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An evaluation of the cardiovascular safety profile of duloxetine: findings from 42 placebo-controlled studies. 总被引:3,自引:0,他引:3
Joachim Wernicke Alberto Lledó Joel Raskin Daniel K Kajdasz Fujun Wang 《Drug safety》2007,30(5):437-455
BACKGROUND AND OBJECTIVE: In recent years, new classes of medication, such as the serotonin-noradrenaline reuptake inhibitors (SNRIs), have been developed for use in the treatment of major depressive disorder (MDD). For many years, treatment options were largely limited to the use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). However, there have been published reports of orthostatic hypotension, arrhythmias and corrected QT (QTc) interval changes in patients treated with TCAs. As new medications become available, it is important to understand how their cardiovascular safety profile compares with that of more established agents to aid clinicians and patients in choosing the best treatment options. This study was designed to evaluate the cardiovascular safety profile of the SNRI duloxetine through evaluation of cardiovascular-related parameters and adverse events (AEs). METHODS: The cardiovascular safety of duloxetine was assessed using all placebo-controlled duloxetine clinical trial data as of December 2005. This consisted of data from 42 placebo-controlled clinical trials of 8504 patients who were treated with duloxetine. Additional information from a high-dose clinical pharmacology study and postmarketing safety surveillance are also presented. Of the placebo-controlled trials included in this analysis, clinical indications under investigation included MDD (15 studies), diabetic peripheral neuropathic pain (3 studies), fibromyalgia (2 studies), generalised anxiety disorder (3 studies) and lower urinary tract disorders (19 studies, all related to incontinence). Cardiovascular safety was evaluated based on vital signs, ECGs and the incidence of treatment-emergent AEs potentially related to cardiovascular safety. These safety parameters were analysed across all indications. To identify both serious and non-serious cardiovascular-related AEs, as well as AEs reported as the reason for discontinuation, a comprehensive list of terms derived from the Medical Dictionary for Regulatory Activities (version 8.0) was generated and used to search the duloxetine databases for cardiovascular-related events. RESULTS: Calculation of change from baseline to maximum in ECG parameters showed significant differences between treatment groups for all parameters, with decreases from baseline in RR, QRS and QT intervals for patients receiving duloxetine and increases from baseline for patients treated with placebo. These shifts were related to small heart rate changes, but the mean differences were not considered clinically relevant. Categorical analyses of shifts from normal to abnormal (or abnormal to normal) for heart rate and QT corrected for heart rate using Fridericia's formula (QTcF) values showed that most patients did not shift from their baseline category. Patients with MDD who were treated for up to 1 year with duloxetine had blood pressure changes early in treatment that then stabilised. Even in patients with elevated blood pressure at baseline in these clinical trials, no increased risk of sustained blood pressure elevation with duloxetine treatment was found. CONCLUSION: Overall, the findings presented here support our conclusions that use of duloxetine does not appear to be associated with significant cardiovascular risks in patients with conditions for which the drug has been approved or studied. 相似文献
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Risperidone is a new benzisoxazole derivative displaying a very potent serotonin antagonism and a potent dopamine antagonism in pharmacological studies. These properties suggest the hypothesis that risperidone may exert antipsychotic effects and be superior to classic neuroleptics in its beneficial effects on negative and affective symptoms and its low extrapyramidal side-effect propensity. In an open pilot study 13 patients suffering from acute schizophrenic psychosis were treated with risperidone within an individually adapted dose range from 1 to 10 mg per day. A good antipsychotic efficacy could be demonstrated in 6 of the 8 patients who completed the trial. Risperidone was very well tolerated. The substance possesses a low EPS-inducing profile. Future research has to test the suggested advantage of risperidone over other neuroleptic drugs and its performance in the treatment of chronic schizophrenic patients. 相似文献
5.
AG Nettetal 《MedR Medizinrecht》2007,25(11):664-666
Abstrakt 1. Nimmt ein Patient einen ihm von seinem (Zahn-)Arzt einger?umten Exklusiv-Termin nicht wahr, obwohl er auf dessen Eigenschaft
ausdrücklich hingewiesen wurde, so hat er dem (Zahn-)Arzt den Behandlungsausfall abzüglich eines angemessenen Eigenanteils
des (Zahn-)Arztes zu ersetzen.
2. Die Ersatzpflicht tritt auch dann ein, wenn der Patient den Termin nicht in der in dem Behandlungsvertrag vorgesehenen
Frist absagt. Eine hierfür seitens des (Zahn-)Arztes bestimmte Frist von zwei Tagen vor Behandlungsbeginn stellt sich für
den Patienten grunds?tzlich auch nicht als unangemessene Benachteiligung i.S. des § 307 BGB dar.
3. Ein Anspruch des Arztes entf?llt auch bei nur mündlicher Vereinbarung nicht unter dem Gesichtspunkt des § 4 Abs. 5b BMV-Z,
denn diese Vorschrift ist teleologisch dahin zu reduzieren, dass nur zahn?rztliche Honoraransprüche aus erfolgten Behandlungen
schriftlich vereinbart werden müssen. Soweit es jedoch um einen vertraglichen Anspruch wegen einer Leistungsst?rung geht,
vermag das Schriftformerfordernis des § 4 Abs. 5b BMV-Z grunds?tzlich nicht einzugreifen. (Leits?tze des Bearbeiters) 相似文献
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Early during rat thymus ontogeny, an important proportion of thymocytes
expresses IL-2R and contains IL-2 mRNA. To investigate the role of the
IL-2-IL-2R complex in rat T cell maturation, we supplied either recombinant
rat IL-2 or blocking anti-CD25 mAb to rat fetal thymus organ cultures
(FTOC) under several experimental conditions. The IL-2 treatment initially
stimulated the growth of thymocytes and, as a result, induced T cell
differentiation, but the continuous addition of IL-2 to rat FTOC, as well
as the anti-CD25 administration, resulted in cell number decrease and
inhibition of thymocyte maturation. These results indicate that immature
rat thymocytes bear functional high- affinity IL-2R and that IL-2 promotes
T cell differentiation as a consequence of its capacity to stimulate cell
proliferation. Modifications in TCR alpha beta repertoire and increased
numbers of NKR- P1+ cells, largely NK cells, were also observed in
IL-2-treated FTOC. Furthermore, IL-2-responsiveness of different thymocyte
subsets changed throughout thymic ontogeny. Immature CD4-CD8-cells
responded to IL-2 in two stages, early in thymus development and around
birth, in correlation with the maturation of two distinct waves of thymic
cell progenitors. Mature CD8+ thymocytes maximally responded to IL-2 around
birth, supporting a role for IL-2 in the increased proliferation of mature
thymocytes observed in vivo in the perinatal period. Taken together, these
findings support a role for IL-2 in rat T cell development.
相似文献
9.
Ghosh D; Stewart DR; Nayak NR; Lasley BL; Overstreet JW; Hendrickx AG; Sengupta J 《Human reproduction (Oxford, England)》1997,12(5):914-920
The present study was undertaken to assess the temporal association between
the profiles of serum concentrations of oestradiol-17beta, progesterone,
chorionic gonadotrophin (CG) and relaxin in pregnancies established
naturally, and after embryo transfer, as well as in failed pregnancies in
rhesus monkeys. In naturally mated cycles (group 1) a conception rate of
75% was obtained. In group 1, the mean day of CG detection in serum was
11.5 +/- 1.9 day post-ovulation, and for relaxin, 9.0 +/- 2.5 day
post-ovulation. In group 2, embryo transfer to synchronous, non-mated
surrogate recipients was performed; seven embryo transfer cycles yielded
three pregnancies which were allowed to continue to term and normal infants
were delivered. In embryo transfer cycles the mean day of CG detection was
14.8 +/- 1.8 day post- ovulation, and for relaxin, 11.4 +/- 2.6 day
post-ovulation. A delay of about 3 days was observed in the appearance in
circulation of CG (P < 0.05) and also of relaxin (P < 0.05) between
natural mated and embryo transfer conception cycles. Significant
differences (P < 0.05 for progesterone and P < 0.03 for oestradiol)
were obtained for the areas under the curves for progesterone and
oestradiol between days 12 and 16 in conception cycles compared with failed
pregnancies. These data provide the first observation of the normal
hormonal signals associated with maternal recognition of transferred
embryos during the peri- implantation period, and suggest that the use of
such an experimental primate embryo transfer model may help to elucidate
components of maternal and embryonic signal-response mechanisms during
embryo implantation.
相似文献
10.
A rapid microagglutination test for the diagnosis of Legionella pneumophila (serogroup 1) infection 总被引:4,自引:3,他引:4 下载免费PDF全文
A rapid microagglutination test has been developed which can be performed in 30 minutes. Ninety-seven percent of 96 patients diagnosed as having Legionella pneumophila (serogroup 1) infection by indirect immunofluorescence were also detected by the rapid microagglutination test. 相似文献