Efficacy and Safety of Lamotrigine in Pediatric Patients

2002 ◽  
Vol 17 (2_suppl) ◽  
pp. 2S34-2S42 ◽  
Author(s):  
John Messenheimer
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Regulatory Authorities ◽  
Treatment Of Epilepsy

Accumulating data suggest that lamotrigine, which has been available for adult use in epilepsy for more than a decade in clinical practice, also confers effective, well-tolerated control of a range of childhood epilepsies. Lamotrigine is currently approved for the treatment of epilepsy by regulatory authorities in 93 countries, more than 70 of which have approved its use in pediatric patients on the basis of data from well-controlled clinical trials. The controlled clinical trials data have been supplemented over the years by clinical practice data, primarily from uncontrolled studies, confirming or demonstrating additional efficacy of lamotrigine for a range of seizure types. This article reviews the data from well-controlled clinical trials and studies conducted in clinical practice to present an updated perspective on the efficacy and safety of lamotrigine in pediatric patients. (J Child Neurol 2002;17:2S34—2S42).

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

Anatomy of a trial

PEDIATRICS ◽  
1977 ◽  
Vol 60 (6) ◽  
pp. 932-934
Author(s):  
Neil A. Holtzman
Keyword(s):  
Clinical Trials ◽  
Clinical Situation ◽  
Enzyme Deficiency ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Biochemical Alterations ◽  
New Treatments ◽  
The Way

Efficacy and safety of new treatments can seldom be predicted with certainty. Even when it addresses biochemical alterations, a therapy may not improve the clinical situation. The low-phenylalanine diet for phenylketonuria (PKU), for instance, followed logically from the discovery of an enzyme deficiency, but the diet's effectiveness in preventing retardation in asymptomatic infants was still in doubt a decade after it was introduced. Studies in which some subjects are not treated can often establish the benefits and risks of therapy. Many obstacles, however, lie in the way of controlled clinical trials despite the advantage they offer. The PKU story exemplifies the issues.

scholarly journals Obstacles in conducting clinical trials in the Saudi Arabia

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan
Keyword(s):  
Clinical Trials ◽  
Saudi Arabia ◽  
Clinical Practice ◽  
Clinical Research ◽  
Strategic Plan ◽  
Good Clinical Practice ◽  
European Countries ◽  
Regulatory Authorities ◽  
Research Institution

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>

Antifungal Prophylaxis in Immunocompromised Hosts

1993 ◽  
Vol 27 (1) ◽  
pp. 53-60 ◽  
Author(s):  
Stan Reents ◽  
S. Diane Goodwin ◽  
Vipul Singh
Keyword(s):  
Clinical Trials ◽  
Antifungal Prophylaxis ◽  
Nausea And Vomiting ◽  
Fungal Colonization ◽  
Solid Organ ◽  
Renal Transplant Recipients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Immunocompromised Hosts ◽  
The Relationship

OBJECTIVE: To review the literature on the efficacy and safety of antifungal agents for prophylaxis of fungal infections in populations of immunocompromised hosts (key words: hematology-oncology, surgical, solid organ transplant, HIV infection), and to develop guidelines and recommendations regarding safe and effective drug regimens for antifungal prophylaxis in this patient population. DATA EXTRACTION: Comprehensive review of clinical trials of antifungal prophylaxis published in the English literature, with an emphasis on controlled trials, and discussion of key clinical trials illustrating efficacy and safety of agents for antifungal prophylaxis in immunocompromised patients. RESULTS: Much of the clinical data evaluating the efficacy and safety of antifungal prophylaxis has been generated in cancer patients. The choice of antifungal agent for prophylaxis in this population remains controversial. However, azole compounds such as clotrimazole, ketoconazole and fluconazole appear to be more effective and better tolerated than nystatin suspension. Although ketoconazole has been shown to reduce fungal colonization in surgical patients, current data do not support the routine use of antifungal prophylaxis in this population. In renal transplant recipients, clotrimazole troches have been shown to be more effective than placebo or nystatin suspension. Selective bowel decontamination with nonabsorbable antibiotics and nystatin may be useful in reducing Candida colonization in liver transplant patients but no definitive recommendations may be made at this time regarding optimal antifungal prophylaxis in these patients. In patients with advanced HIV disease or history of prior fungal disease prophylaxis for oropharyngeal candidiasis is indicated, although the agent of choice remains controversial. Fluconazole is the drug of choice for prevention of relapse of cryptococcal meningitis in patients with AIDS. Finally, only limited data exist assessing the relationship between local colonization and systemic fungal infection. Adverse effects associated with antifungal prophylaxis, generally limited to nausea and vomiting and transient elevations in hepatic transaminases, occur with similar frequency among available oral or topical agents. However, the incidence of nausea and vomiting with resultant poor patient tolerance and compliance is usually higher with nystatin. CONCLUSIONS: Based on available data from controlled clinical trials, azole agents are currently the most effective and best-tolerated drugs for antifungal prophylaxis in immunocompromised hosts. Choice of one agent in this group over another may be dictated by cost. As new antifungal treatments are released onto the market, these drugs should be compared with existing agents in controlled clinical trials. Future studies should be designed to evaluate the relationship between local colonization and disseminated infection.

Response to Erythropoietin in a Multicentric Real-Life Cohort of Myelodysplastic Patients: The Grom Experience

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4958-4958
Author(s):  
Roberto Latagliata ◽  
Maria Antonietta Aloe Spiriti ◽  
Luca Maurillo ◽  
Carolina Nobile ◽  
Anna Lina Piccioni ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Transfusion Requirement ◽  
Conflicts Of Interest ◽  
Real Life ◽  
Low Risk ◽  
Controlled Clinical Trials ◽  
University Hospitals ◽  
Erythroid Response ◽  
High Doses

Abstract Abstract 4958 Erythropoietin (EPO) have been widely employed in the treatment of patients with low-risk Myelodysplastic Syndromes (MDS) and anemia, with response rates ranging from 30 to 60%. These data, however, have been derived only from controlled clinical trials or unicentric single-arm studies; it is still lacking a wider survey evaluating the use of EPO in the real-life clinical practice. To address this issue, the Gruppo Romano Mielodisplasie (GROM) revised retrospectively 394 MDS patients (M/F 225/169, median age at diagnosis 73. 9 yrs, IR 67. 0 – 79. 3) treated with EPO from 1/2002 to 12/2010 by 11 Hematological Centers (5 university hospitals and 6 community-based hospitals) in the metropolitan area of Rome. According to WHO classification, there were 81 (20. 6%) patients with RA, 7 (1. 8 %) with SA, 160 (40. 7%) with RCMD, 17 (4. 3%) with RCMD-S, 75(19. 0%) with RAEB-1, 27 (6. 8%) with RAEB-2 and 27 (6. 8%) with isolated del5q. The IPSS score was calculated in the 307 patients with an available karyotype: 145 (47. 2%) patients were low-risk, 135 (44. 0%) int-1, 24 (7. 8%) int-2 and 3 (1. 0%) high-risk. Median interval from diagnosis to EPO start was 3. 7 months (IR 0. 9 – 12. 1). At EPO start, median age was 74. 5 yrs (IR 68. 3 – 79. 9) with a median haemoglobin level of 8. 9 g/dl (IR 8. 2 – 9. 6). Creatinine level was elevated in 64 (16. 2%) cases: 138 patients (35. 3%) had a previous transfusion requirement. Median serum EPO level was 50. 0 mU/L (IR 26. 2 – 110. 0). The initial doses of EPO were ≤ 40. 000 UI/week in 259 patients (65. 7%) (standard doses, α-EPO in 104 patients, β-EPO in 143 patients, darbepoietin in 12 patients) and 80000 UI/week in 135 patients (34. 3%) (high doses, α-EPO in 130 patients, β-EPO in 5 patients). An erythroid response was observed in 228 (57. 9%) patients, with Hb increase > 1. 5 g/dl in 210 patients (53. 3%) and disappearance of transfusion requirement in 18 (4. 6%): patients receiving initial high doses had a higher response rate compared to patients receiving standard doses [94/135 (69. 6%) vs 134/259 (51. 7%), p=0. 002]. Only 5 thrombotic events (1. 2%) were reported during the treatment. Predicting factors for erythroid response were no previous transfusion requirement (p<0. 001), serum EPO levels at baseline < 50 mU/l (p<0. 001), creatinine levels above the normal values (<0. 001), ferritin levels < 250 ng/ml (p=0. 009) and hemoglobin level at baseline > 8 g/dl (p=0. 017). Median overall survival from EPO start was 70. 7 months (CI 95% 52. 5 – 88. 8) in responders versus 41. 7 months (CI 95% 27, 6 – 55, 7) in resistant patients (p= 0. 018). Our real-life data from a single homogeneous geographic area outline that EPO treatment is safe and effective also in the current clinical practice, beyond controlled clinical trials. However, this latter type of studies is warranted to define the best initial dose of EPO in such patients. Disclosures: No relevant conflicts of interest to declare.

Adalimumab in the Treatment of Psoriasis: Pooled Efficacy and Safety Results from Three Pivotal Studies

2009 ◽  
Vol 13 (5_suppl) ◽  
pp. S58-S66 ◽  
Author(s):  
Kim Papp ◽  
Martin Okun ◽  
Ronald Vender
Keyword(s):  
Clinical Trials ◽  
Human Monoclonal Antibody ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Psoriasis Area Severity Index ◽  
Treatment Groups ◽  
Efficacy Measure ◽  
Efficacy Measures ◽  
Necrosis Factor

Background: Adalimumab, a fully human monoclonal antibody, binds to and neutralizes tumor necrosis factor. Objective: To provide an integrated review of efficacy and safety from adalimumab clinical trials in psoriasis. Methods: Pooled analyses were conducted of three placebo-controlled clinical trials of adalimumab (40 mg every other week) in psoriasis patients. The primary efficacy measure was the Psoriasis Area Severity Index (PASI). The Physician's Global Assessment (PGA) was also assessed. Results: At Week 16, mean percentage PASI improvement was 78.3% for adalimumab-treated patients versus 15.1% for placebo-treated patients. A PGA of “Clear” or “Minimal” was achieved in 63.4% of adalimumab-treated patients versus 5.1% of placebo-treated patients. The response to adalimumab was rapid, with significant improvements for adalimumab-treated patients in most efficacy measures by Week 4. Adverse event incidence was similar between treatment groups and consistent with adalimumab safety profiles in other indications. Conclusion: Adalimumab improved psoriasis and was generally safe and well-tolerated.

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