Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In western societies hypercholesterolemia is one of the major and independent factors that predispose to cardiovascular disease and death from them. According to the clinical study ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women, rates of hypercholesterolemia observed in a sample of urban population was 39% for men and 37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52% for men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk of cardiovascular disease appears to be quite clear in the secondary prevention trials, the 4S (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the benefits of lowering LDL cholesterol in patients with coronary artery disease. Despite these remarkable results, studies were secondary prevention as a major shortcoming, the lack of patients with acute coronary events. This gap came to cover the study MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80 mg was evaluated in 3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute coronary syndrome (myocardial infarction without Q-wave or unstable angina). Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks. Treatment with atorvastatin 80 mg / day increased the latency of the combined primary endpoint, defined as death from any cause, nonfatal myocardial infarction, resuscitated cardiac arrest, or angina with objective evidence of myocardial ischemia requiring admission to hospital, indicating a risk reduction of 16% (p = 0,048). This was mainly due to a 26% reduction in re-hospitalization for angina with objective evidence of myocardial ischemia. The other secondary endpoints were not statistically significant by themselves (total: placebo: 22.2%, Atorvastatin: 22.4%).

Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and 8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P <0,015) nationwide with the appearance episode (event) CV.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Outpatients (External Ambulatory) Patients.

• Male or female patients

• 18 to 99 years

• Patients with Hypercholesterolemia

• Patients with and without treatment with statin

• Patients enrolled in any of the study sites with acute cardiovascular event

• Patients discharged with study medication (Antorcin ®)

• Patients who have agreed and signed the consent form for the recording and processing of their personal data.

Exclusion Criteria:

• Patients under 18 and over 99 years.

• Women in pregnancy or lactation period

• Patients enrolled in any of the study sites for any reason other than an acute cardiovascular event

• Patients who discharged and take another statin drug formulation other than the study drug formulation (Antorcin ®)

• Patients who have not consented and signed the consent form for the recording and processing of their personal data.