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Cinda Van Lierop - One of the best experts on this subject based on the ideXlab platform.
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risk management strategies in the postmarketing period safety experience with the us and european bosentan Surveillance programmes
Drug Safety, 2005Co-Authors: Eleano S Segal, Cecile Valette, Laurence Oste, Luc Ouley, Catarina Edfjall, Pete Herrma, Massimo Raineri, Mary Kempff, Saundra Eacham, Cinda Van LieropAbstract:In view of the shortcomings of the current system for postmarketing Drug Surveillance that is based on voluntary spontaneous adverse Drug reaction (ADR) reporting, new approaches are needed.
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risk management strategies in the postmarketing period safety experience with the us and european bosentan Surveillance programmes
Drug Safety, 2005Co-Authors: Eleano S Segal, Cecile Valette, Catarina Edfjall, Massimo Raineri, Mary Kempff, Laurence Oster, Luc Bouley, Peter Herrmann, Saundra Beacham, Cinda Van LieropAbstract:In view of the shortcomings of the current system for postmarketing Drug Surveillance that is based on voluntary spontaneous adverse Drug reaction (ADR) reporting, new approaches are needed. We describe an approach involving a combination of limited distribution, patient and physician education, as well as a novel pharmacovigilance system that is capable of promoting the safe and adequate use of a new Drug. Importantly, it provides the possibility of calculating true ADR occurrence rates, as the exposed population (denominator) and the number of patients with events (numerator) are known. These measures were taken for the oral dual endothelin ETA/ETB antagonist bosentan (Tracleer®). In recent guidelines issued by the European Society of Cardiology, American College of Chest Physicians and the WHO, this Drug is considered as first-line oral treatment for the treatment of pulmonary arterial hypertension, a devastating orphan disease associated with a poor prognosis. Bosentan was approved in 2001/2 on the basis of two pivotal studies that showed improved exercise capacity and haemodynamic parameters while delaying time to clinical worsening. Elevations in serum liver aminotransferase levels of >3 times the upper limit of normal were noted in 10.2% of patients (placebo-subtracted incidence). Therefore, liver function tests have to be performed on a regular basis. In addition, bosentan has potential as a teratogen. In the US, a controlled distribution network for bosentan (Tracleer® Access Program [T.A.P.]) and the development of a patient database to follow patients was set up. Accompanied by comprehensive physician and patient education programmes, T.A.P. was developed to provide a mechanism to assist with the primary risk management goals for bosentan therapy, namely pregnancy prevention and liver enzyme monitoring and prevention of hepatic injury. In Europe, the Tracleer® Excellence (TRAX PMS) database is a novel European non-interventional, prospective, internet-based Surveillance system initiated by the manufacturer in cooperation with the European Medicines Agency. It collected potential safety signals associated with bosentan use including adverse events, elevations of liver aminotransferase levels, other abnormal laboratory values, death and hospitalisation. TRAX PMS has accrued 79% of all known patients in the EU and the data provide supportive ‘real-life’ evidence on the long-term safety of bosentan. The two different systems had similar goals and outcomes. The data received concerning thousands of patient-years of use have confirmed the clinical trial results regarding product safety and the favourable benefit/risk ratio of bosentan, especially with regard to known type A adverse events. The clinical monitoring algorithm has also been confirmed. In addition, no rare type B events were uncovered despite the increased reporting rate. These systems might serve as templates for future pharmacovigilance efforts regarding Drugs that require particular safety attention.
R Grohmann - One of the best experts on this subject based on the ideXlab platform.
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Galactorrhea during antipsychotic treatment: results from AMSP, a Drug Surveillance program, between 1993 and 2015
European Archives of Psychiatry and Clinical Neuroscience, 2021Co-Authors: C. Glocker, R Grohmann, R. Engel, J. Seifert, S. Bleich, S. Stübner, S. Toto, C. SchüleAbstract:Galactorrhea is a well-known adverse Drug reaction (ADR) of numerous antipsychotic Drugs (APD) and is often distressing for those affected. Methodological problems in the existing literature make it difficult to determine the prevalence of symptomatic hyperprolactinemia in persons treated with APDs. Consequently, a large sample of patients exposed to APDs is needed for more extensive evaluation. Data on APD utilization and reports of galactorrhea caused by APDs were analyzed using data from an observational pharmacovigilance program in German-speaking countries—Arzneimittelsicherheit in der Psychiatrie (AMSP)—from 1993 to 2015. 320,383 patients (175,884 female inpatients) under Surveillance were treated with APDs for schizophrenia and other indications. A total of 170 events of galactorrhea caused by APDs were identified (0.97 cases in 1000 female inpatient admissions). Most cases occurred during the reproductive age with the highest incidence among patients between 16 and 30 years (3.81 cases in 1000 inpatients). The APDs that were most frequently imputed alone for inducing galactorrhea were risperidone (52 cases and 0.19% of all exposed inpatients), amisulpride (30 resp. 0.48%), and olanzapine (13 resp. 0.05%). In three cases, quetiapine had a prominent role as a probable cause for galactorrhea. High dosages of the imputed APDs correlated with higher rates of galactorrhea. Galactorrhea is a severe and underestimated condition in psychopharmacology. While some APDs are more likely to cause galactorrhea, we identified a few unusual cases. This highlights the importance of alertness in clinical practice and of taking a patient’s individual situation into consideration.
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age and adverse Drug reactions from psychopharmacological treatment data from the amsp Drug Surveillance programme in switzerland
Swiss Medical Weekly, 2013Co-Authors: W Greil, R Grohmann, T Schuhmann, Anne Haberle, P BaumannAbstract:Summary QUESTION UNDER STUDY: The frequency of severe adverse Drug reactions (ADRs) from psychotropic Drugs was investigated in hospitalised psychiatric patients in relation to their age. Specifically, the incidence of ADRs in patients up to 60 years was compared to that of patients older than 60 years. METHODS: Prescription rates of psychotropic Drugs and reports of severe ADRs were collected in psychiatric hospitals in Switzerland between 2001 and 2010. The data stem from the Drug Surveillance programme AMSP. RESULTS: A total of 699 patients exhibited severe ADRs: 517 out of 28,282 patients up to 60 years (1.8%); 182 out of 11,446 elderly patients (1.6%, ns). Logistic regression analyses showed a significantly negative relationship between the incidence of ADRs and patients’ age in general and in particular for weight gain, extrapyramidal motor system (EPMS) symptoms, increased liver enzymes and galactorrhoea. A significantly negative relationship was observed for age and the dosages of olanzapine, quetiapine, risperidone, valproic acid and lamotrigine. When comparing age groups, frequency of ADRs was lower in general for antipsychotic Drugs and anticonvulsants, in particular for valproic acid in the elderly. Weight gain was found to be lower in the elderly for antipsychotic Drugs, in particular for olanzapine. For the group of mood-stabilising anticonvulsants (carbamazepine, lamotrigine and valproic acid) the elderly exhibited a lower incidence of reported allergic skin reactions. CONCLUSION: The results suggest that for psychiatric inpatients the incidence of common severe ADRs (e.g., weight gain or EPMS symptoms) arising from psychotropic medication decreases with the age of patients.
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682 age and adverse effects of psychopharmacological treatment data from the Drug Surveillance program amsp in switzerland
European Psychiatry, 2013Co-Authors: W Greil, R Grohmann, A Haeberle, T Schuhmann, P BaumannAbstract:Objectives and aims The frequency of severe adverse Drug reactions (ADR) of psychotropic Drugs in relation to age is investigated and especially the incidence in hospitalized patients aged up to 60 years is compared with patients aged above 60 years. Methods The data - prescription rates of psychotropic Drugs, reports of severe ADR - are taken from psychiatric hospitals in Switzerland between 2001 to 2010 and stem from the Drug Surveillance program AMSP. Results 699 patients exhibited severe ADR: 517 out of 28282 patients up to 60 years (1.8%); 182 out of 11446 elderly patients (1.6%, ns). Linear regression analyses show a significantly decreasing relationship between the incidence of ADR and patients’ age in general and in particular for weight gain, EPMS symptoms, increased liver enzymes and galactorrhoea. Delirium increases with age. A significantly decreasing relationship was observed for age and the dosages of olanzapine, quetiapine, risperidone, valproic acid and lamotrigine. Comparing age groups, lower frequency of ADR in general was found for antipsychotic Drugs and anticonvulsants, in particular also for valproic acid in the elderly. Weight gain was found to be lower in the eldery for antipsychotic Drugs, in particular also for olanzapine. For the group of mood stabilizing anticonvulsants (carbamazepine, lamotrigine and valproic acid) the elderly exhibited a lower incidence of reported allergic skin reactions. Conclusion The results suggest that in hospitalized patients the incidence of common severe adverse effects such as weight gain and EPMS symptoms as a consequence to psychotropic medication decreases with age.
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hyponatraemia during psychopharmacological treatment results of a Drug Surveillance programme
The International Journal of Neuropsychopharmacology, 2012Co-Authors: Martin Letmaier, Annamaria Painold, Anna K Holl, Hartmut Vergin, Rolf R Engel, A Konstantinidis, Siegfried Kasper, R GrohmannAbstract:Hyponatraemia (HN) can be a life-threatening medical condition which may lead to severe neurological and psychiatric symptoms. The AMSP (Arzneimittelsicherheit in der Psychiatrie) is a multicentre Drug Surveillance programme that assesses severe or new adverse Drug reactions during psychopharmaco- logical treatment in psychiatric inpatients. We report on a total of 263 864 psychiatric inpatients monitored from 1993 to 2007 in 80 psychiatric hospitals in Germany, Switzerland and Austria. During this period plasma sodium levels below 130 mmol/l (severe HN according to AMSP) were reported in 93 patients (relative frequency 0.04 %). On average, the plasma sodium levels of all cases were 119.7 mmol/l (i5.8 S.D.) ; median 121 mmol/l (range 104-129 mmol/l). Patients who showed no clinical signs (n=65, 70 %) had a mean sodium level of 121.3 mmol/l (i5.0 S.D.) ; median 122 mmol/l (range 114-129 mmol/l). By contrast, patients with clinical symptoms (n=28, 30 %) had a mean sodium level of 116.0 mmol/l (i6.0 S.D.) ; median 117 mmol/l (range 104-125 mmol/l). HN was mainly observed during treatment with selective serotonin reuptake inhibitors (SSRIs) (0.06 %), Serotonin noradrenaline reuptake inhibitors (SNRIs) (0.08 %), carbamazepine (0.10 %) and oxcarbazepine (1.29 %) ; the highest rate was found for ox- carbazepine. Antipsychotics, mirtazapine and tricyclic antidepressants were only rarely involved in HN (0.003-0.005 %). Combinations of several Drugs known to induce HN significantly increased the risk of HN, e.g. more than 10-fold for SSRI+diuretics+ACE inhibitors (0.37 %) vs. SSRI given alone (0.02 %). This is clinically relevant because such combinations, e.g. SSRI+diuretics may occur especially in elderly patients, who are in general at higher risk of developing HN.
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the amup study for Drug Surveillance in psychiatry a summary of inpatient data
Pharmacopsychiatry, 2004Co-Authors: R Grohmann, Hanns Hippius, Hanfried Helmchen, E Ruther, L G SchmidtAbstract:From 1979 to 1989 the AMUP study (AMUP = Arzneimitteluberwachung in der Psychiatrie) was conducted in two psychiatric hospitals in Germany with the aim to provide a systematic and standardized assessment of all adverse reactions to psychotropic Drugs under conditions of routine practice. A total of 60.7 % of patients experienced at least one adverse Drug reaction (ADR) with probable or definite causality during their stay in the hospital; 37.1 % of patients exhibited ADRs that had some therapeutic impact on further treatment. ADRs that led to Drug discontinuation were observed in 8.6 %. This rate ranged from 9.5 to 5.1 % for haloperidol and perazine, the most common neuroleptics at that time; sedating antidepressants (AD) rated lower than non-sedating (amitriptyline 5.1 %, clomipramine 10.4 %). Lithium salts, antiparkinson Drugs, and benzodiazepines were associated with considerably lower rates of ADRs than neuroleptics or antidepressants. Severe ADRs occurred in 1.4 % of exposed patients (e. g., toxic delirium, grand mal seizures, malignant neuroleptic syndrome, or agranulocytosis). The AMUP data suggest that administration of psychotropic Drugs in psychiatric hospitals at that time was a safe, but also inconvenient treatment for many patients due to a wide range of bothersome side effects that compromised patient compliance. The data can serve as a reference base for comparisons with newer compounds introduced to the market over the last decade such as serotonin reuptake inhibitors (SSRIs) and other new AD, atypical neuroleptics, or other new generation psychotropic Drugs.
Sunil Parikh - One of the best experts on this subject based on the ideXlab platform.
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molecular Surveillance of antimalarial partner Drug resistance in sub saharan africa a spatial temporal evidence mapping study
The Lancet Microbe, 2020Co-Authors: Hanna Y Ehrlich, Justin Jones, Sunil ParikhAbstract:Background Molecular markers for antimalarial Drug resistance can be used to rapidly monitor the emergence and spatial distribution of resistance to artemisinin-based combination therapies (ACTs). Little has been done to analyse molecular Surveillance efforts or to assess Surveillance coverage. This study aimed to develop an evidence map to characterise the spatial-temporal distribution and sampling methodologies of Drug resistance Surveillance in sub-Saharan Africa, specifically focusing on markers associated with ACT partner Drugs. Methods By use of a systematic search, we identified studies that reported data on the following mutations associated with ACT partner Drug resistance: pfmdr1 Asn86Tyr, Tyr184Phe, Asp1246Tyr, and copy number variation and pfcrt Lys76Thr, with sample collection occurring in sub-Saharan Africa between Jan 1, 2004, and Dec 31, 2018, corresponding to the uptake of ACTs. For each identified study, we extracted information on its sampling and laboratory methods, author and publication affiliations, years of sampling and of publication, geographic coordinates of the study sites, and prevalence of the partner Drug resistance-associated markers. We used linear models to test whether urbanicity, population density, and endemicity were predictors of Drug resistance survey sites and linear regressions to identify associations between the number of resistance surveys within a given country and the at-risk malaria population in 2010, the per-capita GDP in 2010, and the mean amount of funding directed to malaria and to determine trends in marker prevalence over time. For country case studies with three or more datapoints, we assessed global spatial autocorrelation using Moran's I. Findings Our search yielded 254 studies encompassing 492 year-specific and location-specific surveys from 35 malaria-endemic countries, the most complete set of molecular partner Drug Surveillance data to date. We observed a median time lag of 3·1 years (95% CI 1·0-7·7) from final sample acquisition to publication. 22 (49%) of the 44 countries in the study region conducted, on average, one or fewer studies every 3 years. The locations of Surveillance sites were positively associated with urbanicity (p<0·0001), and the abundance of country-level data was associated with reported donor funding in 2004-18 (p=0·0011) and local government funding in 2004-09 (p=0·014). Nearly all molecular markers displayed significant regional trends over time and global spatial autocorrelation in space. For selected countries with more widespread coverage of Surveillance data, some markers also displayed spatial heterogeneity. Interpretation In most sub-Saharan countries, molecular data on antimalarial resistance might not be representative of the temporal and geographic heterogeneity of partner Drug resistance, and likely do not represent the true spatially dependent distribution of partner Drug resistance. Our results highlight several inefficiencies that can be improved upon to develop more accurate data landscapes, including the expansion of sentinel Surveillance systems, syndemic usage of research samples, and increased participation in reporting published and unpublished data to centralised platforms.
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molecular Surveillance of antimalarial partner Drug resistance in sub saharan africa a spatial temporal evidence mapping study
Social Science Research Network, 2020Co-Authors: Hanna Y Ehrlich, Justin Jones, Sunil ParikhAbstract:Background: Molecular markers for antimalarial Drug resistance can be used to rapidly monitor the emergence and spatial distribution of resistance to artemisinin-based combination therapies (ACTs). There has been little effort to analyze molecular Surveillance efforts or to standardize data collection and management strategies. This study develops an evidence map to characterize the spatial-temporal distribution and sampling methodologies on partner Drug resistance Surveillance in sub-Saharan Africa. Methods: Through a systematic search, we identified studies that reported data on the following partner Drug resistance-associated mutations: pfmdr1 N86Y, Y184F, D1246Y, or pfcrt K76T, with sample collection occurring in sub-Saharan Africa from 2004–2018, corresponding to the uptake of ACTs. We examined trends associated with Surveillance and transmission of partner Drug resistance. Findings: Our search yielded a total of 254 studies encompassing 501 year- and location-specific surveys from 35 malaria endemic countries, the most complete set of molecular partner Drug Surveillance data to date. We observed an average time lag of 3·2 years from sample acquisition to publication. Over half of the countries in the study region conducted only a single survey, on average, every 3–4 years. The amount of Surveillance data per country was positively associated with reported donor funding. Drug resistance survey sites were 5.6 times as likely to be located in urban areas than malaria prevalence surveys. In countries where data was acquired in a more spatially representative pattern, heterogeneity in molecular marker prevalence was evident across time and space. Interpretation: In the majority of sub-Saharan countries, molecular data on antimalarial resistance remains temporally and geographically limited, likely failing to represent the true heterogeneous distribution of partner Drug resistance. We discuss several inefficiencies in Surveillance efforts that can be improved upon to develop more accurate data landscapes. Funding Statement: HYE was supported by the NIH Ruth L. Kirschstein National Research Service Award (F31AI150168). Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: Not required.
P Baumann - One of the best experts on this subject based on the ideXlab platform.
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age and adverse Drug reactions from psychopharmacological treatment data from the amsp Drug Surveillance programme in switzerland
Swiss Medical Weekly, 2013Co-Authors: W Greil, R Grohmann, T Schuhmann, Anne Haberle, P BaumannAbstract:Summary QUESTION UNDER STUDY: The frequency of severe adverse Drug reactions (ADRs) from psychotropic Drugs was investigated in hospitalised psychiatric patients in relation to their age. Specifically, the incidence of ADRs in patients up to 60 years was compared to that of patients older than 60 years. METHODS: Prescription rates of psychotropic Drugs and reports of severe ADRs were collected in psychiatric hospitals in Switzerland between 2001 and 2010. The data stem from the Drug Surveillance programme AMSP. RESULTS: A total of 699 patients exhibited severe ADRs: 517 out of 28,282 patients up to 60 years (1.8%); 182 out of 11,446 elderly patients (1.6%, ns). Logistic regression analyses showed a significantly negative relationship between the incidence of ADRs and patients’ age in general and in particular for weight gain, extrapyramidal motor system (EPMS) symptoms, increased liver enzymes and galactorrhoea. A significantly negative relationship was observed for age and the dosages of olanzapine, quetiapine, risperidone, valproic acid and lamotrigine. When comparing age groups, frequency of ADRs was lower in general for antipsychotic Drugs and anticonvulsants, in particular for valproic acid in the elderly. Weight gain was found to be lower in the elderly for antipsychotic Drugs, in particular for olanzapine. For the group of mood-stabilising anticonvulsants (carbamazepine, lamotrigine and valproic acid) the elderly exhibited a lower incidence of reported allergic skin reactions. CONCLUSION: The results suggest that for psychiatric inpatients the incidence of common severe ADRs (e.g., weight gain or EPMS symptoms) arising from psychotropic medication decreases with the age of patients.
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682 age and adverse effects of psychopharmacological treatment data from the Drug Surveillance program amsp in switzerland
European Psychiatry, 2013Co-Authors: W Greil, R Grohmann, A Haeberle, T Schuhmann, P BaumannAbstract:Objectives and aims The frequency of severe adverse Drug reactions (ADR) of psychotropic Drugs in relation to age is investigated and especially the incidence in hospitalized patients aged up to 60 years is compared with patients aged above 60 years. Methods The data - prescription rates of psychotropic Drugs, reports of severe ADR - are taken from psychiatric hospitals in Switzerland between 2001 to 2010 and stem from the Drug Surveillance program AMSP. Results 699 patients exhibited severe ADR: 517 out of 28282 patients up to 60 years (1.8%); 182 out of 11446 elderly patients (1.6%, ns). Linear regression analyses show a significantly decreasing relationship between the incidence of ADR and patients’ age in general and in particular for weight gain, EPMS symptoms, increased liver enzymes and galactorrhoea. Delirium increases with age. A significantly decreasing relationship was observed for age and the dosages of olanzapine, quetiapine, risperidone, valproic acid and lamotrigine. Comparing age groups, lower frequency of ADR in general was found for antipsychotic Drugs and anticonvulsants, in particular also for valproic acid in the elderly. Weight gain was found to be lower in the eldery for antipsychotic Drugs, in particular also for olanzapine. For the group of mood stabilizing anticonvulsants (carbamazepine, lamotrigine and valproic acid) the elderly exhibited a lower incidence of reported allergic skin reactions. Conclusion The results suggest that in hospitalized patients the incidence of common severe adverse effects such as weight gain and EPMS symptoms as a consequence to psychotropic medication decreases with age.
Eleano S Segal - One of the best experts on this subject based on the ideXlab platform.
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risk management strategies in the postmarketing period safety experience with the us and european bosentan Surveillance programmes
Drug Safety, 2005Co-Authors: Eleano S Segal, Cecile Valette, Laurence Oste, Luc Ouley, Catarina Edfjall, Pete Herrma, Massimo Raineri, Mary Kempff, Saundra Eacham, Cinda Van LieropAbstract:In view of the shortcomings of the current system for postmarketing Drug Surveillance that is based on voluntary spontaneous adverse Drug reaction (ADR) reporting, new approaches are needed.
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risk management strategies in the postmarketing period safety experience with the us and european bosentan Surveillance programmes
Drug Safety, 2005Co-Authors: Eleano S Segal, Cecile Valette, Catarina Edfjall, Massimo Raineri, Mary Kempff, Laurence Oster, Luc Bouley, Peter Herrmann, Saundra Beacham, Cinda Van LieropAbstract:In view of the shortcomings of the current system for postmarketing Drug Surveillance that is based on voluntary spontaneous adverse Drug reaction (ADR) reporting, new approaches are needed. We describe an approach involving a combination of limited distribution, patient and physician education, as well as a novel pharmacovigilance system that is capable of promoting the safe and adequate use of a new Drug. Importantly, it provides the possibility of calculating true ADR occurrence rates, as the exposed population (denominator) and the number of patients with events (numerator) are known. These measures were taken for the oral dual endothelin ETA/ETB antagonist bosentan (Tracleer®). In recent guidelines issued by the European Society of Cardiology, American College of Chest Physicians and the WHO, this Drug is considered as first-line oral treatment for the treatment of pulmonary arterial hypertension, a devastating orphan disease associated with a poor prognosis. Bosentan was approved in 2001/2 on the basis of two pivotal studies that showed improved exercise capacity and haemodynamic parameters while delaying time to clinical worsening. Elevations in serum liver aminotransferase levels of >3 times the upper limit of normal were noted in 10.2% of patients (placebo-subtracted incidence). Therefore, liver function tests have to be performed on a regular basis. In addition, bosentan has potential as a teratogen. In the US, a controlled distribution network for bosentan (Tracleer® Access Program [T.A.P.]) and the development of a patient database to follow patients was set up. Accompanied by comprehensive physician and patient education programmes, T.A.P. was developed to provide a mechanism to assist with the primary risk management goals for bosentan therapy, namely pregnancy prevention and liver enzyme monitoring and prevention of hepatic injury. In Europe, the Tracleer® Excellence (TRAX PMS) database is a novel European non-interventional, prospective, internet-based Surveillance system initiated by the manufacturer in cooperation with the European Medicines Agency. It collected potential safety signals associated with bosentan use including adverse events, elevations of liver aminotransferase levels, other abnormal laboratory values, death and hospitalisation. TRAX PMS has accrued 79% of all known patients in the EU and the data provide supportive ‘real-life’ evidence on the long-term safety of bosentan. The two different systems had similar goals and outcomes. The data received concerning thousands of patient-years of use have confirmed the clinical trial results regarding product safety and the favourable benefit/risk ratio of bosentan, especially with regard to known type A adverse events. The clinical monitoring algorithm has also been confirmed. In addition, no rare type B events were uncovered despite the increased reporting rate. These systems might serve as templates for future pharmacovigilance efforts regarding Drugs that require particular safety attention.
