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New Metformin Guidelines 2016

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 >>

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 >>

Iodinated Contrast Media Guideline

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 >>

Nice Guidance - Metformin In Type 2 Diabetes - General Practice Notebook

Nice Guidance - Metformin In Type 2 Diabetes - General Practice Notebook

NICE guidance - metformin in type 2 diabetes 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 >>

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 >>

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 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 >>

Using Metformin In The Presence Of Renal Disease

Using Metformin In The Presence Of Renal Disease

Using metformin in the presence of renal disease Using metformin in the presence of renal disease BMJ 2015; 350 doi: (Published 14 April 2015) Cite this as: BMJ 2015;350:h1758 Tahseen A Chowdhury, consultant in diabetes, M Magdi Yaqoob, professor in clinical nephrology 1Departments of Diabetes and Nephrology, Barts and the London School of Medicine and Dentistry, London E1 1BB, UK. Correspondence to: T Chowdhury Tahseen.Chowdhury{at}bartshealth.nhs.uk Current guidelines are too restrictive, and many patients who could benefit are missing out 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 >>

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. 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 >>

Risks Of Metformin In Type 2 Diabetes And Chronic Kidney Disease: Lessons Learned From Taiwanese Data

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 >>

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 >>

In Brief: New Recommendations For Use Of Metformin In Renal Impairment

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 >>

Metformin In Advanced Chronic Kidney Disease: Are Current Guidelines Overly Restrictive?

Metformin In Advanced Chronic Kidney Disease: Are Current Guidelines Overly Restrictive?

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. Discover the world's research 14+ million members 100+ million publications 700k+ research projects Join for free tions is a global concern. Metformin is established as the ing dialysis in the UK, with an incidence of 25.4%.2Overt diabetic The International Diabetes Federation (IDF) estimates that 387 References for this review were identified through searches of 7.0% (53 mmol/mol) in the intensive group and 7.9% (63 diabetes to undergo standard glucose control (mean HbA1c minuria. There was a significantly lower incidence of major the incidence of nephropathy. The use of most classes of oral risk of developing ESRD (65%), microalbuminuria (9%) and They state that its use is contraindicated with a creatinine >1.5 mg/dL (133 μmol/L) in men or >1.4 mg/dL (124 μmol/L) in the prevalence of people with an eGFR of <45 mL/min was the large burden of type 2 diabetes, these data suggest that randomisation op Continue reading >>

Changes In Metformin Use In Chronic Kidney Disease

Changes In Metformin Use In Chronic Kidney Disease

Go to: Fear of LA Metformin is chemically similar to phenformin, but has a different mechanism of action. Although the fear of LA remains, no absolute definitive causal relationship has been proven beyond doubt. Many reported cases of metformin-associated LA (MALA) did not measure metformin levels, whereas in others levels were not high, suggesting ‘metformin coincident lactic acidosis’ [9]. In 1998, Misbin et al. reported that after starting to use metformin, rates of LA in the USA were no different from prior to the approval of metformin [10]. Many reported cases of LA had multiple risk factors besides renal failure. Since DM2 is a risk factor, it is thought that many such cases may have been just from DM2. The putative risk factors for LA described in the literature include old age, decreased cardiac output, respiratory failure or hypoxic conditions, ethanol intoxication, fasting and decreased hepatic function. In a nested case–control analysis that included 50 048 patients, six patients were identified with active use of metformin and LA. Out of those, five patients had sepsis and signs of end-organ damage, suggesting that LA most frequently occurs in acutely worsening clinical scenarios [11]. Continue reading >>

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