title: Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial.
abstract: OBJECTIVE
  To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment.
  
  
  METHODS
  Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35-79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l.
  
  
  BACKGROUND
  www.ClinicalTrials.gov ; trial identifier NCT00407537.
  
  
  METHODS
  The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks.
  
  
  RESULTS
  Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication.
  
  
  CONCLUSIONS
  A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.
authors.affiliation: Hospital Clinico San Carlos, Madrid, Spain. zamorano@secardiologia.es
authors.forename: José
authors.initials: J
authors.lastname: Zamorano
authors.forename: Serap
authors.initials: S
authors.lastname: Erdine
authors.forename: Abel
authors.initials: A
authors.lastname: Pavia
authors.forename: Jae-Hyung
authors.initials: JH
authors.lastname: Kim
authors.forename: Ayman
authors.initials: A
authors.lastname: Al-Khadra
authors.forename: Mogens
authors.initials: M
authors.lastname: Westergaard
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; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069059:Atorvastatin; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000628:therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011314:Preventive Health Services / Q000379:methods* / Q000706:statistics & numerical data; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D059039:Standard of Care / Q000706:statistics & numerical data
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D006538:Heptanoic Acids; D000960:Hypolipidemic Agents; D011758:Pyrroles; D017311:Amlodipine; D000069059:Atorvastatin