Lansoprazole for Endothelial Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University, Stanford, CA
Endothelial Dysfunction
Lansoprazole - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called a proton pump inhibitor (PPI) can increase levels of a marker of endothelial dysfunction called asymmetric dimethylarginine (ADMA).

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Endothelial Dysfunction

Study Objectives

This trial is evaluating whether Lansoprazole will improve 1 primary outcome and 1 secondary outcome in patients with Endothelial Dysfunction. Measurement will happen over the course of Baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks.

Week 12
Change in blood ADMA level
Change in reactive hyperemia index as measured by peripheral arterial tonometry (EndoPAT)

Trial Safety

Safety Progress

1 of 3

Other trials for Endothelial Dysfunction

Side Effects for

TAK-438 20 mg
Pepsinogen test positive
25%
Blood gastrin increased
21%
Pepsinogen I increased
20%
Alanine aminotransferase increased
5%
Dysgeusia
2%
Meningitis
1%
Gastric cancer
1%
Appendicitis
1%
Liver abscess
0%
Angina pectoris
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03050307) in the TAK-438 20 mg ARM group. Side effects include: Pepsinogen test positive with 25%, Blood gastrin increased with 21%, Pepsinogen I increased with 20%, Alanine aminotransferase increased with 5%, Dysgeusia with 2%.

Trial Design

2 Treatment Groups

Proton Pump Inhibitor
1 of 2
Vitamin pill
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lansoprazole is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Proton Pump Inhibitor
Drug
Lansoprazole (Prevacid)
Vitamin pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lansoprazole
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 1 week, 5 weeks, 7 weeks, 11 weeks, 12 weeks for reporting.

Closest Location

Stanford University - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Can communicate effectively with the investigator and their representatives. show original
is considered normal Normal body mass index is between 18 kg/m^2 and 35 kg/m^2. show original
Healthy male or female volunteers aged 18 to 75 years (n=10) or male or female volunteers with a history of coronary or peripheral artery disease (n=10)
, all patients were included in the study show original

Patient Q&A Section

What causes endothelial dysfunction?

"Current research indicates a correlation between coronary atherosclerosis and endothelial dysfunction. The exact mechanisms by which these two factors are causally related are still not known. Further, the pathogenesis of endothelial dysfunction in atherosclerosis is complex and uncertain." - Anonymous Online Contributor

Unverified Answer

What is endothelial dysfunction?

"ED is common in both elderly men and women. In elderly women it was linked to CVD, as well as with the risk of stroke or CVD in elderly men. The reasons for ED in elderly patients are not fully understood." - Anonymous Online Contributor

Unverified Answer

What are the signs of endothelial dysfunction?

"The current results suggest that endothelial dysfunction, as well as other vascular diseases, may be associated with increased risk of breast and colorectal cancer. However, the underlying mechanisms between these diseases should be investigated further." - Anonymous Online Contributor

Unverified Answer

How many people get endothelial dysfunction a year in the United States?

"Around 565,000 cases of the condition were diagnosed each year. By 2030, the US population is expected to reach about 1.2% of the adult male population, and will make approximately 37,000 new diagnoses of the endothelial dysfunction condition by the year 2030." - Anonymous Online Contributor

Unverified Answer

What are common treatments for endothelial dysfunction?

"Typical endothelial dysfunction is treated with a variety of atherosclerosis preventive agents and medications such as aspirin, statins, and ACE inhibitors. In some cases, vascular surgery is required to treat or prevent a chronic ischemic process such as peripheral artery disease or carotid stenosis. Rarely, patients present with acute myocardial infarction (heart attack), and surgical revascularization is required to salvage the heart." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of lansoprazole?

"The common side effects of lansoprazole, in a large cohort of patients from different ethnic backgrounds, can be reliably divided into either gastrointestinal side effects (nausea/vomiting, flatulence, diarrhea, epigastric pain/distension), or non-gastrointestinal side effects (increased blood triglyceride levels, weight gain, and headache)." - Anonymous Online Contributor

Unverified Answer

Does endothelial dysfunction run in families?

"Results from a recent paper provides compelling genetic evidence in a large family demonstrating that endothelial dysfunction (ED), also known as early atherosclerotic process (EAPP), is a heritable disorder with a known genetic basis. We present a unique family in which ED in four siblings is associated with abnormal flow phenomena at the vascular bed of major vessel walls. These data support the notion that ED is an early manifestation of atherosclerotic disease." - Anonymous Online Contributor

Unverified Answer

What does lansoprazole usually treat?

"Most of the patients were H. pylori negative. There was a significant correlation between age and aspirin use at the time of diagnosis. Only one patient required a colonoscopy; none of the patients was eligible for the colonoscopy. There was also a significant correlation between aspirin use and the time of colonoscopy in the case of aspirin use. It is unlikely that lansoprazole has any beneficial effect on colitis." - Anonymous Online Contributor

Unverified Answer

Is lansoprazole typically used in combination with any other treatments?

"In most cases, patients with erosive oesophageal disease were prescribed lansoprazole in combination with other OATs in our study. This may be due to its efficacy, tolerability, and potential for being less expensive than the other most commonly prescribed OAT." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets endothelial dysfunction?

"endoluminal endothelial function is a marker of arterial wall disease in a wide variety of patients of differing age. Endothelial dysfunction has become an established and useful tool to identify asymptomatic individuals with an increased risk of future cardiovascular events. Clinicians should be vigilant of this high-yield tool to further improve the cardiovascular risk profile of patients at high CV risk." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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