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

2012 ◽  
Vol 46 (2) ◽  
pp. 303-304
Author(s):  
J. J. Gagne ◽  
J. Avorn ◽  
W. H. Shrank ◽  
S. Schneeweiss
Keyword(s):  
Systematic Review ◽  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Retrospective Studies

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
Keyword(s):  
Antiepileptic Drugs ◽  
Prospective Studies ◽  
Healthy Subjects ◽  
Generic Substitution ◽  
Retrospective Studies ◽  
Generic Drugs ◽  
Class I ◽  
Class Iii ◽  
Drug Concentrations ◽  
Significant Difference

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.

Crizotinib Versus Chemotherapy on ALK-positive NSCLC: A Systematic Review of Efficacy and Safety

2018 ◽  
Vol 19 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Mingxia Wang ◽  
Guanqi Wang ◽  
Haiyan Ma ◽  
Baoen Shan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Retrospective Studies ◽  
Response Rate ◽  
Objective Response ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Alk Positive

Introduction: Crizotinib was approved to treat anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) by the Food and Drug Administration in 2011.We conducted a systematic review of clinical trials and retrospective studies to compare the efficacy and safety of crizotinib with chemotherapy. </P><P> Methods: We searched electronic databases from inception to Dec. 2016. Clinical trials and retrospective studies regarding crizotinib and crizotinib versus chemotherapy in treatment of NSCLC were eligible. The primary outcomes were the objective response rate (ORR) and disease control rate (DCR). Results: Nine studies (five clinical trials and four retrospective studies) including 729 patients met the inclusion criteria. Crizotinib treatment revealed 1-year OS of 77.1% and PFS of 9.17 months. And crizotinib had a better performance than chemotherapy in ORR (OR: 4.97, 95%CI: 3.16 to 7.83, P<0.00001, I2=35%). DCR revealed superiority with crizotinib than chemotherapy (OR: 3.42, 95% CI: 2.33 to 5.01, P<0.00001, I2=0%). PR (partial response) were significant superior to that of chemotherapy through direct systematic review. No statistically significant difference in CR (complete response) was found between crizotinib-treated group and chemotherapy-treated group. Regarding SD (stable disease), chemotherapy-treated group had a better performance than crizotinib-treated group. Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, nausea, and hematologic toxicity. This systematic review revealed improved objective response rate and increased disease control rate in crizotinib group comparing with chemotherapy group. Crizotinib treatment would be a favorable treatment option for patients with ALK-positive NSCLC. ALK inhibitors may have future potential applications in other cancers driven by ALK or c-MET gene mutations.

The effects of antiepileptic drugs on bone health: A systematic review

2021 ◽  
Vol 173 ◽  
pp. 106619
Author(s):  
Daniel W. Griepp ◽  
David J. Kim ◽  
Marc Ganz ◽  
Eugene J. Dolphin ◽  
Nadia Sotudeh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Antiepileptic Drugs ◽  
Bone Health

scholarly journals Synthetic bone graft versus autograft or allograft for spinal fusion: a systematic review

2016 ◽  
Vol 25 (4) ◽  
pp. 509-516 ◽  
Author(s):  
Zorica Buser ◽  
Darrel S. Brodke ◽  
Jim A. Youssef ◽  
Hans-Joerg Meisel ◽  
Sue Lynn Myhre ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Bone Graft ◽  
Spinal Fusion ◽  
Comparative Studies ◽  
Functional Outcomes ◽  
Retrospective Studies ◽  
Synthetic Bone ◽  
Synthetic Bone Graft ◽  
Bone Graft Substitutes

The purpose of this review was to compare the efficacy and safety of synthetic bone graft substitutes versus autograft or allograft for the treatment of lumbar and cervical spinal degenerative diseases. Multiple major medical reference databases were searched for studies that evaluated spinal fusion using synthetic bone graft substitutes (either alone or with an autograft or allograft) compared with autograft and allograft. Randomized controlled trials (RCT) and cohort studies with more than 10 patients were included. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. The search yielded 214 citations with 27 studies that met the inclusion criteria. For the patients with lumbar spinal degenerative disease, data from 19 comparative studies were included: 3 RCTs, 12 prospective, and 4 retrospective studies. Hydroxyapatite (HA), HA+collagen, β-tricalcium phosphate (β-TCP), calcium sulfate, or polymethylmethacrylate (PMMA) were used. Overall, there were no differences between the treatment groups in terms of fusion, functional outcomes, or complications, except in 1 study that found higher rates of HA graft absorption. For the patients with cervical degenerative conditions, data from 8 comparative studies were included: 4 RCTs and 4 cohort studies (1 prospective and 3 retrospective studies). Synthetic grafts included HA, β-TCP/HA, PMMA, and biocompatible osteoconductive polymer (BOP). The PMMA and BOP grafts led to lower fusion rates, and PMMA, HA, and BOP had greater risks of graft fragmentation, settling, and instrumentation problems compared with iliac crest bone graft. The overall quality of evidence evaluating the potential use and superiority of the synthetic biological materials for lumbar and cervical fusion in this systematic review was low or insufficient, largely due to the high potential for bias and small sample sizes. Thus, definitive conclusions or recommendations regarding the use of these synthetic materials should be made cautiously and within the context of the limitations of the evidence.

Pharmacy and Generic Substitution of Antiepileptic Drugs: Missing in Action?

2007 ◽  
Vol 41 (6) ◽  
pp. 1065-1068 ◽  
Author(s):  
Timothy E Welty
Keyword(s):  
Decision Making ◽  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Careful Consideration ◽  
Professional Organizations ◽  
Missing In Action

Generic substitution of antiepileptic drugs is an issue that is gathering a lot of attention in the neurology community but is not receiving much attention within pharmacy. Several proposals have been drafted that restrict a pharmacist's decision-making in generic substitution. These proposals highlight concerns about the pharmacy community related to generic substitution. Careful consideration needs to be given to these issues by pharmacists and pharmacy professional organizations. Unless pharmacy as a profession takes strong positions in support of a pharmacist's ability to make decisions about pharmacotherapy and addresses many of the pharmacy-related problems of generic substitution, policies that negatively impact pharmacy will be established.

scholarly journals Iridoplasty for plateau iris syndrome: a systematic review

2019 ◽  
Vol 4 (1) ◽  
pp. e000340
Author(s):  
Hugo Bourdon ◽  
Vittoria Aragno ◽  
Christophe Baudouin ◽  
Antoine Labbé
Keyword(s):  
Systematic Review ◽  
Intraocular Pressure ◽  
Retrospective Studies ◽  
Scientific Evidence ◽  
Argon Laser ◽  
Angle Closure ◽  
Current Evidence ◽  
Iridocorneal Angle

Plateau iris syndrome (PIS) is a frequent cause of angle closure. Argon laser peripheral iridoplasty (ALPI) has been proposed in PIS to widen the iridocorneal angle. The objective of the present study was to perform a systematic review of the available studies evaluating the efficacy of ALPI on intraocular pressure (IOP), iridocorneal angle opening and the number of medications in patients with chronic angle-closure associated with PIS. One prospective and seven retrospective studies with a minimum 1 month of follow-up were included. Although ALPI seemed to lower IOP, to decrease the number of topical antiglaucoma medications and widen the iridocorneal angle shortly after the procedure, there is no current evidence of long-term efficacy. To date, there is no robust scientific evidence to advocate ALPI as a treatment for chronic angle-closure caused by PIS.

Sign in / Sign up

Export Citation Format

Share Document