ArticleInternational journal of clinical pharmacy2015
Impact of Japanese regulatory action on metformin-associated lactic acidosis in type II diabetes patients.
Article in International journal of clinical pharmacy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 14 citations in OpenAlex.
- Treatment patterns and satisfaction in patients with type 2 diabetes newly initiating oral monotherapy with antidiabetic drugs in Japan: results from the prospective Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND).BMJ open diabetes research & care · 2022Observational
- A survey on consciousness towards the proper use of metformin and medical cost in Japanese patients with type 2 diabetes.Journal of clinical biochemistry and nutrition · 2021Article
- Lactate Levels with Chronic Metformin Use: A Narrative Review.Clinical drug investigation · 2017Review
- Risk of disseminated intravascular coagulation in patients with type 2 diabetes mellitus: retrospective cohort study.BMJ open · 2017Article
- Associations of Polyethylenimine-Coated AN69ST Membrane in Continuous Renal Replacement Therapy with the Intensive Care Outcomes: Observations from a Claims Database from Japan.Blood purification · 2017Observational
- Retrospective analysis of lactic acidosis-related parameters upon and after metformin discontinuation in patients with diabetes and chronic kidney disease.International urology and nephrology · 2016Article
- Metformin exposure and the incidence of lactic acidosis in critically ill patients with T2DM: A retrospective cohort study.Science progressArticle
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe March 2012 regulatory action issued by the Japanese government signalled the rare but serious complication of lactic acidosis that can occur during metformin treatment, especially with the high dose formulation, h-metformin, and in those above 75 years old.
objectiveTo assess quantitatively the impact of this regulatory action on patient management using a medical information database (MID).
settingEight hospitals in Japan.
methodUsing a commercial MID, we collected data on adult outpatients treated with metformin, including h-metformin, during a 2-year study period between April 1, 2011 and March 31, 2013. The 2-year study period spanned 1 year before and after the regulatory action. The frequencies of lactate measurement in all metformin users, h-metformin users, and new users (started on metformin during the study period) were compared between the periods before and after the regulatory action, using generalized estimating equations. Trends in metformin prescription for elderly patients were analysed month-wise by regression analysis using an interrupted time series design.
main outcome measureThe rate ratios (RR) of lactate testing before and after the regulatory action.
resultsOf 4347 metformin users, 784 patients were >75 years old. A significant increase in lactate measurement was observed after the regulatory action than before in the overall study population, with an adjusted RR of 2.14 (95 % confidence interval 1.24-3.68). No significant change was found in h-metformin users and new users because lactate measurements were being performed as frequently in these subgroups before the regulatory action. There were no meaningful changes in the proportion of elderly metformin users in the overall population.
conclusionThe regulatory action led to increased lactate measurement in the overall metformin users, but did not affect metformin prescription rate in the elderly patients. Our findings probably reflect the doctors' judgement that the benefits of metformin use outweigh the risk of lactic acidosis if lactate testing is performed regularly.
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