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PubMed2005

Differences between statins on clinical endpoints: a population-based cohort study.

OBJECTIVE: Many studies have shown differences between statins based on surrogate endpoints, but few have studied differences in reaching clinical endpoints. This study compares the risk of cardiovascular and cerebrovascular events between atorvastatin users and other statin users in daily general practice. RESEARCH DESIGN AND METHODS: A cohort study was performed in the Integrated Primary Care Information project database, a longitudinal general practice research database with electronic patient records of more than 500,000 individuals in The Netherlands. All new statin users in the period 1st September 1999 to 31st December 2002 were included. Multivariate Cox-regression analysis was used to compare the occurrence of the primary endpoint between atorvastatin users and other statin users. MAIN OUTCOME MEASURES: The primary endpoint was the composite outcome of fatal or non-fatal myocardial infarction, admission for unstable angina pectoris, fatal or non-fatal cerebrovascular accidents, or transient ischaemic events. RESULTS: 3499 new statin users were identified, including 797 patients with a history of cardiovascular disease. 1341 persons started with simvastatin (38.3%), 1154 with atorvastatin (33.0%), 811 with pravastatin (23.2%) and 193 with other statins (5.5%). The median follow-up was 1.9 years. Two hundred and thirty three patients (6.7%) experienced a primary endpoint. Atorvastatin users had a significantly lower risk of cardiovascular and cerebrovascular events than users of other statins (relative risk [RR]: 0.70, 95% confidence interval [CI]: 0.55-0.96). The relative risks of atorvastatin users compared to simvastatin and pravastatin users individually were 0.70 (95% CI: 0.48-1.02) and 0.78 (95% CI: 0.52-1.16), respectively. The protective effect of atorvastatin was more pronounced in persons without a history of cardiovascular or cerebrovascular events. CONCLUSION: Atorvastatin showed a more favourable effect on fatal and non-fatal cardiovascular and cerebrovascular events in the general population than other statins.

Adult↗
PubMed2006

Statins and cancer risk: a literature-based meta-analysis and meta-regression analysis of 35 randomized controlled trials.

PURPOSE: A growing body of literature suggests that statins may have chemopreventive potential against cancer. Our aim was to examine the strength of this association through a detailed meta-analysis and meta-regression analysis of randomized controlled trials (RCTs). METHODS: A comprehensive search for trials published up to 2005 was performed, reviews of each study were conducted, and data were abstracted. Before meta-analysis, the studies were evaluated for publication bias and heterogeneity. Pooled relative risk (RR) estimates and 95% CIs were calculated using the random- and fixed-effects models. Subgroup, sensitivity, and meta-regression analyses were also conducted. RESULTS: Thirty-five RCTs of statins for cardiovascular outcomes contributed to the analysis (n = 109,143). The degree of variability between trials was consistent with what would be expected to occur by chance alone. Statin use was not associated with a substantially increased or decreased overall risk of cancer (RR = 0.99; 95% CI, 0.94 to 1.04). Similarly, statin use did not significantly affect respiratory cancer risk (RR = 0.95; 95% CI, 0.83 to 1.09). However, the meta-regression analysis indicated that age of study participants modified the association between statin use and cancer risk (P = .003). CONCLUSION: Our findings do not support a protective effect of statins against cancer. However, this conclusion is limited by the relatively short follow-up periods (4.5 years on average) of the studies analyzed. Thus, it is important to continue monitoring the long-term safety profiles of statins. Until then, physicians need to be vigilant in ensuring that statin use remains restricted to the approved indications.

Age Factors↗
PubMed2002

Statins as immunomodulators: comparison with interferon-beta 1b in MS.

BACKGROUND: Recent data suggest that statins may be potent immunomodulatory agents. In order to evaluate the potential role of statins as immunomodulators in MS, the authors studied their immunologic effects in vitro and compared them to interferon (IFN)beta-1b. METHODS: Peripheral blood mononuclear cells (PBMC) obtained from untreated or IFN beta-1-treated patients with relapsing-remitting MS or from healthy donors (HD) and T cells were stimulated with concanavalin A, phytohemagglutinin, or antibody to CD3 in the presence of lovastatin, simvastatin, mevastatin, IFN beta-1b, or statins plus IFN beta-1b. The authors analyzed proliferative activity of T cells and B cells, cytokine production and release, activity of matrix metalloproteinases (MMP), and surface expression of activation markers, adhesion molecules, and chemokine receptors on both T and B cells. RESULTS: All three statins inhibited proliferation of stimulated PBMC in a dose-dependent manner, with simvastatin being the most potent, followed by lovastatin and mevastatin. IFN beta-1b showed a similar effect; statins and IFN beta-1b together added their inhibitory potentials. Furthermore, statins reduced the expression of activation-induced adhesion molecules on T cells, modified the T helper 1/T helper 2 cytokine balance, reduced MMP-9, and downregulated chemokine receptors on both B and T cells. Besides strong anti-inflammatory properties, statins also exhibited some proinflammatory effects. CONCLUSIONS: Statins are effective immunomodulators in vitro that merit evaluation as treatment for MS.

Adjuvants, Immunologic↗
PubMed2005

Effect of prior statin use on functional outcome and delayed vasospasm after acute aneurysmal subarachnoid hemorrhage: a matched controlled cohort study.

OBJECTIVE: Hydroxymethylglutaryl coenzyme A reductase inhibitors (statins), which exhibit beneficial cerebrovascular effects by modulating inflammation and nitric oxide production, have not been evaluated in acute aneurysmal subarachnoid hemorrhage (SAH) patients. The effect of prior statin use on 14-day functional outcome and on prevention of vasospasm-induced delayed cerebral ischemia (DCI) or stroke during hospitalization was analyzed. METHODS: We conducted a 1:2 matched (age, admission Hunt and Hess grade, vascular disease/risk history) cohort study of 20 SAH patients on statins and 40 SAH controls. The primary outcome was functional outcome at 14 days (Modified Lawton Physical Self-Maintenance Scale and Barthel Index scale scores). Secondary outcomes were 14-day mortality, Modified Rankin Scale score, DCI, DCI supported by angiography/transcranial Doppler [TCD], cerebral infarctions of any type, and TCD highest mean velocity elevation. RESULTS: Statin users demonstrated a significant protective effect on 14-day Barthel Index scale and Modified Lawton Physical Self-Maintenance Scale scores (77 +/- 10 versus 39 +/- 8, P = 0.003; 12 +/- 7 versus 19 +/- 9, P = 0.03, respectively). Moreover, statin users demonstrated a significantly lower incidence of DCI and DCI supported by angiography/TCD (10% versus 43%, P = 0.02; 5% versus 35%, P = 0.01, respectively), cerebral infarctions of any type (25% versus 63%, P = 0.01), and baseline-to-final TCD highest mean velocity change of 50 cm/s or greater (18% versus 51%, P = 0.03). CONCLUSION: SAH statin users demonstrated significant improvement in 14-day functional outcome, a significantly lower incidence of DCI and cerebral infarctions of any type, as well as prevention of TCD highest mean velocity elevation. However, we did not find a significant statin impact on mortality or global outcome (Modified Rankin Scale) in this small sample. This study provides clinical evidence for the potential therapeutic benefit of statins after acute SAH.

Adult↗
PubMed2002

FDA adverse event reports on statin-associated rhabdomyolysis.

OBJECTIVE: To determine the number of cases of statin-associated rhabdomyolysis reported to the Food and Drug Administration for 6 statins and to profile the cases. METHODS: A retrospective analysis of all domestic and foreign reports of statin-associated rhabdomyolysis between November 1997 and March 2000 was conducted. Outcome measures included the total number of reports (initial plus follow-up), the number of unique cases, age, gender, percentages of report codes and role codes, and frequencies of concomitant interacting drugs that may have precipitated rhabdomyolysis, outcomes codes, and report source codes. RESULTS: There were 871 reports of statin-associated rhabdomyolysis in the 29-month time frame examined, representing 601 cases. The following number of cases were associated with each of the individual statins: simvastatin, 215 (35.8%); cerivastatin, 192 (31.9%); atorvastatin, 73 (12.2%); pravastatin, 71 (11.8%); lovastatin, 40 (6.7%); and fluvastatin, 10 (1.7%). Drugs that may have interacted with the statins were present in the following number of cases: mibefradil (n = 99), fibrates (n = 80), cyclosporine (n = 51), macrolide antibiotics (n = 42), warfarin (n = 33), digoxin (n = 26), and azole antifungals (n = 12). The reports of 62.1% of cases were classified as expedited. Statins were designated as the primary suspect in 72.0% of the cases. Death was listed as the outcome in 38 cases. The majority of reports (n = 556) were from health professionals. CONCLUSIONS: Compared with the other statins, simvastatin and cerivastatin were implicated in a relatively higher number of reports. Because of the various limitations of a spontaneous reporting-system database, caution is urged when interpreting the relative number of cases reported.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Statins and progression of calcified aortic stenosis.

OBJECTIVE: To review the evidence evaluating the efficacy of statins in reducing the progression of calcified aortic stenosis (AS). DATA SOURCES: MEDLINE, EMBASE, and PubMed were searched (all up to November 2006) for studies evaluating the use of statins to reduce the progression of calcified AS. Search terms included statin, HMG CoA reductase inhibitor, calcified AS, valve stenosis, and calcified stenosis. Additional primary trials were located by searching references noted in review articles. STUDY SELECTION AND DATA EXTRACTION: Clinical trials published in the English language were selected for review. Primary efficacy outcomes evaluated were changes in aortic valve measurements, hemodynamic measures of AS, and change in measures of AS severity. DATA SYNTHESIS: Two prospective clinical trials and 5 retrospective studies were included in this review. All of the retrospective studies demonstrated that statin use was associated with a statistically significant delay in the progression of AS. One prospective observation trial showed benefit of statin use; however, a large, randomized, double-blind, prospective trial showed no benefit of statin use in decreasing the progression of AS. CONCLUSIONS: An association between statin use and a delay in AS progression has been observed in retrospective studies; however, prospective trials showed conflicting results. Currently, statins cannot be recommended for medical treatment of AS until larger trials are conducted.

Aortic Valve Stenosis↗
PubMed2004

Antioxidant effects of statins.

Statins, a group of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, are widely used in clinical practice for their efficacy in producing significant reductions in plasma cholesterol and LDL cholesterol and in reducing morbidity and mortality from cardiovascular disease. However, several large clinical trials have suggested that the cholesterol-lowering effects of statins may not completely account for the reduced incidence of cardiovascular disease seen in patients receiving statin therapy. A number of recent reports have shown that statins may also have important antiinflammatory effects, in addition to their effects on plasma lipids. Since inflammation is closely linked to the production of reactive oxygen species (ROS), the molecular basis of the observed antiinflammatory effects of statins may relate to their ability block the production and/or activity of ROS. In this review, we will discuss both the inhibition of ROS generation by statins, through interference with NAD(P)H oxidase expression and activity, and the actions of statins that serve to blunt the damaging effects of these radicals, including effects on antioxidant enzymes, lipid peroxidation, LDL cholesterol oxidation and nitric oxide synthase. These antioxidant effects of statins likely contribute to their clinical efficacy in treating cardiovascular disease as well as other chronic conditions associated with increased oxidative stress in humans.

Antioxidants↗
PubMed2004

Impact of angiotensin-converting enzyme inhibitors and statins on survival in idiopathic pulmonary fibrosis.

STUDY OBJECTIVES: To assess the clinical relevance of angiotensin-converting enzyme inhibitors (ACEI) and 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors (statins) in the context of idiopathic pulmonary fibrosis (IPF). BACKGROUND: IPF is a progressive interstitial lung disease for which there is no effective treatment. ACEI and statins have been shown to possess antifibrotic properties in experimental models in vitro and in vivo. DESIGN, SETTING, AND PATIENTS: Retrospective review of the effects of ACEI and statins on survival of 478 patients with IPF seen at Mayo Clinic Rochester from 1994 through 1996. Fifty-two patients (11%) were receiving ACEI, 35 patients (7%) were receiving statins, and 5 patients (1%) patients were receiving both at their initial visit. RESULTS: For subjects receiving ACEI, the median survival from the index visit was 2.2 years, compared to 2.9 years for subjects not receiving ACEI (p = 0.088). The median survival was 2.9 years if patients were receiving statins or not (p = 0.573). There was also no significant difference in survival between patients with IPF receiving either ACEI or statins vs those receiving neither at the index visit (2.5 years vs 3 years, respectively; p = 0.066). After adjusting for age, gender, recommended IPF treatment, smoking status, prior oxygen use, FVC, diffusion capacity for carbon monoxide, coronary artery disease, congestive heart failure, diabetes mellitus, and hypertension, there were no differences in survival between those subjects receiving either ACEI, statins, or both vs neither. CONCLUSIONS: These data do not suggest a beneficial effect of ACEI and/or statins on survival in patients with IPF.

Adult↗
PubMed2000

Pharmacotherapy of hypercholesterolaemia: statins in clinical practice.

The objective of this article is to evaluate the roles of the lipid-lowering class of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) in reducing cardiovascular events and to review their mechanism of action based on in vitro and in vivo studies. The clinical outcome of 15 major clinical trials has been critically reviewed and summarised; all showed a high degree of efficacy and safety. Statins, either in active or prodrug forms, are potent inhibitors of HMG-CoA reductase, have good absorption rate and their bioavailability depends on their lipophobicity and concomitant use with meals. Abdominal discomfort is the most commonly reported adverse effect. Although the incidence is low, myopathy with or without rhabdomyolysis may be considered a serious adverse effect of statins. A combination of a statin with gemfibrozil seems to increase the risk of this adverse event, particularly in patients with renal impairment. Combination therapy with several other agents, frequently administered to cardiovascular patients, has also been reviewed. Statin therapy is considered highly cost effective in secondary prevention, but it is less cost effective in primary prevention. This factor may underline the rationale for developing other safe and effective agents with an improved cost effectiveness profile. The pleiotropic non-lipid lowering effects of statins may include their anti-oxidant and antithrombotic potential as well as restoration of endothelial function. Statins may also be beneficial in the treatment of osteoporosis. Fewer studies have investigated statins' effects on the quality of lipoprotein particles, the activities of cholesteryl ester transfer protein and lecithin:cholesterol acyltransferase as well as their possible synergistic effects with n-3 fatty acids, anti-oxidants and aspirin in reducing cardiovascular events.

Anticholesteremic Agents↗
PubMed2006

Pharmacoeconomic considerations with statin therapy.

Statins have been shown to reduce morbidity and mortality in patients with and without coronary heart disease, and in patients with elevated and normal or average cholesterol levels. Economic evaluations of these mortality trials have demonstrated statins to be cost-effective. As these trials were placebo comparisons, their results are now of limited use in guiding the drug therapy selection process. The more relevant questions today are focused on ways of optimising statin therapy. More recent studies have found that more intensive statin therapy, using high doses of these agents that produce substantially greater reductions in low-density lipoprotein cholesterol, are associated with greater benefit than less intensive statin therapy. These trials suggest that statins with greater efficacy in reducing low-density lipoprotein cholesterol, would be preferred over less effective statins. So far, economic analyses of these comparative studies have not been published. These economic studies are needed to support formulary and drug therapy selection decisions regarding statins.

Adult↗
PubMed2004

HMG CoA reductase inhibitors (statins): use in stroke prevention and outcome after stroke.

The use of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) has been demonstrated to reduce the risk of primary and secondary ischemic stroke in patients with ischemic heart disease (relative risk reduction is 20-30%), confirmed by several prospective randomized placebo-controlled trials. At least one large prospective trial has also shown a similar benefit in patients without underlying ischemic heart disease. This is in contrast to an open-labeled trial conducted in the USA, which failed to demonstrate a significant benefit of statins in reducing stroke risk in hypertensive hyperlipidemic patients. It is less clear if treatment with statins before or after the onset of ischemic stroke also reduces its severity (improves outcome). Experimental animal studies where mice were pretreated with statins, demonstrated a reduced infarct size compared with untreated animals. Treatment with statins after stroke onset has also been demonstrated to enhance recovery without influencing infarct size (by increased angiogenesis, synaptogenesis and blood flow). A few clinical retrospective studies have demonstrated similar results. Prospective blinded placebo-controlled trials to test these findings are still lacking. This review discusses the various prospective trials in stroke prevention and available data on the effects of statins in improving outcome of established ischemic stroke. Alternate mechanisms of statins besides their lipid-lowering effect and relevance in reducing stroke risk and improving outcome are discussed. Finally, based on the present information, an evidence-based perspective about current and future use of statins in the short- and long-term management of ischemic stroke is presented.

Animals↗
PubMed2001

Prescription and adherence to statins of patients with coronary artery disease and hypercholesterolemia.

OBJECTIVE: Statins have proved to be safe and effective in the secondary prevention of coronary artery disease, but the level of prescription and the reasons for nonadherence to treatment in many coronary diseases treatment centers has not been determined. The purpose of this study was to identify reasons for nonadherence to statin therapy. METHODS: We analyzed 207 consecutive patients with coronary artery disease and hypercholesterolemia (total cholesterol > or = 200 mg/dL or LDL-cholesterol > or = 130 mg/dL). Patients' average age was 61.7 +/- 10 year; 111 (53.6 %) male were and 94 (46.6 %) were female. We analyzed the level of prescription and adherence to treatment with statins. RESULTS: Statins were prescribed for 139 (67 %) patients, but only 85 (41 %) used the drug. In spite of being indicated, statins were not prescribed in 68 (33 %) patients. Of 54 (26 %) patients, nonadherent to statins, 67 % did not use the drug due to its high cost, 31 % due to the lack of instruction, and only 2 % due to side effects. Total cholesterol (260.3 +/- 42.2 vs 226.4 +/- 51.9; p < 0.0001) and LDL cholesterol (174.6 +/- 38.1 vs 149.6 +/- 36.1; p < 0.0001) were lower in patients on medication. HDL-cholesterol increased from 37.6 +/- 9.6 to 41.5 +/- 12.9 mg/dL (p = 0.02), and triglycerides were not modified in patients using statins. CONCLUSION: The prescription of statins in patients with coronary artery disease and dyslipidemia is high; however, its adherence is far from satisfactory, due to the high cost of the medication. Reduction in total cholesterol and LDL cholesterol levels did not reach the targets recommended by the Brazilian Consensus on Dyslipidemia.

Aged↗
PubMed2001

Physician-prompting statin therapy intervention improves outcomes in patients with coronary heart disease.

STUDY OBJECTIVE: To evaluate the effectiveness of a posthospital discharge intervention that prompted physicians to increase the use and effectiveness of statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) in patients with coronary heart disease (CHD). METHODS: Participants were 612 patients with CHD who were admitted to a coronary care unit. The control group (303 patients admitted from October 1-December 31, 1998) received no follow-up intervention. The intervention group (309 patients admitted fromJanuary 1-March 31, 1999) had follow-up letters sent or phone calls made to their primary care physicians with patient-specific recommendations concerning assessment of lipid profiles and statin therapy. Over a 2-year follow-up period, assessment of lipid profiles, use of therapy, and adverse clinical outcomes were compared between the control and intervention groups. RESULTS: At hospital discharge, there was no significant difference in the use of statins between the groups. At each reported follow-up interval, the percentages of patients having lipid profiles measured, being treated with a statin, receiving titrated dosages of a statin, and achieving low-density lipid (LDL) cholesterol goals set by the National Cholesterol Education Program (NCEP) were significantly greater in the intervention group compared with the control group (all p<0.05). At the end of the 2-year follow-up period, nearly three-fourths (72%) of the intervention group were receiving a statin, compared with 43% of the control group. In addition, 55% of the intervention group achieved their NCEP LDL goal, compared with only 10% of the control group. Recurrent myocardial infarction, hospitalization for myocardial ischemia, coronary revascularization, and cardiovascular mortality were significantly reduced in the intervention group compared with the control group (all p<0.05). CONCLUSION: A relatively simple physician-prompting intervention significantly increased assessment of lipid status, frequency of statin use, achievement of LDL treatment goals, and titration of lipid drug dosages. In addition, the improved use of statins significantly reduced adverse cardiovascular outcomes. This intervention tool should be more broadly applied in patient populations eligible to receive these agents.

Aged↗
PubMed2006

Combination of clopidogrel and statins: a hypothetical interaction or therapeutic dilemma?

BACKGROUND: The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and clopidogrel are frequently used in the treatment of patients with various cardiovascular disorders. The possibility of a drug-drug interaction between certain statins and clopidogrel has been extensively investigated in the literature recently. Investigators have proposed that the use of statins that are metabolized by the cytochrome P450 (CYP) system may diminish the conversion of clopidogrel to its active form by inhibiting the CYP3A4 isoenzyme. This inhibition could result in a decreased antiplatelet effect of clopidogrel, which could translate into an increased risk of cardiovascular events. METHODS: We performed a MEDLINE search of the literature from 1993-2005 to evaluate and discuss the existing data on a possible interaction between clopidogrel and statins and to provide clinicians with relevant and practical recommendations. Additional studies were identified from the bibliographies of the reviewed literature. RESULTS: Several articles were discovered that discuss this potential drug-drug interaction. Whereas some studies indicated that there was not a relevant interaction between statins and clopidogrel, other studies demonstrated that the concomitant administration of some statins with clopidogrel resulted in diminished platelet inhibition activity of clopidogrel. CONCLUSIONS: Although the interaction between certain statins and clopidogrel seems to be a pharmacologic certainty, the clinical relevance of this interaction needs further clarification. While investigators continue to evaluate the clinical relevance, we provide several recommendations for clinicians responsible for treating patients who require combination therapy with statins and clopidogrel.

Cardiovascular Diseases↗
PubMedDate not supplied

Determinants of the cost-effectiveness of statins.

OBJECTIVE: To examine the cost-effectiveness of statins in relation to different measures of effectiveness, differences in efficacy among individual statins, and the risk of coronary heart disease. Efficacy is defined here as the magnitude of the effect produced by a given amount of drug, as demonstrated in placebocontrol trials; i.e., the effectiveness per unit dose. DATA SYNTHESIS: Treatment guidelines categorize patients by their risk of coronary events and set lower target cholesterol levels for patients at higher risk. Statins vary in their efficacy. If effectiveness is expressed as percent lowering in low-density lipoprotein cholesterol (LDL-C) and relatively little cholesterol lowering is required.as in low-risk patients.even statins of low efficacy provide adequate cholesterol lowering, and drug price is the determining factor of costeffectiveness. For patients at high risk.the primary target group, which has been expanded in recent guidelines.high-efficacy statins are required to meet the more aggressive cholesterol goals, and efficacy is the important determinant of cost-effectiveness. When effectiveness is expressed in terms of life-years saved, the cost-effectiveness of statins as a class for treatment of high-risk patients compares favorably with the cost-effectiveness of generally accepted medical treatments. CONCLUSION: In order to optimize cost-effectiveness, the level of effectiveness required to treat the specific patient or patient group must be considered. Statin efficacy is the major determinant of cost-effectiveness when greater cholesterol lowering is required, i.e., for high-risk patients, who make up the primary target group. Statin price is the more important factor if only limited cholesterol lowering (e.g., 35% or less reduction in LDL) is required.

Cholesterol, LDL↗
PubMedDate not supplied

Managed care market perspectives on the over-the-counter availability of statins.

OBJECTIVE: In April, May, and June 2003, we conducted market research with decision makers from 3 payer segments to determine their perspectives on the potential introduction of statins to the U.S. over-the-counter (OTC) market. METHODS: We selected a convenience sample of survey participants based upon prominence in the market, membership size, and by willingness to participate in our study. The 12 participating managed care organizations (MCOs) cover approximately 100 million lives. The 4 pharmacy benefit managers (PBMs) cover approximately 200 million lives. The 3 large employers (one employer withheld quantitative results) provide medical coverage to nearly 1.4 million employees, both actives and retirees. Each survey participant received a verbal description of an OTC statin and a proposed patient self-management system. We asked each participant a series of questions to obtain opinions on a number of issues related to the potential introduction of an OTC statin. RESULTS: Our research findings can be summarized in the following key conclusions: (1) MCO representatives generally view OTC statins as a low-risk and beneficial addition to drug therapy options; (2) payer policies will continue to support access to prescription statins with no change in policy following introduction of an OTC option; (3) several of the MCOs and 75% of the PBMs anticipate a sharp, short-term increase in plan costs as a consequence of OTC statin availability; (4) survey participants believe that consumer or member reaction will be mixed and that consumer advertising and physician education will be important; (5) MCOs and PBMs are eager for involvement but cautious about partnerships with pharmaceutical companies; and (6) the details of any OTC statin offering will lay the foundation for its success. CONCLUSIONS: Based upon interviews conducted from April through June 2003, key decision makers from 4 PBMs, 12 MCOs, and 3 large employers generally considered the introduction of an OTC statin as a low risk and a beneficial addition to drug therapy. Most believed that increased awareness would result in an initial increase in plan costs, but long-term savings would accrue through improved care and availability of lower-cost OTC options for low-to-moderate-risk patients. The key concern is how to help patients gain enough knowledge and comfort to manage their own cholesterol therapy safely and successfully.

Humans↗
PubMed2006

Statin use in American Indians and Alaska Natives with coronary artery disease.

PURPOSE: The use and adherence to statin therapy in American Indians and Alaska Natives with coronary artery disease (CAD) were studied. METHODS: A retrospective database analysis of the Phoenix Area of the Indian Health Service was conducted. For the cohort of patients with CAD, prescription data were obtained for all statins during calendar year 2003. Use was determined by the presence of at least one statin prescription, whereas adherence was assessed using the medication possession ratio (MPR), persistence, and median gap. RESULTS: The study cohort was composed of 2095 adults (55.6% men) with at least one medical encounter for CAD during calendar year 2002. The mean +/- S.D. age of the cohort was 62.7 +/- 12.7 years. At least one prescription for any statin drug during 2003 was found for 865 (41.3%) patients. Those who received a statin were more likely to be male, be younger than 80 years, and have a greater number of medical visits. The mean MPR was 0.78 +/- 0.25, and nonadherence was found in approximately 40% of patients receiving statins. In the age category of 65-79 years, men were more adherent than women, and patients in this category were overall more adherent than younger patients. CONCLUSION: The use of statins in a cohort of American Indians and Alaska Natives at high risk for cardiovascular events was approximately 40% with a 60% adherence rate. Age, sex, and number of medical visits were associated with statin use, and age and sex were associated with adherence.

Adult↗
PubMed2005

Statin-induced vascular smooth muscle cell apoptosis: a possible role in the prevention of restenosis?

Growing evidence suggests that statins are more than simple lipid-lowering drugs. The so called pleiotropic effects of statins include multiple actions on cells of the vasculature. A large number of studies have confirmed that these compounds exert beneficial effects by mechanisms unrelated to cholesterol metabolism. For example, statins have been shown to inhibit the migration and proliferation of vascular smooth muscle cells (VSMC), and to induce apoptosis in this cell type. It is not yet clear if the induction of apoptosis in VSMC by statins is beneficial or detrimental. In the context of post-angioplasty restenosis, recurrent plaque growth after intervention, the inhibition of neointimal proliferation as well as a reduction of neointimal cell numbers by apoptosis is appealing. Multiple animal studies and clinical trials have therefore been undertaken to investigate effects of statin treatment on the development of restenosis, with very controversial results. Conversely, in advanced atherosclerotic lesions VSMC in the intima may stabilize the plaque and prevent plaque rupture by synthesizing collagen. VSMC in media adjacent to plaque areas or restenotic lesions should not be exposed to apoptosis promoting agents. In this context, recent evidence suggests that pravastatin protects such lesions by inhibiting inflammation and macrophage activation Our recent findings together with observations from other groups suggest that neointima cells are more sensitive to the induction of apoptosis than media VSMC. Importantly, statins were found to preferentially induce apoptosis in neointimal VSMC in our study. The purpose of the present review is to summarize statin effects on proliferation and apoptosis in VSMC in vitro and in vivo. Furthermore, the development of drug-coated stents may help to deliver high local doses of statins to enhance their effectiveness in the treatment of post-angioplasty restenosis.

Animals↗