressor HCT® - accessdata.fda.gov
2. Metoprolol Tartrate Market Size Report, 2022-2027 - IndustryARC
3. DECISION PAPER - Health.mil
4. LOPRESSOR HCT Prescription & Dosage Information - eMPR.com
5. Antihypertensive Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst.com