F Kajbaf1, J-D Lalau. 1. Service d'Endocrinologie-Nutrition, Hôpital Sud, France.
Abstract
AIMS: To study the quality of pharmacovigilance reporting in cases of so-called 'metformin-associated lactic acidosis' and, ultimately, whether or not the criteria for this condition are indeed met. METHODS: We searched for cases meeting the criteria for metformin-associated lactic acidosis [arterial pH < 7.35, blood lactate > 5 mmol/l (45 mg/dl) and detectable plasma metformin concentration] in a 15-year period (1995-2010) in a pharmacovigilance database of the license holder for metformin (Merck Serono, Lyon, France). RESULTS: We found 869 reports stated as 'metformin-associated lactic acidosis' from 32 countries. The respective criteria for pH, lactate concentration and metformin concentration were met in 51.2, 53.3 and 13.9% of cases. All three criteria were met in just 10.4% of cases. By year, each of the percentages remained roughly stable throughout the study period. CONCLUSIONS: The role of metformin in triggering metformin-associated lactic acidosis was assessed incorrectly in most patients and the quality of reporting did not improve over time.
AIMS: To study the quality of pharmacovigilance reporting in cases of so-called 'metformin-associated lactic acidosis' and, ultimately, whether or not the criteria for this condition are indeed met. METHODS: We searched for cases meeting the criteria for metformin-associated lactic acidosis [arterial pH < 7.35, blood lactate > 5 mmol/l (45 mg/dl) and detectable plasma metformin concentration] in a 15-year period (1995-2010) in a pharmacovigilance database of the license holder for metformin (Merck Serono, Lyon, France). RESULTS: We found 869 reports stated as 'metformin-associated lactic acidosis' from 32 countries. The respective criteria for pH, lactate concentration and metformin concentration were met in 51.2, 53.3 and 13.9% of cases. All three criteria were met in just 10.4% of cases. By year, each of the percentages remained roughly stable throughout the study period. CONCLUSIONS: The role of metformin in triggering metformin-associated lactic acidosis was assessed incorrectly in most patients and the quality of reporting did not improve over time.
Authors: Savas Sipahi; Yalcin Solak; Seyyid Bilal Acikgoz; Ahmed Bilal Genc; Mehmet Yildirim; Ulku Yilmaz; Ahmet Nalbant; Ali Tamer Journal: Int Urol Nephrol Date: 2016-04-21 Impact factor: 2.370
Authors: Samira Bell; Bassam Farran; Stuart McGurnaghan; Rory J McCrimmon; Graham P Leese; John R Petrie; Paul McKeigue; Naveed Sattar; Sarah Wild; John McKnight; Robert Lindsay; Helen M Colhoun; Helen Looker Journal: BMC Nephrol Date: 2017-05-19 Impact factor: 2.388