AIMS: Recent data indicate that fixed-dose combination (FDC) pills, polypills, can produce sizeable risk factor reductions. There are very few published data on the consistency of the effects of a polypill in different @entity1 populations. It is unclear for example whether the effects of the polypill are mainly driven by the individuals with high individual risk factor levels. The aim of the present study is to examine whether baseline risk factor levels modify the effect of polypill treatment on low-density lipoprotein (LDL)- @entity165 , blood pressure (BP), calculated cardiovascular relative risk reduction and adverse events. METHODS: This paper describes a post-hoc analysis of a randomised, placebo-controlled trial of a polypill (containing @entity117 75   mg, @entity3413 20   mg, @entity3593 10   mg and @entity918 12.5   mg) in 378 individuals without an indication for any component of the polypill, but who had an estimated five-year risk for @entity65 >= 7.5%. The outcomes considered were effect modification by baseline risk factor levels on change in LDL- @entity165 , systolic BP, calculated cardiovascular relative risk reduction and adverse events. RESULTS: The mean LDL- @entity165 in the polypill group was 0.9   mmol/l (95% confidence interval (CI): 0.8-1.0) lower compared with the placebo group during follow-up. Those with a baseline LDL- @entity165 >3.6   mmol/l achieved a greater absolute LDL- @entity165 reduction with the polypill compared with placebo, than @entity1 with an LDL- @entity165  <=3.6   mmol/l (-1.1 versus -0.6   mmol/l, respectively). The mean systolic BP was 10   mm Hg (95% CI: 8-12) lower in the polypill group. In @entity1 with a baseline systolic BP >135   mm Hg the polypill resulted in a greater absolute systolic BP reduction with the polypill compared with placebo, than @entity1 with a systolic BP    <=   135   mm Hg (-12 versus -7   mm Hg, respectively). Calculated from individual risk factor reductions, the mean cardiovascular relative risk reduction was 48% (95% CI: 43-52) in the polypill group. Both baseline LDL- @entity165 and estimated cardiovascular risk were significant modifiers of the estimated cardiovascular relative risk reduction caused by the polypill. Adverse events did not appear to be related to baseline risk factor levels or the estimated cardiovascular risk. CONCLUSION: This study demonstrated that the effect of a @entity65 on risk factor levels is modified by the level of these risk factors. Groups defined by baseline LDL- @entity165 or systolic BP had large differences in risk factor reductions but only moderate differences in estimated cardiovascular relative risk reduction, suggesting also that @entity1 with mildly increased risk factor levels but an overall raised cardiovascular risk benefit from being treated with a polypill.

Estimated cardiovascular relative risk reduction from fixed-dose combination pill (polypill) treatment in a wide range of XXXX with a moderate risk of @entity65 .

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'patient'] @entity3413 :: ('MESH:D019821', 'Chemical') :: ['simvastatin'] @entity918 :: ('MESH:D006852', 'Chemical') :: ['hydrochlorothiazide'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity3593 :: ('MESH:D017706', 'Chemical') :: ['lisinopril'] @entity65 :: ('MESH:D002318', 'Disease') :: ['cardiovascular polypill', 'cardiovascular disease'] @entity165 :: ('MESH:D002784', 'Chemical') :: ['cholesterol']
@entity1 :: (9606,Species) :: ['patients']
