Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry.

BACKGROUND AND AIMS: In Italy, the reimbursed use of incretin mimetics and incretin enhancers was subject to enrollment of patients into a web-based system recording the general demographic and clinical data of patients. We report the utilization data of glucagon-like peptide 1 (GLP1) receptor agonists and dipeptidylpeptidase-4 (DPP4) inhibitors in clinical practice as recorded by the Italian Medicines Agency (AIFA) Monitoring Registry. METHODS AND RESULTS: From February 2008 to August 2010, 75,283 patients with type 2 diabetes were entered into the registry and treated with exenatide, sitagliptin, or vildagliptin. The treatment was administered to patients in a wide range of ages (≥75 years, n = 6125 cases), body mass index (BMI) (≥35 kg/m(2), n = 22,015), and metabolic control (HbA(1c) ≥ 11% ((96 mmol/mol), n = 3151). Overall, 1116 suspected adverse drug reactions were registered, including 12 cases of acute pancreatitis (six on exenatide). Hypoglycemic episodes mainly occurred in combination with sulfonylureas. Treatment discontinuation for the three drugs (logistic regression analysis) was negatively associated with the male gender and positively with baseline HbA1c, diabetes duration, and, limitedly to DPP-4 inhibitors, with BMI. Treatment discontinuation (including loss to follow-up, accounting for 21-26%) was frequent. Discontinuation for treatment failure occurred in 7.7% of cases (exenatide), 3.8% (sitagliptin), and 4.1% (vildagliptin), respectively, corresponding to 27-40% of all discontinuations, after excluding lost to follow-up. HbA1c decreased on average by 0.9-1.0% (9 mmol/mol). Body weight decreased by 3.5% with exenatide and by 1.0-1.5% with DPP-4 inhibitors. CONCLUSIONS: In the real world of Italian diabetes centers, prescriptions of incretins have been made in many cases outside the regulatory limits. Nevertheless, when appropriately utilized, incretins may grant results at least in line with pivotal trials.

[Thrombosis of the vertebral artery, shown on angioresonance, in the lateral bulbar syndrome]. / Trombosis de arteria vertebral demostrada por angiorresonancia en el síndrome bulbar lateral.

INTRODUCTION: The lateral bulbar syndrome is a heterogeneous clinical condition. It is usually of vascular origin, due to a reduction in postero inferior cerebellar artery (PICA) and vertebral artery blood flow. CASE REPORT: We studied two cases: a woman aged 59 years and a man of 49 years, who were admitted with Wallenberg s syndrome. The diagnosis was confirmed on magnetic resonance which showed an ischaemic lesion in the lateral bulbar region ipsilateral to the clinical signs. On angioresonance there was lack of filling of the vertebral artery involved, and the PICA was not seen. CONCLUSIONS: At the present time, the most sensitive technique available for the diagnosis of the lateral bulbar syndrome is cranial magnetic resonance (it even appears to be useful for making aetiopathogenic hypotheses). Similarly, arteriography is widely used for assessing disorders of the posterior cerebral circulation, although it is not without risk. According to recent studies, angioresonance gives sensitivity and specificity of over 75% when used to assess anomalies of the vertebral and basilar arteries. So our observations corroborate the finding that angioresonance is a very sensitive, specific investigation for showing disorders of the vertebral arteries and PICA, which spares patients the morbidity associated with conventional arteriography.

Trombosis de arteria vertebral demostrada por angiorresonancia en el síndrome bulbar lateral / Thrombosis of the vertebral artery, shown on angioresonance, in the lateral bulbar syndrome

Introducción. El síndrome bulbar lateral es un cuadro clínico heterogéneo, habitualmente de origen vascular, caracterizado por disminución del flujo en la arteria cerebelosa posteroinferior (ACPI) y, eventualmente, de la arteria vertebral. Casos clínicos. Estudiamos dos casos, mujer de 59 años y varón de 49 años que ingresan con un síndrome de Wallenberg. La resonancia magnética confirma el diagnóstico mostrando una lesión isquémica en región bulbar lateral ipsilateral a la clínica. En la angiorresonancia se observa una falta de relleno de la arteria vertebral responsable, sin que se visualice la ACPI. Conclusiones. En la actualidad, la técnica más sensible para el diagnóstico del síndrome bulbar lateral es la resonancia magnética craneal (incluso parece ser útil para formular hipótesis etiopatogénicas). Del mismo modo, la arteriografía se utiliza ampliamente para evaluar trastornos de la circulación cerebral posterior, aun sin estar exenta de riesgos. La angiorresonancia demuestra, según los últimos estudios, una sensibilidad y una especificidad superiores al 75 por ciento en la valoración de anomalías en las arterias vertebrales y basilar. De esta forma, nuestra observación corrobora que la angioresonancia es una prueba muy sensible y específica para la demostración de patología en las arterias vertebrales y la ACPI, ahorrando al paciente la morbilidad que conlleva la arteriografía convencional (AU)