An exploratory analysis of factors associated with weight change in a 16-week trial of oral vs. orally disintegrating olanzapine: the PLATYPUS study.

BACKGROUND: We conducted exploratory analyses of the data from a multinational, randomised study to identify factors associated with weight change after 16 weeks of treatment with standard olanzapine tablets (SOT) or sublingual orally disintegrating olanzapine (ODO). METHODS: One hundred and forty nine outpatients who gained weight during prior SOT therapy were enrolled into the study and treated with ODO (N = 84) or SOT (N = 65). Exploratory analyses were conducted with the subset of compliant patients (ODO: n = 60; SOT: n = 47). RESULTS: The decrease in the rate of weight gain at the end of study therapy (change from baseline) was greater in the ODO group than the SOT group (-0.59 kg/week vs. -0.38 kg/week, p = 0.0246). Age was negatively associated with weight change (p = 0.0203) in both treatment groups combined: patients gained 0.7 kg less for every 10 years of age. The least squares mean weight gain was lower with ODO than SOT in male patients (0.35 kg vs. 3.04 kg, p = 0.061), but not female patients and in American patients (0.55 kg vs. 6.21 kg, p < 0.0001), but not Canadian or Mexican patients. CONCLUSIONS: Although not conclusive, these data suggest that ODO may be a reasonable treatment option for some patients who gain weight with SOT. Further research is required to confirm these findings.

A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: the PLATYPUS Study.

BACKGROUND: Patients with schizophrenia and bipolar disorder have frequently reported weight gain during olanzapine treatment. Previous studies have observed a decrease in weight gain, or weight loss, in patients switching from standard olanzapine tablets (SOT) to orally disintegrating olanzapine (ODO) tablets. The primary objective of this study was to investigate the change in body mass index (BMI) in patients who had previously gained weight with SOT and continued with this therapy during the study period, compared with those patients who switched to ODO during the study period. METHODS: This was a 16-week, multicentre, randomized, double-blind, double-dummy, study of outpatients diagnosed with schizophrenia, schizoaffective disorder, related psychotic disorder or bipolar disorder, who were taking 5-20 mg SOT daily. Patients continued treatment with 5-20 mg olanzapine in a flexible single daily dose, and were randomized to either receive sublingual ODO plus an oral placebo, or sublingual placebo plus SOT. RESULTS: No statistically significant between group differences in mean change from baseline in BMI, weight or waist circumference were observed. Analysis of change in body weight from baseline, by pre-specified category (no change, loss of >or=1.5 kg, gain of >or=1.5 kg), revealed a significant difference between groups, favoring ODO patients, who also experienced a significant reduction in subjective appetite and better treatment compliance, compared to patients in the SOT group. CONCLUSIONS: In this study, patients treated with ODO experienced a similar mean change in BMI and weight from baseline, to those patients treated with SOT.

Can increased food intake improve psychosis? A brief review and hypothesis.

Weight gain, diabetes, and changes in serum lipid profiles have been reported during treatment with typical and atypical antipsychotics. An association between diabetes and psychotic disorders was described long before the introduction of pharmacological agents for the treatment of schizophrenia. Several theories have been proposed to explain the baseline weight increase and metabolic disturbances in schizophrenia. Some studies suggest that increased food intake may improve psychotic symptoms in patients with schizophrenia but there have been conflicting results. Available clinical and basic research findings are discussed to evaluate the hypothesis that increased food intake may decrease sensitivity to dopamine signaling in the striatum. More research is needed to evaluate this potential link. However, basic animal research and evolutionary approaches can provide insights into metabolic disturbances associated with schizophrenia.

[Analgesia and sedation of ventilated patients in intensive care medicine]. / Analgesie und Sedierung beatmeter Patienten in der Intensivmedizin.

Any patient admitted to an intensive care unit requires individual analgetic and sedative treatment, depending on type and severity of the disease with its associated physical and psychic problems. There is a wide range of possible medicaments and combinations of these from among which the authors investigated combinations of the short-action opiates fentanyl and alfentanyl and midazolam, a benzodiazepine, short-action as well. These were tested for their effects on several circulatory parameters, intracranial pressure, wake-up behaviour, and selected hormonal parameters of mechanically ventilated patients. Both analgosedation schemes yielded best results, when compared to other combinations also continuously administered through perfusion. Individually adapted synchronisation of the patients to respirator and therapeutic concept proved to be practicable at any time, in spite of that fixed combination of analgetic with sedative.