The risk for significant creatine kinase elevation with statins.

BACKGROUND: The HMG-CoA reductase inhibitors (statins) are effective for reducing long-term cardiovascular morbidity and mortality in both primary and secondary prevention. The most serious adverse reaction is significant elevation of creatine kinase (CK) leading to rhabdomyolysis. The incidence of CK elevation is low in randomized, controlled trials. The rate may be higher in 'real-world', less controlled settings. Data on the risks of statin-associated rhabdomyolysis in 'real-world' practice settings are limited. OBJECTIVE: The aim of this study was to examine the risk for CK elevation among statin users in a clinical practice setting. Potential risk factors were identified and evaluated to quantify the risk for CK elevation with statins. METHODS: This case-control study was conducted at Kaiser Permanente Colorado. Patients with prescriptions for lovastatin or simvastatin between 1 January 1999 and 30 June 2006 were identified. Cases (n = 183), i.e. patients with a CK > or =10x the upper limit of normal (ULN) while receiving a statin during this time period, were each matched on the date of statin purchase to ten control patients (n = 1830) without CK > or =10x ULN while receiving a statin. Multivariate, conditional logistic regression was used to assess the associations between the statin, statin dose, demographic, co-morbidity, laboratory, and medication factors potentially associated with CK >or =10x ULN. RESULTS: he mean (SD) age of patients was 64.9 (11.5) years and 56.9% were male. Overall, simvastatin use was associated with a higher likelihood for CK > or =10x ULN than lovastatin (adjusted odds ratio [OR] 4.6; 95% CI 1.1, 12.4). Using simvastatin 40 mg daily as the referent, and in the absence of interacting medications, only simvastatin 80 mg was associated with a higher likelihood for CK > or =10x ULN (OR 2.7; 95% CI 1.1, 6.9). In the presence of interacting medications, all doses of simvastatin and only lovastatin 80 mg were associated with a higher likelihood for CK > or =10x ULN. CONCLUSION: In this study, simvastatin was associated with a higher likelihood for CK > or =10x ULN than lovastatin. High-dose simvastatin, in particular, appears to confer a greater risk than lower doses of either simvastatin or lovastatin.

Statin adherence and mortality in patients enrolled in a secondary prevention program.

OBJECTIVES: To determine statin adherence rates in patients enrolled in a cardiovascular secondary disease prevention program and to evaluate the impact of adherence on subsequent clinical events. METHODS: Patients who had an incident cardiac event between January 1, 2000, and December 31, 2005, and began statin therapy within 90 days of that event were identified and followed until death, a recurrent nonfatal cardiac event, or December 31, 2006. Analysis was conducted in 2007 and 2008. Adherence was calculated using proportion of days covered (PDC), which was dichotomized into overall PDC >80% and PDC 80% compared with those with a PDC 80% had decreased risk of the combined outcome of death or nonfatal recurrent cardiac event compared with those with a PDC

Pharmacologic risk factor management in peripheral arterial disease: a vade mecum for vascular surgeons.

There is broad and compelling evidence for risk factor reduction to limit cardiovascular morbidity and mortality in patients with peripheral arterial disease. Indeed, vascular surgeons have placed a call to arms to ensure this takes place. Despite this fact, some wariness exists on the part of many vascular surgeons to initiate these strategies, functionally abnegating their responsibilities in this regard. The purpose of this article is to provide a simple reference to guide effective therapies for overall cardiovascular risk reduction in patients with peripheral arterial disease. Specific recommendations are made for tobacco cessation, lipid-lowering therapy, antiplatelet therapy, blood pressure control, and maintenance of normoglycemia.

Effect of a clinical pharmacy service on lipid control in patients with peripheral arterial disease.

OBJECTIVE: Our group and others have previously established that patients with peripheral artery disease (PAD) are significantly undertreated with respect to overall cardiovascular risk factor management, despite national guidelines to the contrary. In an effort to maximize risk factor control in our patients with PAD, we established a pharmacist-managed, physician-monitored algorithmic approach to the outpatient management of lipids in patients with PAD. The purpose of this study was to determine the effect of this service on lipid screening and control in patients with PAD. METHODS: We analyzed the records of patients treated at a large, group-model, not-for-profit regional managed care system serving approximately 405,000 members. An electronic medical record provided full examination, laboratory, and pharmacy data for all patients. Pharmacy data were analyzed to determine prescriptions for lipid-lowering agents. Lipid control was assessed through fasting lipid data. Patients with validated PAD and the absence of clinical coronary artery disease (CAD) were offered the service between May 2003 and September 2004 and followed up for a minimum of 6 months. RESULTS: We administratively identified 5159 active patients with a diagnosis of PAD. Of these, 1075 could be validated with a noninvasive arterial study. The exclusion of 384 patients with a diagnosis of CAD resulted in a cohort of 691 patients. Of these, 90 patients were enrolled in the lipid service (study group), and 601 received standard care. Mean follow-up was 17.1 months. Screening fasting lipid profiles were found in 95.6% (86/90) of patients in the study group and only 66.9% (402/601) of the standard care patients (P < .0001). Low-density lipoprotein cholesterol (LDL-C) control was improved in the pharmacist-managed group, with 79.1% (68/86) achieving an LDL-C of less than 100 mg/dL in comparison to the standard care group (54.8% [219/400]; P < .0001). An LDL-C value of more than 130 mg/dL was noted in 1.2% and 14.0% (56/400) in the treatment and control groups, respectively (P < .001). Statin use was present in 51.9% (312/601) of the control group patients and 84.4% (76/90) of the pharmacist-managed group (P < .001). CONCLUSIONS: Despite national consensus of PAD as a CAD equivalent, patients are currently undertreated with regard to atherosclerotic risk factor modification. Initiation of a pharmacist-managed, physician-monitored lipid service provides improved compliance with national guidelines.

The triglyceride-lowering effects of a modest dose of docosahexaenoic acid alone versus in combination with low dose eicosapentaenoic acid in patients with coronary artery disease and elevated triglycerides.

BACKGROUND: Hypertriglyceridemia is a risk factor for coronary artery disease (CAD). The American Heart Association recommends 1000 mg of omega-3 fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), daily for cardioprotection and higher doses for triglyceride-lowering in patients with CAD. METHODS: This was a prospective, randomized, double-blind study comparing DHA to DHA + EPA in patients with CAD and triglycerides greater than 200 mg/dL. Subjects were randomized to either 1000 mg of DHA or 1252 mg of DHA + EPA for eight weeks. Baseline and eight-week laboratories were drawn to assess changes in the fasting lipid profile. The primary objective was to evaluate the change in triglycerides between the two groups at eight weeks. RESULTS: A total of 116 subjects were enrolled; 57 in the DHA group and 59 in the DHA + EPA group. Baseline characteristics were similar between groups. The mean age was 69.4 +/- 9.1 years and 70.7% were male. Triglycerides decreased by an average of 21.8% in the DHA group (p < 0.001) and 18.3% in the DHA + EPA group (p < 0.001). The difference between groups was not significant. A greater proportion of subjects in the DHA group achieved triglyceride goal (less than 150 mg/dL) compared to the DHA + EPA group (24.6% versus 10.2%, p < 0.05). CONCLUSIONS: Our results indicate that the American Heart Association recommended cardioprotective dose of omega-3 fatty acids can also significantly lower triglycerides in patients with CAD. There do not appear to be significant differences in triglyceride-lowering between DHA only and DHA + EPA combination products when dosing is based on DHA.

Atherosclerotic risk factor control in patients with peripheral arterial disease.

BACKGROUND: The presence of peripheral arterial disease (PAD), even in the absence of overt coronary artery disease (CAD), confers the same relative risk of death from a cardiovascular cause as in patients with a previous cardiovascular event. Current guidelines recommend atherosclerotic risk factor-reduction strategies in PAD patients identical to those in patients with a recent coronary event. The purpose of this study was to determine the status of atherosclerotic risk factor control in patients with PAD. METHODS: We analyzed the records of patients treated at 2 regional clinics serving 92,940 individuals. Full examination, laboratory, and pharmacy data were available for all patients. Pharmacy data were analyzed to determine prescriptions for beta-blocker therapy, angiotensin-converting enzyme inhibitors, and lipid-lowering agents. Lipid control was assessed through fasting lipid data. Glycemic control in diabetics was evaluated by using hemoglobin A 1c levels. RESULTS: We administratively identified 2839 patients with a diagnosis of PAD. The exclusion of 1106 patients with a diagnosis of CAD or validated not to have PAD resulted in a cohort of 1733 patients. Of these, 33.1% (574/1733) were currently receiving beta-blockers, 28.9% (500/1733) were receiving an angiotensin-converting enzyme inhibitor, and 31.3% (543/1733) were receiving a statin. Most patients (92%; 1594/1733) had a recent blood pressure recorded. However, 56% (893/1594) had a systolic blood pressure of 130 mm Hg or higher, 45.5% (726/1594) had a diastolic blood pressure of 80 mm Hg or higher, and 13.6% (217/1594) had a diastolic blood pressure of 90 mm Hg or higher. Screening fasting lipid profiles were found in 62.6% (1085/1733) of patients, 56% (508/912) had a low-density lipoprotein of 100 mg/dL or higher, and 21% (187/912) had a value of more than 130 mg/dL. In patients with diabetes, a hemoglobin A 1c level of 7.0% or higher was found in 54.2% (198/365) of patients. CONCLUSIONS: Despite national consensus of PAD as a CAD equivalent, patients are currently undertreated with regard to atherosclerotic risk factor modification. Until broader recognition of this disease process exists, vascular surgeons must continue to champion medical as well as surgical treatments for these patients.