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

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.

Conditions

• Cardiovascular Disorders

Interventions

DRUG

Patients on atorvastatin treatment

Statins Therapy

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.

  lead INDUSTRY

Principal Investigators

• Antonis Ziakas, Ass Professor · AHEPA hospital of Thessaloniki, Greece

• Charalampos Karvounis, Professor · AHEPA hospital of Thessaloniki, Greece

• Georgios Maligos, Registrat A · Papanikolaou hospital of Thessaloniki, Greece

• Ioannis Kanonidis, Professor · Hippokration hospital of Thessaloniki, Greece

• Dimitrios Psyropoulos, Director · Gennimatas hospital of Thessaloniki, Greece

• Ioannis Vogiatzis, Director · Hospital of Veria, Greece

• Pantelis Kligatsis, Director · Hospital of Florina, Greece

• David Symeonidis, Director · Hospital of Kavala, Greece

• Nikolaos Theodoridis, Director · Hospital of Drama, Greece

• Stylianos Lampropoulos, Director · Hospital of Ptolemaida, Greece

• Georgios Spyromitros, Director · Hospital of Katerini, Greece

• Ioannis Tsounos, Director · Agios Pavlos hospital of Thessaloniki, Greece

• Vlasis Pyrgakis, Director · George Gennimatas hospital of Athens, Greece

• Andreas Tsellios, Registrat · NIMTS hospital of Athens, Greece

• Ioannis Kalikazaros, Director · Hippokration hospital of Athens, Greece

• Dimitrios Richter, Director · Euroclinic of Athens, Greece

• Emmanouel Kallieris, Associate Director · Metropolitan hospital of Piraeus, Greece

• Apostolos Katsivas, Director · Red Cross Hospital of Athens, Greece

• Stefanos Foussas, Director · Tzannion hospital of Piraeus, Greece

• Dimitrios Tziakas, Ass. Professor · University Hospital of Alexandroupolis, Greece

• Konstantinos Papaioannou, Director · Hospital of Polygyros, Greece

• Ioannis Styliadis, Director · Papageorgiou Hospital of Thessaloniki, Greece

• Pantelis Makridis, Director · Hospital of Edessa, Greece

• Panayotis Kyriakidis, Director · 424 military hospital of Thessaloniki, Greece

• Georgios Karakostas, Director · Hospital of Kilkis, Greece

• Vasilios Vasilikos, Ass Professor · Hippokration hospital of Thessaloniki, Greece

• Sotirios Patsilinakos, Director · Konstantopoulio General Hospital of Athens

• Dimitrios Sionis, Director · Sismanogleio General Hospital of Athens

• Antonios Sideris, Director · Evagelismos General Hospital of Athens

• Athanasios Manolis, Director · Asklepiion General Hospital of Voula

• Chrysostomos Oikonomou, Director · Laikon General Hospital of Athens

• Panagiotis Pentzeridis, Director · General State Hospital of Nikaia, Piraeus

• Athanasios Pras, Director · General State Hospital of Chania, Crete

• Alkiviadis Dermitzakis, Director · Venizeleio General State Hospital of Heraklion, Crete

• Panagiotis Vardas, Professor · University Hospital of Heraklion, Crete

• Dimitrios Alexopoulos, Professor · Rio University Hospital of Patras

• Andreas Mazarakis, Director · Agios Andreas General State Hospital of Patras

• Antonios Draganigos, Director · General State Hospital of Corfu

• Filippos Tryposkiadis, Professor · University Hospital of Larisa, Thessaly

• Spyridon Zombolos, Director · General State Hospital of Kalamata

• Dimitrios Platogiannis, Director · General State Hospital of Trikala

• Panagiotis Stasinos, Director · General State Hospital of Ierapetra, Crete

• Nikitas Moschos, Director · General State Hospital of Rhodes

• Chrysostomos Dilanas, Director · General State Hospital of Korinthos

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• Greece

Study Locations