OBJECTIVE To determine whether the use of metformin in type 2 diabetic patients with various kidney functions is associated with an increased risk of lactic acidosis (LA). RESEARCH DESIGN AND METHODS This study was a retrospective analysis of U.K. patient records from the Clinical Practice Research Datalink database from 1 January 2007 to 31 December 2012. Inclusion criteria were 1) diagnosis of type 2 diabetes before 1 January 2007, 2) treatment with metformin, and 3) at least one assessment of renal function between 2007 and 2012. Renal function was assessed by glomerular filtration rate and categorized as normal (N), mildly reduced (Mi), moderately reduced (Mo), or severely reduced (Se) function. The outcome of the study was LA. RESULTS A total of 77,601 patients treated with metformin for type 2 diabetes were identified. There were 35 LA events (10.37 [95% CI 7.22–14.42] per 100,000 patient-years) of which none were fatal and 23 were linked to a comorbidity. No significant difference in the incidence of LA was observed across N, Mi, Mo and Se renal function groups (7.6 [0.9–27.5], 4.6 [2.00–9.15], 17 [10.89–25.79], and 39 [4.72–140.89] cases per 100,000 patient-years, respectively). CONCLUSIONS The overall LA incidence rate for patients on metformin in this study was within the range of rates reported in the literature for patients with type 2 diabetes, and no significant difference was observed among patients with N, Mi, Mo, and Se function.

BACKGROUND: Health insurance administrative claims databases represent a valuable source of information regarding the safety profile of marketed products as used in actual clinical practice in a broader range of patients than that assessed in clinical trials. Interferon beta-1a administered sub-

informação sobre o artigo Historial do artigo: Recebido a 27 de abril de 2015 Aceite a 30 de junho de 2015 On-line a 7 de dezembro de 2015 Palavras-chave: Diabetes Estudos observacionais Qualidade de vida Propensity scores r e s u m o Objetivos: O estudo, realizado em doentes diabéticos, teve como objetivo descrever as comorbilidades e complicaç ões associadas à diabetes, e caracterizar a frequência com que os doentes diabéticos fazem autovigilância da sua doença. Adicionalmente, pretendeu-se caracterizar a qualidade de vida do doente diabético, bem como os fatores que a influenciam. Métodos: Estudo observacional transversal. Foram convidadas a participar neste estudo 800 farmácias, com cobertura geográfica a nível nacional. Utentes das farmácias aderentes, com uma prescrição para uso próprio de, pelo menos, um medicamento com indicação para a diabetes (grupo A10 da classificação ATC da Organização Mundial de Saúde [OMS]), foram convidados a participar no estudo, através do preenchimento de 2 questionários. A avaliação dos fatores que influenciam a qualidade de vida foi efetuada através da modelação em 2 fases utilizando propensity scores. Resultados: Duzentas e onze farmácias aceitaram participar no estudo (26,4%). Foram recrutados 1.479 doentes diabéticos adultos, 53,7% do sexo feminino e com idade média de 64,1 anos. Neuropatia (27,3%), retinopatia (22,4%) e nefropatia (11,9%) foram as complicaç ões associadas à diabetes mais frequentemente reportadas. Na maioria dos doentes, a autovigilância da glicemia foi referida com frequência superior a uma ou 2 vezes por mês. Em cerca de 28% dos casos, a autovigilância dos pés nunca ou raramente foi efetuada e 27% dos doentes declarou nunca ter feito uma consulta de oftalmologia. Análises à glicemia e hemoglobina glicosilada foram realizadas anualmente em 25% dos participantes. A maioria dos doentes fazia terapêutica com antidiabéticos orais (ADO). O questionário ADDQoL foi preenchido por 1.151 participantes. A pontuação obtida revelou que o impacto ponderado da diabetes na qualidade de vida é percecionado como negativo. As variáveis que influenciam a qualidade de vida foram: nefropatia (Odds Ratio [OR] = 2,2 [intervalo de confiança 95% {IC95%}: 1,28-3,86]), toma de insulina (OR = 2,2 [IC95%: 1,35-3,50]), idade (OR = 1,9 [IC95%: 1,21-3,05]), retinopatia (OR = 1,8 [IC95%: 1,12-2,91]) e exercício físico (OR = 0,5 [IC95%: 0,33-0,83]). * Autor para correspondência. Correio eletrónico: zilda.mendes@anf.pt (Z. Mendes). http://dx.

Background This study compared the effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa; GONAL-f®) with urinary highly purified human menopausal gonadotropin (hMG HP; Menogon HP®), during assisted reproductive technology (ART) treatments in Germany. Methods Data were collected from 71 German fertility centres between 01 January 2007 and 31 December 2012, for women undergoing a first stimulation cycle of ART treatment with r-hFSH-alfa or hMG HP. Primary outcomes were live birth, ongoing pregnancy and clinical pregnancy, based on cumulative data (fresh and frozen-thawed embryo transfers), analysed per patient (pP), per complete cycle (pCC) and per first complete cycle (pFC). Secondary outcomes were pregnancy loss (analysed per clinical pregnancy), cancelled cycles (analysed pCC), total drug usage per oocyte retrieved and time-to-live birth (TTLB; per calendar week and per cycle). Results Twenty-eight thousand six hundred forty-one women initiated a first treatment cycle (r-hFSH-alfa: 17,725 [61.9%]; hMG HP: 10,916 [38.1%]). After adjustment for confounding variables, treatment with r-hFSH-alfa versus hMG HP was associated with a significantly higher probability of live birth (hazard ratio [HR]-pP [95% confidence interval (CI)]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; relative risk [RR]-pFC [95% CI]: 1.09 [1.05, 1.15], ongoing pregnancy (HR-pP [95% CI]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; RR-pFC [95% CI]: 1.10 [1.05, 1.15]) and clinical pregnancy (HR-pP [95% CI]: 1.10 [1.05, 1.14]; HR-pCC [95% CI]: 1.14 [1.10, 1.19]; RR-pFC [95% CI]: 1.10 [1.06, 1.14]). Women treated with r-hFSH-alfa versus hMG HP had no statistically significant difference in pregnancy loss (HR [95% CI]: 1.07 [0.98, 1.17], were less likely to have a cycle cancellation (HR [95% CI]: 0.91 [0.84, 0.99]) and had no statistically significant difference in TTLB when measured in weeks (HR [95% CI]: 1.02 [0.97, 1.07]; p = 0.548); however, r-hFSH-alfa was associated with a significantly shorter TTLB when measured in cycles versus hMG HP (HR [95% CI]: 1.07 [1.02, 1.13]; p = 0.003). There was an average of 47% less drug used per oocyte retrieved with r-hFSH-alfa versus hMG HP. Conclusions This large (> 28,000 women), real-world study demonstrated significantly higher rates of cumulative live birth, cumulative ongoing pregnancy and cumulative clinical pregnancy with r-hFSH-alfa versus hMG HP.

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