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Metformin Renal Dosing 2016

Metformin In The Treatment Of Adults With Type 2 Diabetes Mellitus

Metformin In The Treatment Of Adults With Type 2 Diabetes Mellitus

INTRODUCTION Two classes of oral hypoglycemic drugs directly improve insulin action: biguanides (only metformin is currently available) and thiazolidinediones (TZDs). In the absence of contraindications, metformin is considered the first choice for oral treatment of type 2 diabetes (table 1). A 2006 consensus statement from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), updated regularly, proposed that metformin therapy (in the absence of contraindications) be initiated, concurrent with lifestyle intervention, at the time of diabetes diagnosis [1-3]. The pharmacology, efficacy, and side effects of metformin for the treatment of diabetes will be reviewed here. A general discussion of initial treatment of type 2 diabetes and the role of metformin in the prevention of diabetes, in the treatment of polycystic ovary syndrome, and in gestational diabetes are reviewed separately. Continue reading >>

Could Metformin Be Used In Patients With Diabetes And Advanced Chronic Kidney Disease?

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 >>

How I Learned To Stop Worrying And Love Metformin

How I Learned To Stop Worrying And Love Metformin

How long should we allow metformin to remain the bogeyman in CKD? Should MALA scare us from ever letting our patients benefit from metformin? Join us as we discuss some rare prospective data on metformin in moderate to severe CKD. **Disclaimer- this study discusses off label use of metformin in later stage CKD. The discussion below is based upon the above paper and does not constitute a change in the product labeling. the current recommended use of metformin based upon kidney function is below. Metformin is a mainstay of treatment in pre-diabetes and diabetes.However, it lives with the sins of its predecessor, phenformin. Phenformin was discovered in the 50's and became a popular in the 60's. By the 70's it began to lose ground as knowledge of it tendency to cause lactic acidosis became wide spread. Phenformin was banned from the US in 1977 . It is still available in a handful of countries (Italy, Brazil, Uruguay, China, Poland, Greece and Portugal)and it sometimes slips into adulterated herbal medicines .Phenformin was estimated to cause 64 cases of lactic acdiosis per 100,000 patient-years. Metformin, the second biguanide, always lived with questions about its safety in patients with Chronic Kidney Disease (CKD). When first approved in 1994, the FDA restricted it from patients with CKD, due to lactic acidosis concern since metformin is largely excreted by the kidneys. Metformin associated lactic acidosis (MALA) is a feared and deadly condition. The FDA revised its warning on metformin and CKD in April 2016. Metformin remained contraindicated in patients with eGFR <30 ml/min/1.73m2.They advised that metformin not be started in patients with eGFR 30-45 ml/min/1.73m2, however if a patient was already on the drug and their eGFR decreased to this level, then the risks and Continue reading >>

Prescribing In Renal Disease

Prescribing In Renal Disease

The appropriate prescribing of many drugs depends on knowledge of the patient's total renal function, which is proportional to their body mass. The Cockcroft-Gault method of calculating creatinine clearance takes into account the patient's weight. The recently introduced estimated glomerular filtration rate, which is now routinely reported with biochemistry test results, is useful for screening for renal disease, but is unsuitable for calculating doses as it does not take into account the patient's size. Both are unreliable at extremes of weight. The list of medications that need dosage adjustment according to renal function is long, but includes commonly prescribed drugs such as antivirals, hypoglycaemic drugs (metformin, sulfonylureas, insulin), spironolactone and allopurinol. Introduction The clearance of many drugs and their metabolites depends on adequate renal function. Renal clearance is especially important for some drugs where the gap between efficacy and toxicity is narrow. Doses of these drugs need careful adjustment if they are prescribed for patients with impaired renal function. Some drugs also have the potential to cause renal toxicity. This is particularly likely to occur in patients who already have some degree of renal impairment, although other factors can increase the risk. Estimating renal function An accurate estimation of renal function, or glomerular filtration rate (GFR), requires sophisticated techniques that are unsuitable for routine or repeated use. In practice, the serum creatinine concentration is used for day-to-day assessment of renal function. It has limitations, but it remains a robust and practical parameter for most clinical situations. Serum creatinine The serum creatinine concentration has important limitations when used for estima Continue reading >>

Therapeutic Considerations For Renal Impairment

Therapeutic Considerations For Renal Impairment

Part A: Therapeutic considerations when using common therapies in patients with diabetes with varying degrees of renal impairment Antihyperglycemic Therapies CKD 1 & 2 eGFR ≥60 mL/min CKD 3 eGFR 30-59 mL/min CKD 4 eGFR 15-29 mL/min CKD 5 eGFR <15 mL/min or dialysis Comments Metformin No dose adjustment Reduce dose Use alternative agent See “Sick Day Medication List” (Appendix 7).Risk of drug accumulation with declining renal function, especially if acute. Alpha-glucosidase Inhibitor Acarbose No dose adjustment No dose adjustment Use alternative agent DPP4-Inhibitors Alogliptin No dose adjustment Lower dose to 12.5 mg daily (<50 mL/min) Use lowest dose (6.25 mg daily) Experience in patients with ESRD or on dialysis is limited. Use with caution in these patients. Linagliptin No dose adjustment required Experience in patients with ESRD or on dialysis is limited. Use with caution in these patients. Saxagliptin No dose adjustment Lower Dose 2.5 mg once daily (<50 mL/min) Use alternative agent Should not be used in patients on dialysis. Sitagliptin No dose adjustment Lower dose (50 mg daily) (30-49 mL/min) Use lowest dose (25 mg daily) Risk of accumulation. GLP-1 Receptor Agonists Albiglutide No dose adjustment required Use caution when initiating or escalating doses in patients with renal impairment Exenatide No dose adjustment Lower dose (5 mcg BID) Use alternative agent Liraglutide No dose adjustment Use alternative agent (<50 mL/min) Insulin Secretagogues Gliclazide No dose adjustment required Risk of hypoglycemia, consider lower dose Risk of hypoglycemia, consider alternative agent Glimepiride No dose adjustment required Risk of hypoglyce- mia, consider lower dose Max 1 mg daily, consider alternative agent Both pharmacokinetics and pharmacodynamics are altered, inc Continue reading >>

Metformin And Renal Function

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 >>

Support Article

Support Article

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 >>

Clinical Research Extending Metformin Use In Diabetic Kidney Disease: A Pharmacokinetic Study In Stage 4 Diabetic Nephropathy

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 >>

Fda Drug Safety Communication: Fda Revises Warnings Regarding Use Of The Diabetes Medicine Metformin In Certain Patients With Reduced Kidney Function

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 >>

Fda Issues Guidance For Metformin Use In Renal Impairment

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 >>

Metformin Use In Renal Impairment Extended

Metformin Use In Renal Impairment Extended

For patients with a creatinine clearance of 45–59ml/min or an eGFR of 45–59ml/min/1.73m2, the initial dose of metformin is 500mg or 850mg once daily in the morning with food. The maximum daily dose is 1g in two divided doses with monitoring of renal function every 3–6 months. This change to the prescribing information reflects the advice given in the NICE clinical guideline on the management of type II diabetes, namely that metformin can be used with caution in patients with renal impairment but the dose should be reviewed if the patient's eGFR drops below 45ml/min/1.73m2 and treatment discontinued if the eGFR drops below 30ml/min/1.73m2. The metformin drug entry in MIMS has been updated to reflect the current Glucophage SPCs. The MIMS drug listings for products containing metformin in combination with other drugs (eg, dipeptidyl peptidase 4 inhibitors, SGLT2 inhibitors, pioglitazone) will be updated when the updated SPCs become available. Prescribers should refer to the product SPCs to check if a combination product is suitable for an individual patient with renal impairment. Follow MIMS on Twitter Continue reading >>

Clinical Research Extending Metformin Use In Diabetic Kidney Disease: A Pharmacokinetic Study In Stage 4 Diabetic Nephropathy

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. Figure 2. Safety profile (venous lactate, bicarbonate, and pH) in all 3 cohorts across the study period. Venous lactate for patient 11 appears as a dotted line. Patients 2 and 19 commenced metformin therapy a few days Continue reading >>

Relaxed Renal Guidelines For Metformin

Relaxed Renal Guidelines For Metformin

SAGE Video Streaming video collections SAGE Knowledge The ultimate social sciences library SAGE Research Methods The ultimate methods library SAGE Stats Data on Demand CQ Library American political resources About Privacy Policy Terms of Use Contact Us Help Health Sciences Life Sciences Materials Science & Engineering Social Sciences & Humanities Journals A-Z Authors Editors Reviewers Librarians Researchers Societies Advertising Reprints Content Sponsorships Permissions ISSN: 2325-1603 Online ISSN: 2325-1611 Continue reading >>

Metformin - Nice Guidance Regarding Renal Function - General Practice Notebook

Metformin - Nice Guidance Regarding Renal Function - General Practice Notebook

metformin - NICE guidance regarding renal function start metformin treatment in a person who is overweight or obese (tailoring the assessment of body-weight-associated risk according to ethnic group ) and whose blood glucose is inadequately controlled by lifestyle interventions (nutrition and exercise) alone metformin should be considered as an option for first-line glucose-lowering therapy for a person who is not overweight metformin should be continued if blood glucose control remains or becomes inadequate and another oral glucose-lowering medication is added the dose of metformin should be stepped up gradually over weeks to minimise risk of gastro-intestinal (GI) side effects. Consider a trial of extended-absorption metformin tablets where GI tolerability prevents continuation of metformin therapy in adults with type 2 diabetes, review the dose of metformin if the estimated glomerular filtration rate (eGFR) is below 45 ml/minute/1.73m2: Stop metformin if the eGFR is below 30 ml/minute/1.73m2 Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of eGFR falling below 45ml/minute/1.73m2 benefits of metformin therapy should be discussed with a person with mild to moderate liver dysfunction or cardiac impairment so that: due consideration can be given to the cardiovascular-protective effects of the drug (1) an informed decision can be made on whether to continue or stop the metformin Continue reading >>

The Fda And The Ema Allow The Use Of Metformin In Patients With Moderate Renal Impairment

The Fda And The Ema Allow The Use Of Metformin In Patients With Moderate Renal Impairment

The FDA and the EMA allow the use of metformin in patients with moderate renal impairment Using metformin in the presence of renal disease BMJ 2015; 350 doi: (Published 14 April 2015) Cite this as: BMJ 2015;350:h1758 The FDA and the EMA allow the use of metformin in patients with moderate renal impairment The FDA and the EMA have both revised warnings regarding the use of metformin in diabetic patients with reduced kidney function, allowing the use of the product for patients with moderate renal function [1-2]. This decision significantly expands the target population using metformin and closes a recurrent debate among diabetologist community, all the more as metformin is often used in clinical practice outside of the current labelling indications. Several authors considered that fear of Metformin-Associated Lactic Acidosis (MALA) was rooted in the history of biguanide-associated lactic acidosis, in particular the experience with phenformin [3] and that the contraindication for metformin in patients with renal insufficiency was too restrictive. Indeed, two recent epidemiological studies have suggested a benefit on mortality in patients with moderate renal impairment using metformin, in accordance with UKPDS results [4]. Compared to other treatments, Roussel et al [5] found a benefit in patients treated by metformin and with eGFR between 30 and 60 ml/min/1.73 m2 (HR = 0.64; 95% CI, 0.48-0.86) whereas Ekstrm et al. [6], of better quality regarding adjustments, found a benefit only in patients with eGFR between 45 to 60 ml/min/1.73 m2 (decrease of mortality of 13%, but wide CI: 0.77-0.99) but not in patients with eGFR between 30 and 45 ml/min/1.73 m2. Nevertheless, it should be noted that the sole randomised study (even underpowered for clinical outcomes), which assessed Continue reading >>

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