CUSP 2009.
Methods | Individual‐level RCT | |
Participants | 130 participants (66 intervention; 64 comparator) from the USA with coexisting, untreated hypertension (SBP = 140 mmHg‐169 mmHg or DBP = 90 mmHg‐105 mmHg) and dyslipidaemia (LDL‐C = 110 mg/dL‐160 mg/dL) but without a history of cardiovascular disease; age > 21 years | |
Interventions | Intervention: single pill amlodipine/atorvastatin (5 mg/20 mg) + therapeutic lifestyle changes Comparator: therapeutic lifestyle changes |
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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 participants 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 | Comparator: 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 participants lost to follow‐up were handled |
Selective reporting (reporting bias) | Low risk | Primary outcomes reported (week 4 blood pressure and LDL targets) |
Other bias | Low risk | No other sources of bias are identifiable |