Findings arising from recent studies have shown that Metformin, the cost-effective diabetes medication is safe for most patients suffering from chronic kidney disease (CKD). Two separate studies which involve 150,000 patients was carried out under the auspices of Johns Hopkins Medical Investigators. The goal of the study is to determine the drug’s association with the development of lactic acidosis among patients with a significant decline in kidney function. The outcome of the study was published in the Journal of American Medical Association.
Metformin Hydrochloride was discovered as early as 1918, used as a first-line diabetes type-2 medication and sold as Glucophage among many other brand names. However, Hopkins researchers mentioned that over a million diabetes patients in the United States who are suffering from various levels of kidney diseases do not receive Metformin-derived medicament. As a result of fear of drug accumulation and lactic acidosis, doctors avoid prescribing the drugs to patients with CKD.
The number of diabetic patients who also suffer from kidney diseases in the United States is about 20% but the studies to confirm the safety of Metformin for such patients have been inconclusive.
The medication was eventually withdrawn from the United States market in 1978 as a result of its safety concerns. However, it was later reinstated in the in 1995 because of its higher efficacy in comparison to other biguanides (glucose-lowering drugs). In recent times, the Food and Drug Administration (FDA) revised the labeling of Metformin to allows usage by patients with CKD.
The study that spanned between 2004 to 2017 analyzed the medical records of diabetes patients with an average age of 60, they are all members of Geisinger Health System in Pennsylvania. The computer-based analysis calculated the risk of developing acidosis among metformin users while using patients who are not on Metformin medication as a control for the investigation. The experiment was also moderated to accommodate the influence of cardiovascular disease and smoking habit. In the study, 45% of the patients were on metformin medication when the research commenced and remaining were prescribed with the metformin over a 5-7 year period.
The research found that linkage between metformin medication and acidosis only exists in patients with extremely decreased kidney function defined as an eGFR of less than 30 mL/min/1.73 m2, where a normal eGFR is 90. This value poses a risk of more than 200% in the same patients who were on another diabetic medication.
Dr. Morgan Grams, an associate professor of medicine and epidemiology at the Johns Hopkins University School of Medicine said in a press release that the study shows that the risks of metformin-derived medicaments in patients with Chronic Kidney Disease are lower than previously perceived. He also said that from the public health perspective, and considering the number of people affected on a global scale, the potential benefits of metformin in patients with diabetes and CKD are enormous.
“Our results support cautious use of metformin in patients with type 2 diabetes and eGFR of at least 30 mL/min/1.73 m2,” Grams concluded.
In a parallel study, using 82,017 patients records from MarketScan ( a database of patient claims from 350 private health systems), researchers made a comparison of new metformin users with the initial users of sulfonylureas which is another class of diabetes medication. The users are diabetic patients with varying levels of CKD.
The research concluded that results from the new metformin users indicate a higher level of safety of metformin when compared with new sulfonylurea users.
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