title: Efficacy and safety of the intensive dose of rosuvastatin 40mg/day in patients with acute coronary syndrome and at high risk of cardiovascular disease-ROSUVEES-2.
abstract: BACKGROUND
  Randomized clinical trials have established the benefits of statin therapy in acute coronary syndromes (ACS) via their pleiotropic effects.
  
  
  OBJECTIVE
  This was a 12-week, open-label, multicenter, postmarketing observational study evaluating the efficacy and safety of rosuvastatin 40 mg/day in very high-risk or high-risk Indian patients according to NCEP ATP III guidelines.
  
  
  METHODS
  One hundred and sixty two patients (age: 30 to 69 years) with evidence of coronary artery disease, hospitalized with chest pain with/without electrocardiogram changes and with non-ST segment elevation ACS and ST segment elevation ACS who received optimal reperfusion therapy were enrolled. The primary endpoint was the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels at 6 and 12 weeks of treatment. Other lipid parameters, high sensitive C-reactive protein (hsCRP), glycosylated hemoglobin, and clinical biochemical parameters were also assessed.
  
  
  RESULTS
  At 12 weeks, intensive therapy with rosuvastatin 40mg/day significantly reduced LDL-C (p<0.001), total cholesterol (TC) (p<0.001), triglyceride (p<0.01), TC/high density lipoprotein cholesterol (HDL-C) ratio (p<0.001), non-HDL-C (p<0.001), LDL-C/HDL-C ratio (p<0.001), and hsCRP (p=0.034) in very high-risk and high-risk patients with ACS. Overall, 54.5% (61/112) patients achieved LDL-C goal of <70mg/dL. However, the change in HDL-C and very low density lipoprotein cholesterol (VLDL-C) were not significant. Few adverse events including myalgia were reported during the study.
  
  
  CONCLUSIONS
  Results of this study showed that 40mg dose of rosuvastatin, initiated early and continued for 12 weeks, was effective in terms of reducing LDL cholesterol and was well tolerated.
authors.affiliation: Interventional Cardiologist, Heart Rhythm Clinic, 3rd Floor, Manu Market, M G Road, Ghatkopar (W), Mumbai 400 086, India. Electronic address: drchetan.shahic@gmail.com.
authors.forename: Chetan P
authors.initials: CP
authors.lastname: Shah
authors.affiliation: Interventional Cardiologist, Ashirwad Heart Hospital, Tilak Road, Ghatkopar (E), Mumbai 400 077, India.
authors.forename: Bhaskar P
authors.initials: BP
authors.lastname: Shah
authors.affiliation: Interventional Cardiologist, Lifecare Institute of Medical Sciences & Research, Borsalli Apartment Road, Near Cama Hotel, Khanpur, Ahmedabad, Gujarat, India.
authors.forename: Sameer I
authors.initials: SI
authors.lastname: Dani
authors.affiliation: Senior Interventional Cardiologist, The Heart Lab, Flat No. 546, Pocket C-8, Sector 8, Rohini, Delhi 110085, India.
authors.forename: B B
authors.initials: BB
authors.lastname: Channa
authors.affiliation: Senior Consultant Internal Medicine and Diabetology, Priya Nursing Home, No. 6 (Old No. 82), Kappal Polu Street, Old Washermenpet, Chennai 600 021, India.
authors.forename: S S
authors.initials: SS
authors.lastname: Lakshmanan
authors.affiliation: Senior Interventional Cardiologist, KC 46 A, Ashok Vihar, Phase 1, New Delhi 110 052, India.
authors.forename: N C
authors.initials: NC
authors.lastname: Krishnamani
authors.affiliation: Senior Consultant Cardiologist, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi 110 060, India.
authors.forename: Ashwani
authors.initials: A
authors.lastname: Mehta
authors.affiliation: Cardio Thoracic Surgeon, S.R.P. Heart Care Centre, Pallavaram, Chennai 600 043, India.
authors.forename: P
authors.initials: P
authors.lastname: Moorthy
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage*; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000068718:Rosuvastatin Calcium
keywords: Acute coronary syndrome; LDL-C; Pleiotropic; Rosuvastatin; Statins