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PubMed2004

Hip fracture risk in statin users--a population-based Danish case-control study.

Based on animal studies, statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) have been suggested as potential agents in the treatment of osteoporosis. In some epidemiological studies, statins have been associated with a reduced fracture risk. Our objective was to examine associations between statin treatment and risk of hip fracture in a population-based case-control study. A total of 6660 subjects with hip fracture and 33,274 gender- and age-matched population controls were identified from 1 January 1994 to 31 December 2001 using the Hospital Patient Register in North Jutland County, Denmark, and the Danish Central Personal Registry, respectively. Data on redeemed prescriptions for statins within the last 5 years before the index date were retrieved from a population-based prescription database. We used conditional logistic regression to estimate odds ratios (OR) for hip fracture according to use of statin prescriptions adjusted for potential confounding factors, i.e. gender, other diseases, and use of other drugs known to affect bone metabolism and fracture risk. After adjustment for potential confounders, statin treatment was associated with a reduced risk of hip fracture (OR=0.68; 95% confidence interval: 0.50-0.93) for those who had redeemed more than three prescriptions for a statin drug. We found that risk of hip fracture decreased with the number of statin prescriptions. Stratified analyses on gender and age did not reveal any major differences between men and women or among different age groups on the estimates between use of statins and hip fracture risk. Our findings support an association between statin treatment and a reduced hip fracture risk. However, it is unclear whether this association is causal.

Adolescent↗
PubMed2002

Relation of statin use and bone loss: a prospective population-based cohort study in early postmenopausal women.

Recent experimental and epidemiologic studies have suggested that the lipid-lowering drugs, statins, may have bone-protective effects. We studied the effects of statin use on the change in bone mineral density (BMD) in a prospective 4.5-year cohort study based on subjects from the Kuopio Osteoporosis Risk Factor and Prevention (OSTPRE) Study, Finland. Six hundred and twenty women aged 53-64 years were divided into four groups: 55 women reported continuous and 63 women occasional statin use during the follow-up; 142 non-users of statins reported hypercholesterolemia whereas 360 non-users did not. Spinal and femoral BMDs were measured by dual-energy X-ray densitometry in 1995-1996 and 1999-2000 and the BMD changes of the four groups were compared. Characteristics of the study population were obtained with postal inquiries. The mean annual spinal and femoral BMD changes of the study groups were 0.29% and -0.50% for the continuous statin users, 0.19% and -0.57% for the occasional statin users, 0.52% and -0.29% for the hypercholesterolemic non-users of statins, and 0.39% and -0.33% for the non-users of statins without hypercholesterolemia, ( p = 0.398 and p = 0.404) respectively. The corresponding BMD changes adjusted for age, years since menopause, body mass index, BMD at baseline, calcium intake, estrogen and cortisone therapy, duration of follow-up and statin use before the baseline were -0.20% and -0.47%, 0.19% and -0.54%, 0.54% and -0.32%, 0.47% and -0.33% ( p = 0.134 and p = 0.628), respectively. Our results suggest that statins do not protect from early postmenopausal bone loss. Randomized trials are needed to confirm these results.

Absorptiometry, Photon↗
PubMed2003

Effect of statins on lipoprotein receptor expression in cell lines from human mast cells and basophils.

OBJECTIVE: Statins are potent inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase and widely used to treat hyperlipidaemia. Apart from their direct lipid-lowering effects, statins may also influence lipid metabolism through modulation of low-density lipoprotein (LDL) receptors. Basophils and mast cells have been reported to express LDL receptors and have been implicated in atherogenesis. The aim of this study was to investigate the effects of statins on the interactions of 125I-LDL with purified primary human blood basophils, a human basophil cell line, KU812, and a human mast cell line, HMC-1. METHODS: Direct binding experiments were carried out with the primary basophils and KU812 as well as HMC-1 cells before and after pretreatment of the cells with atorvastatin, simvastatin, or cerivastatin. The effects of these three statins on the LDL-uptake and degradation as well as on thymidine incorporation in the cells were also studied. RESULTS: Primary basophils, HMC-1 and KU812 cells expressed two classes of LDL binding sites. Exposure to atorvastatin, simvastatin or cerivastatin increased significantly ( P<0.05) the number of 125I-LDL binding sites on primary basophils and HMC-1 as well as KU812 cells. The effects of the statins were dose dependent. The statins also enhanced the uptake and degradation of LDL in primary basophils, HMC-1 and KU812 cells. The increase in the number of LDL binding sites induced by statins was abolished by mevalonic acid (200 micromol/l). Statins had no effect on the thymidine incorporation into the cells in an unstimulated condition. CONCLUSION: Our results provide evidence for the upregulation of LDL binding sites on human basophils and mast cells by statins. We hypothesise that effects of statins on the lipid metabolism might also involve basophils and mast cells.

Basophils↗
PubMed2005

Persistence and determinants of statin therapy among middle-aged patients free of cardiovascular disease.

AIM: Statins have been shown to significantly reduce morbidity and mortality both in patients with coronary artery disease and in those with dyslipidemia when they are taken regularly. Middle-aged patients have the highest level of forecasting benefit, and little is known about the persistence rate of these therapies in a real-life setting.Objective. To evaluate the persistence rate of middle-aged patients initiating statin therapy as well as its relation to patients' demographic and clinical characteristics. METHODS: A cohort of 25,733 patients was reconstructed from prescription data recorded in the Régie de l'assurance maladie du Québec administrative database. All patients aged 50-64 years old who received at least one statin prescription between January 1, 1998 and December 31, 2000 for a new intention of treatment for dyslipidemia were included in the cohort and followed up until June 30, 2001. The date of the first prescription of statin was defined as the index date. The cumulative persistence rate was estimated using a Kaplan-Meier analysis. Cox regression models were used to estimate the rate ratio of ceasing statins after adjustment. RESULTS: Mean age of patients initiating statin agents was 58 years; 39%were male, 24% received social assistance, 19% had diabetes, 30% had hypertension and 11% had a respiratory disease at cohort entry. Persistence with statin therapy fell to 67% in the first 6 months after treatment and continued to decline over the next 3 years to 39%. At 3 years, persistence varied significantly with statin agents. After controlling for individual patients' demographic and clinical characteristics, we found that patients who were prescribed fluvastatin, lovastatin and atorvastatin had a higher rate of cessation than those on simvastatin and pravastatin. The adjusted rate ratio of ceasing statin agents in patients with other risk factors of cardiovascular disease, such as diabetes (HR: 0.78; 0.75-0.82) or hypertension (HR: 0.72; 0.69-0.74), demonstrated a lower cessation rate. We observed lower persistence in patients who used the greatest number of pharmacies and prescribing physicians. CONCLUSION: This analysis indicates that barriers to persistence occur early in the therapeutic course. Overall persistence with statins is low, particularly among patients with few other cardiovascular risk factors.

Atorvastatin↗
PubMed2005

Influence of statins on postoperative wound complications after inguinal or ventral herniorrhaphy.

The lipid-lowering agents, statins, are the most commonly prescribed class of drugs in the western world. Because of their widespread use, many patients undergo surgical procedures while on statins. Statins, in addition to cholesterol-lowering effects, also have anticoagulant, immunosuppressive, and antiproliferative properties that may affect the risk of local wound complications. This study investigated the relationship between statins and postoperative wound complications in a large cohort of patients undergoing inguinal or ventral hernia repair. Data mining was performed in the Veterans Integrated Service Network (VISN)16 Data Warehouse. This database contains clinical and demographic information about all veterans cared for at the ten VA Medical Centers that comprise the South Central VA Healthcare Network in the mid-south region of the US. Aggregate data (age, body mass index, smoking history, gender, race, history of diabetes, statin use, and postoperative wound complications) were obtained for all patients who underwent inguinal or ventral hernia repair during the period October 1, 1996-November 30, 2004. During the period of the query, 10,782 patients (10,676 male, 106 female), 1,242 (11.5%) of whom received statins, underwent herniorrhaphy. Statin use did not affect the risk of wound infection or delayed wound healing. Statin use was, however, associated with an increased rate of local postoperative bleeding complications (P=0.01). When the type of hernia, age, smoking, diabetes, and body mass index were included in a multivariate analysis, statins remained borderline significant as an independent predictor of wound hematoma/postoperative bleeding (P=0.04), odds ratio 1.6 (95% CI 1.03-2.44). Patients who undergo inguinal herniorrhaphy while on statins have an increased risk of postoperative wound hematoma/hemorrhage. Focus on additional factors that may affect the propensity to postoperative bleeding and on meticulous intraoperative hemostasis are particularly important in such patients.

Diabetes Mellitus↗
PubMed2006

Missed opportunities in the secondary prevention of myocardial infarction: an assessment of the effects of statin underprescribing on mortality.

BACKGROUND: The benefits of statins for the secondary prevention of coronary heart disease are well established. Previous research indicates that patients at the greatest risk of cardiovascular events are the least likely to receive statins. We explored the potential reduction in mortality at the population level that could result from improving statin prescribing among patients least likely to be prescribed a statin after acute myocardial infarction (AMI). METHODS: Simulation analysis of detailed clinical data for a population-based sample of 7285 AMI survivors discharged from 102 hospitals between April 1, 1999, and March 31, 2001 in Ontario, Canada, was done. Using estimates obtained from randomized controlled trials, we estimated the reduction in 3-year all-cause mortality associated with improved statin prescribing at hospital discharge. RESULTS: Overall, 35.6% of patients received a statin prescription at hospital discharge. We estimate that increasing statin prescribing among patients least likely to receive them (ie, the lowest quintile of propensity to receive a prescription at discharge) from the current rate of 7.8% to the rate among all patients (35.6%) could decrease AMI mortality by 83 deaths in Ontario per year (2.1% of all post-AMI deaths within 3 years of discharge). Increasing statin prescribing to 70% among all patients with AMI could avert 312 deaths per year in Ontario. Factoring in low rates of adherence to statin therapy would reduce these estimates to 33 and 126, respectively. CONCLUSIONS: Modest increases in statin prescribing for patients least likely to receive one could decrease post-AMI mortality at the population level.

Aged↗
PubMed2005

Statin use and risks of death or fatal rejection in the Heart Transplant Lipid Registry.

Although small, randomized trials have shown that statin use is associated with decreased risks of mortality and severe rejection, no study has examined statin therapy as used in actual practice in large numbers of heart transplant recipients. We analyzed data from the Heart Transplant Lipid Registry (n = 12 centers). Patients were included if they underwent transplantation between 1995 and 1999, survived >/=30 days after transplantation, and had >/=30 days of Registry follow-up. Multivariable Cox regression models, with propensity scoring performed to adjust for nonrandom allocation of statin therapy, were performed to determine the association of statin therapy with death and fatal rejection. The study included 1,186 patients, with a mean follow-up of 580 +/- 469 days; 937 patients (79%) received statin therapy. Overall, 71 patients (6%) died and 40 (3.4%) had fatal rejection. The statin group had a lower frequency of death (4% vs 13.7%, p <0.0001) and fatal rejection (2.4% vs 7.2%, p = 0.0001). Using multivariable Cox regression, with propensity scoring included to adjust for likelihood of receiving statin therapy, statin use was the only factor associated with lower risk of death (hazard ratio 0.29, 95% confidence interval 0.13 to 0.67) and fatal rejection (hazard ratio 0.27, 95% confidence interval 0.09 to 0.78). This study represents the largest population of heart transplant recipients analyzed for the relation between statin therapy and clinical outcomes in actual practice. Statin therapy was significantly associated with lower risk of death and fatal rejection, benefits that were independent of lipid values.

Chi-Square Distribution↗
PubMed2006

Statin safety: a systematic review.

A systematic review of cohort studies, randomized trials, voluntary notifications to national regulatory authorities, and published case reports was undertaken to assess the incidence and characteristics of adverse effects in patients treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins. For statins other than cerivastatin, the incidence of rhabdomyolysis in 2 cohort studies was 3.4 (1.6 to 6.5) per 100,000 person-years, an estimate supported by data from 20 randomized controlled trials. Case fatality was 10%. Incidence was about 10 times greater when gemfibrozil was used in combination with statins. Incidence was higher (4.2 per 100,000 person-years) with lovastatin, simvastatin, or atorvastatin (which are oxidized by cytochrome P450 3A4 [CYP3A4], which is inhibited by many drugs) than pravastatin or fluvastatin (which are not oxidized by CYP3A4). In persons taking simvastatin, lovastatin, or atorvastatin, 60% of cases involved drugs known to inhibit CYP3A4 (especially erythromycin and azole antifungals), and 19% involved fibrates, principally gemfibrozil. The incidence of myopathy in patients treated with statins, estimated from cohort studies supported by randomized trials, was 11 per 100,000 person-years. For liver disease, randomized trials reported fewer hepatobiliary disorders in patients allocated statins than in those allocated placebo. The notification rate of liver failure to regulatory authorities was about 1 per million person-years of statin use. Randomized trials show no excess of renal disease or proteinuria in statin-allocated participants, and the decline in glomerular filtration rate was smaller with statins than with placebo. Evidence from 4 cohort studies and case reports suggests that statins cause peripheral neuropathy, but the attributable risk is small (12 per 100,000 person-years). No change in cognitive function was found in randomized trials of statins in elderly patients.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Effects of statin therapy on the progression of carotid atherosclerosis: a systematic review and meta-analysis.

Observational studies suggested that the progression of carotid atherosclerosis and plaques might be an independent risk factor for coronary artery disease (CAD) and stroke, prior researches of different dosage of statins therapy on the progression of carotid atherosclerosis in patients had small sample sizes and different the results. We aimed to evaluate the efficacy and safety of statins therapy on the rate of carotid atherosclerosis progression through randomized controlled trials (RCTs). We searched MEDLINE (1980-September 2003), the Cochrane Controlled Trials Register, EMBASE (1985-September 2003), Science Citation Index and PUBMED (updated through December 2003). Additional articles were obtained from reference lists of relevant reviews and papers in manual searches. Ten studies (eight studies between statins and placebo, two studies between aggressive statins and conventional therapy) were included. Two reviewers extracted abstracts, and appraised the Jadad Score for Grading Quality of Randomized Controlled Trials independently, and discrepancies were resolved by consensus with a third reviewer. We analyzed the 10 trials with 3443 individuals age range from 30 to 70 years old and follow-up for 1-4 years. Eight studies showed that the rates of carotid IMT progression were consistently significantly different between statins and placebo, the Z score for overall effect of IMT was 10.41 (P<0.00001), Total 95%CI of weighted mean difference (WMD) between two groups was -0.02235 [-0.02656, -0.01614] (mm/y), the chi(2)-test for heterogeneity of IMT between eight studies was 685.33 (P<0.00001), two studies between aggressive statins and conventional statins demonstrated that the Z score for overall effect of IMT was 15.85 (P<0.00001), total 95%CI of WMD between two groups was -0.06326 [-0.07108, -0.05544], chi(2)-test for heterogeneity of IMT between two studies was 3.75 (P=0.05). Conventional statins were not significantly different of adverse events and withdrawal than placebo (P>0.05). Our findings suggest that conventional statins therapy are efficient and safe to decrease the rate of carotid atherosclerosis progression in a long-term, and aggressive statins may provide superior efficacy for carotid atherosclerosis regression.

Adult↗
PubMed2006

Serial intravascular ultrasound evidence of both plaque stabilization and lesion progression in patients with ruptured coronary plaques: effects of statin therapy on ruptured coronary plaque.

Using serial intravascular ultrasound (IVUS), we evaluated the natural evolution of non-culprit/non-target lesion ruptured coronary plaques and assessed the impact of statin therapy. Twenty-eight patients with non-stenotic ruptured plaques underwent baseline and 12-month follow-up IVUS studies; half were treated with statins. Standard IVUS analyses were performed. Complete healing of ruptured plaques was observed in four (29%) statin-treated patients and no non-statin-treated patients (p=0.049). Statin-treated patients had an increase in lumen area of 0.4+/-0.8 mm2 (versus a decrease in lumen area of -0.6+/-1.0 mm2 in non-statin-treated patients, p=0.007) and no change in plaque area (versus an increase in plaque area of 0.6+/-0.9 mm2, p=0.051). During 1-year follow-up, target lesion revascularization was performed in three non-statin-treated patients (21%) and no statin-treated patient (p=0.11). Compared to lesions that did not require revascularization, lesions requiring revascularization had a decrease in lumen area (-1.7+/-1.4 mm2 versus 0.1+/-0.8 mm2, p=0.001) as well as an increase in plaque area (1.6+/-1.0 mm2 versus 0.1+/-0.7 mm2, p=0.002). In conclusion, the current observational follow-up IVUS study showed beneficial effects of statin treatment on reduction of revascularization rates and stabilization of non-culprit/non-target lesion plaque ruptures without significant stenosis. Conversely, healing of non-statin-treated non-culprit/non-target lesion plaque ruptures can be responsible for lesion progression requiring revascularization.

Aged↗
PubMed2004

Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction.

AIMS: Peri-procedural non-Q-wave myocardial infarction is a frequent and prognostically important complication of percutaneous coronary intervention (PCI). It has been postulated that statins may reduce the rate of myocardial injury after PCI. METHODS AND RESULTS: Four hundred and fifty-one patients scheduled for elective PCI and not on statins were randomly assigned to either no treatment or to statin treatment. Statin administration was started at least 3 days before the procedure.Incidence of peri-procedural myocardial injury was assessed by analysis of creatinine kinase myocardial isoenzyme (CK-MB: upper limit of normal [ULN] 3.5 ng/ml) and cardiac troponin I (cTn I, ULN 0.10 ng/ml) before, 6 and 12 h after the intervention. A large non-Q-wave myocardial infarction was defined as a CK-MB elevation >5 times ULN alone or associated with chest pain or ST segment or T wave abnormalities. Median CK-MB peak after PCI was 1.70 (interquartile ranges 1.10-3.70) ng/ml in the Statin group and 2.20 (1.30-5.60) ng/ml in the Control group (p=0.015). Median peak of cTnI after PCI was 0.13 (0.05-0.45) ng/ml in the Statin group and 0.21 (0.06-0.85) ng/ml in the Control group (p=0.033). The incidence of a large non-Q-wave myocardial infarction was 8.0% in the Statin group and 15.6% in the Control group (p=0.012: OR=0.47; 95% CI=0.26-0.86). The incidence of cTnI elevation >5 times ULN was 23.5% in the Statin group and 32% in the Control group (p=0.043: OR=0.65; 95% CI=0.42-0.98). By logistic regression analysis, the independent predictors of CK-MB elevation >5 times ULN after PCI were intra-procedural angiographic complications (OR=9.36; 95% CI=3.06-28.64; p<0.001), statin pre-treatment (OR=0.33; 95% CI=0.13-0.86; p=0.023) and age >65 years (OR=2.58; 95% CI=1.09-6.11; p=0.031). CONCLUSIONS: Pre-procedural statin therapy reduces the incidence of large non-Q-wave myocardial infarction after PCI.

Angioplasty, Balloon, Coronary↗
PubMed2005

Preoperative statin use and in-hospital outcomes following heart surgery in patients with unstable angina.

OBJECTIVE: Unstable angina (UA) is characterized by a state of coronary artery vascular inflammation and endothelial dysfunction. Statins mitigate inflammation and endothelial dysfunction and decrease mortality associated with percutaneous interventions for UA. We determined whether preoperative statin use is associated with decreased mortality and morbidity following coronary artery bypass+/-valve surgery for UA. METHODS: Patients with CCS Class IV angina having CABG+/-valve surgery were identified (n=1706). A logistic regression model determined the association of preoperative statin use with in-hospital mortality (IHM). Propensity score analysis was used to match two sub-groups of patients (GrpI, on statins, n=534; GrpII, not on statins, n=534) on factors known to affect outcomes. Outcomes were IHM, intra-aortic balloon pump (IABP) use, perioperative myocardial infarction (PMI), prolonged (>24 h) ventilation (p-vent), stroke, and a composite outcome (comp) defined as any one or more of the above. RESULTS: Of the 1706 patients, 1075 were on statins and 631 were not. Patients on statins were more likely to have isolated CABG, EF>40%, and be on a beta-blocker (P=0.0001); and less likely to have renal failure, MI<7 days, CHF, and undergoing urgent/emergent surgery (P=0.0001). Unadjusted rates of IHM (9 vs. 5%, P=0.001), stroke (4.4 vs. 2.3%, P=0.015), p-vent (28.4 vs. 19%, P=0.0001), and comp (32.5 vs. 22.8%, P=0.0001) were lower in patients receiving statins. After adjustment, statin use was not associated with a reduction in IHM (OR=1.0, 95% CI=0.6-1.5, P=0.85) or comp (OR=1.1, 95% CI=0.8-1.4, P=0.69). No significant differences were found in any of the propensity-adjusted outcomes for GrpI vs. GrpII: IHM (7.1 vs. 6.4%), PMI (2.8 vs. 1.7%), IABP use (3 vs. 3.8%), stroke (3.8 vs. 3.9%), p-vent (26.4 vs. 23.8%), comp (31.5 vs. 27.5%). CONCLUSIONS: Preoperative statin use is not associated with a reduction in IHM or major morbidity following CABG+/-valve surgery in patients with UA.

Aged↗
PubMed2004

Preoperative statin use and outcomes following cardiac surgery.

BACKGROUND: Cardiac surgery carries a 2-3% early mortality due in part to perioperative myocardial infarction (PMI), low-output syndrome (LOS), and arrhythmias. Statins attenuate thrombogenesis, normalize endothelial dysfunction, and mitigate the oxidative stress and reperfusion injury characteristic of such complications. We sought to determine whether preoperative statin use is associated with reduced early mortality and major morbidity following cardiac surgery. METHODS: Patients having isolated coronary artery bypass grafting (CABG), valve, or combined CABG/valve surgery between May 1998 and June 2003 (n=5469) were identified. A logistic regression model was generated to determine the association of preoperative statin use with in-hospital mortality (IHM). Propensity score analysis was used to match two subgroups of patients (Group I, on statins, n=1443; Group II, not on statins, n=1443) on multiple factors known to impact cardiac surgical outcome. Outcomes assessed were IHM, intra-aortic balloon pump (IABP) use, PMI, prolonged (>24 h) ventilation (p-vent), stroke, and a composite end point (comp) defined as any one or more of the above. RESULTS: Of the 5469 patients, 3555 were on statins and 1914 were not. Unadjusted rates of IHM (2.6% vs. 5.0%), stroke (1.9% vs. 3.3%), p-vent (10.2% vs. 16.6%), and comp (12.7% vs. 19.5%) were lower (p=0.0001) in patients receiving statins. After adjustment, statin use was not associated with a reduction in IHM (OR=0.9, 95% CI=0.6-1.2, p=0.36) or comp (OR=0.9, 95% CI=0.8-1.1, p=0.31). After matching two subgroups using propensity score for statin, no significant differences were found in any of the adjusted outcomes for Group I vs. Group II: IHM (4.0% vs. 4.6%), PMI (1.5% vs. 1.1%), p-vent (15.8% vs. 15.7%), IABP use (2.0% vs. 2.3%), stroke (3.0% vs. 3.3%), and comp (19.1% vs. 18.8%). CONCLUSIONS: Preoperative statin use is not associated with a reduction in IHM or major morbidity following cardiac surgery.

Aged↗
PubMed2006

Long-term (11-year) statin therapy following percutaneous coronary intervention improves clinical outcome and is not associated with increased malignancy.

BACKGROUND: Statins have been proven to reduce cardiac events and mortality. However, there are few studies dealing with the long-term efficacy of statin therapy following percutaneous coronary intervention (PCI). METHODS: We collected data from 575 consecutive patients who underwent PCI between 1987 and 1992. The baseline data, mortality and incidence of cardiovascular events of patients given statins and those not given statins at the time of PCI were compared. RESULTS: There were 243 patients in the statin group and 332 patients in the non-statin group. During follow-up (11.0+/-3.0 years), 68 patients died. At about 10 years, statin use was significantly associated with lower all-cause mortality (8.2% versus 14.5%, P=0.023) and cardiac death (2.5% versus 6.9%, P=0.017). After adjusting for variables, statin use was found to be an independent predictor of death from all causes (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.29-0.99, P=0.048) and cardiac death (HR 0.24, 95% CI 0.07-0.80, P=0.02). CONCLUSION: Statin use at the time of PCI was associated with a significantly reduced risk of death from all causes and cardiac death. Furthermore, this study provides evidence of a clinical benefit at about 10 years of statin use in patients who underwent PCI.

Angioplasty, Balloon, Coronary↗
PubMed2005

Association of statin use with a pathologic complete response to neoadjuvant chemoradiation for rectal cancer.

PURPOSE: To assess whether 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or statins, might enhance the efficacy of neoadjuvant chemoradiation in rectal cancer. METHODS AND MATERIALS: Between 1996 and 2001, 358 patients with clinically resectable, nonmetastatic rectal cancer underwent surgery at Memorial Sloan-Kettering Cancer Center after neoadjuvant chemoradiation for either locally advanced tumors or low-lying tumors that would require abdominoperineal resection. We excluded 9 patients for radiation therapy dose <45 Gy or if statin use was unknown, leaving 349 evaluable patients. Median radiation therapy dose was 50.4 Gy (range, 45-55.8 Gy), and 308 patients (88%) received 5-fluorouracil-based chemotherapy. Medication use, comorbid illnesses, clinical stage as assessed by digital rectal examination and ultrasound, and type of chemotherapy were analyzed for associations with pathologic complete response (pCR), defined as no microscopic evidence of tumor. Fisher's exact test was used for categoric variables, Mantel-Haenszel test for ordered categoric variables, and logistic regression for multivariate analysis. RESULTS: Thirty-three patients (9%) used a statin, with no differences in clinical stage according to digital rectal examination or ultrasound compared with the other 324 patients. At the time of surgery, 23 nonstatin patients (7%) were found to have metastatic disease, compared with 0% for statin patients. The unadjusted pCR rates with and without statin use were 30% and 17%, respectively (p = 0.10). Variables significant univariately at the p = 0.15 level were entered into a multivariate model, as were nonsteroidal anti-inflammatory drugs (NSAIDs), which were strongly associated with statin use. The odds ratio for statin use on pCR was 4.2 (95% confidence interval, 1.7-12.1; p = 0.003) after adjusting for NSAID use, clinical stage, and type of chemotherapy. CONCLUSION: In multivariate analysis, statin use is associated with an improved pCR rate after neoadjuvant chemoradiation for rectal cancer. The low prevalence of statin use limits the power to detect a significant difference at a type I error threshold of p = 0.05 in this analysis. Although no definitive conclusions can be drawn on the basis of this retrospective study, the unusually high incidence of pCR after chemoradiation suggests that the use of statins in the treatment of rectal cancer warrants further evaluation.

Adult↗
PubMed2006

Reduction in ventricular tachyarrhythmias with statins in the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II.

OBJECTIVES: We evaluated whether statins have anti-arrhythmic effects by exploring the association of statin use with appropriate implantable cardioverter-defibrillator (ICD) therapy for ventricular tachycardia/ventricular fibrillation (VT/VF) in the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II. BACKGROUND: A few studies have suggested that lipid-lowering drugs may have anti-arrhythmic effects in patients with coronary artery disease. METHODS: Patients receiving an ICD (n = 654; U.S. centers only) in the MADIT-II study were categorized by the percentage of days each patient received statins during follow-up (90% to 100%, n = 386; 11% to 89%, n = 116; and 0% to 10%, n = 152). The Kaplan-Meier method with significance testing by the log-rank statistic and time-dependent proportional hazards regression analysis were used to evaluate the effect of statin use on the probability of ICD therapy for the combined end point VT/VF or cardiac death and for the end point VT/VF. RESULTS: The cumulative rate of ICD therapy for VT/VF or cardiac death, whichever occurred first, was significantly reduced in those with > or =90% statin usage compared to those with lower statin usage (p = 0.01). The time-dependent statin:no statin therapy hazard ratio was 0.65 (p < 0.01) for the end point of VT/VF or cardiac death and 0.72 (p = 0.046) for VT/VF after adjusting for relevant covariates. CONCLUSIONS: Statin use in patients with an ICD was associated with a reduction in the risk of cardiac death or VT/VF, whichever occurred first, and was associated with a reduction in VT/VF episodes. These findings suggest that statins have anti-arrhythmic properties.

Aged↗
PubMed2004

Effect of pretreatment with statins on the severity of acute ischemic cerebrovascular events.

OBJECTIVE: Treatment with statins reduces the risk of ischemic stroke among patients at increased risk for vascular disease. Recent experimental data suggest neuroprotective properties of statins in acute cerebral ischemia. We investigated whether a premedication with statins is associated with a better outcome in patients with acute ischemic cerebrovascular events. METHODS: Within a cross-sectional study, nested in a cohort we identified 1691 patients with a recent ischemic stroke or transient ischemic attack. Clinical severity of the vascular event was evaluated by the modified Rankin Scale (mRS) after 1 week. By means of multivariate logistic regression modeling, we determined the influence of prior statin use on stroke severity with adjustment for potential confounding factors. RESULTS: Severe stroke, defined as a modified Rankin Scale of 5 or 6 (n=231; 14%), was less frequent in patients receiving statin treatment before the event (6% vs. 14%, OR=0.37; 95% CI 0.19 to 0.74; p=0.004). This association remained significant after adjustment for confounding factors. We found a significant interaction between the presence of diabetes and the effect of pretreatment with statins on stroke outcome. Of the patients with diabetes, none of those on statin treatment but 16% of those without a statin had a bad outcome. After exclusion of the group of diabetic patients with prior statin medication, the protective effect was reduced and not statistically significant anymore. CONCLUSIONS: Pretreatment with statins seems to be associated with reduced clinical severity in patients with acute ischemic cerebrovascular events, particularly in patients with diabetes.

Aged↗
PubMed2006

Prevention of stroke and dementia by statin therapy: experimental and clinical evidence of their pleiotropic effects.

Stroke and dementia are major causes of disability in most countries. Epidemiological studies have demonstrated that statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are likely to reduce the risk for developing these formidable disorders. The favorable outcomes in statin users may be attributable to not only cholesterol-dependent actions, but also various cholesterol-independent actions called "pleiotropic effects." Several clinical trials have suggested that statins decrease the incidence of stroke, especially ischemic stroke. Statins improve endothelial function, inhibit platelet activation, reduce blood coagulability, and suppress inflammatory reactions, all of which may contribute to the beneficial effects of the therapy. Statins also reduce the risk of vasospasm caused by subarachnoid hemorrhage (SAH). In addition, statins might inhibit the development and progression of Alzheimer's disease (AD), the dominant type of dementia in most industrialized countries, upstream of the amyloid cascade. In vitro studies have shown that statins modulate the metabolism of the beta-amyloid precursor protein (APP) and reduce the extracellular level of its proteolytic product, amyloid-beta (Abeta). The aggregated Abeta is cytotoxic, leading to formation of neurofibrillary tangles and neuronal loss in the brain. Inflammatory processes are active in AD and may contribute significantly to AD pathology. We review the experimental background regarding the pleiotropic effects of statins and summarize clinical trials that examined the preventative effects of statin therapy on stroke and dementia. We include current trials in which statin therapy is initiated within 24 hr of onset of acute ischemic stroke.

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