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El análisis estadístico tradicional de las notificaciones de reacciones adversas a medicamentos en pacientes diabéticos ha sido complejo y escaso. Las técnicas de minería de datos -modelo de red de enlaces, modelo de redes de Kohonen- permiten identificar perfiles de pacientes diabéticos tratados con fármacos que sufren reacciones adversas. Son perfiles característicos los trastornos del metabolismo graves no mortales por insulina glargina en mujeres en Cataluña; y los trastornos gastrointestinales no graves por metformina en mujeres de 65-74 años en Aragón. Los pacientes en tratamiento con tres o más agentes orales presentan mayor riesgo de sufrir una reacción adversa

The traditional statistical analysis of notifications of adverse drug reactions in diabetic patients was complex and sparse. The data mining techniques -web graph and Kohonen networks model- allow us to identify drug-treated diabetic patients who suffer adverse reactions. Nonfatal severe metabolic disorders due to insulin glargine in women in Catalonia, and non-serious gastrointestinal metformin disorders in women between 65 and 74 years in Aragon are two characteristics profiles. Patients treated with three or more oral agents are at increased risk of suffering an adverse reaction

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A 93-year-old male was urgently admitted to our hospital with dyspnea and disturbance of consciousness. The patient had been visiting a general physician regularly for ten years, for treatment of type 2 diabetes. He had been treated with glibenclamide and voglibose, until voglibose was replaced with buformin 3 months before admission. During pre-admission treatment, his HbA1c was 10-12% and serum Cr level was around 2mg/dL, but insulin therapy had never been considered because of "being too old". The patient had started taking furosemide one year before admission, because of edema of the lower legs, and also spironolactone two months before admission. Anorexia had continued for one month before admission on May 29, 2003. On admission, his laboratory data were; blood glucose 87mg/dL, HbA1c 12.5%, BUN 75mg/dL, Cr 3.9mg/dL, lactate 253.1 mg/dL, and blood gas analysis; pH 6.97, anion gap 45.3mmol/L breathing room air, suggesting marked lactic acidosis with renal failure. Intensive care with bicarbonate and fluid therapy was successful, and his glycemic control improved markedly with insulin. On the other hand, his activity of daily living (ADL) severely deteriorated while in hospital Home follow-up was therefore not indicated, and he had to change a hospital for further follow-up. This case report gives rise to the question of how we should manage diabetes in the oldest elderly, including the use of insulin and biguanides. In addition, complications of biguanides in the elderly are reviewed.

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We report two diabetic patients who developed lactic acidosis following the use of Buformin. Treatment consisted of mechanical ventilation, massive bicarbonate administration, circulatory support with dopamine and peritoneal dialysis. Despite this, both patients died.

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Disturbances of the vitamin B12 resorption by the therapy with biguanides above all metformin are known from literature. In 59 patients with Buformin retard-monotherapy we determined in 18.7% slight reductions of the vitamin B12 level in the serum, in one patient the serum concentration was lower than 50 pg/ml. That means that also under therapy with Buformin can be reckoned with easy disturbances of resorption for vitamin B12. Occasional controls of Hb and anamnestic establishment of neurological symptoms are to be recommended during a therapy with Buformin, in order not to overlook the clinical signs of a vitamin B12 hypovitaminosis.

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A specific method is described for the quantitation of the oral hypoglycemic biguanide buformin in biological material by gas chromatography. Phenformin, another biguanide derivative, is used as internal standard. Both compounds are converted to the corresponding s-triazine derivatives by reacting with acetic anhydride prior to gas chromatography with nitrogen-specific detection. The described procedure has been applied to the quantitative assay of buformin in body fluids and tissues, obtained from a postmortem case. The results of these toxicological investigations are discussed.

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