The authors of this research note that the rate of statin-reported events is higher in observational studies than in randomised, placebo-controlled trials – this may be due to patient selection in trials, which often exclude patients with co-morbidities.
The aim of this study was to review the different treatment strategies used to improve lipid profiles in patients with prior statin intolerance treated at a large tertiary prevention clinic (Cleveland Clinic Preventive Cardiology Section for statin intolerance), with a focus on intermittent statin dosing. The electronic records of patients referred to this service were searched and a total of 1,605 patients with documented intolerance to at least two statins and at least six months of follow-up were included in the analysis. These patients were split into three groups according to their regimen at the last follow-up: no statin, intermittent dosing, or daily dosing.
The most common type of previous statin intolerance was myalgia; others included weakness/fatigue, gastrointestinal complaints, elevated liver function tests, joint pain and others. After a median follow-up of 31 months, 72.5% of patients were ultimately able to tolerate some form of long-term statin regimen: 63.2% (n=1,014) were on a daily statin regimen and 9.3% (n=149) were on an intermittent regimen. A total of 27.5% (n=442) had completely discontinued statin therapy.
Patients on intermittent statin dosing had lower LDL-C reduction than the daily dosing group (21.3% ± 4.0% vs. 27.7% ± 1.4%, P<0.001), but a higher reduction than the statin discontinued group (21.3% ± 4.0% vs. 8.3 ± 2.2%, P<0.001).
The authors say that the most important finding of their study is that most statin-intolerant patients can tolerate some form of statin therapy; also that intermittent statin use may be an option for some patients to achieve improvement in serum lipid levels. The intermittent dosing strategies utilised did however differ widely, and there is no randomised controlled trial data to show whether intermittent statin dosing is associated with similar clinical outcomes to daily dosing. The authors acknowledge a number of other limitations to their study, for example the historical review of data, the lack of controls, the self-reporting of statin intolerance, the lack of systemic quantification or documentation of non-pharmacological interventions (e.g. diet), lack of data on compliance, and the lack of balancing between the three regimen groups.
The authors conclude that their study provides ‘interesting data’ on the management of this very challenging group of patients, and they call for further research into whether intermittent statin regimens reduce cardiac events and prolong survival.