Generic Substitution of Antiepileptic Drugs: A Systematic Review of Prospective and Retrospective Studies

2011 ◽  
Vol 45 (11) ◽  
pp. 1406-1415 ◽  
Author(s):  
Mikiko Yamada ◽  
Timothy E Welty

Objective: To systematically review the literature on generic antiepileptic drugs (AEDs), evaluate the efficacy and safety of generic AED substitution, and perform pharmacokinetic (PK) analysis using the American Academy of Neurology (AAN) scheme to classify evidence. Data Sources: PubMed and Cumulative Index to Nursing and Allied Health Literature searches from January 1, 1980, to October 15, 2010, were performed using the search terms anticonvulsant, antiepileptic drug, carbamazepine, divalproex, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phénobarbital, Phenytoin, primidone, topiramate, valproate, valproic acid, and zonisamide; bioavailability, bioequivalence, bioequivalency, bioequivalent, and substitution; and generic. Study Selection and Data Extraction: Retrospective and prospective controlled studies of generic substitution of AEDs were included in the review. Non-English-language articles and uncontrolled clinical studies were excluded, Published articles were categorized using the AAN criteria for systematic reviews. Data Synthesis: We identified 156 articles. Of these, 20 met our inclusion criteria; 7 were retrospective studies, 6 were prospective studies in patients with epilepsy, and 7 were prospective studies in healthy subjects. All articles were rated Class I to Class III, using AAN criteria. The retrospective studies were categorized as Class III and showed a significant relationship between generic substitution and increased use of health care resources because of seizures or AED toxicity. Prospective studies were categorized as Class I, II, and III. Prospective studies in patients showed no differences between brand and generic drugs in PK parameters of bioequivalence. Three prospective studies in healthy subjects reported significant differences in maximum drug concentrations. Comparison of brand and generic drugs revealed no significant difference in seizure frequency; however, some prospective studies showed significant differences in PK parameters, primarily those not used for bioequivalence determinations. Conclusions: There is inconsistency between retrospective and prospective studies of generic AED substitution. The highest levels of evidence indicate that there should not be a problem with generic substitution, although some patients are more prone to problems with the generic products. Some evidence suggests that switches between multiple generic AED products in certain individuals may be problematic.

2019 ◽  
Vol 9 (1) ◽  
pp. 59-62
Author(s):  
Manju Bajracharya ◽  
Sunanda Sundas ◽  
Resina Pradhan ◽  
Surendra Maharjan

Introduction: this study was carried to understand Prevalence of malocclusion among the school children of Kathmandu, Sorakhutte residing near school during mixed dentition period. A sample of 600 children ; 365 male, 235 female in age group of 6-13yrs was selected randomly from different school of Kathmandu city. The aim of our study is to find out prevalence of malocclusion among the mixed detention children of Kathmandu. Materials & Method: Data was collected using direct observation of the subjects, Descriptive cross-sectional study method was used in this research. Occlusal assessment were done according to angle’s classification and dewey’s modification type of class I, class III malocclusion. Result: Subjects with normal occlusion was found to be 59.3% and with malocclusion was found to 40.7%. Among them class I malocclusion was majority of (57%) of study population, crowded incisors and significant difference was observed between male and female in the study. Conclusion: This study helps to access the prevalence malocclusion and need of orthodontic treatment for the mixed dentition period children.


2016 ◽  
Vol 21 (5) ◽  
pp. 67-74 ◽  
Author(s):  
Waqar Jeelani ◽  
◽  
Mubassar Fida ◽  
Attiya Shaikh ◽  
◽  
...  

ABSTRACT Introduction: Pubertal growth peak is closely associated with a rapid increase in mandibular length and offers a wide range of therapeutic modifiability. Objective: The aim of the present study was to determine and compare the mean ages of onset and duration of pubertal growth peak among three skeletal classes. Methods: A retrospective cross-sectional study was conducted using lateral cephalograms of 230 subjects with growth potential (110 males, 120 females). Subjects were categorized into three classes (Class I = 81, Class II = 82, Class III = 67), according to the sagittal relationship established between the maxilla and the mandible. The cervical vertebral maturation stage was recorded by means of Baccetti's method. The mean ages at CS3 and CS4 and the CS3-CS4 age interval were compared between boys and girls and among three skeletal classes. Results: Pubertal growth peak occurred on average four months earlier in girls than boys (p = 0.050). The average duration of pubertal growth peak was 11 months in Class I, seven months in Class II and 17 months in Class III subjects. Interclass differences were highly significant (Cohen's d > 0.08). However, no significant difference was found in the timing of pubertal growth peak onset among three skeletal classes (p = 0.126 in boys, p = 0.262 in girls). Conclusions: Girls enter pubertal growth peak on average four months earlier than boys. Moreover, the duration of pubertal growth peak is on average four months shorter in Class II and six months longer in Class III subjects as compared to Class I subjects.


2012 ◽  
Vol 46 (2) ◽  
pp. 303-304
Author(s):  
J. J. Gagne ◽  
J. Avorn ◽  
W. H. Shrank ◽  
S. Schneeweiss

2017 ◽  
Vol 3 (2) ◽  
pp. 40-54
Author(s):  
Kedar Bahadur Rayamajhi

Stress is the mental phenomenon; caused from the various environmental factors. The main aim of this study is to explore relationship between the role-stress and mental health of government officer working under the different ministries of Nepal. The study was conducted among the 284 government officers comprising level I to III. Standard structured questionnaires were used to measure the role-stress and mental health. The study found that there was no significant difference between position regarding the impact of organizational role stress on their mental and physical health. There was no significant difference found between the class I and III at P = 1.000 followed by class I and II at P = 1.000 and class III and class II at P = 1.000. Data shows that perception of mental and physical health has no different on the basis of their position and job roles. The study observed that there is relationship between the role-stress and mental health. If role stress increased then it negatively effect in mental health. Government employee reported the effect of role stress in their daily life but study has not found the serious effect of role stress in mental health of employees because of their practices of coping mechanism. So, there is need to explore their coping mechanism to manage the stress.  Journal of Advanced Academic Research Vol. 3, No. 2, 2016, Page: 40-54


2021 ◽  
Vol 10 (23) ◽  
pp. 5644
Author(s):  
Yu-Chuan Tseng ◽  
Shih-Wei Liang ◽  
Szu-Ting Chou ◽  
Shih-Chieh Chen ◽  
Chin-Yun Pan ◽  
...  

This study investigated the relationship between the thickness of the ramus and skeletal patterns using cone-beam computed tomography (CBCT) for sagittal split ramus osteotomy. Ninety participants were categorized into three skeletal patterns (Class I, Class II, and Class III). The first vertical slice (slice 0) was observed in the intact mandibular canal, and then moved forward to 40 mm (slice 21) with a 2 mm interval. The thickness of buccal bone marrow (B value) was measured. A B value of ≤0.8 mm was considered to be the major risk factor causing the occurrence of postoperative lower lip paresthesia. There were 461 sides with a B value of ≤0.8 mm. There was a significant difference in the skeletal patterns [Class III (198 sides: 15.7%) > Class I (159 sides: 12.6%) > Class II (104 sides: 8.3%)]. Class II participants had significantly larger B values (2.14 to 3.76 mm) and a lower occurrence rate (≤0.8 mm) than those of Class III participants (1.5 to 3 mm) in front of the mandibular foramen (from 6 mm to 20 mm). Class III participants had significantly shorter buccal bone marrow distance and a higher occurrence rate of B values (≤0.8 mm) than Class II.


2015 ◽  
Vol 5 ◽  
pp. 255-261
Author(s):  
D. K. Mahamad Iqbal ◽  
Vivek B. Amin ◽  
Rohan Mascarenhas ◽  
Akther Husain

Objective The objectives of this study were to determine the thickness of skull bones, namely frontal, parietal, and occipital bones in Class I, Class II, and Class III patients. Materials and Methods Three hundred subjects who reported to the Department of Orthodontics requiring orthodontic treatment within the age group 17-35 were selected for the study. They were subdivided into three groups of 100 each according to the skeletal and dental relation. Profile radiographs were taken and the tracings were then scanned, and uploaded to the MATLAB 7.6.0 (R 2008a) software. The total surface areas of the individual bones were estimated by the software, which represented the thickness of each bone. Result Frontal bone was the thickest in Class III malocclusion group and the thinnest in Class II malocclusion group. But the parietal and occipital bone thickness were not significant. During gender differentiation in Class I, malocclusion group frontal bone thickness was more in males than females, In Class II, malocclusion parietal bone thickness was more in males than females. No statistically significant difference exists between genders, in Class III malocclusion group. During inter-comparison, the frontal bone thickness was significant when compared with Class I and Class II malocclusion groups and Class II and Class III malocclusion groups. Conclusion The differences in skull thickness in various malocclusions can be used as an adjunct in diagnosis and treatment planning for orthodontic patients. It was found that the new method (MATLAB 7.6.0 [R 2008a] software) of measuring skull thickness was easier, faster, precise, and accurate.


Author(s):  
Bharat Kumar ◽  
Muhammad Abbas ◽  
Asma Naz ◽  
Naresh Kumar ◽  
Shahid Ali ◽  
...  

Objective: The objective of this study was to evaluate the mean distance between the vibrating line and fovea palatinae in Class I, Class II and Class III Soft Palate types. Methodology: This study was conducted at Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences Karachi among 197patients. Duration of study was six months. All patients were examined for vibrating line clinically, assessed using phonation method. Subsequently, distance between vibrating line and fovea paltatinae was measured with uncalibrated compass in various contours of soft palate. Results: Out of 197 patient, the vibrating line was seen in130 (64%) anterior to fovea palatinae, whereas, 67 (34%) vibrating line was at the fovea palatinae. The mean distance of those anterior located vibrating line from fovea palatine was calculated as 2.13 (±0.82) mm in Class, 2.07 (±0.69) mm in Class II and 1.80 (±0.82) mm in Class III soft palate contours. Statistical analysis showed no significant between gender, while statistically significant difference among age group and mean distance of anterior located vibrating line from fovea palatinae were found. Conclusions: The mean distance of vibrating line which is predominately found anterior to the fovea palatinae was 2.07 (±0.77) mm.


Author(s):  
INES DALLEL ◽  
SANA KANOUN ◽  
MARIEM NAHDI ◽  
MONCEF OMMEZINE ◽  
SAMIR TOBJI ◽  
...  

Objective: The aim of this study was to evaluate the association of the skeletal pattern and angle class with the occlusal plane (OP). This study also examined the effect of orthodontic treatment on this plane. Methods: Lateral cephalometric radiographs of a sample of 135 patients were collected. The angles between the Frankfort horizontal, palatal plane (PP), mandibular plane (MP), and the OP were analyzed and compared between several groups and subsequently before and after treatment. Results: The statistical comparison between 3 skeletal frame groups demonstrates that the cant of the OP showed a major difference. This difference was greater in class III subjects. Examination revealed that the OP was not meaningfully affected within the Angle classification. Statistically, a significant correlation was found between OP steepness and the vertical skeletal pattern. A significant rise of OP/sella-nasion (SN) for class I (p=0.019) and II (p=0.015) after orthodontic treatment. In addition, patients treated with elastics showed a significant decrease of OP/MP (mandibular plane) in Angle class III and considerable increase of OP/SN and OP/PP in Angle class II. Observations of the group treated with bimaxillary extractions showed that OP/SN (sella nasion line) and OP/PP differ in a meaningful way. Conclusion: This study confirms the association between the skeletal pattern and the OP inclination in adults. Concerning the Angle classification, there was no significant difference between the groups. Orthodontic therapy had an influence on the inclination of this plane for the different malocclusions. Premolars extraction in class I cases significantly modified the OP. For class II and III malocclusions, the OP inclination was mainly altered by the use of intermaxillary traction elastics.


2018 ◽  
Vol 7 (2) ◽  
pp. 9-14
Author(s):  
Rajiv Kumar Mishra ◽  
Om Prakash Kharbanda ◽  
Rajiv Balachandran

Introduction: Evaluation of temporo-mandibular joint (TMJ) anatomy and function is an essential part of orthodontic diagnosis and treatment planning. It has been hypothesized that dental and skeletal malocclusions alter the functional loading of TMJ which can affect joint morphology.Objective: Three dimensional (3D) evaluation of condylar position using CBCT in skeletal Class I and Class III growing subjects.Materials & Method: CBCT images of ten growing skeletal Class I & ten Class III patients in the age range of 7-14 years were analyzed. 3D condylar position were evaluated representing antero-posterior, vertical, laterolateral position of condyle, axial condylar angle and coronal condylar angles which were measured in axial, coronal and sagittal sections using Dolphin Imaging software. Antero-posterior and vertical difference of right and left condyle were measured in axial and coronal sections respectively.Result: Paired t-Test revealed no significant difference between right and left sides of condyle in skeletal Class I as well as Class III subjects. Independent t-test and Mann-Whitney U test showed no significant difference between position of condyle in ClassI and Class III subjects.Conclusion: 3D CBCT analysis shows no significant difference in condylar position of skeletal Class I and Class III subjects.


2021 ◽  
Author(s):  
Roberto L. Velásquez ◽  
Jorge C. Coro ◽  
José M. Bustillo ◽  
Sadao Sato

ABSTRACT Objectives To evaluate the horizontal condylar angle (HCA) in mandibular lateral displacement (MLD). Materials and Method s: HCA in MLD malocclusions were examined using cone-beam computed tomography data in subjects with MLD and control subjects. Results HCA in joints of control patients and contralateral side joints of MLD patients were not significantly different. The mean HCA on the shifted side was larger than on the contralateral side (P < .001) in the different HCA groups. HCA was significantly larger on the shifted side than on the contralateral side in skeletal Class I, Class II, and Class III groups (P < .001). Conclusions (1) There was no statistically significant difference between HCA in control patients and on the contralateral side in MLD patients. (2) HCA was significantly larger on the shifted side than on the contralateral side. (3) HCA on the shifted side and the contralateral side in MLD Class I, Class II, and Class III are significantly different.


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