Sarah Hilmer and Danijela Gnjidic, the authors of the article, comment:
We thank Mark Sheppard and Alistair Begg for pointing out the limitations of making clinical judgements based only on chronological age. In older people, in the presence of increasing inter-individual variability, biological age, which is analogous to the degree of frailty, is a much better predictor of outcomes than chronological age. Amongst older people, frailty affects the use, pharmacokinetics, pharmacodynamics, safety and efficacy of medicines.1,2
Clinical trials in older people do not show benefits of statins for primary prevention of cardiovascular disease.3 The participants in these trials are generally fit. The frail are predominantly excluded based on comorbidity, co-medication or impaired physical or cognitive function. In frail older people, we know more about adverse events (from observational studies) than we do about efficacy, which requires randomised controlled trials.4
We wish to clarify what is known about adverse effects of statins in fit older people. The majority of the evidence that statins cause cognitive impairment is from case reports and case series, in which the impairment was generally reversible within days to weeks of stopping the statin. Therefore, if statin-associated cognitive decline is suspected, it is reasonable for clinicians to consider a trial of statin withdrawal. Amongst clinical trial participants who were generally fit, myalgias were reported in 5–10%, myositis in 0.1–0.2%, and rhabdomyolysis was rare. A clinician treating one hundred fit older patients, 40% of whom are taking statins, is expected to see 2–4 patients with myalgias. The elevated hepatic transaminases observed with statins are of uncertain clinical significance.
The prescription of statins for primary prevention should be individualised on the basis of clinical judgement.5 Our article aims to raise awareness of the benefits and risks of statins to help clinicians apply the existing evidence to their patients.