scholarly journals Safety and cardiovascular effects of multiple-dose administration of aripiprazole and olanzapine in a randomised clinical trial

2020 ◽  
Author(s):  
Dora Koller ◽  
Susana Almenara ◽  
Gina Mejia ◽  
Miriam Saiz-Rodriguez ◽  
Pablo Zubiaur ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adverse Events ◽  
Diastolic Blood Pressure ◽  
Adverse Drug Reactions ◽  
Plasma Concentrations ◽  
Cardiovascular Effects ◽  
Randomised Clinical Trial ◽  
Drug Reactions ◽  
The Difference

Objective: To assess adverse events and safety of aripiprazole and olanzapine treatment. Methods: Twenty-four healthy volunteers receiving 5 daily oral doses of 10 mg aripiprazole and 5 mg olanzapine in a crossover clinical trial were genotyped for 46 polymorphisms in 14 genes by qPCR. Drug plasma concentrations were measured by HPLC-MS/MS. Blood pressure and 12-lead ECG were measured in supine position. Adverse events were also recorded. Results: Aripiprazole decreased diastolic blood pressure on the first day and decreased QTc on the third and fifth day. Olanzapine had a systolic and diastolic blood pressure, heart rate and QTc lowering effect on the first day. Polymorphisms in ADRA2A, COMT, DRD3 and HTR2A genes were significantly associated to these changes. The most frequent adverse drug reactions to aripiprazole were somnolence, headache, insomnia, dizziness, restlessness, palpitations, akathisia and nausea while were somnolence, dizziness, asthenia, constipation, dry mouth, headache and nausea to olanzapine. Additionally, HTR2A, HTR2C, DRD2, DRD3, OPRM1, UGT1A1 and CYP1A2 polymorphisms had a role in the development of adverse drug reactions. Conclusions: Olanzapine induced more cardiovascular changes; however, more adverse drug reactions were registered to aripiprazole. In addition, some polymorphisms may explain the difference in the incidence of these effects among subjects.

scholarly journals Cardiovascular Effects of Sedative Infusions of Propofol and Midazolam after Spinal Anaesthesia

1988 ◽  
Vol 16 (3) ◽  
pp. 292-298 ◽  
Author(s):  
D. W. Blake ◽  
G. Donnan ◽  
J. Novella ◽  
C. Hackman
Keyword(s):  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Spinal Anaesthesia ◽  
Forearm Blood Flow ◽  
Recovery Period ◽  
Cardiovascular Effects ◽  
Pelvic Surgery ◽  
Control Group ◽  
Intravenous Sedation ◽  
The Difference

The cardiovascular effects of intravenous sedation were studied in fifty patients after spinal anaesthesia for lower limb or pelvic surgery. Twenty patients received propofol (mean dosage 74 (SD 4) μg/kg/min for 0–20 minutes and 51 (SD 7) μg/kg/min for 20–40 minutes), twenty received midazolam (35 μg/kg + 2.54 (SD 0.2) μg/kg/min for 0–20 minutes and 1.35 (SD 0.2) μg/kg/min for 20–40 minutes) and ten patients received saline infusion only. The forearm vasoconstriction in response to the spinal anaesthesia was measured by strain gauge plethysmography. Spinal anaesthesia lowered systolic and diastolic blood pressure by 18 (SED 4) mmHg and 9 (SED 2) mmHg respectively. (SED = standard error of the difference.) This was associated with a 32% decrease in mean forearm blood flow. Propofol and midazolam caused similar additional reductions in systolic and diastolic blood pressure (10 (SED 4) mmHg and 4 (SED 2) mmHg) and a decrease in heart rate (P< 0.005), but forearm vasoconstriction was not altered. In the control group, however, forearm vasoconstriction increased during 40 minutes in theatre (P<0.05). Recovery from propofol was far more rapid than after midazolam and was virtually complete in ten minutes. This was reflected by an increase in blood pressure and in forearm vasoconstriction in the recovery period.

scholarly journals Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica

2010 ◽  
Vol 3 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Zhao-Xiang Bian ◽  
Hao-Yao Tian ◽  
Lin Gao ◽  
Hong-Cai Shang ◽  
Tai-Xiang Wu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Chinese Materia Medica ◽  
Materia Medica

A device employing a neural network for blood pressure estimation from the oscillatory pressure pulse wave and PPG signal

Sensor Review ◽  
2021 ◽  
Vol 41 (1) ◽  
pp. 74-86
Author(s):  
Jian Tian ◽  
Jiangan Xie ◽  
Zhonghua He ◽  
Qianfeng Ma ◽  
Xiuxin Wang
Keyword(s):  
Neural Network ◽  
Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Pressure Pulse ◽  
Pulse Wave ◽  
Content Type ◽  
The Neural Network ◽  
The Difference ◽  
Oscillatory Pressure ◽  
Mercury Sphygmomanometer

Purpose Wrist-cuff oscillometric blood pressure monitors are very popular in the portable medical device market. However, its accuracy has always been controversial. In addition to the oscillatory pressure pulse wave, the finger photoplethysmography (PPG) can provide information on blood pressure changes. A blood pressure measurement system integrating the information of pressure pulse wave and the finger PPG may improve measurement accuracy. Additionally, a neural network can synthesize the information of different types of signals and approximate the complex nonlinear relationship between inputs and outputs. The purpose of this study is to verify the hypothesis that a wrist-cuff device using a neural network for blood pressure estimation from both the oscillatory pressure pulse wave and PPG signal may improve the accuracy. Design/methodology/approach A PPG sensor was integrated into a wrist blood pressure monitor, so the finger PPG and the oscillatory pressure wave could be detected at the same time during the measurement. After the peak detection, curves were fitted to the data of pressure pulse amplitude and PPG pulse amplitude versus time. A genetic algorithm-back propagation neural network was constructed. Parameters of the curves were inputted into the neural network, the outputs of which were the measurement values of blood pressure. Blood pressure measurements of 145 subjects were obtained using a mercury sphygmomanometer, the developed device with the neural network algorithm and an Omron HEM-6111 blood pressure monitor for comparison. Findings For the systolic blood pressure (SBP), the difference between the proposed device and the mercury sphygmomanometer is 0.0062 ± 2.55 mmHg (mean ± SD) and the difference between the Omron device and the mercury sphygmomanometer is 1.13 ± 9.48 mmHg. The difference in diastolic blood pressure between the mercury sphygmomanometer and the proposed device was 0.28 ± 2.99 mmHg. The difference in diastolic blood pressure between the mercury sphygmomanometer and Omron HEM-6111 was −3.37 ± 7.53 mmHg. Originality/value Although the difference in the SBP error between the proposed device and Omron HEM-6111 was not remarkable, there was a significant difference between the proposed device and Omron HEM-6111 in the diastolic blood pressure error. The developed device showed an improved performance. This study was an attempt to enhance the accuracy of wrist-cuff oscillometric blood pressure monitors by using the finger PPG and the neural network. The hardware framework constructed in this study can improve the conventional wrist oscillometric sphygmomanometer and may be used for continuous measurement of blood pressure.

Abstract 17638: Systemic Cardiovascular Effects of Intravenous Urocortin 2 and Urocortin 3 in Patients with Heart Failure and Healthy Volunteers

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Colin G Stirrat ◽  
Sowmya Venkatasubramanian ◽  
Tania Pawade ◽  
Andrew Mitchell ◽  
Anoop Shah ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Cardiac Index ◽  
Healthy Volunteers ◽  
Diastolic Blood Pressure ◽  
Cardiovascular Effects ◽  
Peripheral Vascular ◽  
Patients With Heart Failure ◽  
Group A ◽  
Urocortin 3

Introduction: Urocortin 2 (UCN 2) and urocortin 3 (UCN 3) are endogenous peptide hormones with an emerging role in the pathophysiology and treatment of heart failure. For the first time, we examined the systemic cardiovascular effects of both UCN 2 and UCN 3 in healthy volunteers and patients with heart failure. Methods: Seven healthy volunteers (Group A) and nine patients with stable chronic heart failure (Group B, New York Heart Association class II and III, left ventricular ejection fraction <35%) on optimal medical therapy underwent non-invasive oscillometric sphygmomanometry and impedance cardiography during incremental intravenous infusions of sodium nitroprusside (0.15/0.5/1.5 μg/kg/min), UCN 2 (0.16/0.48/1.6 μg/min), UCN 3 (5/15/50 μg/min) and saline placebo in a randomised double blind two-way cross over study. Results: Other than diastolic blood pressure (78 vs 72 mmHg for Group A and B respectively, p<0.05), haemodynamic variables were similar at baseline of each infusion and were unchanged by saline placebo infusion (p>0.05 for all). SNP, UCN2 and UCN 3 infusions increased heart rate and cardiac index, and reduced systolic and diastolic blood pressure and peripheral vascular resistance index (PVRI) in both healthy volunteers and patients with heart failure (p<0.05 for all; see Figure 1). There were no significant differences in the changes in cardiac index or PVRI between healthy volunteers and patients with heart failure during either UCN 2 or UCN 3 infusions (p>0.05). Conclusion: Intravenous UCN 2 and especially UCN 3 increase cardiac output and reduce peripheral vascular resistance. This favourable haemodynamic profile suggests that UCN 2 and UCN 3 hold exciting therapeutic potential for the treatment of acute heart failure.

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

scholarly journals Evaluation of the Cardiovascular Effects of Clonidine in Neonates Treated for Neonatal Abstinence Syndrome

2018 ◽  
Vol 23 (6) ◽  
pp. 473-478
Author(s):  
Raymond P. Meddock ◽  
Deirdre Bloemer
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Diastolic Blood Pressure ◽  
Neonatal Intensive Care ◽  
Dose Range ◽  
Safety Data ◽  
Cardiovascular Effects ◽  
Neonatal Abstinence Syndrome ◽  
Abstinence Syndrome

OBJECTIVES Neonatal abstinence syndrome (NAS) is characterized by withdrawal symptoms in neonates exposed to legal or illegal substances in utero, and it is often managed with medications such as opiates, phenobarbital, and clonidine. Clonidine use is increasing, but further safety data regarding its use in neonates are warranted. This study evaluated the effects of clonidine on heart rate and blood pressure in neonates treated for NAS at doses up to 24 mcg/kg/day. METHODS A retrospective review via the electronic medical record of infants at least 35 weeks' gestation treated adjunctively with clonidine for NAS in the neonatal intensive care unit at St Elizabeth was conducted. Heart rate, and systolic and diastolic blood pressure were recorded at baseline, while on different dose ranges of clonidine (small: ≤1.5 mcg/kg per dose every 3 hours; medium: &gt;1.5 to 2 mcg/kg per dose every 3 hours; and large: &gt;2 mcg/kg to 3 mcg/kg per dose every 3 hours), and upon discontinuation. RESULTS A total of 64 infants treated with clonidine for NAS between August 2015 and December 2016 were included. Heart rate decreased in all clonidine dose ranges compared with baseline (average reduction of 7 bpm [CI: −12 to −2], 9 bpm [CI: −16 to −2], and 10 bpm [CI: −18 to −1] for the small, medium, and large dose ranges, respectively; p &lt; 0.0001). Systolic and diastolic blood pressure were not significantly different from baseline when infants were receiving any dose of clonidine, except diastolic blood pressure while on medium–dose range clonidine, where diastolic blood pressure was higher than baseline (p = 0.0128). Increases in systolic and diastolic blood pressure were evident upon discontinuation of clonidine (p &lt; 0.0001 and p = 0.0156, respectively). CONCLUSIONS Clonidine doses up to 24 mcg/kg/day are well tolerated in neonates ≥35 weeks' gestation treated for NAS. Any decreases in heart rate are likely clinically insignificant, and increases in blood pressure upon discontinuing clonidine are mild and may be mitigated further with extended discontinuation protocols. Further trials should be conducted to evaluate the long-term safety of clonidine in this population.

scholarly journals NEUROPSYCHIATRIC ADVERSE EFFECTS OF ANTIBACTERIAL AGENTS

2021 ◽  
pp. 1-8
Author(s):  
SANTA TREASA CYRIAC ◽  
DIVYA SARA IYPE
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Bacterial Growth ◽  
Antibacterial Agents ◽  
Acute Psychosis ◽  
Drug Reactions ◽  
Medical Practitioners ◽  
General Management ◽  
Neuropsychiatric Adverse Effects

Anti-bacterial are agents that inhibit bacterial growth or kills bacteria and are a sub-type of antimicrobials. These are drugs used to treat infections, but they sometimes pose a threat of adverse events. Some of these adverse events are neuropsychiatric, which are generally hard to diagnose and is often paid less attention. They account for about 30% of total Adverse drug reactions (ADRs) caused by drugs in patients without mental abnormalities. The spectrum ranges from episodes of seizure to acute psychosis. The article emphasizes the frequency of such adverse events and means to raise awareness among medical practitioners regarding the same. The various neuropsychiatric adverse effects and the agents responsible have been reviewed, along with their possible mechanisms and general management. The information for writing this review was selected by searching for keywords such as Neurotoxicity, GABA, Psychosis, Naranjo scale, and Antibiomania in databases such as Google Scholar, PubMed, Elsevier, etc. After searching the articles in the above-mentioned databases, the articles were screened concerning their importance with our work and according to their title and abstract. Additional articles were discovered by checking the references in the current study's citations. Using this method, the various neuropsychiatric adverse effects of Antibacterial agents were summarized in this review.

scholarly journals Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults

2020 ◽  
Author(s):  
A. J. Berenstein ◽  
N. Falk ◽  
G. Moscatelli ◽  
S. Moroni ◽  
N. González ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Chagas Disease ◽  
Adverse Drug Reactions ◽  
Drug Tolerance ◽  
Drug Reactions ◽  
Safety Concerns ◽  
Scarce Data

BACKGROUND: Nifurtimox (NF) is one of the only two drugs currently available for Chagas disease (ChD) treatment. However, there is scarce data on NF safety, and many physicians defer or refuse NF treatment because of concerns about drug tolerance. METHODS: Retrospective study of adverse drug reactions (ADRs) associated with NF treatment of ChD. Children received NF doses of 10-15 mg/kg/day for 60-90 days, and adults 8-10 mg/kg/day for 30 days. Results: 215 children (median age: 2.6yrs, range 0-17) and 105 adults (median age: 34yrs, range 18-57) were enrolled. Overall, 127/320 (39.7%) patients developed ADRs, with an incidence of 64/105 in adults, and 63/215 in children (OR = 3.7, 95%CI [2.2;6.3]). We observed 215 ADRs, 131 in adults (median: 2 events/patient (IQR25-75= 1-3) and 84 in children (median: 1 event/patient (IQR25-75= 1-1.5) (PAdjusted < 0.001). ADRs were mainly mild and moderate. Severe ADRs were infrequent (1.2% in children and 0.9% in adults). Nutritional, central nervous and digestive systems were the most frequently affected, without differences between both groups. Treatment was discontinued in 31/320 (9.7%) patients without differences between groups. However, ADR-related discontinuations occurred more frequently in adults than in children (OR = 5.5, 95%CI = [1.5;24]). CONCLUSIONS: Our study supports the safety of NF for ChD treatment. Delaying NF treatment due to safety concerns does not seem to be supported by the evidence.

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