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Biomedical subjects

Daniel L Gillen

Publications and source records attributed to Daniel L Gillen.

At least 19 recordsLinked to original sources

Bayesian evaluation of group sequential clinical trial designs.

Clinical trial designs often incorporate a sequential stopping rule to serve as a guide in the early termination of a study. When choosing a particular stopping rule, it is most common to examine frequentist operating characteristics such as type I error, statistical power, and precision of confidence intervals (Statist. Med. 2005, in revision). Increasingly, however, clinical trials are designed and analysed in the Bayesian paradigm. In this paper, we describe how the Bayesian operating characteristics of a particular stopping rule might be evaluated and communicated to the scientific community. In particular, we consider a choice of probability models and a family of prior distributions that allows concise presentation of Bayesian properties for a specified sampling plan.

Antibodies↗

Evidence that postprandial reduction of renal calcium reabsorption mediates hypercalciuria of patients with calcium nephrolithiasis.

Idiopathic hypercalciuria (IH) is common among calcium stone formers (IHSF). The increased urinary calcium arises from increased intestinal absorption of calcium, but it is unclear whether increased filtered load or decreased renal tubular reabsorption of calcium is the main mechanism for the increased renal excretion. To explore this question, 10 IHSF and 7 normal subjects (N) were studied for 1 day. Urine and blood samples were collected at 30- to 60-min intervals while subjects were fasting and after they ate three meals providing known amounts of calcium, phosphorus, sodium, protein, and calories. Fasting and fed, ultrafiltrable calcium levels, and filtered load of calcium did not differ between N and IHSF. Urine calcium rose with meals, and fractional reabsorption fell in all subjects, but the change was significantly higher in IHSF. The changes in calcium excretion were independent of sodium excretion. Serum parathyroid hormone levels did not differ between N and IHSF, and they could not account for the greater fall in calcium reabsorption in IHSF. Serum magnesium and phosphorus levels in IHSF were below N throughout the day, and tubule phosphate reabsorption was lower in IHSF than N after meals. The primary mechanism by which kidneys ferry absorbed calcium into the urine after meals is via reduced tubule calcium reabsorption, and IHSF differ from N in the magnitude of the response. Parathyroid hormone is not likely to be a sufficient explanation for this difference.

Adult↗

Trends in bariatric surgical procedures.

CONTEXT: The increasing prevalence and associated sociodemographic disparities of morbid obesity are serious public health concerns. Bariatric surgical procedures provide greater and more durable weight reduction than behavioral and pharmacological interventions for morbid obesity. OBJECTIVE: To examine trends for elective bariatric surgical procedures, patient characteristics, and in-hospital complications from 1998 to 2003 in the United States. DESIGN, SETTING, AND PATIENTS: The Nationwide Inpatient Sample was used to identify bariatric surgery admissions from 1998-2002 (with preliminary data for 12 states from 2003) using International Classification of Diseases, Ninth Revision, codes for foregut surgery with a confirmatory diagnosis of obesity or by diagnosis related group code for obesity surgery. Annual estimates and trends were determined for procedures, patient characteristics, and adjusted complication rates. MAIN OUTCOME MEASURES: Trends in bariatric surgical procedures, patient characteristics, and complications. RESULTS: The estimated number of bariatric surgical procedures increased from 13,365 in 1998 to 72,177 in 2002 (P<.001). Based on preliminary state-level data (1998-2003), the number of bariatric surgical procedures is projected to be 102 794 in 2003. Gastric bypass procedures accounted for more than 80% of all bariatric surgical procedures. From 1998 to 2002, there were upward trends in the proportion of females (81% to 84%; P = .003), privately insured patients (75% to 83%; P = .001), patients from ZIP code areas with highest annual household income (32% to 60%, P<.001), and patients aged 50 to 64 years (15% to 24%; P<.001). Length of stay decreased from 4.5 days in 1998 to 3.3 days in 2002 (P<.001). The adjusted in-hospital mortality rate ranged from 0.1% to 0.2%. The rates of unexpected reoperations for surgical complications ranged from 6% to 9% and pulmonary complications ranged from 4% to 7%. Rates of other in-hospital complications were low. CONCLUSIONS: These findings suggest that use of bariatric surgical procedures increased substantially from 1998 to 2003, while rates of in-hospital complications were stable and length of stay decreased. However, disparities in the use of these procedures, with disproportionate and increasing use among women, those with private insurance, and those in wealthier ZIP code areas should be explored further.

Adult↗

Cystatin C and subclinical brain infarction.

Subclinical brain infarcts (SBI) are common in the elderly and are associated with covert neurologic and cognitive impairment. Although renal impairment is associated with accelerated cerebrovascular disease and an increased risk for clinically apparent brain infarct, few studies have examined the relationship between renal function and SBI, and these may have been limited by the inaccuracy of creatinine as a renal function marker. A cross-sectional study was performed among older adults in the Cardiovascular Health Study to examine associations between SBI and two serum markers of renal function: Serum creatinine (SCr) and cystatin C (CysC). Patients had cranial magnetic resonance imaging and renal markers measured in 1992 to 1993. Logistic regression was used to estimate the associations between renal function (estimated by 1/SCr and 1/CysC) and SBI, controlling for potential confounding factors. SBI were present in 789 (28.7%) of 2784 participants. A linear association with SBI was observed for 1/CysC (per 1-SD decrement; odds ratio [OR] 1.20; 95% confidence interval [CI] 1.09 to 1.32; P < 0.001) but not for 1/SCr (OR 1.08; 95% CI 0.98 to 1.19; P = 0.14), for which a quadratic U-shaped association was suggested (P = 0.004). In a model with both markers, 1/CysC was linearly associated with SBI (OR 1.26; P < 0.001), whereas 1/SCr was not (OR 1.06; P = 0.3). The prevalence of SBI was directly associated with quintile of CysC, whereas the association between SCr and SBI was U-shaped, with greater prevalence at high and low levels. Compared with creatinine, CysC, a novel marker of renal function, has a stronger and more direct association with SBI in the elderly.

Age Factors↗

Nephrolithiasis and increased blood pressure among females with high body mass index.

BACKGROUND: We hypothesized that one reason for the heterogeneity in previously reported links between kidney stones and blood pressure (BP) was the differential effects of nephrolithiasis among subgroups of individuals. In particular, we hypothesized that the association between stone history and BP may vary with respect to sex and body size. METHODS: Data from the Third National Health and Nutrition Examination Survey were used to estimate the association between history of stone disease and odds of prior diagnosis of hypertension and mean difference in systolic BP, diastolic BP, and pulse pressure. Nine hundred nineteen persons with a history of stones and 19,120 persons without stones were available for analysis. RESULTS: In women, it was estimated that stone formers (SFs) experienced a 69% increase in odds of self-reported hypertension (95% confidence interval [CI], 1.33 to 2.17; P < 0.001). No significant difference was found in men. The estimated difference in mean systolic and diastolic BP comparing SFs with non-SFs increased with body mass index in both sexes, but was more pronounced in women. Mean systolic BPs in women SFs in quintiles 4 and 5 of body mass index were 7.62 mm Hg (95% CI, 1.04 to 14.2; P = 0.024) and 4.36 mm Hg (95% CI, 0.30 to 8.42; P = 0.036) greater than those in similar women non-SFs, respectively. CONCLUSION: Our findings not only support the link between kidney stone disease and BP, but also suggest that overweight women SFs may be at significantly increased risk for hypertension.

Adolescent↗

Decreased renal function among adults with a history of nephrolithiasis: a study of NHANES III.

BACKGROUND: Although intuitively appealing, the hypothesis that nephrolithiasis is associated with decreased renal function has not thoroughly been investigated. Because the prevalence of nephrolithiasis and chronic renal disease in westernized societies has risen over the past three decades, we sought to determine if persons with a history of kidney stones have lower renal function relative to nonstone formers. METHODS: We used data from the Third National Health and Nutrition Examination Survey (NHANES III) to compare estimated glomerular filtration rate (GFR) between persons over age 30 with and without a history of kidney stones. In total, 876 persons with a history of stones, and 14,129 persons without stones were available for analysis. RESULTS: We observed that the association between history of stones and estimated GFR depends on body mass index (BMI) (P= 0.004). After adjustment for potential confounding factors, mean estimated GFR in stone formers with a BMI >/=27 kg/m(2) was 3.4 mL/min/1.73 m(2) lower than that of similar nonstone formers (95% CI -5.8, -1.1) (P= 0.005). No difference was found among persons with a BMI <27 kg/m(2). The probability of an overweight stone former having an estimated GFR between 30 and 59 mL/min/1.73 m(2) relative to a GFR above 90 mL/min/1.73 m(2) was nearly twice that of a similar nonstone former [relative risk ratio (RRR) = 1.87, 95% CI 1.06, 3.30]. CONCLUSION: Among overweight persons, nephrolithiasis may not merely be a disease of stones, but may also reduce kidney function. Further work in alternate study samples is needed to validate this finding and determine the mechanisms responsible.

Adult↗

A note on P-values under group sequential testing and nonproportional hazards.

Group sequential designs are often used for periodically assessing treatment efficacy during the course of a clinical trial. Following a group sequential test, P-values computed under the assumption that the data were gathered according to a fixed sample design are no longer uniformly distributed under the null hypothesis of no treatment effect. Various sample space orderings have been proposed for computing proper P-values following a group sequential test. Although many of the proposed orderings have been compared in the setting of time-invariant treatment effects, little attention has been given to their performance when the effect of treatment within an individual varies over time. Our interest here is to compare two of the most commonly used methods for computing proper P-values following a group sequential test, based upon the analysis time (AT) and Z-statistic orderings, with respect to resulting power functions when treatment effects on survival are delayed. Power under the AT ordering is shown to be heavily influenced by the presence of a delayed treatment effect, while power functions corresponding to the Z-statistic ordering remain robust under time-varying treatment effects.

Algorithms↗

Comparison of T-scores from different skeletal sites in differentiating postmenopausal women with and without prevalent vertebral fractures.

It is not clear how bone mineral density (BMD) measurements from several regions of lumbar spine and proximal femur should be utilized in assessing fracture risk. We examined how well the newest ISCD recommendations differentiate subjects with and without prevalent vertebral fractures in 187 postmenopausal women presenting for routine bone densitometry. The association between T-scores from proximal femur and lumbar spine sites and the probability of having a vertebral fracture was modeled via logistic regression with adjustment for age. The lowest T-score of any hip or spine sites (the current ISCD recommendation) and the proximal femur measurements, particularly the femoral neck and total hip, displayed the strongest association with the probability of vertebral fractures.Subjects with a T-score < -2.5 at multiple hip sites had a higher probability of having a vertebral fracture. The sensitivity and specificity associated with particular T-score cutoff values varied greatly depending on the site of measurement.Consequently, T-score values from different sites that had comparable sensitivity/specificity for detecting the presence of vertebral fractures differed by as much as 1.5 T-score units. This finding implies that a single cutoff value, such as -2.5, might not be clinically acceptable when applied to T-scores from different sites.

Absorptiometry, Photon↗

Moderate renal impairment and risk of dementia among older adults: the Cardiovascular Health Cognition Study.

Renal impairment is associated with an increased risk of carotid atherosclerosis and stroke, determinants of cognitive dysfunction and dementia. The purpose of this study was to determine whether moderate renal impairment is associated with incident dementia among community-dwelling older adults. Participants in the Cardiovascular Health Cognition Study without prevalent dementia (n = 3349) were included in the analysis. Incident dementia was confirmed through neurologic testing. Renal function at baseline was estimated by the inverse of serum creatinine (1/SCr); moderate renal impairment was defined as SCr > or = 1.3 mg/dl for women and > or = 1.5 mg/dl for men. Cox regression models were used to estimate the association of renal impairment with incident dementia. Because SCr is also a function of muscle mass, the authors determined whether the relationship between SCr and dementia was particularly strong among individuals without severe co-morbidity at baseline, as reflected by self-reported general health status. There were 477 incident dementia cases over a median 6 yr follow-up. After adjustment for potential confounders, moderate renal insufficiency was associated with a 37% increased risk of dementia (95% CI = 1.06 to 1.78). Similarly, a 0.5-unit decrement in 1/SCr (equivalent to an increase in SCr from 1.0 to 2.0 mg/dl) was associated with a 26% increased risk (95% CI = 1.02 to 1.60). These associations were present only among the 84% of older adults who reported good-excellent health. Among those in good-excellent health, higher SCr was associated with vascular-type dementia but not Alzheimer-type dementia. Moderate renal impairment, reflected by a higher SCr, is associated with an excess risk of incident dementia among individuals in good-excellent health. Strategies to prevent or delay the onset of dementia in patients with moderate renal impairment are needed.

Aged↗

Parathyroidectomy rates among United States dialysis patients: 1990-1999.

BACKGROUND: Medical therapy for secondary hyperparathyroidism (SHPTH) has evolved considerably during the past decade. It is not known how changes in medical therapy might impact the parathyroidectomy (PTX) rate among dialysis patients. Relatively low parathyroid hormone (PTH) levels have been found among elderly dialysis patients and those with diabetes. Clinical factors associated with differing PTX rates among United States dialysis patients have not been reported. We report PTX rates in the United States from 1990 to 1999 among persons with end-stage renal disease, accounting for changes in patient characteristics. METHODS: Data from the United States Renal Database were utilized. Patients insured by Medicare or Medicaid and receiving renal replacement therapy between January 1, 1990, and December 31, 1999 were considered for analysis. PTX was determined by ICD-9 procedure codes. Multivariate Poisson models were used to estimate adjusted PTX rates. RESULTS: The overall observed PTX rate in the study sample was 7.16 per 1000 person-years at risk. After a slight rise during the early 1990s, adjusted PTX rates declined by approximately 30% between 1995 and 1999. Adjusted PTX rates were higher among patients who were younger, female, nondiabetic, receiving peritoneal dialysis, and those with a longer cumulative duration of dialysis. CONCLUSION: PTX rates have recently decreased in the United States, independent of changes in patient characteristics. The effectiveness of medical therapy in targeting secondary hyperparathyroidism may be improving. Younger, nondiabetic patients with a longer cumulative dialysis burden are at particularly high risk for PTX.

Aged↗

Survival following parathyroidectomy among United States dialysis patients.

BACKGROUND: Secondary hyperparathyroidism (SHPTH) is highly prevalent among persons with end-stage renal disease (ESRD). SHPTH has been linked to uremic bone disease, vascular calcification, and a higher risk of death. Parathyroidectomy (PTX) can dramatically reduce parathyroid hormone (PTH) and phosphate levels; however, the relationship between PTX and survival is not known. METHODS: We conducted an observational matched cohort study utilizing data from the United States Renal Database System (USRDS) in which 4558 patients undergoing a first PTX while on hemodialysis or peritoneal dialysis were individually matched by age, race, gender, cause of ESRD, dialysis duration, prior transplantation status, and dialysis modality to 4558 control patients who did not undergo PTX. Patients were followed from the date of PTX until they died or were lost to follow-up. RESULTS: The 30-day postoperative mortality rate following PTX was 3.1%. Long-term relative risks of death among patients undergoing PTX were estimated to be 10% to 15% lower than those of matched control patients not undergoing surgery. Survival curves between the 2 groups crossed 587 days following PTX. Median survival was 53.4 months (95% CI: 51.2-56.4) in the PTX group, and 46.8 months (95% CI: 44.7-48.9) in the control group. CONCLUSION: PTX was associated with higher short-term, and lower long-term, mortality rates among U.S. patients receiving chronic dialysis. Measures to attenuate SHPTH may play an important role in reducing mortality among patients with end-stage renal disease.

Adult↗

Increased risk of mortality associated with hip fracture in the dialysis population.

BACKGROUND: Patients with end-stage renal disease (ESRD) are at increased risk of bone loss and hip fracture. Although it is well known that hip fracture in the general population is associated with increased mortality, this relationship is not well elucidated in the ESRD population. The authors studied the association between hip fracture and mortality in dialysis patients. METHODS: The authors used data from the United States Renal Data System to identify patients initiating dialysis between May 1, 1995, and December 31, 2000. Patients with hip fractures were identified using Medicare claims data. Each patient who experienced a hip fracture was matched to 3 nonfracture controls by age, history of cardiovascular disease (CVD), and dialysis duration. Proportional hazards models were used to estimate the risk of all-cause and cardiovascular mortality associated with hip fracture stratified by CVD history. RESULTS: A total of 7,636 patients with a hip fracture and 22,896 matched controls were identified. Median survival time for patients with hip fracture was 289 days (95% confidence interval [CI]: 275, 302) compared with 714 days (95% CI: 697, 732) for those without a hip fracture. The average relative risk of mortality associated with hip fracture was 1.99 (95% CI: 1.91, 2.07; P < 0.001). CONCLUSION: Hip fracture is associated with an increased risk of all-cause mortality in the dialysis population.

Aged↗

Cardiovascular and thromboembolic events following hypertensive pregnancy.

BACKGROUND: Hypertension is a common complication of pregnancy. Previous evidence has linked pregnancy-related hypertension to maternal cardiovascular disease. We conducted a population-based cohort study to estimate the risks for cardiovascular and thromboembolic events in women with pregnancy-related hypertension. METHODS: We analyzed data from all singleton births recorded in Washington State from 1987 to 1998. Mothers were classified as having gestational hypertension, preeclampsia, or chronic hypertension based on hospital discharge and birth record information. Birth records were linked to subsequent hospitalizations within Washington State. Proportional hazards models were used to estimate the relationship between each form of pregnancy-related hypertension and subsequent risk for cardiovascular and thromboembolic events. RESULTS: We identified 31,239 eligible hypertensive pregnancies from 807,010 births. During follow-up, there were 118 hospitalizations for a first acute cardiovascular event and 172 hospitalizations for a first thromboembolic event. Gestational hypertension, mild preeclampsia, and severe preeclampsia were associated with 2.8-fold (95% confidence interval [CI], 1.6 to 4.8), 2.2-fold (95% CI, 1.3 to 3.6), and 3.3-fold (95% CI, 1.7 to 6.5) greater risks for cardiovascular events, respectively. Severe preeclampsia was associated with a 2.3-fold (95% CI, 1.3 to 4.2) greater risk for thromboembolic events. CONCLUSION: Preeclampsia and gestational hypertension are associated with increased risk for cardiovascular events. Pregnancy-induced hypertension appears to be an important risk factor for the development of future cardiovascular disease in young women.

Adult↗

Elevated risk of stroke among patients with end-stage renal disease.

BACKGROUND: Although end-stage renal disease (ESRD) has been associated with accelerated vascular disease of the cerebral circulation, there are no prior studies that have estimated the risk of hemorrhagic and ischemic stroke among the United States dialysis population relative to the general population. METHODS: We performed a population-based cohort study to compare rates of hospitalized ischemic and hemorrhagic stroke among incident dialysis patients in the United States Renal System database and non-ESRD subjects from the general population identified in the National Hospital Discharge Survey. RESULTS: After adjustment for age, gender, and race, estimated rates of hospitalized stroke were markedly higher for dialysis patients compared to the general population. The age-adjusted relative risk (RR) of stroke among dialysis patients compared to the general population was 6.1 [95% Confidence Interval (95% CI) 5.1, 7.1] for Caucasian males, 4.4 (95% CI 3.3, 5.5) for African American males, 9.7 (95%CI 8.2, 11.2) for Caucasians females and 6.2 (95%CI 4.8, 7.6) for African American females. When considered as separate outcomes, hospitalization rates for hemorrhagic and ischemic stroke were both markedly elevated for subjects treated with dialysis (ischemic, RR = 4.3 to 10.1; hemorrhagic, RR = 4.1 to 6.7). CONCLUSION: Incident dialysis patients are at markedly higher risk for hospitalized stroke when compared to the general population. Although prior public health initiatives have focused primarily on cardiac disease among patients treated with dialysis, our data suggest that new initiatives are needed to control the high risk of stroke in this population.

Black or African American↗

Risk factors for upper gastrointestinal bleeding among end-stage renal disease patients.

BACKGROUND: The risk of upper gastrointestinal bleeding (UGIB) is increased among end-stage renal disease (ESRD) patients compared to the general population. However, correlates of UGIB among ESRD patients remain unknown. We conducted a cohort study of dialysis patients to ascertain risk factors for UGIB. METHODS: Data from the United States Renal Data System Dialysis Morbidity and Mortality Studies, Waves 2-4 were used to identify risk factors for incident UGIB among ESRD patients. First hospitalizations for UGIB were identified using hospital diagnosis codes between 12/31/93 and 12/31/99. Cox regression was used to estimate the association between predictors of interest and first diagnosis of UGIB. RESULTS: Cases of UGIB (698) were observed over 30648 patient years of follow-up. Before adjustment for confounding factors, increasing age, diabetes, former and current smoking, cardiovascular disease (CVD), lower serum albumin, malnutrition, and inability to ambulate independently were associated with an increased risk of UGIB, while African Americans and transplant patients had a lower risk of UGIB. After adjustment, African American race was associated with a lower risk of UGIB (RR = 0.90; 0.82, 0.98), while current smoking (RR = 1.11; confidence interval 1.03, 1.19), history of CVD (RR = 1.32; 1.10, 1.59), and inability to ambulate independently (RR = 1.32; 1.07, 1.63) were associated with a higher risk of UGIB. Age, gender, diabetes, lower serum albumin, nourishment, treatment modality, aspirin use, nonsteroidal anti-inflammatory drug (NSAID) use, and antiplatelet or anticoagulant medication use were not found to be significantly related to the risk of UGIB after adjustment for potential confounding factors. CONCLUSION: CVD, current smoking, and risk factors suggesting more disability are associated with a greater risk of UGIB among patients with ESRD.

Activities of Daily Living↗

Risk factors for incident stroke among patients with end-stage renal disease.

Although patients with ESRD experience markedly higher rates of stroke, no studies in the US have identified risk factors associated with stroke in this population. It was hypothesized that black race, malnutrition, and elevated BP would be associated with the risk of stroke among patients with ESRD. Data from the United States Renal Data Systems were used. Adult Medicare-insured hemodialysis and peritoneal dialysis patients without a history of stroke or transient ischemic attack (TIA) were considered for analysis. The primary outcome was hospitalized or fatal stroke. Cox proportional hazards models were used to determine the associations between the primary predictor variables and stroke. The rate of incident stroke was 33/1,000 person-years in the study sample. After adjustment for age and other patient characteristics, three markers of malnutrition were associated with the risk of stroke-serum albumin (per 1 g/dl decrease, hazard ratio [HR] = 1.43), height-adjusted body weight (per 25% decrease, HR = 1.09), and a subjective assessment of undernourishment (HR = 1.27)-as was higher mean BP (per 10 mmHg, HR = 1.11). The association between black race varied by cardiac disease status, with blacks estimated to be at lower risk than whites among individuals with cardiac disease (HR = 0.74), but at higher risk among individuals without cardiac disease (HR = 1.24). This study confirms the extraordinarily high rates of stroke in ESRD patients on dialysis and identifies high mean BP and malnutrition as potentially modifiable risk factors. The association between black race and stroke differs by cardiac disease status; the reasons for this differing effect of race deserve further investigation.

Adult↗

Risk of hip fracture among dialysis and renal transplant recipients.

CONTEXT: Renal failure places people at particularly high risk of hip fracture. However, the possible differential impact of dialysis and renal transplantation on this risk is not well understood. OBJECTIVE: To determine if patients who receive kidney transplants are at greater risk of hip fracture compared with those who continue to undergo dialysis. DESIGN, SETTING, AND PARTICIPANTS: Cohort study of 101 039 patients with end-stage renal disease placed on the renal transplant waiting list in the United States between January 1, 1990, and December 31, 1999. MAIN OUTCOME MEASURES: Hip fractures, identified from Medicare claims data. RESULTS: Among the patients included in this analysis, 971 hip fractures were observed during the follow-up period of 314 767 person-years. The incidence rate of hip fracture in patients receiving dialysis was 2.9 per 1000 patients per year compared with 3.3 hip fractures per 1000 patients per year in those who had previously received a renal transplant. Initially, the relative risk (RR) of hip fracture associated with transplantation was 1.34-fold greater when compared with dialysis (adjusted RR, 1.34; 95% confidence interval [CI], 1.12-1.61) but then decreased by 1% per month (adjusted RR, 0.99; 95% CI, 0.98-0.99) until the estimated risk became equal for dialysis and transplant recipients approximately 630 days after transplantation (adjusted RR, 1.00; 95% CI, 0.87-1.15). Among transplant recipients, risk of fracture was relatively higher in persons with a prolonged period of dialysis before transplantation. CONCLUSION: The high risk of hip fracture among dialysis patients is exceeded by that among renal transplant patients during the first 1 to 3 years after transplantation.

Adult↗

HMG-CoA reductase inhibitors are associated with reduced mortality in ESRD patients.

UNLABELLED: BACKGROUND.: Patients with end-stage renal disease (ESRD) suffer from markedly higher rates of cardiovascular disease than the general population. Although therapy with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors ("statins") has been demonstrated to reduce the mortality from cardiovascular disease in patients without ESRD, only 10% of patients on dialysis are treated with these medications by day 60 of ESRD. We determined whether the use of statins is associated with a reduction in cardiovascular-specific death and total mortality in ESRD patients. METHODS: Data were analyzed from the U.S. Renal Data System Dialysis Morbidity and Mortality Wave-2 study, a cohort of randomly selected patients who were initiating dialysis in 1996. Information about the use of statins as well as other baseline characteristics was abstracted from the patients' dialysis records by dialysis personnel. Cox proportional hazards models were developed to determine the association between use of statins at baseline and subsequent risk of mortality, with adjustment for known mortality risk factors. RESULTS: Follow-up data were available for 3716 patients through July 1998. At baseline, 362 (9.7%) of patients were using statins. These patients had a mortality rate of 143/1000 person-years, compared with a rate of 202/1000 person-years for patients not using statins. Statin use was independently associated with a reduced risk of total mortality [relative risk (RR)=0.68, 95% confidence interval (CI)=0.54, 0.87] as well as cardiovascular-specific mortality (RR=0.64, 95% CI=0.45, 0.91). In contrast, the use of fibrates was not associated with reduced mortality (RR=1.29). CONCLUSIONS: Statin use was associated with a reduction in cardiovascular-specific death and total mortality in patients on dialysis.

Adult↗