OBJECTIVE To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. 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. All analyses were based on intention-to-treat principles. 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. It is also used to treat kidney problems in patients with type 2 diabetes and a history of hypertension. 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. 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. NLM 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. Annual mean ± SE of MAP and HbA1c by treatment group (dashed line, placebo; solid line, losartan). 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. Smith MC, Barrows S, Meibohm A, Shahinfar S, Simpson RL, Weigel K, Dunn MJ. Impact of irbesartan, an angiotensin receptor blocker, on uric acid level and oxidative stress in high-risk hypertension patients. HRs for the various outcomes in each baseline albuminuria stratum and for the combined strata are shown in Table 2. 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). 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. 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. 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). Clipboard, Search History, and several other advanced features are temporarily unavailable. Hypertension. Using losartan with NSAIDs raises your risk of kidney damage. Losartan reverses glomerular podocytes injury induced by AngII via stabilizing the expression of GLUT1. The proportionality assumption was met by each covariate. Which One to Give? Hazard ratios (HRs) were computed using Cox proportional hazards regression. Losartan is used to treat high blood pressure (hypertension). This study was approved by the Institutional Review Board of the National Institute of Diabetes and Digestive and Kidney Diseases. The official page of the U.S. Food and Drug Administration. Thank you for your interest in spreading the word about Diabetes Care. 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. The main strengths of this study include the use of measured GFR and the long follow-up period. It is also used to lower the risk of stroke in certain people with heart disease. As no significant interaction was found between treatment assignment and albuminuria group (P = 0.20), the overall treatment effect was estimated. Annual mean MAP and HbA1c are shown by treatment group assignment in Fig. performed the statistical analysis. 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-sensitive renal damage caused by chronic NOS inhibition does not involve increased renal Ang II concentrations. However, exposure to antihypertensive drugs in the placebo group during the clinical trial was limited to 20% of the total person-time. Other treatment was provided by the primary care physician. 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 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. All authors contributed to the revision of the paper and approved the final version. Cumulative HRs and 95% CIs for the primary GFR outcome at trial closeout and each year of the posttrial follow-up (bottom panel). After 1-month losartan treatment, systolic and diastolic BP (SBP, DBP) decreased significantly throughout the 210-min recording whereas heart rate (HR) was unchanged. Losartan potassium is a type of angiotensin receptor blocker (ARB) known by the brand name Cozaar. Urine albumin concentrations below the detection limit of the assay (≤6.8 mg/L) were set to 6.8 mg/L in the analyses. 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. This eMedTV page provides other warnings and precautions with losartan, including information on who should not take this drug. Subsequent follow-up was considered posttrial follow-up. HbA1c was also measured by high-performance liquid chromatography (Tosoh, Tokyo, Japan). Would you like email updates of new search results? 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. 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). 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). In conclusion, we want pointed out that losartan could affect renal function in a similar way as angiotensin converting enzyme inhibitors (ACEI). 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. OBJECTIVE To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. 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. Your risk may be higher if: you have poor kidney function; are a senior; take a water pill; are dehydrated Epub 2015 Jul 16. 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. Progression to macroalbuminuria (ACR ≥300 mg/g) was examined as a secondary outcome. Besides, because the medicine contains potassium, which will be harmful for kidney disease patients who have high potassiu… 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 median follow-up time to development of macroalbuminuria was 10.1 years (interquartile range 3.3–15.6 years). Clin Sci (Lond). USA.gov. The cumulative incidence for the primary GFR outcome and the serial HRs are presented in Fig. Arnold AC, Okamoto LE, Gamboa A, Shibao C, Raj SR, Robertson D, Biaggioni I. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-0795/-/DC1. Increase of ROS and NADPH oxidase gives rise to inflammation and injury of renal tubular cells, which promotes CaOx stone formation. No interaction was found between treatment assignment and albuminuria group (P = 0.11). 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..  |  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. 11. Although cozaar is harmful for kidney to some extent, it does not mean all the kidney disease patients should stay far away from this medication. 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. Losartan is also used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Given the apparent structural preservation associated with early losartan treatment, we hypothesized that early treatment would provide an extended benefit in reducing the risk of GFR decline in diabetic kidney disease, similar to that observed for early intensive glycemic control. 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). R.G.N. Chida R, Hisauchi I, Toyoda S, Kikuchi M, Komatsu T, Hori Y, Nakahara S, Sakai Y, Inoue T, Taguchi I. Hypertens Res. 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. Participants were then followed posttrial for up to 12 years, with treatment managed outside the study. 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). More information is available at http://www.diabetesjournals.org/content/license. Losartan belongs to the angiotensin II receptor antagonists group of drugs. During the trial and posttrial follow-up, 29 participants randomized to losartan and 35 to placebo reached the primary GFR outcome. Blocking angiotensin II widens (dilates) blood vessels which lowers blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney … I … Why?  |  Mol Biol Rep. 2013 Nov;40(11):6295-301. doi: 10.1007/s11033-013-2742-9. At enrollment, GFR averaged 165 mL/min (interquartile range 49–313 mL/min). The effects of angiotensin II receptor blockade with losartan on systemic blood pressure and renal and extrarenal prostaglandin synthesis in women with essential hypertension. Likewise, Ang 1-7 as a physiologic antagonist of AT1 and losartan could possibly protect the kidney against I/R damage. Characteristics of the study population at the beginning of posttrial follow-up using data from the last examination of the clinical trial. Losartan is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. 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.  |  It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548. P.-J.S. Vital status and development of ESRD were ascertained in all study participants through 31 December 2015. Lowering blood pressure may reduce the risk of strokes and heart attacks. It is also used to lower the risk of stroke in certain people with heart disease. Recent studies have revealed that the renin-angiotensin system might play a role in kidney crystallization and ROS production. Dashed line, placebo; solid line, losartan. Epub 2012 Dec 24. In the current study, longer follow-up attenuated these HRs, so that neither effect was statistically significant. We examined the renal hemodynamic modifications induced by a selective angiotensin II (AII) AT1 receptor antagonist, losartan, in 10 patients with essential hypertension. We do not capture any email address. Additional follow-up of this cohort is needed to determine the long-term effect of early treatment on the risk of ESRD or death. In people with high blood pressure, the most common side effects of losartan include dizziness, stuffy nose, and back pain. 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). 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). 1,788 were here. ESRD was defined by the initiation of renal replacement therapy or death from diabetic kidney disease if the participant refused dialysis. Funding. MAP and HbA1c throughout the study period were compared between treatment groups using mixed models to account for serial correlations over time. After up to 12 additional years of follow-up, 64 participants reached the primary GFR outcome—35 originally randomized to placebo and 29 to losartan—and the HR was 0.72 (95% CI 0.44–1.18). 1993 Sep;22(3):339-47. doi: 10.1161/01.hyp.22.3.339. 2016 Aug;16(4):255-266. doi: 10.1007/s40256-016-0165-4. 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. Alternative end points, such as structural end points from kidney biopsies, may be required to demonstrate renoprotection in early diabetic kidney disease. Upon trial completion, the study drug was no longer supplied. RESULTS After completion of the clinical trial, treatment with renin-angiotensin system inhibitors was equivalent in both groups. This medication has the ability to lower the possible risk of a stroke in people suffering from any heart condition. Salt-dependent renal effects of an angiotensin II antagonist in healthy subjects. At baseline, 92 participants had normoalbuminuria (albumin/creatinine ratio [ACR] <30 mg/g) and 78 had microalbuminuria (ACR 30 to <300 mg/g). NCT00340678, clinicaltrials.gov. The current consensus, based on several clinical trials, is that RAS inhibition provides no benefit for primary prevention in normoalbuminuric, normotensive patients with diabetes and may actually lead to harm (18). 1996 Mar;90(3):205-13. doi: 10.1042/cs0900205. © 2016 by the American Diabetes Association. Each participant provided written informed consent. and K.M.W. 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. The median follow-up to the primary GFR outcome was 12.8 years (interquartile range 8.2–16 years). 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. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. Combining Blood Pressure Drugs May Increase Kidney Damage Risk November 19, 2013 Written by: Martha Garcia 1 Comment; New research suggests that … 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). Kidney damage is one of several reported risks and side effects for statins. 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). The Different Therapeutic Choices with ARBs. It works by blocking a substance in the body that causes blood vessels to tighten. Twenty-six participants progressed to ESRD during follow-up (11 were randomized to placebo and 15 to losartan). Am J Cardiovasc Drugs. R.L.H., W.C.K., and P.H.B. 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. 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. An extended benefit of early intensive glycemic control on microvascular complications even after subsequent return to conventional glycemic control is well described. 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. 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. 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]). Epub 2013 Sep 24. Eighty-six participants developed macroalbuminuria (Supplementary Fig. 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. Losartan helps the kidneys in certain conditions like diabetes. Adjustment for age, sex, diabetes duration, MAP, GFR, and ACR did not significantly alter our results (HR 0.88 [95% CI 0.52–1.48]). 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. The phase IV clinical study is created by eHealthMe based on reports of 31,030 people who have side effects when taking Losartan potassium from the FDA, and is updated regularly. In this study, we report results from analyses that include the posttrial period. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Please enable it to take advantage of the complete set of features! 2014 May 3;6:79-86. doi: 10.2147/CPAA.S61462. Where an interaction was present, results were reported separately by baseline albuminuria status. Mean arterial pressure (MAP) was calculated as (2× diastolic blood pressure + systolic blood pressure)/3. Times to outcomes were compared by treatment group using Kaplan-Meier survival curves and the log-rank test. The effect of treatment on death or the combined end point of end-stage renal disease (ESRD) or death was also examined. 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). 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. Others include pain or weakness in the muscles, confusion, loss of memory, flushing, and rashes. 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). All participants who received a non-RAS inhibitor antihypertensive drug during the posttrial period also received a RAS inhibitor at some point posttrial. 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. Because the acute and chronic effects are different, accounting for them is difficult, particularly when change in GFR is the outcome. We hypothesize that losartan may protect against CIH-induced kidney injury, possibly by suppressing intrarenal RAS activation and subsequently by promoting renal vessel vasodilation. 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). 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