Evidence Table 12Internal validity of trials evaluating statins in children

Study or Author
Year
Randomization adequate?Allocation concealed?Groups similar at baseline?Eligibility criteria specified?Outcome assessors blinded?Care provider blinded?Patient unaware of treatment?Intention-to-treat analysis?Maintained comparable groups?Reported attrition, crossovers, adherence, and contamination?Different or overall high loss to follow-up/withdrawal?CommentsScore
(good/fair/poor)
Clauss et al, 2005YesYesDrug estradiol 61 vs 95 for placebo
Drug LDL 218 vs 199
Drug ApoB 187 vs 168
YesYesNot reportedYesYesYesAttrition reported. No contamination reported.No differential loss or high overall loss. 33/35 (94%) drug and 18/19 (95%) placebo completedGood
deJongh, 2002A
Early Statin Therapy Restores…
Method not describedNRFH groups were similarYesNRNRNR but “placebo”NRNRNRNRPoor
deJongh, 2002b "Efficacy and safety of statin therapy…"YesNRYesYesDescribed as "double blind"NRYesYesYesAttrition reported, no contamination evident78% of those randomized to drug completed to week 48, and 81% of placebo completed to week 48Good-Fair
Knipscheer, 1996Method not describedNRYesYesYesNR (n/a)Unclear, reported as double-blindYesYesAttrition reported (none), no contamination No loss- all completed evidentNo loss- all completedFair
McCrindle, 2003Method not describedNRYesYesYesNR (n/a)Unclear, reported as double-blindNR
Very low attrition
YesAttrition reported. No contamination reported.No differential loss.
98% completed double-blind period
Fair
Stein, 1999Method not describedNRYesYesYes, “double blind”NRYes, “double blind”For safety; for efficacy, those who > one 8-week phase of the study were includedUnclearAttrition reported
No contamination reported
110/132 (83%) completed Period 2.
Drug: 61/67 (91%) completed Period 2.
Placebo: 49/65 (75%) completed Period 2.
Fair
van der Graaf A, et al 2008Not describedNRMore mutiracial participants in SIM monotherapy groups (pooled): 13 (10%) for EZE plus SIM groups vs. 19 (15%); also more cigarette use in previous month for SIM monotherapy groups (pooled): 1(1%) for EZE plus SIM groups. Vs 12 (10%) for SIM monotherapy groups.YesYes “double blind” for steps 1 and 2NRYes for steps 1 and 2Not stated, but they appear to have analyzed 246 people total, out of 248 randomized.YesAttrition reported.
No contamination reported. Adherence NR. Contamination NR.
No.Randomzied to 6 arms of varied doses for two treatment options (SIM alone vs EZE plus SIM), but analyzed in only two groups (lumped all doses together)Fair
Wiegman, 2004YesNot reportedYesYesUnclear, reported as double-blindNR (n/a)Yes, other than they knew whether they got 1/2 or whole tablet (dose 20mg or 40mg).NR
Low attrition
YesAttrition reported.No differential loss.
Treatment: 101/106 (95%)completed
Placebo: 103/108 completed (95%)
Good-Fair

From: Evidence Tables

Cover of Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin
Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report Update 5 [Internet].
Smith MEB, Lee NJ, Haney E, et al.
Portland (OR): Oregon Health & Science University; 2009 Nov.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

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