CUSP 2009.
Methods | Individual-level randomised controlled trial | |
Participants | 130 participants (66 intervention; 64 control) with coexisting, untreated hypertension (SBP=140-169 mmHg or DBP=90-105 mmHg) and dyslipidemia (LDL-C=110-160 mg/dl) but without a history of cardiovascular disease; age >21 years | |
Interventions | Intervention: Single pill amlodipine/atorvastatin (5mg/20mg) + therapeutic lifestyle changes Control: Therapeutic lifestyle changes |
|
Outcomes | Target for BP <140/90 mm Hg and LDL-C <100 mg/dL [2.59 mmol L] at week 4 and week 8: the percentage of patients in whom the single LDL-C goal was reached at weeks 4 and 8; mean changes from baseline in SBP and DBP at weeks 4 and 8; mean changes from baseline in LDL-C at weeks 4 and 8; 10-year Framingham risk of CHD at weeks 4 and 8 | |
Notes | Control: inactive/usual care | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specifically stated: “Patients were randomised in a double-blind manner” |
Allocation concealment (selection bias) | Unclear risk | Not specifically stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not specifically stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specifically stated |
Incomplete outcome data (attrition bias)All outcomes | Unclear risk | Unclear how data from particpants lost to follow-up were handled |
Selective reporting (reporting bias) | Low risk | Primary outcomes reported (week 4 blood pressure and LDL targets) |