Patient Management Guidelines: Metformin And Iv Iodinated Contrast
The ACR recently updated its policy on Metformin use and iodinated contrast. We are therefore updating our policy and the information distributed to patients. This note is to communicate this change with our patient care providers. Soon after introduction of Metformin in the mid 90’s, several cases of lactic acidosis after administration of Iodinated contrast were reported. This resulted in guidelines requiring a 48 hour suspension of Metformin after the contrast study. Additionally providers were to check creatinine levels prior to resuming Metformin for these patients. These guidelines are now being relaxed. Recent studies have shown that the risk of lactic acidosis is nonexistent in patients with normal renal function. As a result the ACR recommends the following management strategy for patients taking Metformin and needing an IV contrast enhanced imaging study (i.e. CT, IVP, angiography): Category 1: Normal renal function (eGFR > 45) and no comorbidities*: No need to discontinue Metformin or check creatinine after the study. Category 2: Normal renal function (eGFR > 45) and comorbidities*: Withhold Metformin for 48 hours. Patient should communicate with their doctor prior to restarting Metformin. The clinician may elect observation, serum creatinine measurement, and/or hydration to ensure stable renal function. A follow-up serum creatinine measurement after the study is not required in the absence of recent risk factors for renal damage. (i.e. nephrotoxic drugs) Category 3: Impaired renal function (eGFR < 45): Metformin should be suspended at the time of contrast administration and cautious follow-up of renal function should be performed until safe reinstitution of Metformin can be assured. *Comorbidities: · Liver dysfunction · Alcohol abuse · Cardia Continue reading >>
Metformin Dosage
Usual Adult Dose for Diabetes Type 2 Immediate-release: Initial dose: 500 mg orally twice a day or 850 mg orally once a day Dose titration: Increase in 500 mg weekly increments or 850 mg every 2 weeks as tolerated Maintenance dose: 2000 mg daily in divided doses Maximum dose: 2550 mg/day Extended-release: Initial dose: 500 to 1000 mg orally once a day Dose titration: Increase in 500 mg weekly increments as tolerated Maintenance dose: 2000 mg daily Maximum dose: 2500 mg daily Comments: -Metformin, if not contraindicated, is the preferred initial pharmacologic agent for treatment of type 2 diabetes mellitus. -Immediate-release: Take in divided doses 2 to 3 times a day with meals; titrate slowly to minimize gastrointestinal side effects. In general, significant responses are not observed with doses less than 1500 mg/day. -Extended-release: Take with the evening meal; if glycemic control is not achieved with 2000 mg once a day, may consider 1000 mg of extended-release product twice a day; if glycemic control is still not achieve, may switch to immediate-release product. Use: To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. Usual Pediatric Dose for Diabetes Type 2 10 years or older: Immediate-release: Initial dose: 500 mg orally twice a day Dose titration: Increase in 500 mg weekly increments as tolerated Maintenance dose: 2000 mg daily Maximum dose: 2000 mg daily Comments: Take in divided doses 2 to 3 times a day with meals. Titrate slowly to minimize gastrointestinal side effects. Safety and effectiveness of metformin extended-release has not been established in pediatric patients less than 18 years of age. Use: To improve glycemic control in children with type 2 diabetes mellitus as an adjunct to diet and exercise. Le Continue reading >>
Metformin And Renal Function
etformin is first-line therapy for the management of type 2 diabetes mellitus, based on the American Diabetes Association and American College of Clinical Endocrinology guidelines. Unless there is a contraindication, metformin should be considered part of a patient’s regimen for type 2 diabetes mellitus. A controversial contraindication for metformin is renal disease or dysfunction. Absolute cut-offs in serum creatinine has been published as times to discontinue metformin therapy (≥1.4 mg/dL for women; ≥1.5 mg/dL for men). Lipska KL, et al, published recommendations for metformin among patients with mild to moderate renal dysfunction. This publication has been used in clinical practice to support “relaxed” dosing of metformin. Based on this publication in Diabetes Care (2011), the following recommendations were suggested: For patients with estimated glomerular filtration rate (eGFR) above 60, then metformin can be continued and renal function should be monitored on an annual basis. For patients with eGFR between 45 and 60, then metformin can be continued but the frequency of monitoring increases to every 3 or 6 months. For patients with eGFR between 30 and 45, there are several options depending on the individual. These options include lowering the dose by 50%; increasing the monitoring of renal function; or discontinuing metformin. For patients with a baseline eGFR 30 and 45, metformin should not be initiated. For patients with eGFR less than 30, then metformin should be stopped (if prescribed) or not initiated (if considered for new patients). As diabetes educators, it is essential to check package inserts and/or drug references for the method (CrCl or eGFR) to assess renal function and appropriate dose adjustments. On Friday, April 8, the Food and Drug Admi Continue reading >>
Using Metformin In The Presence Of Renal Disease
In January, the electronic Medicines Compendium (eMC) updated the Summary of Product Characteristics for Glucophage (metformin), approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The summary states that “Metformin may be used in patients with moderate renal impairment, stage 3a (creatinine clearance [CrCl] 45-59 mL/min or estimated glomerular filtration rate [eGFR] 45-59 mL/min/1.73 m2) only in the absence of other conditions that may increase the risk of lactic acidosis . . . If CrCl or eGFR fall <45 mL/min or <45 mL/min/1.73 m2 respectively, metformin must be discontinued immediately.”1 This is reiterated in the patient information leaflet. Interestingly, the summary for generic metformin states that “Renal failure or renal dysfunction (creatinine clearance <60 ml/min)” is a contraindication to use. In the face of burgeoning levels of type 2 diabetes and associated renal disease, we believe that this restriction is too conservative and will deny an important drug to many thousands of people with diabetes who … Continue reading >>
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As you were browsing PracticeUpdate, something about your browser made us think you were a bot. There are a few reasons this might happen: You're a power user moving through this website with super-human speed. You've disabled JavaScript in your web browser. A third-party browser plugin, such as Ghostery or NoScript, is preventing JavaScript from running. Additional information is available in this . After completing the CAPTCHA below, you will immediately regain access to PracticeUpdate. You reached this page when attempting to access from 35.226.183.143 on 2018-01-06 18:18:13 UTC. Trace: 8d3497e3-c874-476e-b444-70710053403c via f142fe30-0da7-428a-92b2-8a74e399b4ec Continue reading >>
Fda Issues Guidance For Metformin Use In Renal Impairment
Chris Tanski received his PharmD from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences and is now working as a clinical staff pharmacist for Pinnacle Health in Harrisburg, Pennsylvania. He entered the field of hospital pharmacy directly from school, and he was one of the first to pilot a decentralized pharmacist role in the hospital. His other notable work contributions include working on palliative projects and transition of care for COPD patients. Chris was an editor and contributor to a film theory blog, a sketch comedy writer throughout pharmacy school, and he has a significant amount of experience writing drug information papers on neurology and infectious disease topics for both school and work. The FDA has issued new guidance for the use of the first-line diabetes drug metformin in patients with renal impairment. Metformin was approved by the FDA in 1994 for the management of type 2 diabetes. Since its approval, its labeling has warned of a contraindication in elevated serum creatinine (>1.5 mg/dL for males, >1.4 mg/dL for females) due to a risk of lactic acidosis secondary to metformin accumulation.1 Other risk factors for lactic acidosis include contrast dye exposure within 48 hours, chronic or excessive alcohol intake, dehydration, sepsis, acute congestive heart failure, and age. This absolute contraindication was based on clinical trials of an older biguanide called phenformin, which showed a greater risk of lactic acidosis associated with significant mortality and was subsequently pulled off the market in 1977.2 Although phenformin is no longer available in the United States, it’s still available in European and South American markets. Notably, the incidence of lactic acidosis associated with metformin is as low as 0.03 cases per 10 Continue reading >>
Iodinated Contrast Media Guideline
THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS® FACULTY OF CLINICAL RADIOLOGY Iodinated Contrast Media Guideline Faculty of Clinical Radiology Guideline Name of document and version: Iodinated Contrast Media Guideline, 2016 Edition Approved by: Faculty of Clinical Radiology Date of approval: 15 February 2017 Suggested Citation: The Royal Australian and New Zealand College of Radiologists. Iodinated Contrast Media Guideline. Sydney: RANZCR; 2016. ABN 37 000 029 863 Copyright for this publication rests with The Royal Australian and New Zealand College of Radiologists ® The Royal Australian and New Zealand College of Radiologists Level 9, 51 Druitt Street Sydney NSW 2000 Australia Email: [email protected] Website: www.ranzcr.edu.au Telephone: +61 2 9268 9777 Facsimile: +61 2 9268 9799 Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and his/her doctor. Iodinated Contrast Media Guideline, 2016 Version © The Royal Australian and New Zealand College of Radiologists® February 2017 Page 2 of 39 Document name Iodinated Contrast Media Guideline Description The Iodinated Contrast Media Guideline is intended to assist The Royal Australian and New Zealand College of Radiologists®, its staff, Fellows, members and other individuals involved in the administration of iodinated contrast media to patients undergoing medical imaging procedures. Created By Standards of Practice and Accreditation Committee Date Created 2011 Maintained By Faculty of Clinical Radiology, Policy and Advocacy Unit Version Number Modifications Made Date Modified 2011 Document published 2.1 Grammatical Continue reading >>
Risks Of Metformin In Type 2 Diabetes And Chronic Kidney Disease: Lessons Learned From Taiwanese Data
Abstract Like other biguanide agents, metformin is an anti-hyperglycemic agent with lower tendency towards hypoglycemia compared to other anti-diabetic drugs. Given its favorable effects on serum lipids, obese body habitus, cardiovascular disease, and mortality, metformin is recommended as the first-line pharmacologic agent for type 2 diabetes in the absence of contraindications. However, as metformin accumulation may lead to type B non-hypoxemic lactic acidosis, especially in the setting of kidney injury, chronic kidney disease, and overdose, regulatory agencies such as the United States Food and Drug Administration (FDA) have maintained certain restrictions regarding its use in kidney dysfunction. Case series have demonstrated a high fatality rate with metformin-associated lactic acidosis (MALA), and the real-life incidence of MALA may be underestimated by observational studies and clinical trials that have excluded patients with moderate-to-advanced kidney dysfunction. A recent study of advanced diabetic kidney disease patients in Taiwan in Lancet Endocrinology and Diabetes has provided unique insight into the potential consequences of unrestricted metformin use, including a 35% higher adjusted mortality risk that was dose-dependent. This timely study, as well as historical data documenting the toxicities of other biguanides, phenformin and buformin, suggest that the recent relaxation of FDA recommendations to expand metformin use in patients with kidney dysfunction (i.e., those with estimated glomerular filtration rates ≥30 instead of our recommended ≥45 ml/min/1.73 m2) may be too liberal. In this article, we will review the history of metformin use; its pharmacology, mechanism of action, and potential toxicities; and policy-level changes in its use over time. Continue reading >>
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Metformin In Chronic Kidney Disease: Time For A Rethink
Go to: The Case Against Metformin The main problem with metformin is its association with LA. Lactic acidosis is defined as an arterial lactate of > 5 mmol/L and a blood pH ≤ 7.35 (1,2). There are two forms of LA. Type A is anaerobic LA caused by lactate overproduction in order to regenerate adenosine triphosphate (ATP) in the absence of oxygen, and is usually seen in the presence of circulatory collapse, e.g. heart failure, sepsis, and shock. Type B, the aerobic version, is caused by underutilization of lactate due to impaired removal by oxidation or gluconeogenesis, and is the type seen in liver disease, diabetes, cancer, and alcohol and metformin intoxication. Combinations of Type A & B are possible. The therapeutic trough level for metformin is 0.7 (0.3-1.0) mg/L (3) (for μmol/L, multiply by 7.75). The pragmatic upper therapeutic limit is 5 mg/L (4). There is no doubt that metformin in toxic doses is a cause of LA. In rats, plasma lactate begins to rise if the metformin concentration is > 20 mg/L (5). Intentional metformin overdose usually leads to hyperlactemia (6), and often to LA. This can be fatal in cases with plasma metformin > 50 mg/L (7). Some cases are accompanied by a raised creatinine. Since the most common symptom of metformin intoxication is vomiting and diarrhea, it is possible that the reduced renal function is caused by prerenal dehydration and/or circulatory collapse. Metformin is renally excreted (8,9), with a clearance approximately linearly correlated to glomerular filtration rate (GFR). There are thus two situations where metformin intoxication can occur: failure to reduce the dose in the presence of CKD, and acute uremia. It is possible that a vicious cycle can develop with acute uremia causing metformin accumulation leading to vomiting, deh Continue reading >>
Clinical Research Extending Metformin Use In Diabetic Kidney Disease: A Pharmacokinetic Study In Stage 4 Diabetic Nephropathy
Metformin use in advanced chronic kidney disease is controversial. This study sought to examine the pharmacokinetics, safety, and efficacy of low-dose metformin in patients with type 2 diabetes and stage 4 chronic kidney disease. In this open-label, phase I trial, 3 consecutive cohorts (1, 2, and 3) of 6 patients each were recruited to receive 250-, 500-, or 1000-mg once-daily doses of metformin, respectively. All patients underwent a first-dose pharmacokinetic profile and weekly trough metformin concentrations for the duration of 4 weeks of daily therapy. Prespecified clinical and biochemical safety endpoints of serum bicarbonate, venous pH, and serum lactate were assessed weekly. Efficacy was assessed by pre- and post-HbA1c and 72-hour capillary glucose monitoring. There was no evidence of accumulation of metformin in any cohort. There were no episodes of hyperlactatemia or metabolic acidosis and no significant change in any biochemical safety measures. Median (interquartile range) observed trough concentrations of metformin in cohorts 1, 2, and 3 were 0.083 (0.121) mg/l, 0.239 (0.603) mg/l, and 1.930 (3.110) mg/l, respectively. Average capillary glucose concentrations and mean HbA1c decreased in all cohorts. In our patient cohorts with diabetes and stage 4 chronic kidney disease, treatment with 4 weeks of low-dose metformin was not associated with adverse safety outcomes and revealed stable pharmacokinetics. Our study supports the liberalization of metformin use in this population and supports the use of metformin assays for more individualized dosing. Continue reading >>
Could Metformin Be Used In Patients With Diabetes And Advanced Chronic Kidney Disease?
Abstract Diabetes is an important cause of end stage renal failure worldwide. As renal impairment progresses, managing hyperglycaemia can prove increasingly challenging, as many medications are contra-indicated in moderate to severe renal impairment. Whilst evidence for tight glycaemic control reducing progression to renal failure in patients with established renal disease is limited, poor glycaemic control is not desirable, and is likely to lead to progressive complications. Metformin is a first-line therapy in patients with Type 2 diabetes, as it appears to be effective in reducing diabetes related end points and mortality in overweight patients. Cessation of metformin in patients with progressive renal disease may not only lead to deterioration in glucose control, but also to loss of protection from cardiovascular disease in a cohort of patients at particularly high risk. We advocate the need for further study to determine the role of metformin in patients with severe renal disease (chronic kidney disease stage 4-5), as well as patients on dialysis, or pre-/peri-renal transplantation. We explore possible roles of metformin in these circumstances, and suggest potential key areas for further study. Continue reading >>
Fda Drug Safety Communication: Fda Revises Warnings Regarding Use Of The Diabetes Medicine Metformin In Certain Patients With Reduced Kidney Function
[ 4-8-2016 ] The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. We were asked1,2 to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function,3-14 and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin. We have concluded our review, and are requiring changes to the labeling of all metformin-containing medicines to reflect this new information. Health care professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Patients should talk to their health care professionals if they have any questions or concerns about taking metformin. Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs used to treat diabetes (see FDA Approved metformin-containing Medicines). The current drug labeling strongly recommends against metformin use in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially dead Continue reading >>
Metformin In Advanced Chronic Kidney Disease: Are Current Guidelines Overly Restrictive?
Nicholas I Cole, Pauline A Swift, Rebecca J Suckling, Peter A Andrews South West Thames Renal Department, Epsom and St Helier University Hospitals, Surrey, UK Address for correspondence: Dr Nicholas Cole Renal Department, St Helier Hospital, Wrythe Lane, Carshalton, Surrey SM5 1AA, UK Tel: +44 (0)7758217166 Fax: +44 (0)2082962857 E-mail: [email protected] Abstract Type 2 diabetes mellitus and chronic kidney disease (CKD) frequently co-exist and the increasing burden of both conditions is a global concern. Metformin is established as the first-line treatment for type 2 diabetes because it is associated with improved cardiovascular outcomes and a reduced risk of hypoglycaemia compared with other treatment options. Patients with CKD may benefit in particular because they are at high risk of both cardiovascular disease and hypoglycaemic episodes. However, the use of metformin is restricted in this population due to the concerns over lactic acidosis. Recent reviews have evaluated this risk and concluded that current guidelines for prescribing metformin in CKD may be too restrictive. This narrative review considers this evidence further, but also examines the strength of evidence that favours the use of metformin in CKD patients. Key words: type 2 diabetes mellitus, chronic kidney disease, metformin, biguanides, lactic acidosis, lactate, cardiovascular disease, hypoglycaemia Introduction Chronic kidney disease (CKD) commonly co-exists with diabetes mellitus; the estimated prevalence of Kidney Disease Outcomes Quality Initiative (KDOQI) stage 3–5 CKD in the UK for those with diabetes is 31%.1 Diabetic nephropathy is the most common attributed cause of end-stage renal disease (ESRD) in those starting dialysis in the UK, with an incidence of 25.4%.2 Overt diabetic nephropat Continue reading >>
Glycaemic Control After Metformin Discontinuation In Diabetic Patients With A Declining Renal Function
Copyright © 2017 Theresa Leyco et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Metformin is contraindicated in diabetic patients with declining renal function. This study examined the glycaemic control in diabetic patients with chronic kidney disease when metformin was discontinued. This was a retrospective study. We screened 2032 diabetic patients who attended the Diabetes Clinic at a tertiary hospital between 1 September 2014 and 30 September 2015. We analyzed the data on 69 patients whom metformin was discontinued due to declining renal function and had a complete 6-month follow-up. There was no significant difference in the HbA1c and body weight at 6-month follow-up compared to baseline after metformin discontinuation. The eGFR was significantly lower at 6-month follow-up compared to baseline. Upon metformin discontinuation, the majority of patients had their diabetes medication uptitrated (in particular insulin or sulphonylurea). Patients with an improved glycaemia at 6-month follow-up had further declined in eGFR compared to patients with worsened glycaemia. 17% of the study patients experienced hypoglycaemia. Upon metformin discontinuation, glycaemic control could be optimised with uptitration but should be balanced against the risk of hypoglycaemia. Further improvement in the glycaemic control might indicate further deterioration in the renal function. 1. Introduction The rising prevalence of type 2 diabetes mellitus (T2DM) is considered one of the most challenging public health problems. More than 400 million people will be affected by T2DM by the year 2030, with the greatest increase expe Continue reading >>
In Brief: New Recommendations For Use Of Metformin In Renal Impairment
The FDA has required labeling changes that replace serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) as the parameter used to determine the appropriateness of treatment with the biguanide metformin (Glucophage, and others) in patients with renal impairment. These changes will allow more patients with mild to moderate renal impairment to receive metformin, which is generally the first drug prescribed for treatment of type 2 diabetes. Metformin was previously contraindicated in women with a SCr level ≥1.4 mg/dL and in men with a SCr level ≥1.5 mg/dL, but use of SCr as a surrogate indicator tends to underestimate renal function in certain populations (e.g., younger patients, men, black patients, patients with greater muscle mass). The calculation of eGFR takes into account age, race, and sex, as well as SCr level, providing a more accurate assessment of kidney function. A literature review summarized in an FDA Drug Safety Communication concluded that, based on eGFR, metformin is safe to use in patients with mild renal impairment and in some patients with moderate renal impairment.1 The eGFR should be calculated before patients begin treatment with metformin and at least annually thereafter. Metformin is now contraindicated in patients with an eGFR <30 mL/min/1.73 m2, and starting treatment with the drug in patients with an eGFR between 30 and 45 mL/min/1.73 m2 is not recommended. If the eGFR falls below 45 mL/min/1.73 m2 in a patient already taking metformin, the benefits and risks of continuing treatment should be assessed. Metformin should be not be administered for 48 hours after an iodinated contrast imaging procedure in patients with an eGFR <60 mL/min/1.73 m2 or a history of liver disease, alcoholism, or heart failure, or in those receiving Continue reading >>
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