This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-0795/-/DC1. This study was approved by the Institutional Review Board of the National Institute of Diabetes and Digestive and Kidney Diseases. In this study, we examine the long-term effect of early treatment with the angiotensin receptor blocker (ARB) losartan on progression of kidney disease in American Indians with type 2 diabetes. Losartan is used to treat high blood pressure (hypertension).  |  After 1-month losartan treatment, systolic and diastolic BP (SBP, DBP) decreased significantly throughout the 210-min recording whereas heart rate (HR) was unchanged. We suggested that use of losartan in risk situations, like old age, preexiting CRF, stenosis of renal arteries, solitary kidney and diuretic therapy, should be carefully monitored as well as that of ACE I. The HR for the primary GFR outcome in those receiving losartan versus placebo was 0.72 (95% CI 0.44–1.18). In clinic, cozaar can be used to treat kidney problem caused by Diabetes, as it is proven to be effective in slowing long-term kidney damage in … There was no interaction between treatment assignment and albuminuria group in predicting death (P = 0.22) or the combined end point of ESRD or death (P = 0.08). The Different Therapeutic Choices with ARBs. RAS inhibition reduces the risk of ESRD in persons with type 1 (11) and type 2 diabetes (12–14) who have chronic kidney disease and in those with other causes of chronic kidney diseases (15), but its effect on protection from ESRD in early diabetic kidney disease is less well established. Burnier M, Rutschmann B, Nussberger J, Versaggi J, Shahinfar S, Waeber B, Brunner HR. The Collaborative Study Group, Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy, Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes, Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group, The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes, The Angiotensin-Converting-Enzyme Inhibition in Progressive Renal Insufficiency Study Group, Effect of the angiotensin-converting-enzyme inhibitor benazepril on the progression of chronic renal insufficiency, An acute fall in estimated glomerular filtration rate during treatment with losartan predicts a slower decrease in long-term renal function, initial angiotensin receptor blockade-induced decrease in albuminuria is associated with long-term renal outcome in type 2 diabetic patients with microalbuminuria: a post hoc analysis of the IRMA-2 trial, KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update, The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation, Adjusting for treatment effects in studies of quantitative traits: antihypertensive therapy and systolic blood pressure, Long-term effects of ramipril on cardiovascular events and on diabetes: results of the HOPE study extension, Long-term hemodynamic and molecular effects persist after discontinued renin-angiotensin system blockade in patients with type 1 diabetes mellitus, Changing patterns of type 2 diabetes incidence among Pima Indians, Effect of youth-onset type 2 diabetes mellitus on incidence of end-stage renal disease and mortality in young and middle-aged Pima Indians, Predominant effect of kidney disease on mortality in Pima Indians with or without type 2 diabetes, Regression to the Mean Contributes to the Apparent Improvement in Glycemia 3.8 Years After Screening: The ELSA-Brasil Study, Postintervention Effects of Varying Treatment Arms on Glycemic Failure and β-Cell Function in the TODAY Trial, Worldwide Epidemiology of Diabetes-Related End-Stage Renal Disease, 2000–2015, Institutional Subscriptions and Site Licenses, Special Podcast Series: Therapeutic Inertia, Special Podcast Series: Influenza Podcasts, http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-0795/-/DC1, http://www.diabetesjournals.org/content/license. When? no. Of those alive at the end of the clinical trial, 95% participated in the posttrial follow-up study. Urine albumin concentrations below the detection limit of the assay (≤6.8 mg/L) were set to 6.8 mg/L in the analyses. Other treatment was provided by the primary care physician.  |  Several studies have shown that renin angiotensin (Ang) system and activation of Ang II type 1 receptor (AT1) are involved in various forms of kidney diseases. RESULTS After completion of the clinical trial, treatment with renin-angiotensin system inhibitors was equivalent in both groups. HHS wrote the draft of the report and performed the statistical analysis. At enrollment, GFR averaged 165 mL/min (interquartile range 49–313 mL/min). It is also used to treat kidney problems in patients with type 2 diabetes and a history of hypertension. The increase in renal uric clearance accounted for the significant decrease in serum uric acid (195 +/- 49 vs. 183 +/- 43 microM; p < 0.05). To estimate the date of onset of the primary GFR outcome, a linear GFR slope was computed in each participant based on the last two GFR values, with the last GFR value defined as follows: In participants who did not reach the primary GFR outcome, the GFR measured at their last examination; In participants who reached the primary GFR outcome at an examination, the GFR value measured at that examination; and. Consistent with previous findings in antihypertensive drug trials in type 2 diabetes (12–14,19), risk of all-cause mortality in our study did not differ between those randomized to losartan or placebo. Losartan which contains potassium can help kidney disease patients lower their high blood pressure effectively, which will be good for kidney disease patients. To avoid the bias (informative censoring) that occurs when loss to follow-up is related to the study outcome, we used linear imputation to estimate the date of onset of the study outcomes (GFR and albuminuria). The estimated date of onset of the primary GFR outcome was then imputed for all participants from the GFR slope. I … Ischemia/reperfusion (I/R) is a major cause of acute kidney injury. The current study additionally included long duration of treatment and a minority population with a high frequency of type 2 diabetes and diabetic kidney disease (23,24), which is not represented in most clinical trials. Standards of care for people with diabetic kidney disease were evolving, and this modification was required by the ethics committee overseeing the study. Annual mean ± SE of MAP and HbA1c by treatment group (dashed line, placebo; solid line, losartan). However, as all the western medicines can cause side effects to people and losartan can also cause side effects to people. MAP and HbA1c throughout the study period were compared between treatment groups using mixed models to account for serial correlations over time. Upon trial completion, the study drug was no longer supplied. 2015 Nov;38(11):765-9. doi: 10.1038/hr.2015.82. Your risk may be higher if: you have poor kidney function; are a senior; take a water pill; are dehydrated Kidney damage is one of several reported risks and side effects for statins. It prevents the blood vessels in your body from narrowing, thus lowering your blood pressure and improving the blood circulation. Twenty-six participants progressed to ESRD during follow-up (11 were randomized to placebo and 15 to losartan). Death occurred in 58 participants (32 were randomized to placebo and 26 to losartan) and in 11 was preceded by ESRD. Renal effects of angiotensin II receptor blockade and angiotensin-converting enzyme inhibition in healthy subjects. Among the 51 participants with microalbuminuria who had a kidney biopsy at the end of the clinical trial, those who received losartan during the 6-year trial had lower mesangial fractional volume and higher filtration surface area than those who received a placebo. OBJECTIVE To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. Vital status and development of ESRD were ascertained in all study participants through 31 December 2015. Author Contributions. COVID-19 is an emerging, rapidly evolving situation. Please talk to your doctor. At the end of the 6-year trial, 111 participants agreed to a kidney biopsy to determine the effect of losartan on glomerular structure. Lowering blood pressure may reduce the risk of strokes and heart attacks. However, during the subsequent follow-up, adherence to annual research examinations declined, and 15 participants progressed to ESRD without documentation of reaching the primary GFR outcome at a research examination. Funding. During the trial and posttrial follow-up, 29 participants randomized to losartan and 35 to placebo reached the primary GFR outcome. The primary GFR finding, however, was unchanged when the Cox model was adjusted for the 2-mmHg difference in MAP between treatment groups (HR 0.74 [95% CI 0.45–1.21]). In this single-blind study, renal hemodynamic parameters were determined twice (patients were their own controls) first after a 15-day single-blind placebo run-in period and again after a 1-month losartan period. Besides, because the medicine contains potassium, which will be harmful for kidney disease patients who have high potassiu… Please enable it to take advantage of the complete set of features! In conclusion, we found that early treatment with losartan in American Indians with type 2 diabetes did not lead to a statistically significant reduction in the risk of renal function loss relative to placebo during extended follow-up that included a median of ∼8 years of observation following 6 years of randomized treatment. Long-term benefit on nephropathy of early intervention with antihypertensive drugs, however, has not been demonstrated in persons with diabetes, despite the presence of potential mechanisms induced by early treatment with renin-angiotensin system (RAS) inhibitors that might result in a persistent benefit (4). contributed to the data collection and critical revision of the manuscript for intellectual content. The median follow-up to the primary GFR outcome was 12.8 years (interquartile range 8.2–16 years). Eighty-six participants developed macroalbuminuria (Supplementary Fig. During posttrial follow-up, 85% of the participants randomized to losartan and 86% to placebo received RAS inhibitors; 6% of those randomized to losartan and 6% to placebo received ARBs alone, 54% of those randomized to losartan and 52% to placebo received ACE inhibitors alone, and 25% of those randomized to losartan and 28% to placebo received both. Arnold AC, Okamoto LE, Gamboa A, Shibao C, Raj SR, Robertson D, Biaggioni I. P.-J.S. A borderline statistically significant interaction was found between treatment group and baseline albuminuria status when examining annual mean HbA1c (P = 0.05), with losartan treatment being associated with higher HbA1c in those with normoalbuminuria but lower HbA1c in those with microalbuminuria. Moreover, ABP monitoring has been found to be more closely related to target organ damage 20, 21 and to cardiovascular mortality than clinic BP 22, 23. 2014 May 3;6:79-86. doi: 10.2147/CPAA.S61462. Blood pressure was measured while the participant was seated. While high blood pressure is very dangerous and can cause a range of serious medical complications such as kidney damage and increase your risk of developing a stroke, low blood pressure can be dangerous too. Effects of irbesartan on serum uric acid levels in patients with hypertension and diabetes. 2013 Mar;61(3):701-6. doi: 10.1161/HYPERTENSIONAHA.111.00377. OBJECTIVE To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. 1); 16 were randomized to placebo and 18 to losartan in the normoalbuminuria group (P = 0.14) and 28 to placebo and 24 to losartan in the microalbuminuria group (P = 0.26). Alternative end points, such as structural end points from kidney biopsies, may be required to demonstrate renoprotection in early diabetic kidney disease. Of the 169 participants in the clinical trial, 149 remained under observation in the posttrial period (12 died and 8 were lost to follow-up during the clinical trial). In this setting, a commonly used approach of fitting the regression model with RAS inhibitor treatment as a binary variable is not valid (20). In addition, a decision was made midway through the clinical trial to suggest that those who managed these patients consider using other RAS inhibitors in their treatment regimens. Hypertension. Annual mean MAP and HbA1c are shown by treatment group assignment in Fig. Apart from the UKPDS, which had a median posttrial follow-up duration of 8 years, to our knowledge, no previous long-term follow-up of ACE inhibitor or ARB trials beyond 2–4 years of observation has been reported (19,21,22). STUDY DESIGN: A total of 35 adult male Wistar rats were divided into control, diabetic, diabetic gliclazide, diabetic resveratrol, and diabetic losartan groups. Schmitt F, Natov S, Martinez F, Lacour B, Hannedouche TP. In the microalbuminuria group, the HR for developing macroalbuminuria was 0.68 (95% CI 0.40–1.18). 1,788 were here. To avoid extrapolations over too long an interval, the imputation was truncated at 2 years after the last measured GFR, so that follow-up continued for each participant for 2 years after the last measured GFR or until the primary GFR outcome, death, or 31 December 2015, whichever came first. Times to outcomes were compared by treatment group using Kaplan-Meier survival curves and the log-rank test. The main strengths of this study include the use of measured GFR and the long follow-up period. In individuals with type 2 diabetes taking losartan to manage kidney problems, the most common side effects include chest pain, diarrhea, high blood potassium, low blood pressure, low blood sugar, and tiredness. Enter multiple addresses on separate lines or separate them with commas. Sign In to Email Alerts with your Email Address. The same approach was used to compute follow-up time and event status for the albuminuria outcome, assuming that development of ESRD also reflected progression to macroalbuminuria. Cumulative HRs were not shown prior to the end of the trial because of the few number of events and the absence of events prior to year 4 in the losartan group. 1995 Dec;8(12 Pt 1):1177-83. doi: 10.1016/0895-7061(95)00361-4. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney … Clinical trial reg. Parts of this study were presented in abstract form at the 76th Scientific Sessions of the American Diabetes Association, New Orleans, LA, 10–14 June 2016. The current study further illustrates the challenges of establishing whether RAS inhibition clearly provides renoprotection in early type 2 diabetes, because a statistically significant reduction in clinical outcomes was not observed even after ∼14 years of follow-up, and long-term follow-up of larger antihypertensive drug trials is rarely attempted. © 2016 by the American Diabetes Association. 1993 Sep;22(3):339-47. doi: 10.1161/01.hyp.22.3.339. The advantages of angiotensin II antagonism. This site needs JavaScript to work properly. Epub 2012 Dec 24. Losartan is an angiotensin II receptor blocker (ARB). NRK-52E cells were incubated with CaOx crystals, and glyoxylic acid-induced hyperoxaluric r… Chida R, Hisauchi I, Toyoda S, Kikuchi M, Komatsu T, Hori Y, Nakahara S, Sakai Y, Inoue T, Taguchi I. Hypertens Res. Participants were then followed posttrial for up to 12 years, with treatment managed outside the study. Losartan helps the kidneys in certain conditions like diabetes. Characteristics of the study population at the beginning of posttrial follow-up were compared between treatment groups using an independent samples t test for normally distributed variables and the Kruskal-Wallis test for nonnormally distributed variables. The cumulative incidence for the primary GFR outcome and the serial HRs are presented in Fig. This research was supported by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases, the American Diabetes Association (Clinical Science Award 1-08-CR-42), and Merck, which provided the study drug and placebo tablets. The effect of losartan on the primary GFR outcome was then reanalyzed for the entire study period, including the clinical trial and posttrial follow-up. Acute kidney failure is found among people who take Losartan potassium, especially for people who are female, 60+ old, have been taking the drug for 5 - 10 years. Rather than occurrence of any modification in filtration fraction (FF), a significant decrease in microalbuminuria was evident (57 +/- 77 vs. 40 +/- 59 mg/24 h, p < 0.05). HbA1c was also measured by high-performance liquid chromatography (Tosoh, Tokyo, Japan). We re-evaluated the effect of losartan treatment assignment on the primary GFR outcome and on progression to macroalbuminuria throughout the trial and posttrial period. The National Library of Medicine (NLM), on the NIH campus in Bethesda, Maryland, is the world's largest biomedical library and the developer of electronic information services that delivers data to millions of scientists, health professionals and members of the public around the globe, every day. Before taking losartan, let your physician know if you have heart disease, liver disease, or diabetes. All participants who received a non-RAS inhibitor antihypertensive drug during the posttrial period also received a RAS inhibitor at some point posttrial. It works by blocking a substance in the body that causes blood vessels to tighten. It also improves your survival if you're taking it … Calcium oxalate (CaOx) is the most common type of urinary stone. R.L.H., W.C.K., and P.H.B. Urinary sodium excretion was not modified, but an almost significant (p = 0.07) decrease in proximal sodium reabsorption was observed (72.9 +/- 7.7 vs. 68.1 +/- 6.4% of filtered sodium). So Losartan will not damage your kidneys and if your blood pressure is high then it is possible that another antihypertensive may have to be added. Glomerular filtration rate (GFR, inulin clearance), renal plasma flow [RPF; para-aminohippurate (PAH) clearance], microalbuminuria, sodium excretion, proximal sodium tubular reabsorption (lithium clearance), and acid uric metabolism were measured. All authors contributed to the revision of the paper and approved the final version. CONCLUSIONS Long-term risk of GFR decline was not significantly different between persons randomized to early treatment with losartan and those randomized to placebo. 1996 Mar;90(3):205-13. doi: 10.1042/cs0900205. Where no interaction was present, the analysis was stratified by baseline albuminuria status to account for the stratified sampling design, and the overall results were generally reported for both albuminuria groups combined. Intervals between research examinations sometimes increased as kidney disease progressed, which could lead to differential misclassification of the study-based outcomes (GFR and albuminuria), requiring an imputation method to compute these outcomes. R.G.N. Urine albumin concentration was measured by nephelometric immunoassay and urine creatinine by a modified Jaffé reaction (Siemens, Erlangen, Germany) (10). There was no such interaction for MAP (P = 0.42), but there was a significant difference in MAP by treatment assignment (P = 0.04) that was most apparent in the last 3 years of observation, with lower MAP in those assigned to losartan. 2016 Aug;16(4):255-266. doi: 10.1007/s40256-016-0165-4. During the clinical trial (7), 97.5% of research examinations were conducted according to the prespecified examination schedule. Prior Presentation. performed the statistical analysis. Losartan may be used for the treatment of high blood pressure or certain types of kidney disease. Accordingly, we found no evidence of an extended benefit of early losartan treatment on slowing GFR decline in persons with type 2 diabetes. During the clinical trial, 67% of participants in the placebo group were treated with RAS inhibitors at some point (5% with ARB, 47% with ACE inhibitors, and 15% with both), whereas 12% were treated with non-RAS inhibitor antihypertensive drugs (1% were treated solely with non-RAS inhibitor antihypertensive drugs). Am J Cardiovasc Drugs. 2. Subsequent follow-up was considered posttrial follow-up. At baseline, 92 participants had normoalbuminuria (albumin/creatinine ratio [ACR] <30 mg/g) and 78 had microalbuminuria (ACR 30 to <300 mg/g). Long-term Effect of Losartan on Kidney Disease in American Indians With Type 2 Diabetes: A Follow-up Analysis of a Randomized Clinical Trial, Intensive diabetes therapy and glomerular filtration rate in type 1 diabetes, Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study at 30 years: advances and contributions, 10-year follow-up of intensive glucose control in type 2 diabetes, Antihypertensive therapy in diabetes: the legacy effect and RAAS blockade, Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38, Long-term follow-up after tight control of blood pressure in type 2 diabetes, Effect of losartan on prevention and progression of early diabetic nephropathy in American Indians with type 2 diabetes, Diabetes mellitus in American (Pima) Indians, Structural Predictors of Loss of Renal Function in American Indians with Type 2 Diabetes, Determination of creatinine by means of automatic chemical analysis, The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. Furthermore, the risk of kidney disease progressing to ESRD in this population may differ from that in other populations because of poor glycemic control and because of the lower risk of competing cardiovascular deaths prior to the onset of renal replacement therapy (25). In the normoalbuminuria group, the HR for the first appearance of elevated albuminuria (ACR ≥30 mg/g) among those receiving losartan versus placebo was 1.02 (95% CI 0.65–1.62), and for the appearance of macroalbuminuria, the HR was 1.40 (95% CI 0.71–2.78). Treatment with losartan attenuated CIH-induced renal tissue damage, suggesting that activation of RAS is the primary cascade involved in CIH-induced kidney injury. The present analysis combines data collected during the clinical trial and data collected at annual research examinations that continued for a maximum of 12 years posttrial. The Epidemiology of Diabetes Interventions and Complications (EDIC) study showed significant sustained reduction in risk of impaired glomerular filtration rate (GFR) (1) and nephropathy during the posttrial period in participants with type 1 diabetes who received intensive glucose control for 6.5 years (2). Log-rank test for the GFR outcome yielded P = 0.28. In this study, we report results from analyses that include the posttrial period. Doctors prescribe it to treat hypertension and nephropathy, which is damage … The proportionality assumption was met by each covariate. At the end of our 6-year clinical trial, nine participants had reached the primary GFR outcome for an HR of 0.50 (95% CI 0.12–1.99) in those assigned to losartan versus placebo (7). is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. 56 (1999), pp. In conclusion, we want pointed out that losartan could affect renal function in a similar way as angiotensin converting enzyme inhibitors (ACEI). Thank you for your interest in spreading the word about Diabetes Care. An extended benefit of early intensive glycemic control on microvascular complications even after subsequent return to conventional glycemic control is well described. Data on other antihypertensive drugs received during and after the trial were ascertained by self-report. Reliance on renal function changes or on surrogate markers such as albuminuria may not be sufficient to adequately evaluate renoprotection in early diabetic kidney disease even after many years of follow-up. During a median of 13.5 years following randomization, 29 participants originally assigned to losartan and 35 to placebo reached the primary GFR outcome with an HR of 0.72 (95% CI 0.44–1.18). On progression to macroalbuminuria ( ACR ≥300 mg/g ) was examined as secondary! A significant difference in MAP by treatment group ( P = 0.28 follow-up measurements and was excluded from (! Reported separately by baseline albuminuria stratum and for the 149 participants who received RAS. Then imputed for all participants from the last clinical trial, 95 % participated in the losartan and kidney damage! Gfr is the most common type of angiotensin II, independent of renin. 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