Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-03-31

Brief Summary

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The primary end point was to reduce LDL-C levels by at least 50%, while the secondary end point was to achieve an LDL-C level below 55 mg/dL. The incidence and specifics of side effects and laboratory abnormalities were recorded throughout the follow-up period to evaluate safeguarding. Liver function tests were performed at baseline and 12 weeks later. Any muscle-related complaints were noted at baseline and during the 12-week sessions. CK total and Hba1c were also assessed

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Detailed Description

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CVD are the world's leading cause of death. Egypt has the largest population among the MENA countries, ranks the 2nd in the region for CVD, accounting for 268.11 deaths, or 32.40% of all deaths. Egypt is also ranked 15th globally for cardiovascular mortality.

The total economic costs from non-communicable illnesses in low- and middle-income countries (LMICs) are anticipated to surpass $7 trillion, representing approximately 4% of their annual output. An estimated $25 billion yearly might be saved by a 10% decrease in mortality from IHD greatly paying the expenses of preventative programs The 2019 and 2023 ESC guidelines state that individuals with ACS should aim for a target LDL-C level of \< 55 mg/dL (less than 1.4 mmol/L) and achieve a decrease in LDL-C of at least 50% from the initial level

High-intensity statin regimens are medications that decrease LDL-C concentrations by a minimum of 50% . Some examples of high-intensity regimens include rosuvastatin administered at a dose of 20-40 mg and atorvastatin administered at a dose of 40-80.

Statins have been proven to be safe and well-tolerated in managing ACS. However, high-dose statins occasionally resulted in increased in liver transaminases, particularly ALT, and an elevated frequency of ADR. In addition, the muscular symptoms associated with statin use include clinical rhabdomyolysis and myalgia .

Comparing the effects of high-intensity statins in patients who are globalized after ACS, a topic of numerous investigations recently, rosuvastatin appears to decrease LDL-C levels more effectively than atorvastatin. However, no clinical studies have investigated this issue at Assiut University Heart Hospital. Consequently, this investigation aimed to evaluate the effectiveness and safety of atorvastatin 40 mg and rosuvastatin 20 mg in Egyptian patients who had experienced ACS.

Conditions

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Acute Coronary Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The first group=atorvastatin on 40 mg/day,

The first group=atorvastatin on 40 mg/day, the second group = rosuvastatin 20 mg.

all groups received standard therapy included dual antiplatelets ,ACEIs, beta blockers.

Atorvastatin 40 mg

Intervention Type DRUG

Rosuvastatin 20 mg

Interventions

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Atorvastatin 40 mg

Rosuvastatin 20 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged exceeding 18 years,
* Those with ACS confirmation, and those who had not started statin medication during the last 2 months were included

Exclusion Criteria

* Patients using bile acid sequestrants (colesevelam, cholestyramine), fenofibrate, ezetimibe, niacin, and/or omega-3, as well as those taking concurrently interacting medications (cyclosporine, gemfibrozil, clarithromycin, and/or itraconazole), were excluded from consideration
* During the recruitment process, the study excluded women who were pregnant, nursing, or of childbearing age without a reliable method of contraception.
* As well as patients with bile duct issues, active liver disease, elevated ALT levels exceeding three times the upper normal limit (UNL), serum creatinine levels above 2 mg/dL,
* Individuals who had undergone or reported a hypersensitivity reaction to any currently used statins

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No