| Methods |
Design: multi centre 2 x 3 factorial design (normal or intensive advice x pravastatin, placebo or no drug)
Purpose: examine the effect of pharmacological and non‐pharmacological strategies on cardiovascular risk |
| Participants |
Patients: out‐patients with increased risk of cardiovascular disease and moderately increased serum‐cholesterol
Baseline comparability: yes |
| Interventions |
Placebo: tablet with no pravastatin (with usual or intense advice)
Untreated: no pharmacological intervention (with usual or intense advice)
Experimental: pravastatin (with usual or intense advice)
(Co‐intervention: usual health care advice on diet conducted by a GP or intense health care advice where usual advice is supplemented by group sessions) |
| Outcomes |
Serum‐cholesterol (mmol/l)
Serum‐cholesterol: high and low density lipoprotein
Serum‐triglycerides
Blood‐glycose
Blood pressure
Framingham risk score |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'A prospective, double‐blind, randomized, controlled trial...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 453 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly stated |
