PMID- 23464930
OWN - NLM
STAT- MEDLINE
DCOM- 20140123
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 29
IP  - 6
DP  - 2013 Jun
TI  - Post hoc analysis of the Cluster Randomized Usual Care versus Caduet 
      Investigation Assessing Long-term risk (CRUCIAL) trial.
PG  - 589-96
LID - 10.1185/03007995.2013.783795 [doi]
AB  - OBJECTIVE: A proactive, multifactorial intervention strategy incorporating 
      single-pill amlodipine/atorvastatin (SPAA) (5-10/10 mg up-titrated to 5-10/20 mg, 
      where approved) is more effective than physician's usual care (UC) for reducing 
      calculated 10 year coronary heart disease (CHD) risk, in patients with 
      hypertension and additional risk factors (CRUCIAL trial: Curr Med Res Opin 
      2011;27:821--33). As SPAA combinations containing atorvastatin 20 mg are not 
      approved in some countries, this post hoc analysis investigated the efficacy and 
      safety of a proactive intervention strategy incorporating low-dose SPAA (5/10 or 
      10/10 mg) only (low-dose PI) versus UC. METHODS: Of 1461 CRUCIAL participants 
      (35-79 years; hypertension and >/=3 additional risk factors; no CHD; total 
      cholesterol </=6.5 mmol/L), 105 were prescribed SPAA containing 20 mg atorvastatin 
      and excluded. The primary endpoint was difference between treatment arms in 
      Framingham 10 year CHD risk after 52 weeks; secondary assessments included 
      difference in calculated CHD risk at Week 16; SCORE cardiovascular mortality 
      (Week 16 and 52); blood pressure (BP)/lipid parameters; adverse events (AEs). 
      RESULTS: Baseline BP (149.2/89.2 vs. 144.3/86.5 mmHg) and calculated CHD risk 
      (19.6% vs. 18.1%) were higher for low-dose PI (n = 655) versus UC (n = 657) 
      patients. Least-squares mean treatment difference (low-dose PI vs. UC) in 
      calculated 10 year CHD risk was -26.8 (95% CI: -31.7, -22.0; p < 0.001) after 52 
      weeks' follow-up and -24.8 (-29.8, -19.9; p < 0.001) after 16 weeks' follow-up. 
      Treatment difference in SCORE mortality was -20.1 (-24.7, -15.6; p < 0.001) and 
      -22.4 (-26.8, -18.0; p < 0.001) after 16 and 52 weeks' follow-up. Risk 
      calculations are surrogate endpoints and may not translate into actual reductions 
      in cardiovascular events. Overall, 49.1% (low-dose PI) and 44.0% (UC) reported 
      AEs. CONCLUSION: A proactive, multifactorial approach to cardiovascular 
      management based on low-dose SPAA led to statistically significant improvements 
      in calculated 10 year CHD risk versus physician's UC, comparable to that reported 
      in the full CRUCIAL trial. These data will inform healthcare providers in 
      countries where SPAA (5/10 or 10/10 mg) only are licensed.
FAU - Hradec, Jaromir
AU  - Hradec J
AD  - University General Hospital, Charles University, Prague, Czech Republic. 
      Jaromir.Hradec@vfn.cz
FAU - Zamorano, Jose
AU  - Zamorano J
FAU - Sutradhar, Santosh
AU  - Sutradhar S
LA  - eng
SI  - ClinicalTrials.gov/NCT00407537
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130403
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Heptanoic Acids)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyrroles)
RN  - 0 (amlodipine, atorvastatin drug combination)
RN  - 1J444QC288 (Amlodipine)
RN  - A0JWA85V8F (Atorvastatin)
SB  - IM
MH  - Amlodipine/administration & dosage/adverse effects/*therapeutic use
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Atorvastatin
MH  - Blood Pressure/*drug effects
MH  - Coronary Disease/*prevention & control
MH  - Drug Combinations
MH  - Female
MH  - Heptanoic Acids/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/adverse 
      effects/therapeutic use
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pyrroles/administration & dosage/adverse effects/*therapeutic use
MH  - Risk Factors
EDAT- 2013/03/08 06:00
MHDA- 2014/01/24 06:00
CRDT- 2013/03/08 06:00
PHST- 2013/03/08 06:00 [entrez]
PHST- 2013/03/08 06:00 [pubmed]
PHST- 2014/01/24 06:00 [medline]
AID - 10.1185/03007995.2013.783795 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2013 Jun;29(6):589-96. doi: 10.1185/03007995.2013.783795. Epub 
      2013 Apr 3.