Not quite 10 years after her controversial ‘statin expose’ on ABC TV’s Catalyst program, Dr Maryanne Demasi is back with another critique arguing the benefits of statin are modest and “most trial participants who took statins derived no clinical benefit”.
Dr Demasi and colleagues performed a systematic review and meta-analysis of the association between low-density lipoprotein cholesterol (LDL-C) reduction with statin treatment and relative and absolute effects on cardiovascular outcomes.
The research, published in JAMA Internal Medicine, said 21 trials – both primary and secondary prevention trials – were included in the analysis.
“The [absolute risk reduction] ARR was 0.6% for all-cause mortality, 0.7% for MI, and 0.3% for stroke in primary prevention and 0.9%, 2.2%, and 0.7%, respectively, in secondary prevention.”
“The [relative risk reduction] RRR was 13% for all-cause mortality, 38% for MI, and 24% for stroke in primary prevention and 14%,27%, and 13%, respectively, in secondary prevention,” it said.
The researchers said the results of the meta-analysis suggested a benefit in all clinical outcomes.
However, “Reporting the reduction in cardiovascular outcomes as RRR without reporting the corresponding ARR has the potential to inflate the clinical importance of an intervention and may exaggerate trivial associations.”
‘Moreover, the benefits of a treatment also depend on baseline risk. Reporting RRR without baseline risk has been described as “the first sin against transparent reporting,” as it increases people’s willingness to receive a treatment, advise treatment, and pay to prevent the risk compared with ARR or other methods for communicating risk.”
“Some patients who experience harms might choose to discontinue their use of the drug if they were counseled about the absolute degree of risk and benefit.”
“Thus, we believe that ARR is essential for clinical decision-making and provides the clinician with a more accurate means of discussing the true benefits and harms of a specific therapy with their patients.”
They said, for various reasons however, clinicians did not routinely report the benefits of interventions in terms of ARR.
They also said their meta-regression was inconclusive in proving or disproving an association between the magnitude of LDL-C reduction and the size of treatment effect.
This was in contrast with 2018 American cholesterol guidelines which stated “the more LDL-C is reduced on statin therapy, the greater will be subsequent risk reduction.”
“This systematic review and meta-analysis found that the ARR of statins appears to be modest compared with the RRR, but these calculated benefits must be interpreted with caution because of the presence of significant heterogeneity,” they concluded.
“In addition to considering the absolute benefit, patients and clinicians need to examine the potential for harm from treatment with statin therapy,” they said.
“This has been an area of considerable controversy, and the exact incidence and definition of statin harms have been debated.”
A two-part series ‘The Heart of the Matter’ aired on Catalyst in 2013 but was removed after an investigation found the program was flawed and had the potential to cause harm.