Case report: dyslipidaemia-dramatic increase in haemoglobin A1c following statin initiation.

Background: Statin therapy is associated with an increased risk of hyperglycaemia and new-onset diabetes mellitus. The absolute increase in glycosylated haemoglobin (HgbA1c, a measure of average glucose level over the past three months) is typically small; dramatic and clinically relevant increases are rare. Case summary: A 52-year-old man of South Indian descent with a history of hyperlipidaemia was started on rosuvastatin 40 mg daily for primary prevention of atherosclerotic cardiovascular disease. He did not have a history of diabetes mellitus. He developed polyuria and weight loss within weeks of starting statin therapy. Laboratory assessment was notable for HgA1c of 12.4% and LDL cholesterol of 84 mg/dL. Rosuvastatin was discontinued. He was not started on antidiabetic therapy as there was suspicion that statin therapy was the culprit for his HgbA1c rise. He soon had symptom resolution, and follow-up HgA1c 3 months later was 5.5%. Two years later, patient presented to the hospital with an acute coronary syndrome. He was discharged on rosuvastatin 40 mg daily and developed polyuria 1 week later. Rosuvastatin was discontinued, and atorvastatin 40 mg daily was initiated. Antidiabetic therapy was not started. He had resolution of his symptoms; follow-up HgA1c was below the diabetes threshold. Discussion: Statins are associated with a small increased risk of developing diabetes mellitus. The beneficial effects of statins on cardiovascular events typically outweigh any increased risk conferred by hyperglycaemia. While high-intensity statin therapy is routinely used as initial therapy for secondary prevention, we have no documentation explaining the choice of high-intensity statin for primary prevention in this case.

Facility-Level Variation in Reported Statin-Associated Side Effects Among Patients with Atherosclerotic Cardiovascular Disease-Perspective from the Veterans Affair Healthcare System.

PURPOSE: Statin-associated side effects (SASEs) can limit statin adherence and present a potential barrier to optimal statin utilization. How standardized reporting of SASEs varies across medical facilities has not been well characterized. METHODS: We assessed facility-level variation in SASE reporting among patients with atherosclerotic cardiovascular disease receiving care across the Veterans Affairs (VA) healthcare system from October 1, 2014, to September 30, 2015. The facility rates for SASE reporting were expressed as cases per 1000 patients with ASCVD. Facility-level variation was determined using hierarchical regression analysis to calculate median rate ratios (MRR [95% confidence interval]) by first using an unadjusted model and then adjusting for patient, provider, and facility characteristics. RESULTS: Of the 1,248,158 patients with ASCVD included in our study across 130 facilities, 13.7% had at least one SASE reported. Individuals with a history of SASE were less likely to be on a statin at follow-up compared with those without SASE (72.0% vs 80.8%, p < 0.01). The median (interquartile range) facility rate of SASE reported was 140.5 (109.4-167.7) cases per 1000 patients with ASCVD. Significant facility-level variation in the rate of SASE reported was observed: MRR 1.38 (1.33-1.44) in the unadjusted model and MRR 1.56 (1.47-1.65) in the adjusted model. CONCLUSION: Significant facility-level variation in SASE reporting was found within the VA healthcare system suggesting room for improvement in standardized documentation of SASEs among medical facilities. This has the potential to lead to improvement in statin utilization.

Association of patient, provider and facility related characteristics with statin associated side effects and statin use: Insight from the Veteran's Affairs healthcare system.

BACKGROUND: Statin associated side effects (SASE) are a leading cause of statin discontinuation. OBJECTIVE: We evaluated patient, provider, and facility characteristics associated with SASEs and whether these characteristics impact statin utilization. METHODS: Patients with atherosclerotic cardiovascular disease (ASCVD) receiving care across the Veterans Affairs healthcare system from October 1, 2014 to September 30, 2015 were included. Multivariable logistic regression analyses were performed to determine (a) factors associated with SASE and (b) factors associated with statin use in those with SASE. RESULTS: Our cohort included 1,225,576 patients with ASCVD. Of these, 171,189 (13.7%) had at least 1 reported SASE since year 2000. The most significant odds for SASEs were observed with female sex (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.36, 1.45), White race (OR 1.43, 95% CI 1.41, 1.45), hypertension (OR 1.37, 95% CI 1.33, 1.41) and ischemic heart disease (IHD: OR 1.45, 95% CI 1.43, 1.47). Lower odds were noted with care at a teaching facility (OR 0.89, 95% CI 0.88, 0.90). Factors most associated with being on a statin among patients with SASE included having diabetes (OR 1.18, 95% CI 1.15, 1.20), IHD (OR 1.39, 95% CI 1.35, 1.43) and a higher number of cardiology visits (OR 1.08, 95% CI 1.07, 1.09), while female sex was associated with lower odds (OR 0.65, 95% CI 0.61, 0.69). CONCLUSION: There are significant disparities in statin use by sex, ASCVD type, and comorbidities among secondary prevention patients with SASE, which represent areas for improvement in optimizing statin utilization.

How I treat statin-associated side effects in an outpatient setting.

Dyslipidemia promotes atherosclerosis and causes cardiovascular diseases. Statins are potent lipid-lowering medications with a cardiovascular mortality benefit. They are generally safe and well tolerated but sometimes can be associated with side effects of variable severity. The most common side effect is statin-associated muscle symptoms. Uncommon side effects include new-onset diabetes mellitus and elevation in liver enzymes. These effects can lead to noncompliance and premature discontinuation of the medication. Hence, it is crucial to identify patients with true statin-associated side effects (SASE) to ensure optimal statin use. The appropriate evaluation of the patient before starting statins and proactive utilization of available diagnostic tests to rule out alternate etiologies mimicking adverse effects are essential for accurate diagnosis of SASE. In patients with true SASE, timely intervention with modified statin or non-statins is beneficial. Herein, we discuss key clinical trial data on statins and non-statins, and describe our center's approach toward patients with SASE.

Shared Decisions: A Qualitative Study on Clinician and Patient Perspectives on Statin Therapy and Statin-Associated Side Effects.

Background Despite guideline recommendations and clinical trial data suggesting benefit, statin therapy use in patients with atherosclerotic cardiovascular disease remains suboptimal. The aim of this study was to understand clinician and patient views on statin therapy, statin-associated side effects (SASEs), SASE management, and communication around statin risks and benefits. Methods and Results We conducted qualitative interviews of patients with atherosclerotic cardiovascular disease who had SASEs (n=17) and clinicians who regularly prescribe statins (n=20). We used directed content analysis, facilitated by Atlas.ti software, to develop and revise codebooks for clinician and patient interviews. The most relevant codes were "pile sorted" into 5 main topic domains: (1) SASEs vary in severity, duration, and time of onset; (2) communication practices by clinicians around statins and SASEs are variable and impacted by clinician time limitations and patient preconceived notions of SASEs; (3) although a "trial and error" approach to managing SASEs may be effective in allowing clinicians to keep patients with atherosclerotic cardiovascular disease on a statin, it can be frustrating for patients; (4) outside sources, such as the media, internet, social networks, and social circles, influence patients' perceptions and often impact the risk benefit discussion; and (5) a decision aid would be beneficial in facilitating clinician decision-making around SASEs and discussion of SASEs with the patients. Conclusions Statin use among patients with atherosclerotic cardiovascular disease remains suboptimal because of various patient- and clinician-related factors. The development of a decision aid to facilitate discussion of SASEs, clinician decision-making, and SASE management may improve statin use in this high-risk population.

The use of structured data elements to identify ASCVD patients with statin-associated side effects: Insights from the Department of Veterans Affairs.

BACKGROUND: Accurate identification of patients with statin-associated side effects (SASEs) is critical for health care systems to institute strategies to improve guideline-concordant statin use. OBJECTIVE: The objective of this study was to determine whether adverse drug reaction (ADR) entry by clinicians in the electronic medical record can accurately identify SASEs. METHODS: We identified 1,248,214 atherosclerotic cardiovascular disease (ASCVD) patients seeking care in the Department of Veterans Affairs. Using an ADR data repository, we identified SASEs in 15 major symptom categories. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were assessed using a chart review of 256 ASCVD patients with identified SASEs, who were not on high-intensity statin therapy. RESULTS: We identified 171,189 patients (13.71%) with documented SASEs over a 15-year period (9.9%, 2.7%, and 1.1% to 1, 2, or >2 statins, respectively). Statin use, high-intensity statin use, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol levels were 72%, 28.1%, 99 mg/dL, and 129 mg/dL among those with vs 81%, 31.1%, 84 mg/dL, and 111 mg/dL among those without SASEs. Progressively lower statin and high-intensity statin use, and higher low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol levels were noted among those with SASEs to 1, 2, or >2 statins. Two-thirds of SASEs were related to muscle symptoms. Sensitivity, specificity, PPV, NPV compared with manual chart review were 63.4%, 100%, 100%, and 85.3%, respectively. CONCLUSION: A strategy of using ADR entry in the electronic medical record is feasible to identify SASEs with modest sensitivity and NPV but high specificity and PPV. Health care systems can use this strategy to identify ASCVD patients with SASEs and operationalize efforts to improve guideline-concordant lipid-lowering therapy use in such patients. The sensitivity of this approach can be further enhanced by the use of unstructured text data.