Burnier M, Rutschmann B, Nussberger J, Versaggi J, Shahinfar S, Waeber B, Brunner HR. 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. The cumulative incidence for the primary GFR outcome and the serial HRs are presented in Fig. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. RESEARCH DESIGN AND METHODS We conducted a 6-year clinical trial in 169 American Indians with type 2 diabetes and urine albumin/creatinine ratio <300 mg/g; 84 participants were randomly assigned to receive losartan and 85 to placebo. RESULTS After completion of the clinical trial, treatment with renin-angiotensin system inhibitors was equivalent in both groups. HHS NCT00340678, clinicaltrials.gov. Using this drug with NSAIDs raises your risk of kidney damage. This site needs JavaScript to work properly. We had expected that the early structural differences seen on kidney biopsy at the end of the clinical trial might lead to an extended functional benefit of early treatment in our cohort (7). NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. 2015 Nov;38(11):765-9. doi: 10.1038/hr.2015.82. HRs for the various outcomes in each baseline albuminuria stratum and for the combined strata are shown in Table 2. Losartan reverses glomerular podocytes injury induced by AngII via stabilizing the expression of GLUT1. 11. 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. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548. During the trial and posttrial follow-up, 29 participants randomized to losartan and 35 to placebo reached the primary GFR outcome. Would you like email updates of new search results? Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. The median follow-up time to development of macroalbuminuria was 10.1 years (interquartile range 3.3–15.6 years). To study the losartan influence on renal function and uric acid (UA), CRP and baseline immunoreactive insulin (IRI) plasma concentration in essential hypertensive (EH) patients (pts) with hypertensive Chronic Kidney Disease (CKD). 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. Losartan may be used for the treatment of high blood pressure or certain types of kidney disease. Accordingly, we used a preferred approach of adjusting the observed GFR in each participant according to changes in RAS inhibitor treatment during follow-up, and we found that this adjustment did not alter our results. Kidney damage is one of several reported risks and side effects for statins. During the clinical trial (7), 97.5% of research examinations were conducted according to the prespecified examination schedule. In the current study, longer follow-up attenuated these HRs, so that neither effect was statistically significant. P.-J.S. We hypothesize that losartan may protect against CIH-induced kidney injury, possibly by suppressing intrarenal RAS activation and subsequently by promoting renal vessel vasodilation. It is also used to lower the risk of stroke in certain people with heart disease. Primary outcome was a decline in glomerular filtration rate (GFR; iothalamate) to ≤60 mL/min or to half the baseline value in persons who entered with GFR <120 mL/min. Kidney stones is found among people who take Losartan potassium, especially for people who are male, 60+ old, have been taking the drug for 1 - 6 months. Please talk to your doctor. Losartan works by blocking the effect of angiotensin II, a hormone that causes blood vessels to narrow (constrict) increasing blood pressure. 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. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney … During the trial, nine persons reached the primary outcome with a hazard ratio (HR; losartan vs. placebo) of 0.50 (95% CI 0.12–1.99). Eighty-six participants developed macroalbuminuria (Supplementary Fig. Kirsty, Losartan is known to cause an increase in creatinine but as long as it is a small increase, the consultants accept this as a side effect of the medication and not significant as a problem with your kidney function as such. During the clinical trial, we found that the HR for macroalbuminuria in those treated with losartan versus placebo was 8.12 (95% CI 1.02–64.98) among participants with normoalbuminuria and 0.54 (95% CI 0.26–1.10) among those with microalbuminuria at enrollment (7). In contrast, mesangial fractional volume at the end of the trial was lower in participants with microalbuminuria who were assigned to losartan than in those who were assigned to placebo (7). HbA1c was also measured by high-performance liquid chromatography (Tosoh, Tokyo, Japan). After 1-month losartan treatment, renal function was well preserved; the decrease in uric acid may be of clinical interest when adjuvent diuretic therapy is required. Because the acute and chronic effects are different, accounting for them is difficult, particularly when change in GFR is the outcome. Here, we investigated the involvement of Ang II/AT1R and losartan in CaOx stone formation. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Sign In to Email Alerts with your Email Address. 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. In the microalbuminuria group, the HR for developing macroalbuminuria was 0.68 (95% CI 0.40–1.18). no. This approach permitted us to estimate whether a participant who missed scheduled visits and did not reach the primary GFR outcome by their last examination would have done so if they had remained under observation. 222–231 Losartan-sensitive renal damage caused by chronic NOS inhibition does not involve increased renal angiotensin II concentrations A. MARJAN G. VERHAGEN, BRANKO BRAAM, PETER BOER, HERMANN-JOSEF GRO¨NE, HEIN A. KOOMANS, and JAAP A. JOLES Department of Nephrology, University Hospital Utrecht, The Netherlands, and the Department of … Cumulative HRs and 95% CIs for the primary GFR outcome at trial closeout and each year of the posttrial follow-up (bottom panel). NIH Subsequent follow-up was considered posttrial follow-up. R.G.N. Losartan is an angiotensin II receptor blocker (ARB). A similar reduction in incidence and progression of nephropathy with prior tight glycemic control was reported in type 2 diabetes by the UK Prospective Diabetes Study (UKPDS), many years after the conclusion of the clinical trial itself (3). At the end of the 6-year trial, 111 participants agreed to a kidney biopsy to determine the effect of losartan on glomerular structure. The median follow-up to the primary GFR outcome was 12.8 years (interquartile range 8.2–16 years). Further, losartan is FDA-approved to treat kidney damage in people who have type 2 diabetes, a condition that occurs when the body does not use insulin effectively and blood glucose (sugar) rises too high. 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). Renal effects of angiotensin I-receptor blockade and angiotensin convertase inhibition in man. More information is available at http://www.diabetesjournals.org/content/license. Although exposure of those in the placebo arm to these additional agents was low, the study ultimately examined efficacy of losartan versus standard care, and this change may have reduced the magnitude of any long-term treatment effect. Although the cumulative HR increased initially following completion of the clinical trial, it then began to decline again, but remained not statistically significant during the follow-up period. Duality of Interest. Before taking losartan, let your physician know if you have heart disease, liver disease, or diabetes. Progression to macroalbuminuria (ACR ≥300 mg/g) was examined as a secondary outcome. As no significant interaction was found between treatment assignment and albuminuria group (P = 0.20), the overall treatment effect was estimated. To account for the acute effects of initiating treatment with RAS inhibitors, GFR measured at each research examination, conducted either during or after the clinical trial at which the participant was treated with a RAS inhibitor, was adjusted upward by 3.75% as described previously (9). The estimated date of onset of the primary GFR outcome was then imputed for all participants from the GFR slope. HRs (95% CI) for the effect of early treatment with losartan on long-term outcomes in each baseline albuminuria stratum and for the combined strata. The effects of angiotensin II receptor blockade with losartan on systemic blood pressure and renal and extrarenal prostaglandin synthesis in women with essential hypertension. In this study, we report results from analyses that include the posttrial period. Liver damage, known as fibrosis, is caused by the unwanted accumulation of excess fibrous connective tissue which is produced and maintained by a specialised cell, the liver myofibroblast. 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). The advantages of angiotensin II antagonism. Additional follow-up of this cohort is needed to determine the long-term effect of early treatment on the risk of ESRD or death. Doctors prescribe it to treat hypertension and nephropathy, which is damage … Each participant provided written informed consent. In participants who progressed to ESRD without a GFR measurement indicating that they had reached the GFR outcome, a GFR of zero was assigned as of the date of onset of renal replacement therapy. Our study highlights the need for larger studies and long-term follow-up to evaluate the renoprotective efficacy of RAS inhibitors in persons with early diabetic kidney disease or with no clinically apparent kidney disease if currently accepted outcomes are used. Blood pressure was measured while the participant was seated. Smith MC, Barrows S, Meibohm A, Shahinfar S, Simpson RL, Weigel K, Dunn MJ. Losartan potassium is a type of angiotensin receptor blocker (ARB) known by the brand name Cozaar. Losartan which contains potassium can help kidney disease patients lower their high blood pressure effectively, which will be good for kidney disease patients. Death occurred in 58 participants (32 were randomized to placebo and 26 to losartan) and in 11 was preceded by ESRD. Losartan belongs to the angiotensin II receptor antagonists group of drugs. However, exposure to antihypertensive drugs in the placebo group during the clinical trial was limited to 20% of the total person-time. Where an interaction was present, results were reported separately by baseline albuminuria status. © 2016 by the American Diabetes Association. 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. Other treatment was provided by the primary care physician. Enter multiple addresses on separate lines or separate them with commas. Nakamura M, Sasai N, Hisatome I, Ichida K. Clin Pharmacol. 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). It prevents the blood vessels in your body from narrowing, thus lowering your blood pressure and improving the blood circulation. and K.M.W. 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. Mean arterial pressure (MAP) was calculated as (2× diastolic blood pressure + systolic blood pressure)/3. Epub 2012 Dec 24. This study was approved by the Institutional Review Board of the National Institute of Diabetes and Digestive and Kidney Diseases. The study is created by eHealthMe based on reports of 28,684 people who have side effects when taking Losartan potassium from the FDA, and is updated regularly. Although the number of ESRD events was insufficient for informative analyses, the HR for death in those receiving losartan versus placebo was 0.79 (95% CI 0.47–1.32) and for either ESRD or death was 0.88 (95% CI 0.56–1.40). It works by blocking a substance in the body that causes blood vessels to tighten. The lack of a statistically significant reduction in early kidney disease progression in the current study suggests that combined beneficial effects of RAS inhibition in early diabetic kidney disease are, at best, modest. Epub 2013 Sep 24. Vital status and development of ESRD were ascertained in all study participants through 31 December 2015. An interaction term between treatment assignment and baseline albuminuria group was included to test whether the relationship between treatment and outcomes differed by baseline albuminuria status. 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.  |  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). ESRD was defined by the initiation of renal replacement therapy or death from diabetic kidney disease if the participant refused dialysis. Increase of ROS and NADPH oxidase gives rise to inflammation and injury of renal tubular cells, which promotes CaOx stone formation. For outcomes determined independently of the annual research examinations (ESRD and death), follow-up time accumulated from enrollment into the trial until the date of the event or 31 December 2015, whichever came first. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-0795/-/DC1. I … The 2-year follow-up interval was selected because it represented the median time interval between the last GFR measurement and the onset of ESRD in the study cohort. Likewise, Ang 1-7 as a physiologic antagonist of AT1 and losartan could possibly protect the kidney against I/R damage. Limitations of this study include its modest sample size, the small number of events, and the inclusion of participants from only a single center, which might limit the generalizability of the findings. Characteristics of the study population at the beginning of posttrial follow-up using data from the last examination of the clinical trial. Mol Biol Rep. 2013 Nov;40(11):6295-301. doi: 10.1007/s11033-013-2742-9. Of the 170 participants randomized in the clinical trial, one had no follow-up measurements and was excluded from analysis (7). Kidney International, Vol. When analyzed separately, the HR was 1.04 (95% CI 0.48–2.25) for the normoalbuminuria group and 0.56 (0.29–1.07) for the microalbuminuria group. 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). 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. An extended benefit of early intensive glycemic control on microvascular complications even after subsequent return to conventional glycemic control is well described. 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. Recent studies have revealed that the renin-angiotensin system might play a role in kidney crystallization and ROS production. NRK-52E cells were incubated with CaOx crystals, and glyoxylic acid-induced hyperoxaluric r… Losartan-sensitive renal damage caused by chronic NOS inhibition does not involve increased renal Ang II concentrations. Losartan is also used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. 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). contributed to the data collection and critical revision of the manuscript for intellectual content. Iothalamate concentration was measured in blood and urine samples by high-performance liquid chromatography (Waters, Milford, MA). Hypertension. When? Prior Presentation. OBJECTIVE: To compare the protective effects of resveratrol, gliclazide, and losartan, at biochemical and histopathological levels, on the rat kidney with experimentally induced type 1 diabetes. 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. Adjustment for the acute effects of RAS inhibitor use did not significantly alter the HR for the primary GFR outcome (HR 0.74 [0.46–1.21]). 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. One trial reported that treatment with losartan slowed the rate of estimated GFR decline in patients with macroalbuminuria (16), whereas another found that a reduction in the development of elevated albuminuria in irbesartan-treated patients with microalbuminuria was independently associated with reduced estimated GFR decline (17), but neither study demonstrated reduction in clinical outcomes such as ESRD. There was a significant difference in MAP by treatment group throughout the study period (P = 0.04), but not for HbA1c. 1,788 were here. 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). No potential conflicts of interest relevant to this article were reported. wrote the draft of the report and designed the clinical trial. G.D.F. This eMedTV page provides other warnings and precautions with losartan, including information on who should not take this drug. No interaction was found between treatment assignment and albuminuria group (P = 0.11). R.G.N. Combining Blood Pressure Drugs May Increase Kidney Damage Risk November 19, 2013 Written by: Martha Garcia 1 Comment; New research suggests that … 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. Losartan helps the kidneys in certain conditions like diabetes. Log-rank test for the GFR outcome yielded P = 0.28. Author Contributions. 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. However, as all the western medicines can cause side effects to people and losartan can also cause side effects to people. Which One to Give? Cumulative incidence of the first occurrence of the primary GFR outcome by treatment group (top panel). Hypertension. Annual mean ± SE of MAP and HbA1c by treatment group (dashed line, placebo; solid line, losartan). 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 … Am J Hypertens. Of those alive at the end of the clinical trial, 95% participated in the posttrial follow-up study. After 1-month losartan treatment, systolic and diastolic BP (SBP, DBP) decreased significantly throughout the 210-min recording whereas heart rate (HR) was unchanged. Participants were then followed posttrial for up to 12 years, with treatment managed outside the study. © 2021 by the American Diabetes Association. wrote the draft of the report. 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. Ultimately, in this underpowered study, it is difficult to disentangle whether our findings indicate no benefit of early RAS blockade on diabetic kidney disease or whether any benefit that may be present, particularly if small, was masked by the use of RAS inhibitors in the placebo group. 2. We examined the renal hemodynamic modifications induced by a selective angiotensin II (AII) AT1 receptor antagonist, losartan, in 10 patients with essential hypertension. Arnold AC, Okamoto LE, Gamboa A, Shibao C, Raj SR, Robertson D, Biaggioni I. This medication has the ability to lower the possible risk of a stroke in people suffering from any heart condition. The HR for the primary GFR outcome in those receiving losartan versus placebo was 0.72 (95% CI 0.44–1.18). 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. 1. 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. At enrollment, GFR averaged 165 mL/min (interquartile range 49–313 mL/min). Participants with type 2 diabetes who were randomized to tight blood pressure control with either captopril or atenolol in the UKPDS had a 29% reduction in risk of urinary albumin concentration ≥50 mg/L during the trial (5), but this effect was not sustained long term (6). Effects of irbesartan on serum uric acid levels in patients with hypertension and diabetes. It also improves your survival if you're taking it … 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. 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]). Dashed line, placebo; solid line, losartan. Losartan is a medicine widely used to treat high blood pressure and heart failure, and to protect your kidneys if you have both kidney disease and diabetes.. Losartan helps to prevent future strokes, heart attacks and kidney problems.. 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. Times to outcomes were compared by treatment group using Kaplan-Meier survival curves and the log-rank test. The Different Therapeutic Choices with ARBs. 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This medication has the ability to lower the risk of stroke in certain people with diabetic disease... Hba1C by treatment group using Kaplan-Meier survival curves and the serial HRs are presented in Fig those at. The GFR outcome and on progression to macroalbuminuria throughout the study period compared...

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