Beyond Front-Line Therapy for Unresectable Gastroesophageal Adenocarcinoma: Are There Differences in Subsequent Therapy Sequencing?

Oncology ◽  
2021 ◽  
Author(s):  
Jane E. Rogers ◽  
Xuemei Wang ◽  
Allison Trail ◽  
Jaffer A. Ajani
Keyword(s):  
Therapy Group ◽  
Disease Diagnosis ◽  
Second Line ◽  
Front Line ◽  
Line Therapy ◽  
Sequence Versus ◽  
Group A ◽  
Gastroesophageal Adenocarcinoma ◽  
Third Line ◽  
Group B

Background: Platinum + fluoropyrimidine is standard front-line therapy for unresectable gastroesophageal adenocarcinoma (GA). Subsequent therapy recommendations are ramucirumab + paclitaxel (RAM/PAC), taxane, irinotecan, or trifluridine-tipiracil. RAM/PAC is the preferred 2nd line choice; however, patients can have a contraindication due to cumulative neuropathy. Our study assessed varied sequencing of second-line and third-line therapies comparing RAM/PAC followed by fluoropyrimidine + irinotecan (FOLFIRI/CAPEIRI) vs the opposite sequence. Methods: We retrospectively analyzed metastatic GA patients who received at least 3 lines of therapy. Two cohorts were studied. Group A: RAM/PAC second-line with FOLFIRI/CAPIRI third-line or Group B: FOLFIRI/CAPEIRI second-line followed by RAM/PAC. Primary outcome was overall survival (OS). Results: 94 patients were available for analysis (51 pts Group A: 43 pts Group B). No difference was observed in median OS from the start of second-line therapy (Group A =10.5 months vs. Group B = 11.1 months, p=0.97) or median OS from metastatic disease diagnosis (Group A = 19.8 months vs Group B = 19.4 months, p=0.73). Conclusions: Our study, examining a practical issue of how to sequence 2nd and 3rd line therapies, documents that one sequence versus the other does not compromise patient outcomes and overall our patients had an outstanding OS of beyond 19 months when they receive 3rd line therapy.

Treatment of Molecular and Clinical Relapse of Acute Promyelocytic Leukemia (APL) with Arsenic Trioxide: Results of the European Registry of Relapsed APL

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 15-15 ◽  
Author(s):  
Eva Lengfelder ◽  
Francesco Lo-Coco ◽  
Pau Montesinos ◽  
David Grimwade ◽  
Lionel Ades ◽  
...  
Keyword(s):  
Research Funding ◽  
Promyelocytic Leukemia ◽  
Clinical Relapse ◽  
Consolidation Therapy ◽  
Front Line ◽  
Molecular Remission ◽  
Line Therapy ◽  
Group A ◽  
Group B ◽  
European Registry

Abstract Abstract 15 Arsenic trioxide (ATO) is presently regarded as the best treatment option in relapsed PML-RARA+ acute promyelocytic leukemia (rAPL). However, given the relative rarity of relapses following standard front-line APL therapy, the optimal management of this group of patients remains to be firmly established. For this reason, and in order to ensure homogeneity in patient data collection and gain insights into the epidemiology and clinical aspects of rAPL, a European registry of rAPL was established in 2008 under the auspices of the European LeukemiaNet (ELN). Patients with a genetically confirmed (PML-RARA+) molecular or clinical relapse of APL occurring from January 2003 onwards were eligible for registration using uniform CRFs. Management of relapse was at the discretion of the treating physician, but could be based on the treatment recommendations developed by an expert panel provided on the ELN website (www.leukemia-net.org/content/). By 15 July 2010, 122 cases of rAPL had been registered by participants of 7 European countries (Spain, Italy, UK, France, Germany, Greece, Poland) representing the starting group of this ongoing initiative open for participation. In 80 pts (69 in first, 11 in 2nd and later relapse), information was available on ATO salvage therapy. At time of first diagnosis median age was 43 years (14-77); all pts had received all-trans retinoic acid (ATRA) and anthracyclines ± ara-C as first-line therapy. No patients received ATO as part of front-line therapy. According to Sanz Score, 26% were low risk, 45% intermediate and 29% high risk. 39% of pts had the bcr1/2 and 61% the bcr3 isoform of PML-RARA. Median duration of first remission was 493 days (93d to 5.7 years). The usual dosage of ATO was 0,15mg/kg/day, or regimens with the same cumulative dose were used. ATO induction therapy was combined with ATRA (45 mg/m2/day) in 40% of pts and during the consolidation cycle in 50% of pts, respectively. The median duration of ATO (± ATRA) for induction was 30 days and for consolidation 25 days. CNS relapses were treated with intrathecal application of methotrexate ± ara-C ± hydrocortisone and ATO. Among the 69 pts with first relapse, there were (Group A) 25 molecular and (Group B) 42 hematological relapses (bone marrow), in three pts combined with CNS involvement. Two pts had isolated CNS or extramedullary relapse. Main characteristics of pts at start of induction therapy in Group A vs. B were: median WBC count (x109/L) 4.4 (1.9-6.2) vs. 2.3 (0.5-102) (p=0.015); median platelet count (x109/L) 178 (40-392) vs. 87 (9-273) (p=0.0007); median Hb (g/L) 14 (10.6-15.7) vs. 12 (7.6-14.8) (p=0.0008). In Group A, none of the pts had coagulopathy compared to 8 of 25 (32%) pts with coagulopathy in Group B (p=0.004). In Group A, ATO therapy was not complicated by hyperleukocytosis and no episodes of differentiation syndrome were observed. In Group B, 9 (21%) pts had suspected or manifest differentiation syndrome (p=0.02), and additional chemotherapy was administered in 14 (33%) pts to control hyperleukocytosis. Other toxicities were rare and had no significant influence on therapy. In Group A, the rate of 2nd molecular remission after induction was 52% (13 of 25 pts) and after consolidation therapy 64%. No pt died. In Group B, 39 (88%) pts achieved 2nd CR, 2 (5%) pts were resistant and 3 (7%) pts died early from cerebral bleeding. Second molecular remission was reached in 12 of 32 (38%) pts after induction and in 62% after consolidation. Information on postconsolidation therapy was available in 45 pts of Group A and B. Of these, 14 pts underwent allogeneic, 18 pts autologous transplantation and 13 pts further therapy with ATO ± gemtuzumab ozogamicin. 11 of the 45 (24%) pts relapsed (median 2nd remission duration 10 months, 4 to 26), and 9 deaths were reported between 9 and 14 months after the end of consolidation therapy. In pts with 2nd and later relapse, despite previous exposure to ATO, further responses with this agent were observed. Conclusions: ATO is an effective therapy for all stages of relapsed APL. The results argue in favor of serial PML-RARA monitoring in front-line therapy of APL to allow early treatment of emergent relapses, avoiding hyperleukocytosis and risk of death due to bleeding and differentiation syndrome. Furthermore, the favorable toxicity profile of ATO seems to benefit the feasibility of subsequent transplantation. Disclosures: Lengfelder: Cephalon: Research Funding. Fenaux: CELGENE, JANSSEN CILAG, AMGEN, ROCHE, GSK, NOVARTIS, MERCK, CEPHALON: Honoraria, Research Funding.

scholarly journals Six-year experience with a comprehensive approach to the treatment of recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85). A relapse study of the BFM group

Blood ◽  
1991 ◽  
Vol 78 (5) ◽  
pp. 1166-1172 ◽  
Author(s):  
G Henze ◽  
R Fengler ◽  
R Hartmann ◽  
B Kornhuber ◽  
G Janka-Schaub ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Acute Lymphoblastic Leukemia ◽  
Therapy Group ◽  
Lymphoblastic Leukemia ◽  
Cell Phenotype ◽  
Front Line ◽  
Extramedullary Relapse ◽  
Group A ◽  
First Relapse ◽  
Group B

Abstract Between April 1985 and March 1987 130 children and adolescents up to 18 years of age with first relapse of acute lymphoblastic leukemia (ALL) were registered on the stratified and randomized multicentric trial ALL- REZ BFM 85 designed for patients pretreated with intensive front-line therapies. Stratification criteria were time and site of relapse: bone marrow (BM) relapse on or up to 6 months after stopping front-line therapy (group A), BM relapse beyond 6 months after therapy (group B), and isolated extramedullary relapse at any time (group C). Treatment consisted of alternating courses of polychemotherapy including randomly administered high- or intermediate-dose methotrexate (HDMTX:12 g/m2 as 4-hour infusion; IDMTX: 1 g/m2 as 36-hour infusion). During maintenance therapy the patients received daily oral thioguanine and biweekly intravenous (IV) MTX. The overall second complete remission (CR) rate was 92% (groups A, B, and C: 88%, 92%, and 100%), and the probability of event-free survival (EFS) at 6 years is 0.31 +/- 0.04 (groups A, B, and C: 0.18 +/- 0.05, 0.30 +/- 0.07, and 0.72 +/- 0.11). HDMTX did not prove to be superior to IDMTX, which led to premature stopping of randomization. Risk factor analyses showed early relapse, particularly BM relapse within 18 months, and T-cell phenotype to be independent predictors of poor outcome. The incidence of central nervous system (CNS) relapses following BM relapse was 19%, indicating that reprophylaxis to the CNS with IV/intrathecal (IT) MTX was insufficient. For 17 children who received bone marrow transplantation in second CR from HLA-compatible siblings the EFS was 0.53 +/- 0.12 at 5 years. Their outcome was not influenced by the above-mentioned risk factors. With the proposed treatment regimen long-lasting second remissions can be achieved in about one third of patients even after intensive front- line treatment.

Sequential therapy with sorafenib and sunitinib in renal cell carcinoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5106-5106 ◽  
Author(s):  
A. Dham ◽  
A. Z. Dudek
Keyword(s):  
Renal Cell Carcinoma ◽  
Disease Progression ◽  
Median Duration ◽  
Stable Disease ◽  
Response To Treatment ◽  
Second Line ◽  
Line Therapy ◽  
Group A ◽  
Group B

5106 Background: Sunitinib and sorafenib are two small-molecule tyrosine kinase inhibitors (TKI) that have been shown to have antitumor activity in advanced renal cell carcinoma (RCC). However, the optimal sequence of first- and second-line therapies with sunitinib and sorafenib is still unclear. The purpose of this study was to assess whether an objective disease response could be identified in patients after receiving sequential treatment with these two agents. Methods: Patients who had progressed or experienced unacceptable toxicity after first-line therapy with either sunitinib or sorafenib and then subsequently received second-line therapy with the other TKI agent were evaluated for their response to sequential treatment using RECIST criteria. Results: Thirty-seven patients were identified (29 male and 8 female) with a median age of 62 years (range 32–75). Twenty-three patients received sorafenib followed by sunitinib (Group A), and 14 patients received sunitinib followed by sorafenib (Group B). According to Memorial Sloan-Kettering prognostic model, 35% of patients in Group A had favorable risk, 52% had intermediate and 13% had poor risk, whereas 50% of patients in Group B had favorable risk, 43% had intermediate and 7% had poor risk. Three patients (13%) in Group A and two (14%) in Group B switched TKI due to toxicity, while all remaining patients switched due to disease progression. For patients in Group A, median duration of stable disease after starting sunitinib was 32 weeks (range 6–37 weeks)(median follow up 266 days); 9% were not evaluable for response to treatment; 34% had disease progression; and four patients (17%) had an objective partial response of 31%, 36%, 27% and 50%, respectively. For patients in Group B, median duration of stable disease after starting sorafenib was 8 weeks (range 4–10 weeks) (median follow up 179 days); 7% were not evaluable for response to treatment; 50% had disease progression; and one patient (7%) had no evidence of disease after tumor resection. The median duration of disease control in Groups A and B was 42 weeks (range: 10–113 wks) and 30.5 weeks (range: 4–56 wks), respectively. Conclusions: While disease control was observed in both sequences, the duration of response was longer in patients receiving sorafenib followed by sunitinib. [Table: see text]

A randomized phase III trial of second-line chemotherapy comparing CPT-11 alone versus S-1 plus CPT-11 combination therapy in advanced gastric cancer refractory to first-line therapy with S-1 (JACCRO GC-05).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 87-87 ◽  
Author(s):  
Kazuhiro Nishikawa ◽  
Kazuaki Tanabe ◽  
Masashi Fujii ◽  
Chikara Kunisaki ◽  
Akihito Tsuji ◽  
...  
Keyword(s):  
Response Rate ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Group A ◽  
Group B ◽  
Line Chemotherapy

87 Background: In East Asia, S-1 + CDDP (SP) has been employed as first-line therapy for advanced gastric cancer (AGC) from the results of SPIRITS trial. Patients who were resistant to chemotherapy with S-1 in the first-line treatment were widely treated with taxane alone or CPT-11 alone as the second-line treatment. On the other hand, the response rate of combination therapy with S-1 is higher than that of CPT-11 alone. Then, we hypothesized that S-1 + CPT-11 prolongs survival in the second-line treatment comparing with CPT-11 alone after failure in the first-line treatment with S-1. (NCT00639327). Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with SP, S-1 + cocetaxel or S-1 alone except S-1 + CPT-11 were allocated into S-1 plus CPT-11 group (Group A) or CPT-11 alone group (Group B) as second-line chemotherapy. Patients who were relapsed to adjuvant chemotherapy with S-1 were not enrolled. Primary endpoint was overall survival, and secondary endpoints were progression free survival, response rate and adverse events. Results: From March 2008 to June 2011, 304 patients were enrolled, and 294 were eligible for analysis. The overall survival was 8.8 months (M) in the Group A and 9.4M in the Group B. There is no statistically significant difference in both groups (P=0.9156). The progression free survival was 4.8M in the Group A and 4.9M in the Group B (P=0.1568). The response rate was 7.6% in the Group A and 7.4% in the Group B. Grade 3 or higher leukopenia, neutropenia and febrile neutropenia were observed more frequently in the Group A than in the Group B. Conclusions: From our results, we do not recommend consecutive use of S-1 as second-line treatment in patients who are refractory to S-1 in first-line chemotherapy. Clinical trial information: 00639327.

scholarly journals Six-year experience with a comprehensive approach to the treatment of recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85). A relapse study of the BFM group

Blood ◽  
1991 ◽  
Vol 78 (5) ◽  
pp. 1166-1172 ◽  
Author(s):  
G Henze ◽  
R Fengler ◽  
R Hartmann ◽  
B Kornhuber ◽  
G Janka-Schaub ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Acute Lymphoblastic Leukemia ◽  
Therapy Group ◽  
Lymphoblastic Leukemia ◽  
Cell Phenotype ◽  
Front Line ◽  
Extramedullary Relapse ◽  
Group A ◽  
First Relapse ◽  
Group B

Between April 1985 and March 1987 130 children and adolescents up to 18 years of age with first relapse of acute lymphoblastic leukemia (ALL) were registered on the stratified and randomized multicentric trial ALL- REZ BFM 85 designed for patients pretreated with intensive front-line therapies. Stratification criteria were time and site of relapse: bone marrow (BM) relapse on or up to 6 months after stopping front-line therapy (group A), BM relapse beyond 6 months after therapy (group B), and isolated extramedullary relapse at any time (group C). Treatment consisted of alternating courses of polychemotherapy including randomly administered high- or intermediate-dose methotrexate (HDMTX:12 g/m2 as 4-hour infusion; IDMTX: 1 g/m2 as 36-hour infusion). During maintenance therapy the patients received daily oral thioguanine and biweekly intravenous (IV) MTX. The overall second complete remission (CR) rate was 92% (groups A, B, and C: 88%, 92%, and 100%), and the probability of event-free survival (EFS) at 6 years is 0.31 +/- 0.04 (groups A, B, and C: 0.18 +/- 0.05, 0.30 +/- 0.07, and 0.72 +/- 0.11). HDMTX did not prove to be superior to IDMTX, which led to premature stopping of randomization. Risk factor analyses showed early relapse, particularly BM relapse within 18 months, and T-cell phenotype to be independent predictors of poor outcome. The incidence of central nervous system (CNS) relapses following BM relapse was 19%, indicating that reprophylaxis to the CNS with IV/intrathecal (IT) MTX was insufficient. For 17 children who received bone marrow transplantation in second CR from HLA-compatible siblings the EFS was 0.53 +/- 0.12 at 5 years. Their outcome was not influenced by the above-mentioned risk factors. With the proposed treatment regimen long-lasting second remissions can be achieved in about one third of patients even after intensive front- line treatment.

Trends in chemotherapy for elderly patients with non-small cell lung cancer: The experience of one institution

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19081-e19081
Author(s):  
Y. Kim ◽  
Y. Nishiwaki ◽  
K. Yoh ◽  
S. Niho ◽  
K. Goto ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Phase Iii ◽  
Second Line ◽  
Platinum Based Chemotherapy ◽  
Group A ◽  
Third Line ◽  
Group B ◽  
Year 2000 ◽  
Egfr Tki ◽  
Line Chemotherapy

e19081 Background: In approximately the year 2000, the results of a number of important studies of non-small-cell lung cancer (NSCLC) were published. These included the first elderly-specific phase III trial and phase III trials showing a survival benefit for docetaxel when used as second-line chemotherapy. These results had a significant impact on clinical practice relating to advanced NSCLC in elderly patients. Methods: Between July 1992 and December 2003, 223 patients with NSCLC aged ≥70 years received chemotherapy alone as their initial treatment at the National Cancer Center Hospital East. These patients were divided into 2 groups: those that began treatment between 1992 and 1999 (group A) and between 2000 and 2003 (group B). The details of chemotherapy regimens and outcomes were compared. Results: In group A, 83% of patients received platinum-based chemotherapy, two-thirds of these regimens comprised platinum[[Unsupported Character -  ]]plus second-generation combination chemotherapy. In contrast, although 55% of patients received platinum-based chemotherapy in group B, 41% of patients received non-platinum-based chemotherapy. Among patients in group B, performance status was significantly associated with the selection of platinum-based or non- platinum-based chemotherapy; age was marginally associated with this selection. In group A, second-line chemotherapy was administered to only 4 patients (5%) and no patients received third-line chemotherapy. In group B, second-line and third-line chemotherapy was administered to 62 (42%) and 22 (15%) patients, respectively. Median survival time (MST), 1-year survival rate, and 2 year-survival rate were 6.7 months, 14%, and 7%, respectively, in group A, and 8.1 months, 35%, and 20% in group B (p = 0.0109). However, these differences disappeared when patients treated with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) were removed from the analysis (6.7 months in group A vs. 6.9 months in group B, p = 0.3684). Conclusions: In and after the year 2000, chemotherapy regimens changed greatly and survival of elderly patients significantly improved. However, the improvement in survival seems to be due mostly to the use of EGFR-TKI treatment. No significant financial relationships to disclose.

Randomized trial of medical compression stockings versus two-layer short-stretch bandaging in the management of venous leg ulcers

Phlebologie ◽  
2009 ◽  
Vol 38 (04) ◽  
pp. 157-163 ◽  
Author(s):  
A. Franek ◽  
L. Brzezinska-Wcislo ◽  
E. Blaszczak ◽  
A. Polak ◽  
J. Taradaj
Keyword(s):  
Drug Therapy ◽  
Randomized Clinical Trials ◽  
Therapy Group ◽  
Long Term Results ◽  
Leg Ulcers ◽  
Compression Stockings ◽  
Venous Leg Ulcers ◽  
Group A ◽  
Group B ◽  
Medical Compression Stockings

SummaryA prospective randomized clinical trial was undertaken to compare a medical compression stockings with two-layer short-stretch bandaging in the management of venous leg ulcers. Study endpoints were number of completely healed wounds and the clinical parameters predicting the outcome. Patients, methods: Eighty patients with venous leg ulcers were included in this study, and ultimately allocated into two comparative groups. Group A consisted of 40 patients (25 women, 15 men). They were treated with the compression stockings (25–32 mmHg) and drug therapy. Group B consisted of 40 patients (22 women, 18 men). They were treated with the short-stretch bandages (30–40 mmHg) and drug therapy, administered identically as in group A. Results: Within two months the 15/40 (37.50%) patients in group A and 5/40 (12.50%) in group B were healed completely (p = 0.01). For patients with isolated superficial reflux, the healing rates at two months were 45.45% (10/22 healed) in group A and 18.18% (4/22 healed) in group B (p = 0.01). For patients with superficial plus deep reflux, the healing rates were 27.77% (5/18 healed) in group A and 5.55% (1/18 healed) in group B (p = 0.002). Comparison of relative change of the total surface area (61.55% in group A vs. 23.66% in group B), length (41.67% in group A vs. 27.99% in group B), width (46.16% in group A vs. 29.33% in group B), and volume (82.03% in group A vs. 40.01% in group B) demonstrated difference (p = 0.002 in all comparisons) in favour of group A. Conclusion: The medical compression stockings are extremely useful therapy in enhancement of venous leg ulcer healing (both for patients with superficial and for patients who had superficial plus deep reflux). Bandages are less effective (especially for patients with superficial plus deep reflux, where the efficiency compared to the stockings of applied compression appeared dramatically low). These findings require confirmation in other randomized clinical trials with long term results.

THE ROLE OF MANUAL THERAPY IN THE TREATMENT OF CHRONIC CERVICAL PAINS

2020 ◽  
pp. 1-4
Author(s):  
George-Sebastian Iacob ◽  
Constantin Munteanu
Keyword(s):  
Manual Therapy ◽  
Therapy Group ◽  
Neck Disability Index ◽  
Initial Assessment ◽  
Visual Analogue Pain Scale ◽  
Rehabilitation Protocol ◽  
Visual Analogue Pain ◽  
Therapeutic Exercises ◽  
Group A ◽  
Group B

Cervical back pain is one of the most important and common musculoskeletal disorders in medical recovery clinics and clinics. The main objective of the study was to highlight the effectiveness of an individualized therapeutic program adapted to the particularities of 22 subjects, which combines physical exercise with manual therapy. Subjects were randomly assigned to two equal groups. Group A - rehabilitation protocol consisting of therapeutic exercises (specific to the head, neck and upper limbs). Group B - rehabilitation protocol that included both therapeutic exercises and manual therapy (specific maneuvers of vertebral mobilization, massage, myofascial techniques, stretching and manipulations). The Visual Analogue Pain Scale (VAS) and the Neck Disability Index (NDI) were used to monitor the evolution of the research subjects, both of which have a specific applicability character to chronic pain. According to VAS (p <0.001), Group B showed mean values reduced to 2.2 ± 0.9 at week 12, compared to 7.3 ± 0.92, following the initial assessment. NDI values indicate better functional status after 12 weeks of treatment for both groups of subjects. NDI showed a beneficial decrease for Group B (13.2 ± 2.2 after 12 weeks, compared to 25.8 ± 2.3 in the first week). The mean results of VAS and NDI indicated a better evolution of symptoms in the case of the protocol that combined exercise and manual therapy (group B), but there were no statistically significant differences (compared to group A).

An Efficacy and Safety Study of Remogliflozin in Obese Indian Type 2 Diabetes Mellitus Patients Who Were Inadequately Controlled on Insulin glargine plus other oral hypoglycemic agents

2020 ◽  
Vol 17 ◽  
Author(s):  
Anand Shankar
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Therapy Group ◽  
Insulin Dose ◽  
Blood Glucose Control ◽  
Hypoglycemic Agents ◽  
Oral Drug ◽  
Group A ◽  
Group B

Aim & Objective: The objective of this retrospective study was to investigate the efficacy of adding remogliflozin to current insulin glargine plus two oral drug i.e. metformin and teneligliptin therapy in poorly controlled Indian type 2 diabetes. Material and Methods: 173 study participants were initially selected from patient database who continued on their insulin glargine or received an increased dose of insulin glargine along with other OHA based therapy (Group A) and 187 were selected who had received remogliflozin (100 mg BD) (Group B) in addition to insulin glargine along with other OHA based therapy. Glycated haemoglobin (HbA1c), total daily insulin dose, body weight, and the number of hypoglycemic events were recorded at weeks 0, 12 and 24. Result: During the study, mean values of HbA1c, FBG and P2BG were significantly reduced in both groups. Insulin requirements decreased from 45.8 ± 16.7 IU/day to 38.5 ± 13.5 IU/day (P < 0.001) and at week 24 even further decreased to 29.5 ± 14.5 IU/Day . Twenty three patients in group B were able to cease insulin treatment altogether after 24 week treatment. It has been observed to attain tight blood glucose control we need to increase insulin dose in group A from 45.5 ± 16.5 IU/Day to 51.5 ± 14.5 at week 12 (P<0.01) and which further increased to 53.8 ± 12.8 IU/Day at week 24 (P<0.01). Adding remogliflozin showed significant effect on blood pressure (P < 0.001) and weight reduction (P < 0.001). It has been observed that 38% patients has achieves targeted HbA1c (≤7%) in group B where it was 22% in group A. Conclusion: Results demonstrate that in uncontrolled T2DM patients remogliflozin 100 mg BD can successfully lay a foundation for prolonged good glycemic control. Early addition of remogliflozin with insulin glargine plus OHAs may be an alternative compare to intensive up titration of insulin daily dose in people with uncontrolled T2DM. Clinical Trial Registration Number: A 2358

Moxifloxacin Based Triple Therapy as Alternative to Standard Therapy in Helicobacter Pylori Eradication.

2020 ◽  
Vol 18 ◽  
Author(s):  
Mohammed Hussien Ahmed ◽  
Sherief Abd-Elsalam ◽  
Aya Mohammed Mahrous
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Therapy Group ◽  
Low Cost ◽  
High Rate ◽  
Helicobacter Pylori Eradication ◽  
Treatment Regimens ◽  
Group A ◽  
H Pylori ◽  
Group B

Introduction: Helicobacter pylori eradication remains a problematic issue. We are in an urgent need for finding a treatment regimen that achieves eradication at a low cost and less side effect. Recent published results showing a high rate of resistance and with clarithromycin-based treatment regimens. The aim of the study was to compare moxifloxacin therapy and classic clarithromycin triple therapy in H. pylori eradication. Methods: This was a pilot study that enrolled 60 patients with helicobacter pylori associated gastritis. Diagnosis was done by assessment of H. pylori Ag in the stool. The patients were randomly assigned to receive either moxifloxacin based therapy (Group A), or clarithromycin based therapy (Group B) for two weeks. We stopped the treatment for another two weeks then reevaluation for cure was done. Results: 90 % of patients had negative H. pylori Ag in the stool after 2 weeks of stoppage of the treatment in group A versus 66.7 % in Group B. None of the patients in both groups had major side effects. Conclusion: Moxifloxacin-based therapy showed higher eradication power and less resistance when compared to clarithromycin triple therapy.

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