The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease

November 4, 2024 updated by: Islam Abd El-aziz Hassan Mahmoud, Sohag University

The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease in a Low Income Community

the use of Statin in diabetic patients and its correlation to the guidelines recommendation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by hyperglycemia due to insulin resistance resulting in vascular complications. It accounts for approximately 75% of all atherosclerosis-related events.

Moreover, 65% of patients with diabetes die from any type of cardiovascular disease or stroke. Currently, lipid-lowering statin therapy is recommended for the primary prevention of atherosclerotic cardiovascular diseases, as well as for secondary prevention in DM patients with established cardiovascular disease.

The cardiovascular effects of statins extend beyond their effects on lipid fractions and include atherosclerotic plaque stabilization, anti-inflammatory effects, inhibition of vascular smooth muscle cell proliferation, inhibition of platelet function, and improved vascular endothelial function.

Diabetes mellitus (DM) increases cardiovascular disease (CVD) incidence and mortality. While guidelines endorse statin use in type 2 DM (T2DM) to mitigate cardiovascular risks and mortality, challenges like statin initiation and prompt treatment adjustments affect patient outcomes.

According to the ADA and ACC/AHA guidelines, moderate-intensity statin and lifestyle modifcations are recommended for all diabetic patients aged 40-75 without contraindication to statin therapy to achieve an LDL goal of less than 100 mg/dL. Furthermore, high-intensity statin therapy is recommended for patients with cardiovascular risk factors or overt cardiovascular disease to achieve the LDL goal of less than 70 mg/day.

Even though statins should be prescribed for diabetic patients (> 40) regardless of their LDL laboratory values, monitoring their LDL is needed because some patients may have high LDL values even though they are using statins. It is imperative to consider this because high LDL values build up fatty deposits in the arteries, which reduce blood flow, leading to an increased risk of heart attack.

For primary prevention, moderate-dose statin therapy is recommended for those aged $40 years although high-intensity therapy should be considered in the context of additional ASCVD risk factors. The evidence is strong for people with diabetes aged 40-75 years, an age-group well represented in statin trials showing benefit. Since cardiovascular risk is enhanced in people with diabetes, as noted above, individuals who also have multiple other coronary risk factors have increased risk, equivalent to that of those with ASCVD. Therefore, current guidelines recommend that in people with diabetes who are at higher cardiovascular risk, especially those with one or more ASCVD risk factors, high intensity statin therapy should be prescribed to reduce LDL cholesterol by $50% from baseline and to target an LDL cholesterol of <70 mg/dL (<1.8 mmol/L) Five categories for reasons for statin nonuse were finalized after manual annotation: statin-associated side effects/contraindication, guideline discordant clinician practice, clinical inertia, statin hesitancy, and nonspecific reasons. In addition to side effects attributed to prior statin use, if statins were avoided based on pre-existing comorbidities (such as liver disease) or perceived contraindications (including pregnancy) without a trial or challenge, these reasons were categorized within the side effects/contraindication category. This was done because of low individual frequencies for some of these reasons and to comply with privacy regulations that prevent the reporting of groups with fewer than 10 patients. Clinicians avoiding statin use based on lipid levels was considered guideline-discordant practice, given that statin indications for diabetes are primarily independent of lipid levels. Deferral of statin decisions to future visits despite their indications was considered clinical inertia. Statin hesitancy was noted when patients expressed a preference to avoid statins despite discussion of their indication. Nonspecific documentation was recorded when statin nonuse was documented without additional explanation.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Usama M Abdelaal, Professor
  • Phone Number: 00201065962094

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag University Hospital
        • Contact:
          • Usama M Abdelaal, Professor
          • Phone Number: 00201065962094
        • Contact:
          • Ahmed M Aly, Assoc. professor
          • Phone Number: 00201011145537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Use of Statin in diabetic patients and its correlation to the guidelines recommendation.

Description

Inclusion Criteria:

  • All diabetic > 18 years.

Exclusion Criteria:

  • Diabetic Patients with known to have Atherosclerotic cardiovascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in lipid profile in response to treatment with statin in diabetc patients
Time Frame: 12 Weeks
Guidelines endorse statin use in Type 2 Diabetes Mellitus (T2DM) to mitigate cardiovascular risks and mortality.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Statin in diabetic patient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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