Data from the Dialysis Outcomes and Practice Patterns Study validate an association between high intravenous iron doses and mortality.

Intravenous (IV) iron is required for optimal management of anemia in the majority of hemodialysis (HD) patients. While IV iron prescription has increased over time, the best dosing strategy is unknown and any effect of IV iron on survival is unclear. Here we used adjusted Cox regression to analyze associations between IV iron dose and clinical outcomes in 32,435 HD patients in 12 countries from 2002 to 2011 in the Dialysis Outcomes and Practice Patterns Study. The primary exposure was total prescribed IV iron dose over the first 4 months in the study, expressed as an average dose/month. Compared with 100-199 mg/month (the most common dose range), case-mix-adjusted mortality was similar for the 0, 1-99, and 200-299 mg/month categories but significantly higher for the 300-399 mg/month (HR of 1.13, 95% CI of 1.00-1.27) and 400 mg/month or more (HR of 1.18, 95% CI of 1.07-1.30) groups. Convergent validity was proved by an instrumental variable analysis, using HD facility as the instrument, and by an analysis expressing IV iron dose/kg body weight. Associations with cause-specific mortality (cardiovascular, infectious, and other) were generally similar to those for all-cause mortality. The hospitalization risk was elevated among patients receiving 300 mg/month or more compared with 100-199 mg/month (HR of 1.12, 95% CI of 1.07-1.18). In light of these associations, a well-powered clinical trial to evaluate the safety of different IV iron-dosing strategies in HD patients is urgently needed.

Variation in intravenous iron use internationally and over time: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: To examine patterns of intravenous (IV) iron use across 12 countries from 1999 to 2011. METHODS: Trends in iron use are described among 32 192 hemodialysis (HD) patients in the Dialysis Outcomes and Practice Patterns Study. Adjusted associations of IV iron dose with serum ferritin and transferrin saturation (TSAT) values were also studied. RESULTS: IV iron was administered to 50% of patients over 4 months in 1999, increasing to 71% during 2009-11, with increasing use in most countries. Among patients receiving IV iron, the mean monthly dose increased from 232 ± 167 to 281 ± 211 mg. Most countries used 3 to 4 doses/month, but Canada used about 2 doses/month, Italy increased from 3 to almost 6 doses/month and Germany used 5 to 6 doses/month. The USA and most European countries predominantly used iron sucrose and sodium ferric gluconate. A significant use of iron dextran was limited to Canada and France; iron polymaltose was used in Australia and New Zealand; and Japan used ferric oxide saccharate, chondroitin polysulfate iron complex and cideferron. Ferritin values rose in most countries: 22% of patients had ≥ 800 ng/mL in the recent years of study. TSAT levels increased to a lesser degree over time. Japan had much lower IV iron dosing and ferritin levels, but similar TSAT levels. In adjusted analyses, serum ferritin and TSAT levels increased signifcantly by 14 ng/mL and 0.16%, respectively, for every 100 mg/month higher mean monthly iron dose. CONCLUSIONS: IV iron prescription patterns varied between countries and changed over time from 1999 to 2011. IV iron use and dose increased in most countries, with notable increases in ferritin but not TSAT levels. With rising cumulative IV iron doses, studies of the effects of changing IV iron dosing and other anemia management practices on clinical outcomes should be a high priority.

Oxidative effect of several intravenous iron complexes in the rat.

The objective of this study was to compare the oxidative stress induced in rat internal organs by the administration of the following clinically used intravenous (IV) iron (Fe) containing compounds: iron sucrose (IS), iron dextran (ID), ferric carboxymaltose and ferumoxytol. Groups of six adult rats received 1 mg/kg of each compound weekly for 5 doses. Seven days following the last dose, animals were euthanized and tissue samples of heart, lung, liver, and kidney were obtained, washed in warmed saline and frozen under liquid nitrogen and stored at -80 °C for analysis for nitrotyrosine (NT) and dinitro phenyl (DNP) as markers of oxidative stress. All tissues showed a similar pattern of oxidative stress. All Fe products stimulated an increase in the tissue concentration of both NT and DNP. In general, DNP was stimulated significantly less than NT except for IS. DNP was stimulated to an equal degree except for ID where NT was significantly higher than the NT concentrations in all other Fe compounds. ID produced over 10-fold the concentration of NT than any other Fe. IV Fe compounds present a risk of oxidative stress to a variety of internal organs. However, we found that IS was the least damaging and ID was the worst.

Management of iron deficiency and anemia after Roux-en-Y gastric bypass surgery: an observational study.

BACKGROUND: Iron deficiency (ID) is common after Roux-en-Y gastric bypass surgery (RYGB). Optimal iron management in this population is unclear. The objective of this study was to assess our management of RYGB patients with ID and anemia. METHODS: Clinic visit records of RYGB patients with ID or anemia from January 1, 2008, to February 1, 2010 were evaluated. Demographic characteristics, postsurgery iron and anemia indices, and prescribed treatments were recorded. Three separate definitions for ID and anemia were used (standard textbook, ASBMS, and recent literature). An intravenous iron protocol was later implemented, and follow-up laboratory values were obtained. RESULTS: A total of 125 with ID or anemia (89% female, 86% Caucasian), mean (SD) age 44.7 (8.6) years, and BMI 47.3 (10.8) kg/m(2) at time of RYGB, were included. Proportion of values meeting criteria for ID or anemia at first follow-up: standard textbook, hemoglobin (Hb, 35%), transferrin saturation (Tsat, 48%), ferritin (28%); ASBMS, ferritin (43%); recent literature, ferritin (58%), serum iron (21%). At mean follow-up of 45.7 (43) months, oral iron (n = 49) or intravenous iron (n = 4) had been prescribed for 53 (42.4%) patients, and 32 (25.6%) patients received multiple blood transfusions. Nine patients received intravenous iron using the new protocol (400-1400 mg), resulting in increases in Hb (1.8 g/dL; P<.05) and ferritin (31.8 ng/mL; P< .002). CONCLUSION: Iron management was inadequate. Hematologic values often were deficient for sustained periods. Initially, few patients received intravenous iron after oral iron failure, many received no iron supplementation, and there was high use of blood transfusions. Subsequently, administration of intravenous iron was beneficial.

Differences in the reporting rates of serious allergic adverse events from intravenous iron by country and population.

BACKGROUND: Previous studies have compared rates of adverse events between intravenous (IV) iron preparations; however, there has been no comparison of adverse event rates by country and population. OBJECTIVES: To compare rates of adverse events to IV iron products by country and population. METHODS: All adverse events reported from 18 countries from January 1, 2003 to June 30, 2009 were obtained for iron dextran (ID), iron sucrose (IS), IS similars (ISS), and sodium ferric gluconate (FG). Rates of all adverse events and serious adverse events (anaphylaxis plus other serious allergic reactions) were calculated as number of events per gram of iron sold (gFe) per million inhabitants (mil) × 10-3. Odds ratios (ORs) were calculated for the risks of adverse events between products. RESULTS: Iron use ranged from 1 gFe/mil (Poland) to 48,674 gFe/mil (Italy). Rates of all adverse events (reports/gFe/mil × 10-3) varied: for IS, it ranged from 0 (Poland, Austria, Czech Republic) to 1,222 (Ireland); for FG, from 3.3 (Czech Republic) to 183.6 (United States); for ID, from 0.9 (Turkey) to 46,875 (Switzerland). There were no reports of adverse events in ISS. In a subset of countries that used 2 or more iron products and had more than 1 serious adverse event, rates (reports/gFe/mil × 10-3) of all adverse events and serious adverse events were lowest for IS (39.8 and 1.7), intermediate for FG (54.8 and 4.5), and greatest for ID (337.7 and 20.5). IS had lower risks for all adverse events (OR, 0.63; P<.0001) and serious adverse events (OR, 0.31; P=.001) versus FG, and for all adverse events (OR, 0.13; P<.0001) and serious adverse events (OR, 0.07; P<.0001) versus ID. FG had lower risks for all adverse events (OR, 0.20; P<.0001) and serious adverse events (OR, 0.24; P<.0001) versus ID. CONCLUSIONS: Considerable international variation existed in the extent and choice of iron product and adverse event reporting, suggesting under-reporting in some instances. Clinicians should appreciate the differential risks between available products, and should critically review local reporting practices.

Comparison of rates of reported adverse events associated with i.v. iron products in the United States.

PURPOSE: An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. METHODS: All AE reports to the Food and Drug Administration (FDA) citing iron sucrose, ferric gluconate, high- and low-molecular-weight iron dextran products, or ferumoxytol from October 2009 through June 2010 were evaluated. The rates of various classifications of reported AEs were calculated on a per-unit-sold basis and, for comparison of products supplied in different unit sizes, also in terms of 100-mg dose equivalents (DEq) of iron. RESULTS: A total of 197 reported AEs were identified (a cumulative rate of 14.1 AEs per million units sold). The rates of all AE classifications combined ranged from 5.25 to 746 per million units sold for iron sucrose and ferumoxytol, respectively; using the other method of calculation, the rates ranged from 5.24 per million DEq (iron sucrose) to 147 per million DEq (ferumoxytol). Relative to iron sucrose and sodium ferric gluconate, ferumoxytol was associated with significantly elevated risks of death (odds ratio [OR], 475 and 156, respectively; p < 0.0001), serious nonfatal AEs (OR, 263 and 121, respectively; p < 0.0001), and all evaluated AE classifications combined (OR, 142 and 109, respectively; p < 0.05). CONCLUSION: Analysis of reports submitted to FDA revealed large differences among i.v. iron products in reported deaths, serious AEs, other major AEs, and other AEs. Iron sucrose and sodium ferric gluconate were associated with much lower rates of AEs per million units sold than iron dextran or ferumoxytol, which were associated with the highest rates of all reported AE classifications.

Differences in spontaneously reported hypersensitivity and serious adverse events for intravenous iron preparations: comparison of Europe and North America.

Spontaneously-reported rates of adverse events (AEs) of intravenous (i.v.) iron products have not been compared since 2007. AEs in Europe (Eur) and North America (NA) have never been compared. New products have been marketed and many changes in prescribing habits have occurred since then, and the effect on AEs reporting is unclear. It was hypothesized that changing practices for i.v. iron products has caused changes in the rates of serious AEs and large differences exist between Eur and NA. Rates of AEs for three i.v. iron preparations (iron sucrose [IS], ferric gluconate [FG] and high and low MW iron dextran [HMWID, LMWID]) were compared by product and continent from January 1, 2003 to June 30, 2009 for selected countries in Eur and NA, using the Uppsala Monitoring Center's database. Rates of total, anaphylaxis and other serious allergic AEs were calculated as number of AEs divided by i.v. iron sales standardized to 100 mg dose equivalents (DEq) of iron. Quarterly sales (millions of 100 mg DEq of iron) increased from the first quarter 2003 to the end of the second quarter of 2009 by 1% for FG, 16% for IS and 2% for ID. Total AEs for NA plus Eur were similar for FG and IS, but total AEs were 6- to 7-fold higher for ID. Rates of anaphylaxis were 6- to 11-fold higher in Eur plus NA combined for ID than for IS or FG. In NA, there were substantially higher reports for total, anaphylaxis and other serious allergic AEs with FG compared to IS, whereas the reverse was the case in Eur. Odds ratios (OR) showed higher risks of anaphylaxis with FG in NA vs. Eur (OR = 4.40, P < 0.0001) and lower risks with IS (OR = 0.24, P < 0.0001). Odds of anaphylaxis with LMWID in Eur vs. FG and IS were 42.08 and 16.92 (both P < 0.0001), respectively. In NA, odds of anaphylaxis with ID vs. FG and IS were 2.36 and 17.73 (both P < 0.0001), respectively. Differences between NA and Eur may be related to varied treatment practices. ID had the highest rates of all types of AEs, and IS and FG had a continued trend for lowest rates of AEs.

Quantifying home medication regimen changes and quality of life in patients receiving nocturnal home hemodialysis.

Medication regimen simplification may improve adherence in end-stage kidney disease. The effect of nocturnal home hemodialysis (NHHD) on medication burden is unknown. A retrospective pilot study of NHHD patients was conducted. Medication information was collected at baseline, NHHD start, and at 3, 6, 12, 18, and 24 months. SF-36 scores were collected at baseline, 6, 12, and 24 months. The number of medications, pill burden, and number of administrations per day were determined. Medication Regimen Complexity Index was used at each time point as a comparator. Medications for anemia, mineral and bone disorders (MBD), cardiovascular (CV) disease, infection, and vitamins were analyzed for number of medications and pill burden. Thirty-five patients were included. Patients used 10.5 ± 4.4 medications at baseline and 11.8 ± 4.7 at the end of the study (P=NS). Regarding the number of medications, anemia medications, anti-infectives, and vitamins increased; MBD and CV medications decreased by the end of the study. Total pill burden did not change over 24 months, nor did anemia pill burden. Mineral bone disorder and CV pill burden decreased, and vitamins and anti-infective pill burden increased. Daily medication administration times decreased significantly from 5.0 ± 1.5 to 3.6 ± 1.5 by 24 months. Switching to NHHD was associated with a significant increase in Medication Regimen Complexity Index at 24 months (P<0.05). SF-36 scores increased significantly once patients began on NHHD. No measure of medication regimen complexity was correlated with the SF-36 score. Medication burden changes over time after starting NHHD. It is unknown what effect NHHD has on adherence or medication costs, and warrants further study in a prospective comparative investigation.

Efficacy and safety of ferric carboxymaltose in correcting iron-deficiency anemia: a review of randomized controlled trials across different indications.

Ferric carboxymaltose (FCM, Ferinject) was effective and well tolerated in the treatment of iron-deficiency anemia (IDA) in nine, Phase III, randomized, controlled, multicenter trials in a diverse range of indications, including patients with inflammatory bowel disease (IBD), post-partum anemia (PPA) or abnormal uterine bleeding (AUB), chronic heart failure (CHF), non-dialysis-dependent chronic kidney disease (CKD) and those undergoing hemodialysis (HD). In most trials, patients received either FCM doses of < or = 1000 mg, administered intravenously (i.v.) over < or = 15 min. or oral ferrous sulfate (FeSulf) 325 mg (65 mg iron), three times daily (t.i.d.), or 304 mg (100 mg iron), twice daily (b.i.d.). In one trial, patients on HD received 200 mg i.v. of either FCM or iron sucrose (ISC), two-to-three times weekly. In a pilot study in patients with CHF and CKD, patients received 200 mg of FCM by push injection compared with 200 mg of ISC slow injection. FCM was usually administered until the patient's calculated total iron replacement dose was achieved. Treatment with FCM improved indices of anemia (hemoglobin [Hb], ferritin and transferrin saturation [TSAT] values). In patients on HD with IDA secondary to CKD, FCM demonstrated comparable efficacy to ISC in achieving an increase in Hb. In patients with IBD or PPA, improvements in Hb levels were more rapid with FCM than with FeSulf. Patients with PPA receiving FCM compared with those receiving oral iron achieved an Hb rise > or = 2.0 g/dl earlier (7 days compared with 14 days; p < 0.001), were more likely to achieve an Hb rise > or = 3.0 g/dl at any time beginning at day 14 (86.3% compared with 60.4%; p < 0.001), and achieve an Hb > 12.0 g/dl at the end of the study (Day 42; 90.5% compared with 68.6%, p < 0.01). Serum ferritin increased in the i.v. FCM treatment group, but not in the oral iron group. Differences between groups were significant at each study interval. TSAT increased significantly at every interval in both groups; however, FCM-treated patients showed higher TSAT at each interval after the first week. FCM improved patient quality of life to an equivalent extent to oral FeSulf in patients with IBD or PPA, and to a greater extent than oral FeSulf in women with AUB. FCM also improved quality of life as well as functional symptoms and exercise capacity in patients with CHF. Safety data from more than 3000 patients showed that FCM was well tolerated. No safety concerns have been identified in breastfed infants of mothers receiving FCM. FCM is, therefore, an effective and well-tolerated option in the treatment of IDA.

Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia.

There is limited safety information about ferric carboxymaltose (FCM), a new intravenous iron preparation. This randomized, crossover study compared the safety and tolerability of double-blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia. Subjects (559) with iron deficiency anemia received a dose of either FCM (15 mg/kg, maximum 1000 mg) over 15 minutes or placebo on day 0. On day 7, subjects received the other agent. Safety evaluations were performed on days 7 and 14. The primary endpoint was the incidence of treatment-emergent adverse events during each 7-day study period. During the first 24 hours and during the 7-day treatment period, at least one treatment-emergent adverse event was experienced by 15.0% and 29.3% of subjects after FCM and 11.4% and 19.7% after placebo, respectively. Most were classified as Grade 1 or 2. Six subjects had Grade 3 treatment-emergent adverse events after FCM and 9 subjects after placebo. One subject had a Grade 4, and 1 subject had a Grade 5 treatment-emergent adverse event, but neither was considered study drug-related. During the first 24 hours of the treatment period, drug-related adverse events were reported in 9.3% of subjects receiving FCM and 4.8% receiving placebo. Of drug-related Grade 3 events, 4 subjects received FCM and 5 subjects received placebo. Administration of FCM (15 mg/kg, maximum of 1000 mg) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia.

Rosiglitazone is associated with mortality in chronic hemodialysis patients.

Recent studies have associated rosiglitazone, a thiazolidinedione drug, with adverse cardiovascular outcomes in the general population with diabetes. Using data from the Dialysis Outcomes and Practice Patterns Study in the United States, we examined cardiovascular hospitalization and mortality associated with prescription of rosiglitazone, compared with other oral hypoglycemic agents, among 2393 long-term hemodialysis patients who were followed for a median of 1.1 yr. We assessed mortality risk using Cox models in patient-level and dialysis facility-level analyses that used the facility proportion of patients on rosiglitazone as the predictor (instrumental variable approach) and adjusted the models for demographics, comorbid conditions, laboratory values, and achieved dialysis dosage. Compared with patients prescribed other oral hypoglycemic agents, patients prescribed rosiglitazone had significantly higher all-cause (hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.05 to 1.82) and cardiovascular (HR 1.59; 95% CI 1.14 to 2.22) mortality, and their adjusted HR for hospitalization with myocardial infarction was 3.5-fold higher (P = 0.02). We did not observe similar associations in a secondary analysis evaluating pioglitazone. By the instrumental variable approach, facilities with more than the median adjusted percentage (6.2%) of patients who had diabetes and were prescribed rosiglitazone had significantly higher all-cause mortality (HR 1.36; 95% CI 1.15 to 1.62) and cardiovascular mortality (HR 1.42; 95% CI 1.07 to 1.88) than facilities with less than the median expected percentage prescribed rosiglitazone. Our practice-based findings suggest significant associations of rosiglitazone use with higher cardiovascular and all-cause mortality among hemodialysis patients with diabetes.

A project management approach to an ACPE accreditation self-study.

In preparation for an on-site evaluation and accreditation by the American Council on Pharmaceutical Education (ACPE), the Albany College of Pharmacy employed project management techniques to complete a comprehensive self-study. A project lifecycle approach, including planning, production, and turnover phases, was used by the project's Self-Study Steering Committee. This approach, with minimal disruption to college operations, resulted in the completion of the self-study process on schedule. Throughout the project, the Steering Committee maintained a log of functions that either were executed successfully or in hindsight, could have been improved. To assess the effectiveness of the project management approach to the the self-study process, feedback was obtained from the College community through a poststudy survey. This feedback, coupled with the Steering Committee's data on possible improvements, form the basis for the lessons learned during this self-study process.

Diuretic use, residual renal function, and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Pattern Study (DOPPS).

BACKGROUND: Information about residual renal function (RRF) and outcomes associated with practices of diuretic use in patients with end-stage renal disease is not available worldwide. METHODS: Diuretic use was investigated in 16,420 hemodialysis patients from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of hemodialysis patients selected from nationally representative facilities on 3 continents. Logistic regressions were used to investigate associations between diuretic use and patient characteristics. Outcomes of interdialytic weight gain, increased serum potassium and phosphorus levels, and odds of retaining RRF after 1 year were investigated. Cox regression was used to analyze the association between mortality and diuretic use. RESULTS: Facility diuretic use varied substantially from 0% to 83.9% of patients. Diuretic use decreased sharply after the start of dialysis therapy. Loop diuretic use ranged from 9.2% in the United States to 21.3% in Europe, whereas use within 90 days of starting dialysis therapy ranged from 25.0% in the United States to 47.6% in Japan. Diuretic use was associated with lower interdialytic weight gain and lower odds of hyperkalemia (potassium > 6.0 mmol/L). Patients with RRF on diuretic therapy had almost twice the odds of retaining RRF after 1 year in the study versus patients not on diuretic therapy. Patients administered diuretics had a 7% lower all-cause mortality risk (P = 0.12) and 14% lower cardiac-specific mortality risk (P = 0.03) versus patients not administered diuretics. CONCLUSION: Variation exists in facility practices of diuretic use. In patients with RRF, there may be benefit associated with continuing diuretic use rather than automatically discontinuing diuretic therapy at dialysis initiation.

Sexual dysfunction in dialysis patients treated with antihypertensive or antidepressive medications: results from the DOPPS.

BACKGROUND: The relationship between medication prescription and sexual dysfunction (SD) in dialysis patients is unclear. METHODS: We studied antihypertensive and antidepressive agents prescribed for 7346 patients in the Dialysis Outcomes and Practice Patterns Study phase 1 (DOPPS I) and 8891 patients in DOPPS II. At baseline, DOPPS I patients completed a quality of life survey, including four questions about sexual functioning, from which we created a composite SD scale. DOPPS II patients were asked only one question about SD. We examined predictors of SD with logistic regression, using numerous patient characteristics, comorbid conditions and additional variables. RESULTS: Reported SD ranged from 66.4% (France) to 84.5% (Spain). The mean composite SD score ranged from 6.4 (Spain) to 7.9 (Germany) (on a 3-15 scale). Peripheral alpha-blockers increased odds of DOPPS I patients having their sex life bothered by end-stage renal disease (ESRD) (OR=1.18), and there were elevated odds of arousal problems with central antagonists, loop diuretics and peripheral alpha-blockers (OR=1.19, 1.24 and 1.29, respectively). Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines increased odds of problems with enjoyment (OR=1.59 and 1.26, respectively) and arousal (OR=1.70 and 1.24, respectively), and having sex life bothered by ESRD (DOPPS I: OR=1.36 and 1.24; DOPPS II: 1.30 and 1.31, respectively). Vasodilators reduced the odds of sexual enjoyment problems (OR=0.75). Composite SD scores worsened with peripheral alpha-blockers (+0.41), tricyclics (+0.78), SSRIs (+0.80) and benzodiazepines (+0.50), but not with vasodilators (-0.57). CONCLUSIONS: Awareness of associations between SD and prescribed medications may offer opportunities for intervention.

Iron and the anaemia of chronic disease: a review and strategic recommendations.

BACKGROUND: The incidence of anaemia is high in many chronic conditions, yet it often receives little attention. SCOPE/METHODS: A panel of international experts with experience in haematology, nephrology, oncology, rheumatology and pharmacy was convened to prepare strategic guidelines. A focused literature search was conducted after key issues had been identified. A series of recommendations was agreed, backed, wherever possible, by published evidence which is included in the annotations. RECOMMENDATIONS: Anaemia is a critical issue for patients with chronic diseases. Healthcare professionals need to recognise that anaemia is a frequent companion of cancer and chronic conditions such as rheumatoid arthritis and heart failure. It reduces patients' quality of life and can increase morbidity and mortality. Anaemia should be considered as a disordered process in which the rate of red cell production fails to match the rate of destruction which leads eventually to a reduction in haemoglobin concentration; this process is common to all chronic anaemias. The aim of anaemia management should be to restore patient functionality and quality of life by restoring effective red cell production. Blood transfusion can elevate haemoglobin concentration in the short term but does nothing to address the underlying disorder; red cell transfusion is, therefore, not an appropriate treatment for chronic anaemia. Patients with anaemia of chronic disease may benefit from iron therapy and/or erythropoiesis stimulating agents (ESAs). Intravenous iron should be considered since this can be given safely to patients with chronic diseases while intramuscular iron causes unacceptable adverse effects and oral iron has limited efficacy in chronic anaemia. CONCLUSION: The management of anaemia calls for the development of a specialist service together with education of all healthcare professionals and transfer of skills from areas of good practice. Improvement in the management of anaemia requires a fundamental change of attitude from healthcare professionals.

Large variations in prescriptions of gastrointestinal medications in hemodialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Little is known about proton pump inhibitor (PPI) or H(2) receptor antagonist (HA) prescription patterns or regarding use of predictors in hemodialysis patients. Proton pump inhibitor and HA prescribing patterns were investigated in 8628 hemodialysis patients from seven countries enrolled in the prospective, observational Dialysis Outcomes and Practice Patterns Study. Logistic regression examined predictors associated with PPI and HA use, adjusting for age, sex, country, time with end-stage renal disease, medications, 14 comorbid conditions, and the association between the number of comorbid conditions and the prescription of gastrointestinal (GI) medications. In a cross-section from February 1, 2000, 3.4% to 36.9% of patients received an HA and 0.8% to 26.9% took a PPI, depending upon the country. From 1996 to 2001, the prescription of HAs declined while PPI use increased. Facility use of HAs and PPIs ranged from 0% to 94% of patients. H2 receptor antagonist or PPI use was significantly and independently associated with age, narcotic use, corticosteroids, acetaminophen, nonsteroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors, coronary artery disease history, cardiovascular diseases other than hypertension or congestive heart failure, peripheral vascular disease, pulmonary disease, and GI bleed. Proton pump inhibitors or HAs were more likely to be prescribed in Italy, Spain, and the United Kingdom than in the United States. The odds of PPI prescription increased if serum phosphorus <5.5 mEq/L or serum albumin <3.5 g/dL. Prescription of GI medications was associated with many comorbidities and use of several medications. Extreme variability of prescription patterns suggests that there is no standard approach in treatment practices.

Clinical practice guidelines for bone metabolism and disease in chronic kidney disease: an overview.

The National Kidney Foundation developed and oversees the Kidney Disease Outcomes Quality Initiative, a process that develops clinical practice guidelines in nephrology. Recent guidelines address the aberrations in bone metabolism and disease that occur as a complication of chronic kidney disease. These guidelines provide, for the first time, a standard approach to the detection and management of alterations in calcium, phosphorus, and parathyroid hormone metabolism. The problems and sequelae of soft-tissue calcification are discussed, and recommendations are provided for reducing the associated morbidity and mortality.