Reasons for disparity in statin adherence rates between clinical trials and real-world observations: a review.
Level 5 - mechanism / opinion, no new human data
Narrative review synthesizing trial design characteristics without systematic review methodology reported in the abstract
PubMed 30099530 · doi:10.1093/ehjcvp/pvy028
What was done
The authors reviewed randomized clinical trials (RCTs) with more than 1,000 participants included in the Cholesterol Treatment Trialists Collaboration to evaluate whether the inclusion of a statin test dose during a run-in phase biased adherence and adverse event rates.
What was found
The background adverse event rate is noted as 1-2% in RCTs versus 10-20% in clinical practice. The review reported that the majority of RCTs did not use a statin test dose in the run-in phase, and trials with a test dose showed no significantly improved adherence compared to trials without one. No specific trial counts, patient numbers, or numerical adherence rates were reported in the abstract.
Why it matters
This review challenges the common hypothesis that low adverse event rates in statin trials are driven by run-in periods that screen out intolerant patients.
Limits
The abstract describes a narrative review and does not report the total number of studies analyzed, total sample size, effect sizes, confidence intervals, or formal meta-analytic methodology. Other proposed explanations discussed in the text are noted by the authors as mostly lacking scientific data support.
Cited by
- contradicts Most statin clinical trials exclude patients who experience early adverse effects during run-in periods before formal randomization begins.