scholarly journals Utilization of Mycophenolic Acid, Azathioprine, Tacrolimus, Cyclosporin, Sirolimus, and Everolimus: Multinational Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Majda Sahman ◽  
Snezana Mugosa ◽  
Nemanja Rancic
Keyword(s):  
Mycophenolic Acid ◽  
Anatomical Therapeutic Chemical ◽  
Positive Trend ◽  
Defined Daily Dose ◽  
Multinational Study ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Daily Dose ◽  
Transplanted Organs

Background: Organ transplantations are difficult, complicated and very expensive interventions. In order to preserve the transplanted organs, it is necessary to provide medical care to the patients in terms of immunosuppression. According to the guidelines, the first-line therapy choices for achieving immunosuppression after transplantation are tacrolimus, cyclosporine, mycophenolic acid, azathioprine, sirolimus, everolimus„ and corticosteroids. The aim of our study was to examine the utilization of this drugs in Montenegro and to compare the results with the ones from Finland, Croatia, and Serbia.Methods: In our investigation we used Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) methodology. Prices per DDD of drugs are presented in euros (€).Results: In all observed countries, there is a positive trend in the consumption of all 6 drugs during the analyzed period. The prices per DDD of these drugs generally show a negative trend. Tacrolimus and mycophenolic acid in Montenegro recorded the largest reduction in the price per DDD. Price per one DDD of tacrolimus decreased from €13.28 in 2009 to €5.11 in 2019, thus by about 260%, and as regards mycophenolic acid, the price per one DDD decreased from €9.59 in 2009 to € 3.36 in 2019, thus by almost 300%.Conclusion: Despite the reduction in the price per DDD, drugs that are used as immunosuppressants are showing increasing costs from year to year. Since these drugs are expensive, they participate in a significant percentage in the budget for medicines in each country.

Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7592-7592 ◽  
Author(s):  
Markus Frederic Renschler ◽  
Isamu Okamoto ◽  
Jeremy K. Hon ◽  
Vera Hirsh ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Phase Iii ◽  
Positive Trend ◽  
First Line ◽  
Phase Iii Trial ◽  
Efficacy Analysis ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3 ◽  
And Gender

7592 Background: Treatment of advanced NSCLC differs by histology, with fewer options and poorer outcomes in pts with squamous histology. In a phase III trial of nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C, the primary endpoint of ORR was significantly improved from 25% to 33%, p = 0.005, with a 1-month improvement in OS (p = NS) and improved safety. This analysis evaluated efficacy and safety by histology. Methods: Pts with untreated stage IIIB/IV NSCLC were randomized 1:1 (stratified by age, histology, region, stage, and gender) to C AUC 6 day 1 and either nab-P 100 mg/m2 on days 1, 8, 15 or sb-P 200 mg/m2 day 1 q 21 days. ORR and PFS were determined by blinded centralized review. Results: In squamous pts, nab-P/C produced a significantly higher ORR (41% vs 24%, p < 0.001), similar PFS (5.6 vs 5.7 mo, HR: 0.865) and >1-month improvement in OS (10.7 vs 9.5 mo, HR: 0.890) vs sb-P/C (Table). nab-P/C was as effective as sb-P/C in nonsquamous pts for ORR (26% vs 25%, p = 0.808), PFS (6.9 vs 6.5 mo, HR: 0.933), and OS (13.1 vs 13.0 mo, HR: 0.950). In both squamous and nonsquamous pts, nab-P/C vs sb-P/C produced lower rates of grade 3/4 neuropathy (3% vs 11% and 3% vs 12%, respectively, p < 0.001 both), neutropenia (43% vs 51%, p = NS, and 50% vs 63%, p = 0.008), and higher but manageable rates of anemia (27% vs 4% and 28% vs 9%, p < 0.001 both) and thrombocytopenia (21% vs 7% and 16% vs 11%, p < 0.001 both). Conclusions: In pts with advanced NSCLC, nab-P/C demonstrated a favorable risk-benefit profile as a first-line therapy regardless of histology. Significantly improved ORR and a positive trend in OS were observed in pts with squamous histology. [Table: see text]

Pharmacokinetics of Dasatinib as a First Line Therapy In Newly Diagnosed CML Patients (OPTIM dasatinib trial): Correlation with Safety and Response.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3432-3432 ◽  
Author(s):  
Philippe Rousselot ◽  
Stéphane Boucher ◽  
Gabriel Etienne ◽  
Franck E Nicolini ◽  
Emmanuelle Chauzit ◽  
...  
Keyword(s):  
Chronic Phase ◽  
Fluid Retention ◽  
Newly Diagnosed ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Daily Dose ◽  
Sokal Score ◽  
Nm Range

Abstract Abstract 3432 Introduction. Dasatinib 100 mg QD is now validated as a first line option in patients with chronic myelogenous leukaemia in chronic phase (CML in CP). Our hypothesis was that significant adverse events observed with dasatinib including fluid retention, pleural effusions and grade 3–4 cytopenias, may be driven by the level of the residual dosage of dasatinib (Cmin). We initiated an optimization study based on the monitoring of dasatinib plasma levels (Cmin and Cmax) in patients with CML in chronic phase newly diagnosed and treated with dasatinib as front line therapy. Patients and methods. Patients aged 18 years old or more were eligible if they were diagnosed with CML in CP for less than 3 months without having being exposed to tyrosine kinase inhibitors. Dasatinib was initiated at the daily dose of 100 mg QD. Dasatinib daily dose adaptation was randomized in patients with a Cmin over 3nM. For all other patients, dasatinib was given at the dose of 100 mg QD. The pharmacokinetic (PK) evaluation (Cmin and Cmax measurements) was performed after 7 to 10 days of therapy and then every 15 days in the treatment adaptation arm (until a level of Cmin under 3nM) and every 3 months therafter as in the non-adapted arm. Cmax was assessed 2 hours after dasatinib intake. Results. The results of the first 78 patients included in the trial from May 2009 to May 2010 are reported. Median age was 47 years (19 – 77) with a sex ratio M/F of 1.85. The Sokal score distribution was 51.9%, 30.7% and 17.4% for Low, intermediate and high risk respectively. Median Cmin and Cmax values were 2.1 nM (range 0.2–18.7) and 107.6 nM (range 20.5–353) at first PK analysis. The median Cmin value was significantly lower in patients with age <47y compared to patients >47y (1.6 nM versus 2.8 nM, p=0.0028). By contrast, the median Cmax value was comparable in both age groups. Efficacy analysis was performed on the 53 patients with a 3 months follow-up and on the 36 patients with a 6 months follow-up. The complete cytogenetic response (CCR) rates at 3 and 6 months were 83.3% and 90.9% respectively. At 3 and 6 months, the major molecular response (MMR) rates were 15.1% and 69.4%. All patients in cytogenetic failure had high Sokal score values (p=0.023). Median PK values at months 3 and 6 were not statistically different compared to initial PK values, suggesting a stable exposure to the treatment with time. With a median follow-up of 7.2 months, the rate of significant adverse events was 11.5%. Fluid retention (n=2) and pleural effusion (n=1) were observed in patients with high Cmin values (mean 3.7 nM). A trend was observed between the Cmax and response at month 3 (CCR, p=0.05 and MMR, p=0.08). Patients with lymphocytosis may have a higher MMR rate (p=0.07). Conclusion. Dasatinib 100 mg QD as first line therapy in CP CML provided a high rate of MMR and CCR rates. Pharmacokinetic parameters of dasatinib were different in aged patients. A trend was observed first between Cmax and responses and second between Cmin and fluid retention or pleural effusion. A complete analysis with correlation to response and safety will be presented on more patients with 6 and 12 months follow-up. Disclosures: Rousselot: Bristol Myers Squibb: Research Funding. Off Label Use: Dasatinib as first line therapy for CML.

scholarly journals Benefits of Metformin Combined with Pemetrexed-Based Platinum Doublets as a First-Line Therapy for Advanced Lung Adenocarcinoma Patients with Diabetes

Biomolecules ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1252
Author(s):  
Jiun-Long Wang ◽  
Yi-Ting Tsai ◽  
Ching-Heng Lin ◽  
Abdulkadir Cidem ◽  
Theresa Staniczek ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Lung Adenocarcinoma ◽  
Survival Benefit ◽  
Diabetic Patients ◽  
User Group ◽  
First Line ◽  
Survival Status ◽  
First Line Therapy ◽  
Line Therapy ◽  
Daily Dose

Lung cancer remains a challenge in daily practice. Chemotherapy is first considered for advanced lung adenocarcinoma bearing no active driver mutations. Maintaining drug efficacy and overcoming drug resistance are essential. This study aimed to explore the real-world use of anti-diabetic agent metformin in combination with pemetrexed-based platinum doublets in a first-line setting. We retrospectively collected data during 2004~2013 from TaiwaN′s National Health Insurance Research Database to access the survival benefit of metformin combined with pemetrexed-based platinum doublets as a first-line therapy for diabetic patients with advanced lung adenocarcinoma. Demographic data and information regarding platinum reagents, diabetes medications, and metformin doses were gathered, and overall survival status regarding metformin use was analyzed. Overall survival status based on the daily dose and the calculated cumulative defined daily dose (DDD) of metformin prescribed during the first 3 months after lung cancer was diagnosed was also assessed. A total of 495 patients were enrolled with a mean age of 67 years old, and the majority of the patients were male. After adjusting for age, sex, diabetes medication, and platinum reagents used, the adjusted hazard ratio (HR) for the metformin-user group was 0.61 (95% confidence interval (CI); 0.46~0.79; p < 0.001). The metformin-user group had a survival benefit (log-rank p < 0.001). We analyzed metformin dosing during the first 3 months after lung cancer diagnosis, and for a daily dose ≥ 1500 mg, the adjusted hazard ratio (aHR) was 0.42 (95% CI; 0.27~0.65; p < 0.001). Regarding the cumulative DDD of metformin, a DDD equal to or exceeding 21 resulted in aHR of 0.48 (95% CI; 0.34~0.69; p < 0.001). In this study, we found that the combination of metformin and pemetrexed-based platinum doublets provides a robust survival benefit as a first-line therapy for diabetic patients with advanced lung adenocarcinoma. It is worth conducting a large and randomized clinical trial to further investigate the antitumor effects of metformin on advanced lung adenocarcinoma when used as a first-ling therapy, including in non-diabetic patients.

1904: Outcomes of Large Renal Calculi (>2-Cm) Treated with ESWL as First Line Therapy

2004 ◽  
Vol 171 (4S) ◽  
pp. 503-503
Author(s):  
Richard Vanlangendock ◽  
Ramakrishna Venkatesh ◽  
Jamil Rehman ◽  
Chandra P. Sundaram ◽  
Jaime Landman
Keyword(s):  
Renal Calculi ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Is digoxin still justifiable as single first-line therapy in fetal SVT associated with fetal hydrops?

2008 ◽  
Vol 68 (S 01) ◽  
Author(s):  
DJ Kersten ◽  
J McDougall ◽  
C Schuller ◽  
JP Pfammatter ◽  
L Raio ◽  
...  
Keyword(s):  
First Line ◽  
Fetal Hydrops ◽  
First Line Therapy ◽  
Line Therapy

EFFICACY OF MODIFIED BISMUTH QUADRUPLE THERAPY (RBMA) AS FIRST-LINE THERAPY FOR ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH CHRONIC GASTRITIS

2019 ◽  
pp. 28-32
Author(s):  
Van Huy Tran
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Effects ◽  
Chronic Gastritis ◽  
Eradication Rate ◽  
High Rate ◽  
First Line ◽  
Helicobacter Pylori Eradication ◽  
Quadruple Therapy ◽  
First Line Therapy ◽  
Line Therapy

Background and aims: Efficacy with substitution of tetracycline with amoxicillin, an antibiotics having a very low resistance rate and a high tolerability, in bismuth quadruple therapy (BQT) have not been studied in Vietnam. Our study aimed to evaluate the efficacy and tolerability of modified BQT vs. standard BQT for first-line Helicobacter pylori eradication. Patients and methods: This is a randomized, prospective study. 120 patients with H.pylori positive-chronic gastritis were randomly divided into two groups. The RBMA group containing rabeprazole 20 mg, bismuth subsalicylic 524mg, metronidazole 500mg, amoxicillin 1000mg, all 2 times a day, for 14 days. The RBMT group received rabeprazole, bismuth subsalicylic, metronidazole and tetracycline. Evaluation for compliance and drug-related side effects were evaluated at the end of two weeks. 4-6 weeks after the end of treatment, the H.pylori eradication rate was determined by the C13urease breath test. Results: Eradication rate was not statistically significative different between the RBMA and the RBMT: 91.2%; 95% confidence interval, 78.2% - 96.7%) vs. 90%; 95% CI, 81.6% - 96.3%) by per-protocol analysis (p = 0.42) and 86.7% (95%CI, 75.84% - 93.09%) vs. 75% (95%CI, 62.1% - 85.3%) by intention-to-treat analysis (ITT, p = 0.06). Adverse effects were significant higher in the RBMT group than in the RBMA group (48.3% vs. 26.7%; p = 0.071) and rate of good compliance was significantly higher in RBMA group than in RBMT group (p < 0.05). Conclusion: The modified BQT including rabeprazole, bismuth, metronidazole and amoxicillin achieved a fairly high rate of H.pylori infection eradication with a higher compliance and lower rate of adverse effects compared to the BQT in patients with chronic gastritis. Further studies need to conduct to confirm this new regimens as a first-line therapy in our country. Key words: Modified bismuth quadruple therapy, BQT, Helicobacter pylori eradication

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