Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience

doi:10.1016/j.ahj.2013.06.004

American Heart Journal

Volume 166, Issue 3, September 2013, Pages 597-603

https://doi.org/10.1016/j.ahj.2013.06.004 Get rights and content

Background

Statin therapy is a proven effective treatment of hyperlipidemia. However, a significant number of patients cannot tolerate statins. This study was conducted to review treatment strategies for patients intolerant to statin therapy with a focus on intermittent statin dosing.

Methods and results

We performed a retrospective analysis of medical records of 1,605 patients referred to the Cleveland Clinic Preventive Cardiology Section for statin intolerance between January 1995 and March 2010 with at least a 6-month follow-up. The changes in lipid profile, achievement of low-density lipoprotein cholesterol (LDL-C) goals, and statin tolerance rate were analyzed. Most (72.5%) of patients with prior statin intolerance were able to tolerate a statin for the median follow-up time of 31 months. Patients on intermittent statin dosing (n = 149) had significantly lower LDL-C reduction compared with daily dosing group (n = 1,014; 21.3% ± 4.0% vs 27.7% ± 1.4%, P < .04). However, compared with the statin discontinued group (n = 442), they had a significantly higher LDL-C reduction (21.3% ± 4.0% vs 8.3 ± 2.2%, P < .001), and a significantly higher portion achieved their Adult Treatment Panel III goal of LDL-C (61% vs 44%, P < .05). There was a trend toward a decrease in all-cause mortality at 8 years for patients on daily and intermittent statin dosing compared with those who discontinued statin (P = .08).

Conclusions

Most patients with previous statin intolerance can tolerate subsequent trial of statin. A strategy of intermittent statin dosing can be an effective therapeutic option in some patients and may result in reduction in LDL-C and achievement of LDL-C goals.

Section snippets

Methods

We reviewed the electronic records of patients referred to the Cleveland Clinic Preventive Cardiology Section for statin intolerance between January 1995 and March 2010. We used the Preventive Cardiology Information System database, which contains information from patients referred to this clinic. At the time of baseline visit, demographic information, medical history, physical examination, and laboratory data are obtained and entered into an electronic medical record. Patients are classified

Statistical analysis

Patient characteristics of the 3 groups of statin-intolerant patients are presented as mean ± SD for continuous variables with normal distribution (median and 25th and 75th percentiles for nonnormally distributed data) and percents for categorical variables. Comparisons of continuous data were made using analysis of variance for normally distributed data and Kruskal-Wallis for nonnormally distributed data. Categorical data were compared using χ² or exact tests.

Percent changes in total

Results

During the median follow-up time of 31 months, 72.5% (n = 1,163) of the subjects remained on a regular regimen of statin therapy, with 63.2% (n = 1,014) on a daily regimen and 9.3% (n = 149) on an intermittent statin regimen. Statins were completely discontinued for 27.5% (n = 442) of patients. The patients' demographics are presented in Table I. Most patients were female (n = 919; 57%) and whites (n = 1,347; 84%). There were a higher proportion of men in the daily statin dosing group. Patients

Discussion

In the present study, we reviewed treatment strategies used in 1,605 patients with statin intolerance referred to a single institution and assessed serum lipid levels, tolerance of therapies, and all-cause mortality. In particular, we analyzed the tolerance and the efficacy of intermittent statin therapy. The most important finding of this study is that most statin-intolerant patients can tolerate some form of statin therapy and that intermittent statin use can be an option for some patients to

Limitations

There are several limitations to our study. First, this is an observational study reviewing historical data with no placebo controls in a single center. Second, statin intolerance symptoms were self-reported and not objectively assessed. Third, although a comprehensive medical and lifestyle therapy was provided to this population, nonprescriptive pharmacologic interventions such as exercise and diet were not systematically quantified or documented. It is therefore difficult to determine the

Conclusions

This study shows that prior statin intolerance does not preclude long-term statin therapy and achievement of ATP-III goals. Most patients with statin intolerance are able to maintain a stable long-term statin treatment regimen. A strategy of intermittent statin dosing can be an effective therapeutic option in some statin-intolerant patients and may result in reduction in LDL-C and achievement of LDL-C goals.

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Clinical InvestigationPrevention and RehabilitationTreatment strategies in patients with statin intolerance: The Cleveland Clinic experience

Background

Methods and results

Conclusions

Section snippets

Methods

Statistical analysis

Results

Discussion

Limitations

Conclusions

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Clin Ther

Am J Cardiol

Am J Cardiol

Am J Med

J Clin Lipidol

Am J Cardiol

Am J Cardiol

Am Heart J

Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines

Curr Opin Cardiol

Risks associated with statin therapy: a systematic overview of randomized clinical trials

Circulation

Clinical Investigation
Prevention and Rehabilitation
Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience