CLINICAL TRIALS PROFILE FOR CARDIZEM

All Clinical Trials for Cardizem

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.
NCT00313157 ↗	RATe Control in Atrial Fibrillation	Completed	Asker & Baerum Hospital	Phase 3	2006-04-01	The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Abbott Medical Devices	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

Clinical Trial Conditions for Cardizem

Condition Name

Condition Name for Cardizem
Intervention	Trials
Atrial Fibrillation	4
Atrial Flutter	1
Pulmonary Arterial Hypertension	1
Diltiazim	1

Condition MeSH

Condition MeSH for Cardizem
Intervention	Trials
Atrial Fibrillation	4
Hypertension	2
Substance-Related Disorders	1
Heart Failure	1

Clinical Trial Locations for Cardizem

Trials by Country

Trials by Country for Cardizem
Location	Trials
United States	21
Canada	1
Norway	1

Trials by US State

Trials by US State for Cardizem
Location	Trials
Minnesota	2
Tennessee	2
West Virginia	1
Florida	1
Texas	1

Clinical Trial Progress for Cardizem

Clinical Trial Phase

Clinical Trial Phase for Cardizem
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Cardizem
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Cardizem

Sponsor Name

Sponsor Name for Cardizem
Sponsor	Trials
Mayo Clinic	2
Abbott Medical Devices	1
Duke Clinical Research Institute	1

Sponsor Type

Sponsor Type for Cardizem
Sponsor	Trials
Other	10
Industry	5

CARDIZEM (Diltiazem): Clinical Trials, Market Analysis, and Projections

Introduction

CARDIZEM, known generically as diltiazem, is a calcium channel blocker widely used in the management of various cardiovascular conditions. This article delves into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy of Diltiazem in Coronary Vasomotor Dysfunction

A significant clinical trial, the EDIT-CMD (Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: A Randomized Clinical Trial), investigated the effect of diltiazem on coronary vasomotor dysfunction in patients with nonobstructive coronary artery disease (ANOCA). The trial found that six weeks of diltiazem treatment did not substantially improve coronary microvascular dysfunction, symptoms, or quality of life compared to placebo. However, diltiazem did reduce the prevalence of epicardial spasm[1].

Post Infarction Trial

The Multicenter Diltiazem Post Infarction Trial (MDPIT) examined the impact of diltiazem on mortality and cardiac events in patients following myocardial infarction. The study, which enrolled 2,466 patients, showed that diltiazem resulted in 11% fewer first recurrent cardiac events (cardiac death or nonfatal reinfarction) compared to placebo, although this difference was not statistically significant[4].

Mechanism of Action and Indications

Diltiazem acts as a calcium ion cellular influx inhibitor, dilating coronary arteries and reducing myocardial oxygen demand. It is indicated for the management of chronic stable angina and angina due to coronary artery spasm. Additionally, diltiazem is effective for initial ventricular rate control in patients with atrial fibrillation[3].

Market Analysis

Current Market Size and Growth

The global diltiazem market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the growing geriatric population. As of 2021, the market size was estimated at US$ 369.95 million and is expected to reach US$ 832.51 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 12.3% during this period[2][5].

Market Segmentation

The diltiazem market is segmented by product type (capsules, injection, and tablets) and application (angina, hypertension, and others). In 2021, the tablets segment held the largest share of the market, while the capsules segment is expected to witness the fastest CAGR during the forecast period. The hypertension segment currently dominates the market by application, but the angina segment is anticipated to grow at the fastest CAGR in the coming years[2][5].

Regional Insights

North America dominated the global diltiazem market in 2020, driven by the high incidence of cardiovascular diseases and an aging population. The Asia Pacific region is also expected to see significant growth due to the rising prevalence of atrial fibrillation and other cardiovascular conditions[2][5].

Key Players

The diltiazem market includes major players such as Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer, Inc, Glenmark, Sandoz (Novartis Ag), Sun Pharmaceutical Company Ltd, Hikma Pharmaceuticals, and Zydus Pharmaceuticals. These companies are focusing on product innovations, market expansion, and customer acquisition to maintain their market presence[2][5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular diseases, particularly among the elderly, is a significant driver for the diltiazem market.
• Growing Geriatric Population: Structural and functional changes in the cardiovascular system associated with aging contribute to the increased demand for diltiazem[2][5].

Challenges

• Side Effects: The potential side effects of diltiazem, such as hypotension, bradycardia, and other adverse reactions, could hamper market growth[5].

Future Projections

Market Growth

The diltiazem market is expected to continue its robust growth trajectory, driven by the increasing demand for effective treatments for cardiovascular diseases. The market is projected to reach US$ 832.51 million by 2028, with a CAGR of 12.3% from 2021 to 2028[2][5].

Emerging Trends

• Product Innovations: Companies are likely to focus on developing new formulations and delivery systems to enhance patient compliance and efficacy.
• Geographical Expansion: The market is expected to expand in regions like Asia Pacific, where the prevalence of cardiovascular diseases is increasing rapidly[2][5].

Key Takeaways

• Clinical Trials: Recent trials indicate that while diltiazem may not significantly improve coronary microvascular dysfunction, it can reduce epicardial spasm and is effective in managing angina and atrial fibrillation.
• Market Growth: The diltiazem market is driven by the increasing prevalence of cardiovascular diseases and the growing geriatric population.
• Market Segmentation: The market is segmented by product type and application, with tablets and hypertension treatment being the dominant segments.
• Regional Insights: North America currently leads the market, but the Asia Pacific region is expected to see significant growth.
• Challenges: Potential side effects of diltiazem could impact market growth.

FAQs

What is the primary indication for CARDIZEM (diltiazem)?

CARDIZEM is primarily indicated for the management of chronic stable angina and angina due to coronary artery spasm, as well as for initial ventricular rate control in patients with atrial fibrillation[3].

What were the findings of the EDIT-CMD trial?

The EDIT-CMD trial found that six weeks of diltiazem treatment did not substantially improve coronary microvascular dysfunction, symptoms, or quality of life compared to placebo, but it did reduce the prevalence of epicardial spasm[1].

What is the projected market size of diltiazem by 2028?

The global diltiazem market is projected to reach US$ 832.51 million by 2028, growing at a CAGR of 12.3% from 2021 to 2028[2][5].

Which segment of the diltiazem market is expected to grow the fastest?

The angina segment is expected to grow at the fastest CAGR during the coming years, while the capsules segment by product type is also anticipated to witness significant growth[2][5].

What are the major drivers of the diltiazem market?

The major drivers include the increasing prevalence of cardiovascular diseases and the growing geriatric population, which lead to higher demand for diltiazem[2][5].

Sources

1. Efficacy of Diltiazem to Improve Coronary Vasomotor Dysfunction in ... - Journal of the American College of Cardiology[1].
2. Diltiazem Market Worth US$ 369.95 Million at 12.3% CAGR of by 2028 - PR Newswire[2].
3. Ditiazem Hydrochloride - Drug Targets, Indications, Patents - Synapse[3].
4. The Multicenter Diltiazem Post Infarction Trial - MDPIT - American College of Cardiology[4].
5. Diltiazem Market Size, Share & Growth Analysis by 2028 - The Insight Partners[5].