CLINICAL TRIALS PROFILE FOR NITROGLYCERIN IN DEXTROSE 5%

All Clinical Trials for Nitroglycerin In Dextrose 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000503 ↗	Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1982-08-01	To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction.
NCT00001716 ↗	Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia	Completed	National Institutes of Health Clinical Center (CC)	Phase 2	1998-07-01	Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels and cause pain and injury to organs. Some of the complications caused by the sticking of blood cells are called acute pain crisis and acute chest syndrome (ACS). Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle cell hemoglobin molecules, thereby improving blood flow through small vessels. This study is designed to evaluate the effects of NO, when taken in combination with a drug called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects of these two drugs only last while the patient is receiving them. Researchers hope the information learned from this study will help to develop new therapies for sickle cell anemia.
NCT00034060 ↗	The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	2002-04-01	This study has two phases. Phase 1 will examine the role of inflammatory mediators called cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for the treatment of RA. It lowers the levels of a key inflammatory mediator called tumor necrosis factor-alpha and is very effective in reducing arthritis symptoms. Growth hormone promotes bone and muscle growth. With aging, people lose muscle mass and bone strength, possibly because of decreased levels of growth hormone. People with RA have bone and muscle changes similar to those in older people, perhaps also due to decreased levels of growth hormone. The first part of this study will see if the inflammatory mediators responsible for joint inflammation (warmth, redness, pain, and swelling) in RA are related to the lowered growth hormone levels in this disease. The second part will evaluate the effect of etanercept treatment on muscle mass and bone density, in addition to growth hormone levels. Premenopausal women between 18 and 55 years of age with a recent diagnosis of rheumatoid arthritis (less than 3 years) are eligible for this study. Healthy volunteers will also be enrolled in the first phase of the study as control subjects. This study is conducted at two sites, the NIH and the Johns Hopkins Medical Center in Baltimore. Healthy volunteers enrolled in this study will be interviewed about their health status and will fill out questionnaires on diet and general physical function, including fatigue, energy and well being. In addition, they will be hospitalized once at the NIH Clinical Center for 24-hour blood sampling and will visit to Johns Hopkins Medical Center in Baltimore for a brachial artery reactivity study, as follows: - 24-hour blood sampling for growth hormone levels. Blood samples (1/2 teaspoon each) will be collected every 20 minutes from 8 AM one day until 8 AM the following day through a plastic tube in an arm vein. - Dual energy X-ray absorptiometry (DEXA) scan on a small area of the spine, hip and wrist to assess bone density and a total body DEXA scan to assess the amount and distribution of muscle and body fat. - Blood vessel (brachial artery reactivity) study to measure the ability of the brachial artery to dilate and increase its blood flow. For this procedure, the subject lies on a table with electrocardiogram leads attached to the chest. A blood pressure cuff is inflated for several minutes and a drop of nasal spray of nitroglycerin is given that may cause a headache. Blood pressure and headache are monitored and treated as needed. Patients with rheumatoid arthritis will be seen at the NIH clinic on six separate visits (weeks 0, 1, 6, 12, 18, and 26) over 26 weeks. Week 0 is a screening visit. At weeks 1 and 26, patients will be admitted to the hospital for 24-hour blood sampling, DEXA scans, and brachial artery reactivity tests, as described above, plus X-rays of the hand and feet. After the first visit, they will start taking etanercept, given by self-injection under the skin (like insulin shots) twice a week. Follow-up visits at weeks 6, 12, and 18 will involve evaluations of disease activity and drug side effects through joint examination, blood tests, and questionnaires.
NCT00043719 ↗	Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	2002-07-01	Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women. Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.

Clinical Trial Conditions for Nitroglycerin In Dextrose 5%

Condition Name

Condition Name for Nitroglycerin In Dextrose 5%
Intervention	Trials
Hypertension	9
Coronary Artery Disease	8
Heart Failure	5
Raynaud's Disease	5

Condition MeSH

Condition MeSH for Nitroglycerin In Dextrose 5%
Intervention	Trials
Coronary Artery Disease	15
Myocardial Ischemia	15
Hypertension	13
Coronary Disease	12

Clinical Trial Locations for Nitroglycerin In Dextrose 5%

Trials by Country

Trials by Country for Nitroglycerin In Dextrose 5%
Location	Trials
United States	175
Egypt	17
Canada	16
China	10
Mexico	9

Trials by US State

Trials by US State for Nitroglycerin In Dextrose 5%
Location	Trials
California	20
New York	10
Texas	9
Ohio	9
Maryland	9

Clinical Trial Progress for Nitroglycerin In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Nitroglycerin In Dextrose 5%
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	29
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for Nitroglycerin In Dextrose 5%
Clinical Trial Phase	Trials
Completed	108
Unknown status	26
Recruiting	23

Clinical Trial Sponsors for Nitroglycerin In Dextrose 5%

Sponsor Name

Sponsor Name for Nitroglycerin In Dextrose 5%
Sponsor	Trials
MediQuest Therapeutics	9
Vanderbilt University	6
National Heart, Lung, and Blood Institute (NHLBI)	5

Sponsor Type

Sponsor Type for Nitroglycerin In Dextrose 5%
Sponsor	Trials
Other	209
Industry	44
NIH	12

Nitroglycerin in 5% Dextrose: Clinical Trials, Market Analysis, and Projections

Introduction

Nitroglycerin in 5% Dextrose Injection is a vasodilator used in various clinical settings, including the management of perioperative hypertension, heart failure in acute myocardial infarction, and treatment of angina pectoris. This article provides an update on clinical trials, market analysis, and projections for this drug.

Clinical Pharmacology

Nitroglycerin in 5% Dextrose works by relaxing vascular smooth muscle, particularly reducing oxygen demand rather than increasing myocardial oxygen supply. It achieves this through the dilation of veins, which promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure. Additionally, it reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure through arteriolar relaxation, and it dilates coronary arteries[1][2][4].

Clinical Trials

Clinical trials on nitroglycerin in 5% dextrose have primarily focused on its hemodynamic effects during surgical procedures. One notable study indicated that continuous intravenous nitroglycerin lost almost all of its hemodynamic effect after 48 hours, suggesting a potential for tolerance development. However, intermittent administration (e.g., 12 hours out of every 24) maintained its efficacy without significant attenuation[2][4].

Rebound and Withdrawal Effects

Some trials have observed rebound or withdrawal effects, where patients experienced increased anginal attacks and decreased exercise tolerance during nitrate-free intervals. The clinical significance of these findings is still under investigation[1][4].

Safety and Efficacy

While blinded, placebo-controlled trials are limited, open-label studies have consistently shown the efficacy of nitroglycerin in 5% dextrose for its indicated uses. However, the drug is contraindicated in patients with pericardial tamponade, restrictive cardiomyopathy, constrictive pericarditis, and increased intracranial pressure[2][4].

Indications and Usage

Nitroglycerin in 5% Dextrose Injection is indicated for several critical clinical scenarios:

• Perioperative Hypertension: Control of blood pressure during and after surgical procedures, especially cardiovascular surgeries.
• Heart Failure: Management of congestive heart failure in the setting of acute myocardial infarction.
• Angina Pectoris: Treatment of angina in patients who have not responded to conventional antianginal agents.
• Intraoperative Hypotension: Induction of controlled hypotension during surgery[1][2][4].

Market Analysis

Current Market

The market for nitroglycerin in 5% dextrose is driven by its critical role in managing acute cardiovascular conditions. The demand is steady, particularly in hospital settings where it is used for perioperative care and in intensive care units for managing heart failure and angina.

Competitive Landscape

The vasodilator market is competitive, with various nitrates and other vasodilators available. However, nitroglycerin in 5% dextrose maintains a strong position due to its specific indications and the reliability of its formulation.

Pricing and Accessibility

The pricing of nitroglycerin in 5% dextrose can vary based on concentration and volume, but it generally remains within a range that is accessible for hospital use. The cost-effectiveness, especially in critical care settings, contributes to its market stability[2][4].

Projections

Future Demand

The demand for nitroglycerin in 5% dextrose is expected to remain stable or increase slightly due to the growing need for effective perioperative and critical care medications. Advances in surgical procedures and an aging population with increased cardiovascular risks are likely to drive this demand.

Technological Advancements

Improvements in infusion technology and the development of more precise dosing systems could enhance the efficacy and safety of nitroglycerin in 5% dextrose. Nonadsorptive tubing, for example, has been recommended to ensure accurate dosing and minimize the risk of tolerance development[3][4].

Regulatory Considerations

Regulatory oversight, such as the FDA's monitoring of product potency and safety, is crucial for maintaining market confidence. Any recalls or warnings, such as those related to sub-potency issues, can impact market dynamics but are typically addressed through stringent quality control measures[5].

Adverse Effects and Safety Considerations

Common Adverse Effects

Common adverse effects include hypotension, headache, and dizziness. Rare but serious adverse effects can include methemoglobinemia and dyspnea[2][4].

Contraindications

Nitroglycerin in 5% Dextrose is contraindicated in patients allergic to it, those with pericardial tamponade, restrictive cardiomyopathy, constrictive pericarditis, and increased intracranial pressure[2][4].

Dosage and Administration

The drug is administered intravenously using an infusion pump to maintain a constant infusion rate. The initial adult dosage is typically 5 mcg/min, with subsequent titration guided by clinical response. It is crucial to use nonadsorptive tubing to avoid dose attenuation[3][4].

Key Takeaways

• Clinical Pharmacology: Nitroglycerin in 5% Dextrose works by reducing oxygen demand and dilating vascular smooth muscle.
• Clinical Trials: Trials show efficacy but also potential for tolerance development with continuous use.
• Indications: Used for perioperative hypertension, heart failure in acute myocardial infarction, angina pectoris, and intraoperative hypotension.
• Market Analysis: Steady demand driven by critical care needs, with a competitive but stable market position.
• Projections: Expected stable or increasing demand due to growing surgical and critical care needs.
• Safety Considerations: Common adverse effects include hypotension and headache; contraindicated in certain cardiac and intracranial conditions.

FAQs

What are the primary indications for Nitroglycerin in 5% Dextrose Injection?

Nitroglycerin in 5% Dextrose Injection is indicated for the control of perioperative hypertension, management of heart failure in acute myocardial infarction, treatment of angina pectoris, and induction of intraoperative hypotension[1][2][4].

Can Nitroglycerin in 5% Dextrose cause tolerance or rebound effects?

Yes, continuous intravenous administration of nitroglycerin in 5% dextrose can lead to tolerance, and rebound or withdrawal effects have been observed during nitrate-free intervals[1][4].

What are the contraindications for Nitroglycerin in 5% Dextrose Injection?

The drug is contraindicated in patients with pericardial tamponade, restrictive cardiomyopathy, constrictive pericarditis, increased intracranial pressure, and those allergic to nitroglycerin[2][4].

How is Nitroglycerin in 5% Dextrose typically administered?

It is administered intravenously using an infusion pump to maintain a constant infusion rate, with an initial adult dosage of 5 mcg/min and subsequent titration based on clinical response[3][4].

What are the common adverse effects of Nitroglycerin in 5% Dextrose Injection?

Common adverse effects include hypotension, headache, and dizziness. Rare but serious adverse effects can include methemoglobinemia and dyspnea[2][4].

Sources

1. Baxter Canada. PRODUCT MONOGRAPH NITROGLYCERIN IN 5% DEXTROSE INJECTION.
2. Drugs.com. Nitroglycerin in Dextrose: Package Insert / Prescribing Info.
3. American Journal of Health-System Pharmacy. Index to Volume 35.
4. Baxter PI. Nitroglycerin in 5% Dextrose Injection.
5. FDA. Search results for Nitroglycerin.