scholarly journals ES-1 Clinical results of tumor treating fields in patients with glioblastoma in Japan, compared with global surveillance

2020 ◽  
Vol 2 (Supplement_3) ◽  
pp. ii3-ii3
Author(s):  
Yoshihiro Muragaki ◽  
Masayuki Nitta ◽  
Taiichi Saito ◽  
Shunichi Tutsuki ◽  
Atsushi Fukui ◽  
...  
Keyword(s):  
Side Effects ◽  
Insurance Coverage ◽  
Intermediate Frequency ◽  
Clinical Results ◽  
Tumor Treating Fields ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Us Fda ◽  
Medical University

Abstract INTRODUCTION: The tumor treatment field induces apoptosis of tumor cells by providing a low intensity, intermediate frequency, alternating current electric field via a transducer array. TTFields is based on Phase 3 EF-11 and EF-14 trials for glioblastoma in the US FDA and Japan PMDA. Therefore, I will report the statistics of TTFields use in Japan along with recent papers. METHODS: 410 patients were treated with TTFields in Japan (December 2017-), of which 17 were at Tokyo Women’s Medical University. We also referred to papers about global post-marketing surveillance and recent studies. RESULTS: Of the 410 patients, 409 (99.8%) were diagnosed with ndGBM(male: female, 66.8%: 33.2%). As of June 2020, 222 patients (54.1%) were on treatment and 188 (45.9%) were discontinued. In 17 cases at TWMU, the average age was 46.3 years. The average treatment period was 218 days, with 6 patients (35%) continuing treatment, 6 patients (35%) discontinuing due to patient wishes, and 5 patients (30%) discontinuing treatment due to recurrence. Side effects were contact dermatitis under the array in 9 patients (57%) and mild malaise in 7 patients (43%). We experienced long-term progression-free cases with TTF use of 25 months (survival 30 months after surgery) with a glioma partially resected and 21 months (survival 27 months after surgery) with a biopsied glioma. In the biopsy case, bevacizumab was used in combination during the treatment. Conclusion: In global surveillance, use for rGBM accounts for 39%, but Japan is limited to use for ndGBM due to insurance coverage. In terms of side effects, it showed a good safety profile comparable to previous trials. Long-term progression-free cases have been observed, and it is necessary to examine the characteristics of patients who respond to treatment and the effect of concomitant use with bevacizumab by prospective studies

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

Long Term Results of Stereotactic Thalamotomy for Cerebral Palsy

Neurosurgery ◽  
1983 ◽  
Vol 12 (2) ◽  
pp. 195-202 ◽  
Author(s):  
G. Broggi ◽  
L. Angelini ◽  
R. Bono ◽  
C. Giorgi ◽  
N. Nardocci ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Side Effects ◽  
Clinical Picture ◽  
Clinical Results ◽  
Long Term Results ◽  
Abnormal Movements ◽  
Average Intelligence ◽  
Stereotactic Thalamotomy

Abstract A group of 33 patients (between 10 and 30 years old and with average intelligence) underwent stereotactic surgery for abnormal movements due to cerebral palsy. Neurological, neurofunctional, and neuropsychological examinations were performed pre- and postoperatively. The length of follow-up ranged between 1 and 4 years. The clinical results are reported and discussed in relation to the targets, the side of the lesion, and the clinical picture. Our data show that better results are obtained in patients with tremor and hyperkinesias; dystonia is improved to a lesser extent, whereas spasticity tends to recur. Operation is more effective for patients with unilateral signs than for patients with bilateral symptoms. The clinical results are stable in time, and the side effects fade away after a few months.

scholarly journals Kezdeti tapasztalataink spinalis muscularis atrophiában szenvedő gyermekek intravénás génterápiájával

2020 ◽  
Vol 161 (42) ◽  
pp. 1806-1816
Author(s):  
Borbála Mikos ◽  
Anita Gergely ◽  
Réka Balázsfi ◽  
Edina Bányász ◽  
Beáta Gyömörei ◽  
...  
Keyword(s):  
Side Effects ◽  
Troponin I ◽  
Muscular Atrophy ◽  
Safety Data ◽  
Clinical Results ◽  
Genetic Diagnostics ◽  
Number Of Patients ◽  
Movement Performance ◽  
Term Basis

Összefoglaló. A veleszületett gerincvelői izomsorvadás ritka, progresszív neurodegeneratív betegség, a gyermekkori halál egyik legjelentősebb genetikai oka. Az orvostudomány lehetőségei a XXI. század előtt a progresszió megfékezésére, a szövődmények késleltetésére és ellátására korlátozódtak. A legsúlyosabb génhibában szenvedő gyermekeket általában kétéves kor előtt elveszítettük. A genetikai diagnosztika fejlődése lehetővé teszi a korai diagnózist, a súlyosság és a progresszió előrejelzését. A 2018-ban hazánkban engedélyezett intrathecalis nuszinerszennel a nagy betegszámon alapuló klinikai eredmények meggyőzőek. A 2019-től elérhető új, intravénás génpótló terápiával (onaszemnogén abeparvovek) kapcsolatos tapasztalatok még kisebb betegszámon alapulnak. Hazánkban öt betegnél került sor az alkalmazására a Bethesda Gyermekkórházban, szigorú szakmai kritériumok és előkészületek alapján. Közülük annak a három gyermeknek a kezeléséről számolunk be dolgozatunkban, akiknél már rendelkezünk utánkövetési tapasztalatokkal. Vizsgálatunk szerint a készítmény elősegíti a mozgásteljesítmény javulását. A mellékhatások elsősorban reverzibilis májenzim-emelkedésben, thrombocytopeniában, granulocytopeniában és a szívizom-nekroenzim emelkedésében nyilvánultak meg. Ezért fontosnak tartjuk a betegek szoros és tartós követését, a mellékhatások korai észlelése és elhárítása érdekében. Orv Hetil. 2020; 161(42): 1806–1816. Summary. Congenital spinal muscular atrophy is a rare, progressive neurodegenerative disease, one of the major genetic causes of childhood death. The possibilities of medicine to curb its progression and to delay and treat the disease’s complications were limited before the 21st century. Therefore, children with the most severe genetic defects were usually lost before their second birthday. Advances in genetic diagnostics allow for early diagnosis, prediction of severity and expected progression. Using intrathecal nusinersen (available in Hungary since 2018), clinical results based on a large number of patients are convincing. Experience with the new intravenous gene therapy (onasemnogene abeparvovec) available from 2019 is still based on a less number of patients. It was used in Hungary in Bethesda Hospital in five children based on strict professional criteria and preparations. Our paper summarizes the most important efficacy and safety data of the first three consecutive patients. According to our experiences, the product helps to improve movement performance. Side effects are mainly reversible elevations of liver enzymes and serum troponin-I levels, thrombocytopenia and granulocytopenia. Therefore, we found that it is important to monitor patients closely on a long-term basis in order to detect and eliminate side effects early. Orv Hetil. 2020; 161(42): 1806–1816.

scholarly journals Psoriasis Therapies and the Risk of Cutaneous Malignancy

2017 ◽  
Vol 1 (2) ◽  
pp. 55
Author(s):  
Emily E Dando ◽  
Rina A Anvekar
Keyword(s):  
Large Body ◽  
Carcinogenic Risk ◽  
Severe Psoriasis ◽  
Uvb Radiation ◽  
Cutaneous Malignancy ◽  
Post Marketing Surveillance ◽  
Increased Risk ◽  
Dose Dependent Fashion ◽  
Post Marketing

AbstractBackground: Systemic therapies for moderate to severe psoriasis target the dysregulated inflammatory response. However, their immunomodulatory properties may also contribute to carcinogenesis, leading to increased risk of cutaneous malignancy in patients exposed to systemic agents.Objective: A review of the literature was performed to evaluate the risk of cutaneous malignancy associated with the following therapies for moderate to severe psoriasis: PUVA, UVB, cyclosporine, methotrexate, retinoids, TNF-a inhibitors, IL-12/23 inhibitors, and IL-17 inhibitors.Results: Rates of NMSC, most notably SCC, increase linearly with number of PUVA exposures. UVB radiation, both narrowband and broadband, has no clear association with skin cancer. There is a well-characterized association between cyclosporine and NMSC, particularly SCCs, although it is less clear whether cyclosporine predisposes to malignant melanoma. Methotrexate appears to increase the risk of melanoma and NMSC in a dose-dependent fashion. Retinoids, on the other hand, have chemopreventative properties and may decrease risk of NMSC in patients with psoriasis. A large body of evidence supports an increased risk of NMSC, particularly SCC, in TNF-a inhibitors, but an association with melanoma is less clear. The newly-developed agents, IL-12/23 and IL-17 inhibitors, do not clearly show increased carcinogenic risk, but their long-term safety profiles are still under investigation.Conclusions: Many systemic psoriasis therapies, including PUVA, cyclosporine, methotrexate, and TNF-a inhibitors, appear to increase the risk of cutaneous malignancy. When prescribing these agents, physicians must weigh the benefit of treatment with their carcinogenic potential. Additional post-marketing surveillance is required to better understand the long-term risks of the newer biologic agents.

scholarly journals Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

2021 ◽  
Vol 24 (2) ◽  
pp. 141-155
Author(s):  
K. Tobe ◽  
H. Maegawa ◽  
I. Nakamura ◽  
S. Uno
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Renal Impairment ◽  
Japanese Patients ◽  
Surveillance Study ◽  
Post Marketing Surveillance ◽  
Post Marketing

STELLA-LONG TERM, a 3-year post-marketing surveillance study, evaluated the safety and effectiveness of the sodiumglucose cotransporter 2 inhibitor ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients. Final results in the safety (n = 6697) and effectiveness populations (n = 5625) were analyzed by stratifying patients by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) into four subgroups (≥90, 60 to <90, 45 to <60, and <45) and two subgroups (≥60 and <60). Adverse drug reaction (ADR) incidence, and changes from baseline in glycosylated hemoglobin (HbA1c), bodyweight, and eGFR were assessed. The percentage of patients experiencing ADRs and serious ADRs was similar across most eGFR subgroups. Polyuria/pollakiuria was the most common ADR. Renal disorders and volume depletion ADRs were more frequent in the subgroups with more severe renal impairment at baseline than in those with an eGFR of 60 to <90 or ≥90 mL/min/1.73 m2. Bodyweight and HbA1c decreased in all subgroups, the latter by − 0.91% to − 0.40% (P <0.05 vs. baseline). eGFR increased in the 45 to <60 mL/min/1.73 m2 subgroup (+ 1.42 ± 8.77 mL/min/1.73 m2; P = 0.006). It decreased in the ≥90 and 60 to <90 mL/min/1.73 m2 subgroups (− 8.27 ± 13.73 and − 1.22 ± 10.34 mL/min/1.73 m2; P <0.001), but not to <60 mL/min/1.73 m2. In conclusion, there were no new or unexpected safety findings in Japanese patients treated with ipragliflozin for T2DM, and long-term sustained improvements in HbA1c and bodyweight were observed regardless of the presence of renal impairment.

scholarly journals Risks of Skin, Hair, and Nail Supplements

2020 ◽  
pp. e2020089
Author(s):  
Emily K. Burns ◽  
Ariadna Perez-Sanchez ◽  
Rajani Katta
Keyword(s):  
Allergic Reactions ◽  
Post Marketing Surveillance ◽  
Increased Risk ◽  
Surveillance Programs ◽  
Post Marketing ◽  
Potential Risks ◽  
High Doses ◽  
Risk Of Cancer ◽  
Very High

Skin, hair, and nail supplements, sometimes referred to as “beauty supplements” or “ingestible skin care”, are a large and growing industry. These products may contain vitamins and minerals, sometimes in very high doses. They may also contain herbs, hormones, microbes, or animal derivatives such as fish oils and collagen powders. Dietary supplements are regulated as foods, not drugs, by the U.S. Food and Drug Administration. Therefore, manufacturers do not need to provide any proof of safety, efficacy, or quality prior to sale. This is of serious concern, as many adverse effects due to supplement components have been reported. The potential risks cover multiple categories. These include acute toxicities such as choking, as well as chronic toxicities, such as increased risk of diabetes. Teratogenicity and interaction with drugs and laboratory testing have been documented in research studies. Other risks include potentially increased risk of cancer with long-term use, allergic reactions, and others. It is vital that physicians educate their patients on these risks. As no post-marketing surveillance programs are required for supplements, our understanding of supplement risks is incomplete. Physicians should be wary of these risks and encourage further research and regulation.

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