Abstract Background: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem.
from the repository of Utrecht University: "OBJECTIVES: Antipsychotic drugs are frequently prescribed to elderly patients, but they are associated with serious adverse effects. The objective of the current study was to investigate the association between use of antipsychotics by elderly women and the risk of urinary tract infections (UTIs). COHORT STUDY SETTING: Dispensing data were obtained from the PHARMO Database Network for the period 1998-2008. PARTICIPANTS: Ambulatory Dutch women (≥65 years) with current and past use of antipsychotics. MEASUREMENTS: Incidence rates of UTIs, as defined by use of nitrofurantoin, was calculated within and outside the period of exposure to antipsychotic drugs. Cox proportional hazard regression analysis with Andersen-Gill extension for recurrent events was used to calculate crude and adjusted hazard ratios (HRs). RESULTS: During the study period, 18,541 women with a first prescription of an antipsychotic were identified. Current use of antipsychotics was associated with an increased risk of UTI compared to past use: HR, adjusted for age and history of UTIs, 1.33, 95% CI 1.27-1.39. A strong temporal relationship was found: the risk of being treated for a UTI was higher in the first week after the start of the treatment (adjusted HR 3.03, 95% CI 2.63-3.50) and decreased after 3 months (adjusted HR 1.22, 95% CI 1.17-1.28). Cumulative exposure was not associated with an increased risk of UTIs. There was no difference in effect between conventional and atypical antipsychotics. CONCLUSION: Our results show an increased risk of uncomplicated UTIs during antipsychotic use in older female patients, especially in the first week of treatment."
LINK
BACKGROUND: Recent evidence suggests that an increase in baccalaureate-educated registered nurses (BRNs) leads to better quality of care in hospitals. For geriatric long-term care facilities such as nursing homes, this relationship is less clear. Most studies assessing the relationship between nurse staffing and quality of care in long-term care facilities are US-based, and only a few have focused on the unique contribution of registered nurses. In this study, we focus on BRNs, as they are expected to serve as role models and change agents, while little is known about their unique contribution to quality of care in long-term care facilities. METHODS: We conducted a cross-sectional study among 282 wards and 6,145 residents from 95 Dutch long-term care facilities. The relationship between the presence of BRNs in wards and quality of care was assessed, controlling for background characteristics, i.e. ward size, and residents' age, gender, length of stay, comorbidities, and care dependency status. Multilevel logistic regression analyses, using a generalized estimating equation approach, were performed. RESULTS: 57% of the wards employed BRNs. In these wards, the BRNs delivered on average 4.8 min of care per resident per day. Among residents living in somatic wards that employed BRNs, the probability of experiencing a fall (odds ratio 1.44; 95% CI 1.06-1.96) and receiving antipsychotic drugs (odds ratio 2.15; 95% CI 1.66-2.78) was higher, whereas the probability of having an indwelling urinary catheter was lower (odds ratio 0.70; 95% CI 0.53-0.91). Among residents living in psychogeriatric wards that employed BRNs, the probability of experiencing a medication incident was lower (odds ratio 0.68; 95% CI 0.49-0.95). For residents from both ward types, the probability of suffering from nosocomial pressure ulcers did not significantly differ for residents in wards employing BRNs. CONCLUSIONS: In wards that employed BRNs, their mean amount of time spent per resident was low, while quality of care on most wards was acceptable. No consistent evidence was found for a relationship between the presence of BRNs in wards and quality of care outcomes, controlling for background characteristics. Future studies should consider the mediating and moderating role of staffing-related work processes and ward environment characteristics on quality of care.
