BackgroundPhase III clinical studies have confirmed that enoxaparin is superior to standard heparin in reducing the rate of recurrent ischaemic events in patients with non-ST elevation acute coronary syndromes. Patients with moderate to severe renal impairment were, however, excluded from these studies. Due to the hydrophilic disposition of enoxaparin, accumulation is likely in patients with renal dysfunction, thereby increasing the risk of haemorrhagic complications if standard weight adjusted treatment doses are used. Arbitrary dose reduction has been repor ted to increase the risk of ischaemic events, presumably due to inadequate enoxaparin concentrations. AimThe aims of this study were to investigate the influence of glomerular filtration rate (GFR) on the pharmacokinetics of subcutaneously administered enoxaparin, and to develop a practical dosing algorithm in renal impairment that can easily be used at the bedside. MethodsThirty-eight patients, median age 78 years (range 44-87), mean GFR 32 ml min -1 (range 16-117) and mean weight 69 kg (range 32-95), presenting with acute coronary syndrome were recruited into the study. Approximately 10 anti-Xa concentrations were taken per patient over their period of therapy. A population pharmacokinetic model was developed using non linear mixed effects modelling techniques, utilizing the software NONMEM. Stochastic simulations were performed to identify the most suitable dosing regimen. ResultsThree hundred and thirteen anti-Xa concentrations were collected. A two compar tment, first order input model was identified as the best baseline model. Covariates found to improve model fitting were GFR as a linear function on clearance (CL) and weight as a linear function on the central volume compartment (V c ). The fraction of drug excreted unchanged ( F u ) was estimated at 71%. CL and V c from the final covariate model were estimated as; CL (l h -1 ) = 0.681 per 4.8 l hr -1 (GFR) + 0.229 V c (l) = 5.22 per 80 kg (total body weight) Correspondence Bruce Green,
Aims: This preliminary study addresses three related issues. Firstly, there is a need to test the effectiveness of CBT (Cognitive Behavioural Therapy) for binge eating in populations with type 2 diabetes. Secondly, the impact of a treatment for binge eating on diabetes management is unknown.Finally, whilst a number of treatment modalities have been shown to improve binge eating there has not been a comparison between CBT and a non-specific therapy for binge eating.Methods: Group CBT for binge eating was compared to a Group Non-Prescriptive Therapy (NPT), a therapy for which there is no theoretical or empirical support in eating disorders, in a randomised trial which included a post-treatment assessment and a three-month follow-up.Results: There were no differences between CBT and NPT at post-treatment with both treatments being associated with significant changes in binge eating, mood and BMI. However there was a significant relapse in binge eating at the three-month follow-up in the NPT condition. This was in contrast to the CBT condition where treatment gains were maintained. Finally, across treatments, reduction in binge eating from pre-to post-treatment was associated with reduction in HbA1c.Conclusions: Binge eating in type 2 diabetes is responsive to psychosocial treatment, and reduction in binge eating appears to improve glycemic control. However this is a small study with a short followup period. Future studies will need to extend the follow-up period to assess for long-term maintenance of the effects of CBT on binge eating and diabetic control in this population.
This study characterizes the exposure-response relationship of AMD3100 in mobilizing CD34 + cells after subcutaneous administration. This PK-PD model will be useful in assessing relevant covariates and for optimizing the use of AMD3100 in various patient populations.
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