Statins is recognized as an effective and safe intervention to address cardiovascular problems. However, there are a significant number of patients that have intolerance to statins. Intolerance to statins among patients is as a result of muscular symptoms and/or increase of hepatic aminotransferases. The side effects that are arise during statin therapy concern both doctors and patients – and contribute to poor patient outcome when recovering from cardiovascular diseases. Hence, it is imperative for clinicians to enhance their knowledge on the various clinical side effects of muscular and hepatic during statin therapy – this will enable them to manage patients with statin intolerance (Williams, Ilten, & Bower, 2016) .
Step 0: The Spirit of Inquiry Ignited
The spirit of inquiry is an essential phase in an evidence-based practice process. This step is described as a continuous inquisitive process concerning the best evidence that can be used to guide a clinical decision. Therefore, clinicians collaborate to address clinical problems through the application of clinical reasoning and judgment. The questions below can be used to prompt the spirit of inquiry for this study.
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What are the common clinical aspects and approaches that are considered to be responsible for the common statin-related side effects?
What are the available interventions to manage statin-intolerant patients?
Are the first adverse side effects directly related to statin therapy? Can altering the statin dosage or use non-statin compounds be effective strategies?
Are there any cardiovascular benefits associated with the identified strategies?
Step 1: The PICOT Question Formulated
PICOT Question: In patients that have failed statin therapy, do lifestyle changes with no medications added decrease cholesterol levels over a period of one year?
Population – Statin-intolerant patients with high cholesterol levels.
Intervention of interest – Statin therapy.
Comparison of intervention - Lifestyle change without medication.
Outcomes – Decrease in cholesterol levels.
Time – 12 months.
Step 2: Search Strategy Conducted
Keywords such as statin therapy, cardiovascular disease, statin-intolerant patients, and clinical trial for statin therapy – were used to collect data from online databases. The keywords for searching were modified according on the database used. The research procedure was evaluated to determine the significance of each article and ascertain whether the outcomes would be relevant to answer the PICOT question addressed in this paper. Furthermore, the research articles were filtered based on age, study type, article type, publication range, and language – to substantiate the quality of each research study referenced.
Step 3: Critical Appraisal of the Evidence Performed
Critical appraisal checklists were used to assess the validity, reliability and applicability of the studies used. Therefore, the critical appraisal for the research articles had to address the following questions:
Are the outcomes of the study valid?
What are the outcomes?
Will the results contribute in caring for my patient?
The study by Rosenson et al. (2017), affirmed that Intolerance to statin therapy is commonly observed in clinical practice due to muscular symptoms or elevation of hepatic aminotransferase. Meor et al. (2017) supported these results in their study which revealed that statins affect the lipid profile as they are dose dependent. Additionally, most studies that examined the impact of statin therapy on lipids revealed that rosuvastatin has the most significant effect on lipid profile. While researching on the side effects on statin therapy on patients on online databases, a number of a systematic review and meta‐analysis of randomized placebo‐controlled trials including a study by Sahebkar et al. (2016), proved that statin therapy has a significant effect on plasma leptin concentration. A study by Winchester et al. (2010) argued that statin administration among patients should be introduced before invasive treatments – since it minimizes the effects of post-procedural MI. moreover, the outcomes of the study proved that statin decrease the risk of atrial fibrillation after CABG.
Step 4: Evidence Integrated with Clinical Expertise and Patient Preferences to Inform a Decision and Practice Change Implemented
The aim of this study based on the data and information collected is to measure the change in LDL cholesterol level for patients using lifestyle therapy and no added medication as an alternative to failed statin therapy due to increased serum creatinine kinase. The lifestyle therapy applied included feeding on a healthy diet, regular exercise, reducing the amount of alcohol consumption, avoiding smoking, consumption of low cholesterol and fat saturation feeds, increased fiber, Omega-3 and other foods that help to reduce LDL cholesterol.
A sample of patients with adverse statin therapy side effects of an increase in serum creatinine kinase and LDL cholesterol levels of 190 mg/dL or above were identified and their response to the program was included (Sahebkar, Giua, & Pedone, 2016). Additionally, prescribe lifestyle therapy with no medication as an alternative to failed statin therapy was implemented. Therefore, lifestyle therapy included feeding on a healthy diet, regular exercise, a reduced amount of alcohol consumption, barred smoking, consumption of low cholesterol and fat saturation feeds, increased fiber, Omega-3 and other foods that help to reduce LDL cholesterol. (Harvard Health Publishing, 2017). During the study a close observation on the adherence of patients to the lifestyle therapy program was done to monitor patient responses. Furthermore, records keeping for the LDL cholesterol level were done to help identify the patients’ level of risks. According to (Harvard Health Publishing, 2017), high LDL cholesterol means increased patient risk and may require the use of alternative medications such as fibrates, resins, ezetimibe, and niacin. Throughout the study the LDL cholesterol level was maintained over intervals of 3 months.
Step 5: Outcomes Evaluated
All the patients enrolled in the program completed the 12 months study. The patients reported slight to zero changes in their cholesterol levels over the 1 year period they undertook the statin therapy. From the study by Winchester, Wen, Xie, & Bavry, (2010), if the p-value < level of significance, 0.05, then we reject the null hypothesis and conclude that lifestyle therapy with no medication added decrease cholesterol levels over a period of 1 year for cases of failed statin therapy. Thus, it was concluded that lifestyle therapy with no medication added did not have significant effect on cholesterol levels over a period of 1 year for cases of failed statin therapy.
Step 6: Project Outcomes Successfully Disseminated
Clinicians and health care practitioners within the community are keen to monitor the side effects displayed by statin-intolerant patients. This way they can evaluate and implement alternative treatment procedures that address the patient’s needs without exposing them to extreme side effects.
Conclusion
The study revealed that lifestyle change does not have significant impact on the cholesterol levels of a patient. Therefore, clinicians should eliminate any secondary causes of side effects among statin-intolerant patients. Additionally, the clinician should determine whether the identified side effects are adverse and if they are associated with statin therapy. If the side effects symptoms are not resolved, the clinician should administer the statin at a lower dosage.
References
Harvard Health Publishing. (2017, April 27). Help for your cholesterol when the statins won't do. Retrieved from https://www.health.harvard.edu/newsletter_article/help-for-your-cholesterol-when-the-statins-wont-do
Meor Anuar Shuhaili, M., Samsudin, I. N., Stanslas, J., Hasan, S., & Thambiah, S. C. (2017). Effects of Different Types of Statins on Lipid Profile: A Perspective on Asians. International journal of endocrinology and metabolism , 15 (2), e43319. doi:10.5812/ijem.43319
Rosenson, R. S., Baker, S., Banach, M., Borow, K. M., Braun, L. T., Bruckert, E., ... & Moriarty, P. M. (2017). Optimizing cholesterol treatment in patients with muscle complaints. Journal of the American College of Cardiology, 70(10), 1290-1301.
Sahebkar, A., Giua, R., & Pedone, C. (2016). Impact of statin therapy on plasma leptin concentrations: a systematic review and meta-analysis of randomized placebo-controlled trials. British Journal of Clinical Pharmacology , 82 (6), 1674-1684. doi:10.1111/bcp.13086
Williams, K. N., Ilten, T. B., & Bower, H. (2016). Meeting communication needs: topics of talk in the nursing home. Journal of Psychosocial Nursing and Mental Health Services, 43(7), 38-45.
Winchester, D. E., Wen, X., Xie, L., & Bavry, A. A. (2010). Evidence of Pre-Procedural Statin Therapy: A Meta-Analysis of Randomized Trials. Journal of the American College of Cardiology , 56 (14), 1099-1109. Retrieved from https://doi.org/10.1016/j.jacc.2010.04.023
