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Biomedical subjects

Martina Hummer

Publications and source records attributed to Martina Hummer.

At least 19 recordsLinked to original sources
PubMed2006

Alterations of glucose metabolism during treatment with clozapine or amisulpride: results from a prospective 16-week study.

Although second-generation antipsychotics have notable benefits as compared to typical antipsychotics, their use has been associated with metabolic disturbances, such as alterations of glucose homeostasis. It is still being debated whether this is a class effect of second-generation antipsychotics. We conducted a prospective, open study comparing body weight, parameters of insulin resistance in schizophrenia patients treated with either clozapine (n = 10) or amisuLpride ( n = 12). All parameters were assessed monthly over a period of 12 to 16 weeks. Body mass index (BMI), fasting serum insulin levels and the Homeostasis Model Assessment (HOMA) index for insulin resistance increased significantly in patients treated with clozapine. None of these parameters increased significantly in patients treated with amisulpride. This study indicates that treatment with clozapine appears to have a higher risk to lead to metabolic disturbances than amisupride.

Adolescent↗
PubMed2006

Association between antipsychotic-induced elevation of liver enzymes and weight gain: a prospective study.

We conducted a prospective, open study in schizophrenia patients treated with second-generation antipsychotics in order to investigate the risk for elevation of liver enzymes and its correlation to antipsychotic-induced weight gain. Body mass index, serum transaminases, plasma serum levels of the antipsychotic used, and blood cell counts were measured weekly during the first 6 weeks of treatment and monthly thereafter. A considerable proportion of subjects showed an increase beyond normal levels of at least one of the measured transaminases. In all but one case, the elevation of liver enzymes was transient. We found a statistically significant correlation between weight gain and liver enzyme elevation. The group of patients that had gained at least 7% of the baseline body weight showed significantly higher increases of transaminases as compared with those who had gained less than 7% weight. We conclude that antipsychotic-induced elevation of liver enzymes is mostly transient and could be associated with weight gain.

Adolescent↗
PubMed2006

Early changes of plasma lipids during treatment with atypical antipsychotics.

Metabolic side effects have been found earlier during treatment with second-generation antipsychotics. Among those disturbances serum lipids are less investigated. We conducted a prospective, open study in schizophrenia patients in order to compare body weight and serum lipids during treatment with amisulpride, ziprasidone, clozapine or olanzapine over a period of 4 weeks. Body mass index, total cholesterol and triglycerides increased in patients treated with clozapine and olanzapine whereas high-density lipoprotein cholesterol decreased in those patients. In patients treated with amisulpride or ziprasidone, we found a decrease in body mass index and total cholesterol whereas high-density lipoprotein cholesterol increased. Our results indicate that treatment with ziprasidone and amisulpride is more favourable than treatment with clozapine and olanzapine with respect to the risk to induce weight gain and hyperlipidaemia. These results are important with regard to the increased risk for cardiovascular complications in patients with schizophrenia.

Adolescent↗
PubMed2005

Correlates of subjective and functional outcomes in outpatient clinic attendees with schizophrenia and schizoaffective disorder.

Outcome in schizophrenia is multidimensional and, thus, consists of clinical,humanitarian, rehabilitative and cost domains. Accordingly, recovery is conceptualized as the ability to function in the community, socially and vocationally, as well as being relatively free of disease-related psychopathology. The present cross-sectional study examined the relationship of premorbid functioning, psychopathology, insight, attitudes toward medication and side-effects, as well as sociodemographic factors with treatment outcomes in terms of quality of life (QOL) and psychosocial functioning among 60 regular attendees of a specialized schizophrenia outpatient clinic. Both insight into the illness as well as attitudes toward treatment indicated satisfactory compliance. Premorbid school and social functioning were positively correlated with actual employment status, and premorbid social functioning was further positively correlated with QOL and global functioning. Attitudes toward treatment were positively associated with global QOL, and with the patients' living situation. Both positive and negative symptoms as well as asthenia were negatively associated with QOL, while cognitive symptoms negatively influenced occupational functioning. Older patients lived independently and/or in a partnership more often, but had a lesser likelihood of competitive employment. Our observations suggest that subjective and functional outcomes in highly compliant patients are mainly predicted by psychopathological symptoms and unchangeable sociodemographic variables.

Activities of Daily Living↗
PubMed2005

Dropout rates in placebo-controlled and active-control clinical trials of antipsychotic drugs: a meta-analysis.

CONTEXT: Dropout rates in randomized clinical trials of antipsychotic drugs have consistently been reported to be high, and the use of a placebo-controlled design is hypothesized to be one of the reasons for this. OBJECTIVE: To investigate this hypothesis in a meta-analysis of available data from pertinent clinical trials. DATA SOURCES: Comprehensive search of PubMed- and MEDLINE-listed journals. STUDY SELECTION: Double-blind randomized controlled clinical trials of the second-generation antipsychotics risperidone, olanzapine, quetiapine, amisulpride, ziprasidone, and aripiprazole meeting the following criteria: unselected patient population with a diagnosis of schizophrenia or schizoaffective disorder, change in psychopathologic symptoms as the primary end point, and trial duration of 12 weeks or less. DATA EXTRACTION: Sample size, mean age, baseline disease severity, dropout rate, trial design, trial duration, and publication year. DATA SYNTHESIS: Thirty-one trials meeting the inclusion criteria were found, comprising 10 058 subjects. Weighted mean dropout rates in the active treatment arms were significantly higher in placebo-controlled trials (PCTs) than in active-control trials: 48.1% (PCTs) vs 28.3% (active-control trials) for second-generation antipsychotics (odds ratio, 2.34; 95% confidence interval, 1.58-3.47) and 55.4% (PCTs) vs 37.2% (active-control trials) for classical antipsychotics (odds ratio, 2.10; 95% confidence interval, 1.29-3.40). Within PCTs, attrition rates were significantly higher in the placebo arms than with second-generation antipsychotics (60.2% vs 48.1%; odds ratio, 1.63; 95% confidence interval, 1.37-1.94). Within the subset of trials in which both second-generation and classical antipsychotics were used, dropout rates were significantly higher with classical antipsychotics. CONCLUSIONS: Use of a placebo-controlled design had a major effect on the dropout rates observed. Because high dropout rates affect the generalizability of such studies, it is suggested that, in addition to the PCTs, studies with alternative designs need to be considered when evaluating an antipsychotic's clinical profile.

Antipsychotic Agents↗
PubMed2005

Patient outcomes in schizophrenia I: correlates with sociodemographic variables, psychopathology, and side effects.

OBJECTIVE: The present cross-sectional study examined the relationships of psychopathology, side effects, and sociodemographic factors with treatment outcomes in terms of patients' quality of life (QOL), functioning, and needs for care. METHOD: Sixty outpatients with chronic schizophrenia who had been treated with either clozapine or olanzapine for at least 6 months were investigated. RESULTS: Most psychopathological symptoms as well as psychic side effects, weight gain, and female sex were associated with lower QOL, while cognitive symptoms correlated with better QOL. Female sex, cognitive symptoms, and parkinsonism negatively influenced occupational functioning, and negative symptoms determined a lesser likelihood of living independently. Age, education, depression/anxiety, negative symptoms, and psychic side effects were predictors of patients' needs for care. CONCLUSION: Our results highlight the complex nature of patient outcomes in schizophrenia. They reemphasize the need of targeting effectiveness, i.e. both symptomatic improvement as well as drug safety, in such patients.

Adult↗
PubMed2005

Patient outcomes in schizophrenia II: the impact of cognition.

BACKGROUND: Cognitive dysfunction is increasingly considered to be the strongest clinical predictor of poor long-term outcome in schizophrenia. Associations have been found between the severity of cognitive deficits and social dysfunction, impairments in independent living, occupational limitations, and disturbances in quality of life (QOL). METHODS: In this cross-sectional study, the relationships of cognitive deficits and treatment outcomes in terms of QOL, needs, and psychosocial functioning were examined in 60 outpatients with schizophrenia who had a duration of illness over 2 years and had been treated with either clozapine or olanzapine for at least 6 months. RESULTS: The present study suggests that cognitive functioning might be a predictor of work functioning/independent living outcome in stabilized patients with schizophrenia: deficits of visual memory and working memory were negatively associated with occupational functioning, and older patients lived independently and/or in a stable partnership more often. The patients' assessments of QOL and needs for care did not show any significant associations with cognitive functioning. DISCUSSION: These findings suggest that cognitive functioning is a key determinant of work functioning/independent living for stable outpatients with schizophrenia.

Adult↗
PubMed2005

QTc variability in schizophrenia patients treated with antipsychotics and healthy controls.

QTc prolongation is associated with the administration of some antipsychotics but the QTc interval is also known to vary physiologically. There is little published evidence about changes in QTc variability during treatment with antipsychotics. In this prospective investigation, we analyzed ECGs in 61 patients suffering from a schizophrenic disorder who were treated with different antipsychotics and 31 sex- and age-matched healthy controls. We found no differences in QTc intervals nor in QTc variability between patients and controls. Our results raise the question of the clinical relevance of a single ECG for diagnostics of cardiac complications in schizophrenia patients and suggest the need to conduct ECG monitoring in patients at high risk for cardiac complications during antipsychotic treatment.

Adult↗
PubMed2005

Osteoporosis in patients with schizophrenia.

OBJECTIVE: Osteoporosis is regularly mentioned as a possible consequence of treatment with prolactin-increasing antipsychotic medications, but little is known about the prevalence and the degree of loss of bone mineral density in patients suffering from schizophrenia. The authors' goals were to investigate the association between schizophrenia and a decrease in bone mineral density and to get more insight into potential underlying pathophysiological mechanisms. METHOD: In a cross-sectional study, the authors used dual x-ray absorptiometry to determine bone mineral density of 75 inpatients and outpatients suffering from schizophrenia. All patients had been treated with antipsychotics for at least 1 year, and only patients between the ages of 19 and 50 were studied to exclude patients with age-related idiopathic osteoporosis. RESULTS: In men but not women with schizophrenia, bone mineral density was significantly lower than normal in the lumbar region. A comparison of loss of bone mineral density in male and female patients showed significant differences between the sexes. Bone mineral density showed a negative correlation with negative symptoms and Positive and Negative Syndrome Scale total score and a positive correlation with 25-hydroxy-vitamin D3 levels and body mass index in male patients. In female patients, a positive correlation between body mass index and bone mineral density was found. Exposure to prolactin-increasing antipsychotics was not related to bone mineral density. CONCLUSIONS: The male patients with schizophrenia in this study suffered from low bone density. This finding as well as other reports lend support to directing more attention to bone metabolism in patients with schizophrenia, although there is no universally accepted screening policy to identify individuals at high risk for osteoporosis.

Absorptiometry, Photon↗
PubMed2005

Switching between second-generation antipsychotics: why and how?

The introduction of second-generation antipsychotics represents an important advance in the treatment of schizophrenia. Although these drugs are generally very effective, not all patients respond in the same way. Partial response with persistent positive and negative symptoms and residual symptoms may force physicians to change antipsychotic medication. As more and more second-generation antipsychotics are introduced, the need for practical guidelines on switching these medications becomes increasingly important. In this article we provide a short summary of the second-generation antipsychotics, focusing on efficacy, adverse effect profile and safety. Indications for switching antipsychotic medication are outlined, as well as recommendations when switching is disadvantageous. Three basic switching strategies (abrupt, gradual and overlapping switching) and their potential risks and benefits are described. We review the available evidence concerning techniques, problems and consequences when switching from one second-generation antipsychotic agent to another and discuss potential difficulties.

Antipsychotic Agents↗
PubMed2004

Hyperprolactinaemia and antipsychotic therapy in schizophrenia.

Prolactin is a polypeptide hormone that exists as a number of isoforms and is involved in a multitude of physiological processes. Prolactin secretion is promoted by various physiological stimuli and pathological processes and is inhibited by the action of dopamine on the lactotroph cells of the hypothalamus. Hyperprolactinaemia, an elevation of prolactin levels above the norm, is a physiological occurrence and is not of concern (including sexual dysfunction and decreased bone mineral density). Treatment of hyperprolactinaemia is usually confined to the removal of the primary cause of the disease, but several dopamine agonists have been investigated. Hyperprolactinaemia is also a side-effect of the conventional, and some of the second-generation, antipsychotics used in the treatment of schizophrenia. These agents rely on their dopamine antagonistic properties to provide their antipsychotic effects. However, this also removes the brake on prolactin secretion, leading to hyperprolactinaemia. While antipsychotic use has been linked to certain hyperprolactinaemia-related side-effects (sexual dysfunction), its link to others (decreased bone mineral density) has proved more controversial. The association of symptoms with antipsychotic use is further complicated by the fact that patients with schizophrenia can suffer from some of these symptoms because of the disease itself. In managing antipsychotic-induced hyperprolactinaemia, the initial step is to exclude other causes of hyperprolactinaemia while monitoring the occurrence of adverse effects. The physician should also engage in close consultation with the patient with regard to the benefits of the antipsychotic medication and the impact of any adverse effects. A regular risk-benefit discussion will allow the clinician to achieve optimal outcomes in each case.

Algorithms↗
PubMed2004

The generic alternative in schizophrenia: opportunity or threat?

Pharmacological treatment of schizophrenia often requires careful dosage titration to achieve satisfactory symptom control whilst minimising the risk of adverse effects. Relapses requiring hospitalisation are an important potential source of additional cost for the health service and any inadequate symptom control increases the indirect costs of schizophrenia relating to, for example, the need for sheltered accommodation or intensive social services support. The availability of generic drugs is widely regarded as an opportunity to reduce expenditure on drug costs and deploy limited resources more widely and effectively. However, generic drugs may differ from branded drugs in their formulation and may not show precise bioequivalence with the branded product. This may have consequences for the pharmacokinetic profile of the generic drug. A higher maximum plasma concentration (C(max)) could lead to increased or emergent adverse effects, whereas a decreased absorption or minimum plasma concentration (C(min)) may result in a reduced therapeutic effect. For example, plasma levels of clozapine are critical to therapeutic response. Symptom aggravation occurred in approximately 10% of patients switched from branded to generic clozapine in a small, randomised, crossover study. Patients with schizophrenia may also show suspicion and hostility regarding their treatment. This may result in unwillingness to take an unfamiliar medication and decreased compliance, thus increasing the risk of a relapse. Thus, great care should be taken by psychiatrists when switching patients with schizophrenia from branded to generic antipsychotic drugs; this entails monitoring clinical outcome closely and adjusting the treatment in case of symptom aggravation or emergence of adverse effects.

Antipsychotic Agents↗
PubMed2004

Compliance in schizophrenia: psychopathology, side effects, and patients' attitudes toward the illness and medication.

OBJECTIVE: In a cross-sectional study, we investigated the influence of several factors on compliance in schizophrenia outpatients, including patients' attitudes toward the illness and medication, specifically antipsychotic medication; adverse effects; and attitudes of caregivers and relatives toward the illness and medication. METHOD: Patients suffering from schizophrenia (ICD-10 diagnosis) of at least 1-year's duration whose discharge from an inpatient ward was at least 6 weeks prior to inclusion in the study were investigated. Study instruments included a semi-structured compliance interview, the Positive and Negative Syndrome Scale, the Udvalg for Klinske Undersogelser Side Effect Rating Scale, the St. Hans Rating Scale, and the Hillside Akathisia Scale. Data were collected from May 1998 to December 2001. RESULTS: 52.5% (N = 32) of the 61 investigated patients were fully compliant, 39.3% (N = 24) were partially compliant, and only 8.2% (N = 5) were noncompliant. We found positive correlations between compliance and the patients' feelings of a positive effect of the drug on the illness, between compliance and negative symptoms, and between compliance and antipsychotic-induced psychological side effects. CONCLUSION: Our findings reemphasize the importance of taking subjective attitudes and concerns of patients with respect to their illness and medication seriously. Therefore, it is indispensable to include patients and, if possible, their relatives in the treatment decision process to enhance medication compliance in schizophrenia patients.

Adult↗
PubMed2004

Quality of life in schizophrenia: the impact of psychopathology, attitude toward medication, and side effects.

BACKGROUND: Quality of life (QOL) is now seen as a key outcome variable in schizophrenia. Factors deemed relevant in this context include severity of symptoms, antipsychotic-induced side effects, sociodemographic variables, and patients' subjective response to medication. METHOD: In the current cross-sectional study, 80 patients with a schizophrenic disorder according to ICD-10 criteria who had a duration of illness over 1 year and whose discharge from an inpatient unit had been at least 6 weeks earlier were investigated. Apart from the registration of demographic data, various rating scales were used: the Positive and Negative Syndrome Scale (PANSS), the St. Hans Rating Scale for Extrapy-ramidal Syndromes, the UKU Side Effect Rating Scale, the Drug Attitude Inventory, and the Lancashire Quality of Life Profile. RESULTS: More than half of all patients (47/80) indicated that they were satisfied with their life in general. The specific areas of subjective dissatisfaction that were most commonly noted in the present sample concerned partnership and mental health. The depression/anxiety component of the PANSS, parkinsonism, and a negative attitude toward antipsychotic medication negatively influenced the patients' QOL, while cognitive symptoms and employment status correlated with higher QOL. CONCLUSION: Our results highlight the importance of recognizing the complex nature of QOL in schizophrenia patients. They suggest that special attention should be paid to patients who experience anxiety and depressive symptoms or parkinsonism, to those who are unemployed, and to those with negative feelings and attitudes toward antipsychotics.

Antipsychotic Agents↗
PubMed2003

Placebo or active control trials of antipsychotic drugs?

The placebo-controlled trial has been the standard method to demonstrate efficacy and safety of antipsychotic drugs. We reviewed the scientific and ethical advantages and disadvantages of the placebo-controlled trial and an alternative method, the active-control trial, focusing more specifically on the active-control noninferiority trial. Recent meta-analyses indicate that a therapeutic dose of second-generation antipsychotic will very likely be statistically superior to placebo in an adequate trial, and that the average improvement of schizophrenia symptoms in a placebo arm will be small. These findings strengthen the scientific and ethical justification for the active-control noninferiority trial. New drugs in the pharmacotherapy for schizophrenia are often claimed to differ from their marketed competitors in their safety profile rather than in antipsychotic efficacy. Thus, in many cases, it appears sufficient to demonstrate mere noninferiority (rather than superiority) of antipsychotic efficacy in comparison with a standard antipsychotic. The active-control noninferiority trial is suitable for such demonstration. Sample size requirements for various equivalence margins in noninferiority trials are provided. Scientific and ethical arguments should lead to a more frequent use of the active-control noninferiority trial design.

Antipsychotic Agents↗