Higher risk of colorectal cancer in patients with newly diagnosed diabetes mellitus before the age of colorectal cancer screening initiation.

Type 2 diabetes mellitus (T2DM) is associated with greater risk for colorectal cancer (CRC). The age of onset of T2DM is decreasing worldwide. An increased CRC risk in young T2DM patients could be relevant for the age at which to initiate CRC screening. We report on CRC risk in T2DM patients with attention to age of diagnosis. We used pharmacy data (from 1998 to 2010) from the PHARMO Database Network linked to the Eindhoven Cancer Registry. Multivariable time-dependent Cox regression analyses were conducted to calculate hazard ratios (HR) for developing CRC comparing T2DM with non-T2DM. During 2,599,925 years of follow-up, 394 CRC cases among 41,716 diabetes patients (mean age 64.0 yr, 48% men) and 1,939 CRC cases among 325,054 non-diabetic patients (mean age 51.2 yr, 46% men) were identified. Diabetes was associated with an increased CRC risk in both men and women (HR 1.3, 95% CI 1.2-1.5), particularly in the first 6 months after T2DM diagnosis and pronounced in the proximal colon. This risk was even higher in men younger than 55 years (HR 2.0, 95% CI 1.0-3.8). T2DM was associated with a time-varying and subsite-specific increased CRC risk, which was even higher in men aged <55 years.

Comparing tolerability and efficacy of generic versus brand alendronate: a randomized clinical study in postmenopausal women with a recent fracture.

INTRODUCTION: An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate. METHODS: In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models. RESULTS: There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12. CONCLUSIONS: Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture. TRIAL REGISTRATION: Dutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1867.

Unexpected high risk of contamination with staphylococci species attributable to standard preparation of syringes for continuous intravenous drug administration in a simulation model in intensive care units.

OBJECTIVE: To determine the risk of bacterial contamination of the infusate in a simulation model of syringes prepared for continuous intravenous drug administration by intensive care unit nurses. Widely accepted standard procedures in the intensive care unit were compared with syringes prepared by pharmaceutical technicians working under standard aseptic conditions according to national guidelines. DESIGN: Prospective study. SETTING: Intensive care units of four general teaching hospitals and two university hospitals. SUBJECTS: We examined 650 syringes prepared from 10-mL ampules and 100 syringes prepared from rubber-compound-capped 50-mL vials by intensive care unit nurses of six hospitals. Also, 100 syringes from 10-mL ampules and 100 syringes from rubber-compound-capped 50-mL vials were prepared by pharmaceutical technicians. INTERVENTIONS: Turbidity of syringes after culturing for 7 days at 37 degrees C was used as the criterion for possible bacterial contamination, which was proved with subsequent Gram staining. MEASUREMENTS AND MAIN RESULTS: A median contamination rate of 22% (range, 7% to 44%) was observed for the syringes prepared from 10-mL ampules by intensive care unit nurses, compared with only 1% for the syringes prepared from ampules by technicians (p <.001). In >75% of all contaminated syringes, Gram-positive cocci were identified. At least 12% of all prepared syringes proved to be contaminated with staphylococci species. The contamination rate of syringes prepared from vials was much lower: 2% in the intensive care unit and 0% at the department of clinical pharmacy. CONCLUSIONS: In the intensive care unit, standard procedures for preparing syringes for intravenous administration of drugs lack vigorous aseptic precautions, leading to a high contamination rate of the infusate. This risk is increased when ampules instead of 50 mL-vials are used to prepare the syringes.