Comparison of the Safety of Standard and Triple Dose Gadodiamide Injection in MR Imaging of the Central Nervous System

1994 ◽  
Vol 35 (4) ◽  
pp. 396-399 ◽  
Author(s):  
M. G. Svaland ◽  
T. Christensen ◽  
E. Lundorf
Keyword(s):  
Mr Imaging ◽  
Adverse Events ◽  
Contrast Enhancement ◽  
Dose Group ◽  
Serum Bilirubin ◽  
Diagnostic Yield ◽  
Blood Chemistry ◽  
New Information ◽  
Safety Parameters ◽  
The Central Nervous System

Gadodiamide injection was administered intravenously to 49 patients with known or suspected CNS lesions undergoing MR imaging. Two parallel groups were used to evaluate the efficacy and safety of single doses of 0.1 (25 patients) and 0.3 (24 patients) mmol/kg b.w. The principal measures of efficacy were diagnostic yield of MR and the overall contrast enhancement. Adverse events and serum bilirubin were the main safety parameters. Contrast enhancement of the lesion was observed for 16 patients in each dose group. Thirteen patients in the 0.1 and 17 in the 0.3 mmol/kg group had their diagnosis amended following the postcontrast image, but only one patient in each dose group had their management affected by new information from the postcontrast image. The overall diagnostic utility of gadodiamide injection was good, but there were no differences between the 2 doses studied in this respect. No injection-associated discomfort or other adverse events were reported. No clinically important changes in serum bilirubin, or other parameters of blood chemistry, or hematology were observed. Overall, the safety profile of gadodiamide injection 0.3 mmol/kg b.w. in this study was similar to that of 0.1 mmol/kg b.w.

Tolerance and Efficacy of Omniscan (Gadodiamide Injection) in MR Imaging of the Central Nervous System

1996 ◽  
Vol 37 (1P1) ◽  
pp. 223-228 ◽  
Author(s):  
S. Ekholm ◽  
E. Jonsson ◽  
L. Sandvik ◽  
M. Fagerlund ◽  
S. Holtås ◽  
...  
Keyword(s):  
Mr Imaging ◽  
Adverse Events ◽  
Contrast Medium ◽  
Standard Dose ◽  
Multicenter Trial ◽  
Outpatient Basis ◽  
Efficacy Evaluation ◽  
Before And After ◽  
The Central Nervous System ◽  
Cns Lesions

Purpose: This Swedish multicenter trial was performed on patients with known or suspected lesions of the CNS for which an MR examination using a contrast medium was indicated. A total of 8 MR centers participated in the study to establish the safety and efficacy of Omniscan (gadodiamide injection) in clinical routine using a standard dose of 0.1 mmol Gd/kg b.w. Material and Methods: Seven hundred adult patients who had been referred for MR investigation of suspected CNS lesions were included in the study. Since most patients were examined on an outpatient basis, it was decided to use an explicit questionnaire regarding adverse events that developed within 24 h after examination. The efficacy evaluation involved comparisons of detectability, delineation, and number of lesions before and after injection of Omniscan. Results: No serious or unexpected adverse event was found. There were a total of 70 (10.2%) patients with adverse events, excluding those judged not to be contrast media-related. However, only 15 patients (2.2%) had adverse events that possibly or probably were related to the contrast medium. Usually, the symptoms were headache, dizziness, abnormal taste, and nausea. Two patients complained of itching, but only one developed urticaria. The efficacy was similar to that of other currently used Gd-based MR agents. Lesions were more often seen on T2-weighted images, but the contrast medium improved lesion delineation, contributing to higher certainty in diagnosis, and provided more confidence in excluding suspected abnormality. Conclusion: Omniscan was found to be a safe and clinically valuable contrast medium for MR imaging of the CNS.

Cabergoline in the long-term therapy of hyperprolactinemic disorders

1992 ◽  
Vol 126 (6) ◽  
pp. 489-494 ◽  
Author(s):  
Carlo Ferrari ◽  
Alessandra Paracchi ◽  
Anna M Mattei ◽  
Sangrila de Vincentiis ◽  
Alberto D'Alberton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Data ◽  
Blood Chemistry ◽  
Serum Prolactin ◽  
Term Therapy ◽  
Drug Discontinuation ◽  
Complete Disappearance ◽  
Efficacy And Safety ◽  
Safety Parameters ◽  
Long Acting

The efficacy and safety of the new long-acting dopamine agonist cabergoline were evaluated in 127 hyperprolactinemic patients (124F and 3M; 71 with microprolactinoma, 14 with macroprolactinoma, 5 with operated macroprolactinoma and 37 with idiopathic disorder) who were treated with the drug for from 3 to 52 months (median, 14 months). Cabergoline was administered orally at dose levels ranging between 0.2 and 3.5mg per week, given once weekly in 92 patients, twice weekly in 22, thrice weekly in 9 and daily in 4. Serum prolactin and progesterone levels, hematology, blood chemistry and electrocardiograms were frequently evaluated throughout treatment. CT or MR imaging of the pituitary was repeated during treatment in patients with macroprolactinoma and in 38 with microprolactinoma. After drug discontinuation, serum prolactin and gonadal function were evaluated monthly for three months in 65 patients and for up to two years in 12. Serum prolactin levels were normalized in 114 patients (90%). Of 56 women with amenorrhea, 52 resumed menses (with presumptive evidence of ovulation in 49); 17 women became pregnant; and sexual potency was restored in the 3 men. Evidence of tumor shrinkage was obtained in 13 of the 14 patients with macroprolactinoma and in 28 of 38 with microprolactinoma; complete disappearance of the tumor image was achieved in 2 macro and 14 microprolactinomas. A total of 48 adverse events was reported by 29 patients (2 3%), almost all typical of the pharmacological class and mild to moderate; no patient withdrew from treatment due to adverse events. Safety parameters did not change. Following cabergoline discontinuation, prolactin levels increased slowly, being still markedly lower than pretreatment values after three months; 10 patients out of 32 had persistently normal prolactin levels during one year of follow-up. Of 28 previously amenorrheic women who resumed menses during treatment and were followed for at least six months after cabergoline withdrawal, 23 continued to have cyclic ovulatory menses. These efficacy and safety data, including those obtained on drug withdrawal, compare favorably with those reported for bromocriptine and other prolactin-lowering drugs. Because of its very simple administration schedule, which should increase patient compliance, cabergoline may become the drug of choice for hyperprolactinemic disorders.

scholarly journals Multiple Sclerosis Biomarker Discoveries by Proteomics and Metabolomics Approaches

2021 ◽  
Vol 16 ◽  
pp. 117727192110133
Author(s):  
Ameneh Jafari ◽  
Amirhesam Babajani ◽  
Mostafa Rezaei-Tavirani
Keyword(s):  
Multiple Sclerosis ◽  
Complex Disease ◽  
Biomarker Discovery ◽  
Response To Treatment ◽  
Inflammatory Disorder ◽  
Protein Marker ◽  
Complex Disorders ◽  
New Information ◽  
The Central Nervous System ◽  
Monitoring Treatment

Multiple sclerosis (MS) is an autoimmune inflammatory disorder of the central nervous system (CNS) resulting in demyelination and axonal loss in the brain and spinal cord. The precise pathogenesis and etiology of this complex disease are still a mystery. Despite many studies that have been aimed to identify biomarkers, no protein marker has yet been approved for MS. There is urgently needed for biomarkers, which could clarify pathology, monitor disease progression, response to treatment, and prognosis in MS. Proteomics and metabolomics analysis are powerful tools to identify putative and novel candidate biomarkers. Different human compartments analysis using proteomics, metabolomics, and bioinformatics approaches has generated new information for further clarification of MS pathology, elucidating the mechanisms of the disease, finding new targets, and monitoring treatment response. Overall, omics approaches can develop different therapeutic and diagnostic aspects of complex disorders such as multiple sclerosis, from biomarker discovery to personalized medicine.

Yolk–shell magnetic composite Fe3O4@Co/Zn-ZIF for MR imaging-guided chemotherapy of tumors in vivo

2021 ◽  
Author(s):  
Ying Li ◽  
Lu-Lu Jiang ◽  
Ya-Xian Qiao ◽  
Dong Wan ◽  
Yan-Feng Huang
Keyword(s):  
Mr Imaging ◽  
Contrast Enhancement ◽  
Magnetic Composite ◽  
Loading Capacity ◽  
Ph Responsive

The yolk–shell composites Fe3O4@Co/Zn-ZIF exhibited high doxorubicin loading capacity, pH-responsive release characteristics, and strong T2-weighted MR imaging contrast enhancement, and were used for MR imaging-guided chemotherapy of tumors in vivo.

scholarly journals The Diagnostic Yield of Magnetic Resonance Cholangiopancreatography in the Setting of Acute Pancreaticobiliary Disease — A Single Center Experience

2021 ◽  
pp. 084653712110137
Author(s):  
Sultan Yahya ◽  
Abdullah Alabousi ◽  
Peri Abdullah ◽  
Milita Ramonas
Keyword(s):  
Magnetic Resonance ◽  
Diagnostic Yield ◽  
Binary Logistic Regression ◽  
Magnetic Resonance Cholangiopancreatography ◽  
Significant Discrepancy ◽  
Logistic Regression Models ◽  
Single Center Experience ◽  
New Information ◽  
Clinically Significant ◽  
Enzyme Elevation

Purpose: To discern whether preceding ultrasound (US) results, patient demographics and biochemical markers can be implemented as predictors of an abnormal Magnetic Resonance Cholangiopancreatography (MRCP) study in the context of acute pancreaticobiliary disease. Methods: A retrospective study was performed assessing US results, age, gender, elevated lipase and biliary enzymes for consecutive patients who underwent an urgent MRCP following an initial US for acute pancreaticobiliary disease between January 2017-December 2018. Multivariable binary logistic regression models were constructed to assess for predictors of clinically significant MRCPs, and discrepant US/MRCP results. Results: A total of 155 patients (mean age 56, 111 females) were included. Age (OR 1.03, P < 0.05), hyperlipasemia (OR 5.33, P < 0.05) and a positive US (OR 40.75, P < 0.05) were found to be independent predictors for a subsequent abnormal MRCP. Contrarily, gender and elevated biliary enzymes were not reliable predictors of an abnormal MRCP, or significant MRCP/US discrepancies. Of 66 cases (43%) of discordant US/MRCPs, half had clinically significant discrepant findings such as newly discovered choledocholithiasis and pancreaticobiliary neoplasia. Age was the sole predictor for a significant US/MRCP discrepancy, with 2% increase in the odds of a significant discrepancy per year of increase in age. Conclusion: An abnormal US, hyperlipasemia and increased age serve as predictors for a subsequent abnormal MRCP, as opposed to gender and biliary enzyme elevation. Age was the sole predictor of a significant US/MRCP discrepancy that provided new information which significantly impacted subsequent management. In the remaining cases, however, MRCP proved useful in reaffirming the clinical diagnosis and avoiding further investigations.

scholarly journals In search of an ideal drug for safer treatment of obesity: The false promise of pseudoephedrine

2021 ◽  
Author(s):  
Antonio Munafò ◽  
Stefano Frara ◽  
Norberto Perico ◽  
Rosaria Di Mauro ◽  
Monica Cortinovis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Options ◽  
Public Health Problem ◽  
Cardiovascular Death ◽  
Regulation Of Transcription ◽  
Major Public Health Problem ◽  
Obese Patients ◽  
Ephedra Sinica ◽  
The Central Nervous System ◽  
Treatment Of Obesity

AbstractObesity is a major public health problem worldwide. Only relatively few treatment options are, at present, available for the management of obese patients. Furthermore, treatment of obesity is affected by the widespread misuse of drugs and food supplements. Ephedra sinica is an old medicinal herb, commonly used in the treatment of respiratory tract diseases. Ephedra species contain several alkaloids, including pseudoephedrine, notably endowed with indirect sympathomimetic pharmacodynamic properties. The anorexigenic effect of pseudoephedrine is attributable primarily to the inhibition of neurons located in the hypothalamic paraventricular nucleus (PVN), mediating satiety stimuli. Pseudoephedrine influences lipolysis and thermogenesis through interaction with β3 adrenergic receptors and reduces fat accumulation through down-regulation of transcription factors related to lipogenesis. However, its use is associated with adverse events that involve to a large extent the cardiovascular and the central nervous system. Adverse events of pseudoephedrine also affect the eye, the intestine, and the skin, and, of relevance, sudden cardiovascular death related to dietary supplements containing Ephedra alkaloids has also been reported. In light of the limited availability of clinical data on pseudoephedrine in obesity, along with its significantly unbalanced risk/benefit profile, as well as of the psychophysical susceptibility of obese patients, it appears reasonable to preclude the prescription of pseudoephedrine in obese patients of any order and degree.

scholarly journals 1374. Integrated Safety Summary of Omadacycline: A Novel Aminomethylcycline Antibiotic

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S421-S421 ◽  
Author(s):  
Steven Opal ◽  
Thomas M File ◽  
Tom Van Der Poll ◽  
Paul McGovern ◽  
Evan Tzanis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Fungal Infections ◽  
Vital Signs ◽  
Study Drug ◽  
Drug Discontinuation ◽  
Once Daily ◽  
Atypical Pathogens ◽  
Safety Parameters ◽  
Study Drug Discontinuation ◽  
Electrocardiogram Ecg

Abstract Background Omadacycline (OMC) is a novel aminomethylcycline with activity against Gram-positive, many Gram-negative, anaerobic, and atypical pathogens. It is in clinical development as once-daily oral (PO) and intravenous (IV) monotherapy for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Cumulative safety results from Phase 3 clinical trials are reported. Methods This pooled safety analysis is based on 2,150 subjects: OASIS-1 (N = 645), OASIS-2 (N = 735) in ABSSSI; OPTIC (N = 770) in CABP. Comparators were linezolid (LZD) 600 mg IV then PO in ABSSSI (n = 689); moxifloxacin (MOX) 400 mg IV then PO in CABP (n = 388). Safety parameters included treatment-emergent adverse events (TEAEs), laboratory evaluations, vital signs, and electrocardiogram (ECG) findings. Results A total of 1,073 subjects received OMC: 705 received OMC IV then PO (ABSSSI, n = 323; CABP, n = 382); 368 received OMC PO only for ABSSSI. Overall, 60.6% were male and 91.6% white; mean age ranges were 44.7–45.1 and 60.9–62.1 years in ABSSSI and CABP studies, respectively. TEAEs were observed in 47.5% (OMC), 41.2% (LZD), and 48.5% (MOX) of subjects, with gastrointestinal events the most common TEAEs. Serious TEAEs were low (3.6% OMC, 1.9% LZD, 6.7% MOX). Nausea (14.9% OMC, 8.7% LZD, 5.4% MOX) and vomiting (8.3% OMC, 3.9% LZD, 1.5% MOX) were the most frequently reported TEAEs. Diarrhea was observed in 2.4% OMC, 2.9% LZD, and 8.0% MOX subjects, with no cases of Clostridium difficile in OMC-treated subjects. Most TEAEs were mild to moderate and did not result in study drug discontinuation (3.1% OMC, 1.5% LZD, 7.0% MOX); 4 OMC, 1 LZD, and 0 MOX subjects discontinued for nausea and vomiting. Frequency of hepatic TEAEs was similar for OMC, LZD, and MOX: 4.3% OMC, 4.1% LZD, and 4.5% MOX subjects had post-baseline ALT &gt;3× upper limit of normal. Vital signs and ECGs had comparable clinically notable values post-baseline in each treatment group. Known tetracycline class adverse events such as fungal infections were similar in all groups. Conclusion Pooled analyses demonstrate a favorable OMC safety profile, consistent with its tetracycline heritage. OMC was generally well tolerated in subjects with ABSSSI and CABP, with infrequent treatment discontinuations. Disclosures T. M. File Jr., BioMerieux: Consultant, Consulting fee; Curetis: Consultant, Consulting fee; Melinta Therapeutics: Consultant, Consulting fee; Merck: Consultant, Consulting fee; Motif Bio: Consultant, Consulting fee; Nabriva Therapeutics: Consultant and Investigator, Consulting fee and Research grant; Paratek Pharmaceuticals: Consultant, Consulting fee; Pfizer: Consultant, Consulting fee. T. Van Der Poll, Paratek Pharmaceuticals: Consultant, Consulting fee. P. McGovern, Paratek Pharmaceuticals: Employee, Salary. E. Tzanis, Paratek Pharmaceuticals: Employee, Salary.

Effect of Cotherapy Reduction on Tolerability of Epilepsy Add-On Therapy: A Randomized Controlled Trial

2005 ◽  
Vol 39 (3) ◽  
pp. 418-423 ◽  
Author(s):  
Dean K Naritoku ◽  
Joseph F Hulihan ◽  
Lesley Kraut Schwarzman ◽  
Marc Kamin ◽  
William H Olson
Keyword(s):  
Adverse Events ◽  
Dose Group ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Primary Study ◽  
Open Label ◽  
Open Label Study ◽  
Effective Doses ◽  
Receive Treatment ◽  
To Receive

BACKGROUND: Adverse effects are the most common cause for failure of an antiepileptic drug (AED), especially when an AED is added to existing therapy. With the increased drug load, it may not be possible to titrate the newly added AED to effective doses. Reducing the dosage of AED cotherapy as the new drug is introduced may improve tolerability. OBJECTIVE: To evaluate reduction of AED cotherapy as a strategy to improve tolerability and patient retention when a new AED is added to existing therapy. METHODS: In a 20-week, randomized, open-label study, topiramate was initiated as add-on therapy in adults and adolescents (⩾12 y of age) with inadequately controlled partial-onset seizures. Patients were randomized to receive treatment in which adverse events could be managed by adjustments in AED cotherapy (flex-dose group) or treatment in which AED cotherapy dosages remained fixed (fixed-dose group). Topiramate could be adjusted as needed in both groups. In the flex-dose group, patients exited randomized treatment when topiramate was discontinued. In the fixed-dose group, patients exited when AED cotherapy was reduced due to adverse events or when topiramate was discontinued. The primary study outcome was the percentage of patients exiting randomized treatment due to adverse events. RESULTS: The flex-dose group comprised 297 patients; 302 patients were in the fixed-dose group. Significantly fewer patients in the flex-dose group exited the study due to adverse events (16% vs 23% in the fixed-dose group; p = 0.02). In the flex-dose group, 10% (17 of 168) of patients discontinued topiramate due to adverse events after AED cotherapy was reduced versus 22% (29 of 129) when AED cotherapy was not reduced. CONCLUSIONS: Reduction of AED cotherapy is a useful strategy to improve tolerability and retention when topiramate is initiated as adjunctive therapy.

scholarly journals Carbon dioxide versus room air insufflation during balloon-assisted enteroscopy: A systematic review with meta-analysis

2017 ◽  
Vol 05 (01) ◽  
pp. E67-E75 ◽  
Author(s):  
Ashok Shiani ◽  
Seth Lipka ◽  
Andrew Lai ◽  
Andrea Rodriguez ◽  
Christian Andrade ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Systematic Review ◽  
Adverse Events ◽  
Diagnostic Yield ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Insertion Depth ◽  
Co2 Insufflation ◽  
Air Insufflation

Abstract Background and study aims Carbon dioxide (CO2) insufflation has been suggested to be an ideal alternative to room air insufflation to reduce trapped air within the bowel lumen after balloon assisted enteroscopy (BAE). We performed a systematic review and meta-analysis to assess the safety and efficacy of utilizing CO2 insufflation as compared to room air during BAE. Patients and methods The primary outcome is mean change in visual analog scale (VAS; 10 cm) at 1, 3, and 6 hours to assess pain. Secondary outcomes include insertion depth (anterograde or retrograde), adverse events, total enteroscopy rate, diagnostic yield, mean anesthetic dosage, and PaCO2 at procedure completion. We searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until May 2015. Multiple independent extractions were performed, the process was executed as per the standards of the Cochrane collaboration. Results Four randomized controlled trials (RCTs) were included in the meta-analysis. VAS at 6 hours favored CO2 over room air (MD 0.13; 95 % CI 0.01, 0.25; p = 0.03). Anterograde insertion depth (cm) was improved in the CO2 group (MD, 58.2; 95 % CI 17.17, 99.23; p = 0.005), with an improvement in total enteroscopy rate in the CO2 group (RR 1.91; 95 % CI 1.20, 3.06; p = 0.007). Mean dose of propofol (mg) favored CO2 compared to air (MD, – 70.53; 95 % CI – 115.07, – 25.98; P = 0.002). There were no differences in adverse events in either group. Conclusions Despite the ability of CO2 to improve insertion depth and decrease amount of anesthesia required, further randomized control trials are needed to determine the agent of choice for insufflation in balloon assisted enteroscopy.

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