title: Changes in calculated coronary heart disease risk using proactive multifactorial intervention versus continued usual care in Latin-American and non-Latin-American patients enrolled in the CRUCIAL trial.
abstract: OBJECTIVE
  To compare the change in calculated coronary heart disease (CHD) risk using a proactive multifactorial intervention (PMI) versus usual care (UC), among Latin-American (LA) and non-LA patients enrolled in the CRUCIAL trial.
  
  
  METHODS
  This is a sub-analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial. CRUCIAL was a prospective, multinational, open-label, cluster-randomized trial. Eligible patients had hypertension and ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol ≤6.5 mmol/l (250 mg/dl). The PMI strategy was implemented by the inclusion of single-pill amlodipine/atorvastatin (SPAA) in the patients' treatment regimen. Overall, 20% of patients resided in the LA region.
  
  
  METHODS
  Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions.
  
  
  RESULTS
  A greater relative reduction in calculated CHD risk after 52 weeks' follow-up was observed for patients in the PMI arm compared with UC arm in both LA (-32.8% vs. -7.5%, p = 0.003) and non-LA regions (-33.1% vs. -3.3%, p < 0.001), region interaction p = 0.316. The proportion of patients discontinuing treatment in the PMI arm due to adverse events (AEs) was low in both regions (both 5.9%).
  
  
  CONCLUSIONS
  The PMI approach based on the inclusion of SPAA in the patients' treatment regimen may improve the management of CHD risk among patients residing in LA and non-LA regions. Clinicians may be reassured by the low rate of AEs leading to discontinuation of SPAA in both regions.
authors.affiliation: Hospital General de México, Ciudad de México, México. vanina@prodigy.net.mx
authors.forename: Abel
authors.initials: A
authors.lastname: Pavia
authors.forename: José
authors.initials: J
authors.lastname: Zamorano
authors.forename: Santosh
authors.initials: S
authors.lastname: Sutradhar
authors.forename: Carla
authors.initials: C
authors.lastname: Yunis
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002784:Cholesterol / Q000097:blood; D003327:Coronary Disease / Q000097:blood / Q000453:epidemiology / Q000208:ethnology / Q000628:therapy*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006538:Heptanoic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors
chemical_list: D000924:Anticholesteremic Agents; D004338:Drug Combinations; D006538:Heptanoic Acids; D011758:Pyrroles; C487936:amlodipine, atorvastatin drug combination; D017311:Amlodipine; D002784:Cholesterol