Correlates of Insulin Selection as a First-Line Pharmacological Treatment for Gestational Diabetes

2021 ◽  
Author(s):  
Anna Palatnik ◽  
Rachel K. Harrison ◽  
Madhuli Y. Thakkar ◽  
Rebekah J. Walker ◽  
Leonard E. Egede
Keyword(s):  
Gestational Diabetes ◽  
Patient Choice ◽  
Antidiabetic Medication ◽  
Provider Type ◽  
First Line ◽  
Loading Test ◽  
Hispanic Ethnicity ◽  
Prenatal Factors ◽  
Oral Antidiabetic ◽  
To Receive

Objective The aim of this study was to investigate prenatal factors associated with insulin prescription as a first-line pharmacotherapy for gestational diabetes mellitus (GDM; compared with oral antidiabetic medication) after failed medical nutrition therapy. Methods This is a retrospective cohort study of 437 women with a singleton pregnancy and diagnosis of A2GDM (GDM requiring pharmacotherapy), delivering in a university hospital between 2015 and 2019. Maternal sociodemographic and clinical characteristics, as well as GDM-related factors, including provider type that manages GDM, were compared between women who received insulin versus oral antidiabetic medication (metformin or glyburide) as the first-line pharmacotherapy using univariable and multivariable analyses. Results In univariable analysis, maternal age, race and ethnicity, insurance, chronic hypertension, gestational age at GDM diagnosis, glucose level after 50-g glucose loading test, and provider type were associated with insulin prescription. In multivariable analysis, after adjusting for sociodemographic and clinical maternal factors, GDM characteristics and provider type, Hispanic ethnicity (0.26, 95% confidence interval [CI]: 0.09–0.73), and lack of insurance (0.34, 95% CI: 0.13–0.89) remained associated with lower odds of insulin prescription, whereas endocrinology management of GDM (compared with obstetrics and gynecology [OBGYN]) (8.07, 95% CI: 3.27–19.90) remained associated with higher odds of insulin prescription. Conclusion Women of Hispanic ethnicity and women with no insurance were less likely to receive insulin and more likely to receive oral antidiabetic medication for GDM pharmacotherapy, while management by endocrinology was associated with higher odds of insulin prescription.This finding deserves more investigation to understand if differences are due to patient choice or a health disparity in the choice of pharmacologic agent for A2GDM. Key Points

Use of palliative chemotherapy and targeted agents in elderly patients with metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6018-6018
Author(s):  
Matthew Chan ◽  
Daniel John Renouf ◽  
Caroline Speers ◽  
Winson Y. Cheung
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Elderly Patients ◽  
Systemic Therapy ◽  
Patient Choice ◽  
Advanced Age ◽  
First Line ◽  
Co Morbidity ◽  
The Impact ◽  
To Receive

6018 Background: Elderly patients are increasingly diagnosed with advanced cancers, but they are consistently underrepresented in clinical trials, which may lead to undertreatment. Our aims were to 1) evaluate the impact of advanced age on patterns of first-line chemotherapy and bevacizumab use in mCRC, 2) examine the reasons for treatment choices and 3) compare adverse events and treatment discontinuations in elderly vs young patients. Methods: A random sample of mCRC patients diagnosed from 2006 to 2007 and referred to any 1 of 5 regional cancer centers in British Columbia, Canada was reviewed. Summary statistics were used to describe treatment patterns between the elderly (>/=70 years) and young (<70 years). Cox regression was used to determine the effect of systemic therapy on overall survival, controlling for age and confounders. Results: We identified 800 patients: 43% elderly and 57% young; 56% men; and 26 / 36 / 38% ECOG 0 / 1 / 2+, respectively. Fewer elderly patients were given chemotherapy (52% vs 79%, p<0.001). Among those treated, most common first-line palliative regimens for elderly vs young included: capecitabine (50 vs 15%), FOLFIRI (26 vs 38%), and FOLFOX (15 vs 37%) (all p<0.001). Those aged >/=70 were also less likely to receive bevacizumab in their regimens (22 vs 50%, p<0.001). The most frequent reasons for no systemic therapy were similar between age groups: patient choice (31 vs 28%), poor ECOG (16 vs 17%), and significant co-morbidity (11 vs 13%). Risk of chemotherapy (p=0.30) and bevacizumab (p=0.39) adverse events were comparable between elderly and young as were rates of early chemotherapy (p=0.07) and bevacizumab (p=0.79) discontinuation. Receipt of systemic therapy +/- bevacizumab was associated with improved survival from mCRC (HR for death 0.50, 95% CI 0.31-0.62, p<0.001), regardless of advanced age (p interaction for age and treatment = 0.33). Conclusions: Elderly patients with mCRC are more likely to receive no chemotherapy, capecitabine monotherapy, or a regimen without bevacizumab. However, in carefully selected elderly patients, adverse events, treatment discontinuations, and overall survival benefit from treatment appear similar to those observed for younger patients.

Proposal for the administration of metformin in patients with chronic kidney disease

2012 ◽  
Vol 153 (39) ◽  
pp. 1527-1535 ◽  
Author(s):  
Zoltán Balogh ◽  
János Mátyus
Keyword(s):  
Lactic Acidosis ◽  
Chronic Renal Disease ◽  
Antidiabetic Agent ◽  
First Line ◽  
Oral Antidiabetic Agent ◽  
Oral Antidiabetic ◽  
Cardiovascular Morbidity And Mortality ◽  
Glomerular Filtrate ◽  
Life Threatening

Metformin is the first-line, widely used oral antidiabetic agent for the management of type 2 diabetes. There is increasing evidence that metformin use results in a reduction in cardiovascular morbidity and mortality, and might have anticancer activity. An extremely rare, but potentially life-threatening adverse effect of metformin is lactic acidosis, therefore, its use is traditionally contraindicated if the glomerular filtrate rate is below 60 mL/min. However, lactic acidosis is always associated with acute events, such as hypovolemia, acute cardiorespiratory illness, severe sepsis and acute renal or hepatic failure. Furthermore, administration of insulins and conventional antihyperglycemic agents increases the risk of severe hypoglycemic events when renal function is reduced. Therefore, the magnitude of the benefit of metformin use would outweigh potential risk of lactic acidosis in moderate chronic renal disease. After reviewing the literature, the authors give a proposal for the administration of metformin, according to the calculated glomerular filtrate rate. Orv.Hetil., 2012, 153, 1527–1535.

scholarly journals 1393. Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S706-S706
Author(s):  
Tanaz Petigara ◽  
Ya-Ting Chen ◽  
Zhiwen Liu ◽  
Michelle Goveia ◽  
David Johnson ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
The United States ◽  
Vaccination Schedule ◽  
Provider Type ◽  
Factors Associated ◽  
Study Investigator ◽  
Region Of Residence ◽  
Birth Dose ◽  
To Receive

Abstract Background The US vaccination schedule includes DTaP, IPV, Hib and HepB doses in the first 6 months of life. A previous analysis found variability in the timing of HepB doses in infants receiving DTaP-IPV/Hib. We explored factors associated with co-administration of DTaP-IPV/Hib and HepB on the same day. Methods This was a retrospective study using the MarketScan® commercial claims and encounters database. Infants born from 1 July 2010 - 30 June 2016, continuously enrolled in an insurance plan for ≥ 13 months and receiving ≥ 3 DTaP-IPV/Hib doses were included. Infants were assessed for HepB claims relative to the first and third DTaP-IPV/Hib doses. Because a HepB birth dose was assumed, the first HepB claim from 29 - 169 days following birth was counted as Dose 2, and the second claim from 170 days - 12 months as Dose 3. Associations between demographic, provider, and insurance characteristics, receipt of other pediatric vaccines, and co-administration of DTaP-IPV/Hib and HepB were analyzed using multivariate logistic regression. Results Among 165,553 infants who received a first DTaP-IPV/Hib dose, 60.7% received HepB Dose 2 on the same day. Among 162,217 infants who received a third DTaP-IPV/Hib dose, 45.1% received HepB Dose 3 on the same day. Infants in the Northeast were less likely (OR=0.38, 95%CI=0.36-0.39), while those in the West were more likely (OR=1.41, 95%CI=1.36-1.46) than infants in the South to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day. Infants vaccinated by pediatricians (OR=0.54, 95%CI=0.53-0.55) were less likely to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day compared to infants vaccinated by family physicians. Infants who received PCV on the same day as the first dose of DTaP-IPV/Hib were more likely to receive HepB Dose 2 (OR=6.96, 95%CI=6.30-7.70) that day. These factors were also associated with co-administration of the third dose of DTaP-IPV/Hib and HepB Dose 3. Conclusion Differences in co-administration of DTaP-IPV/Hib and HepB were associated with region of residence, provider type and co-administration of PCV. The reasons underlying these differences merit exploration. A hexavalent vaccine containing DTaP, IPV, Hib, and HepB could improve timeliness of HepB vaccination, while reducing the number of injections during infancy. Disclosures Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Zhiwen Liu, PhD, Merck & Co., Inc., (Employee) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)

Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4500-4500
Author(s):  
Brian I. Rini ◽  
Elizabeth R. Plimack ◽  
Viktor Stus ◽  
Tom Waddell ◽  
Rustem Gafanov ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Final Analysis ◽  
Similar Proportion ◽  
First Line ◽  
Cell Renal Cell Carcinoma ◽  
Superior Efficacy ◽  
Treatment Naïve ◽  
To Receive ◽  
Safety Signals

4500 Background: In the first interim analysis of the randomized, multicenter, open-label, phase 3 KEYNOTE-426 study (NCT02853331), treatment with pembro + axi significantly improved OS, PFS, and ORR vs sunitinib monotherapy in treatment-naive advanced ccRCC. Extended follow-up (median, 30.6 mo) continued to demonstrate the superior efficacy of pembro + axi vs sunitinib monotherapy in this patient population. Here, we present the results of the prespecified final analysis with 42.8-mo median follow-up. Methods: Treatment-naive patients (pts) with advanced ccRCC, KPS ≥70%, and measurable disease (RECIST v1.1) were randomly assigned 1:1 to receive pembro 200 mg IV Q3W for up to 35 doses + axi 5 mg orally BID or sunitinib 50 mg orally QD on a 4-wk on/2-wk off schedule until progression, intolerable toxicity, or withdrawal. Randomization was stratified by IMDC risk (favorable vs intermediate vs poor) and geographic region (North America vs Western Europe vs Rest of World). Dual primary endpoints were OS and PFS. Secondary endpoints were ORR, DOR, and safety. The protocol-specified final analysis was based on a target of 404 OS events. No formal hypothesis testing was performed because all efficacy endpoints were met previously at the first interim analysis; nominal P values are reported. Results: Overall, 861 pts were randomly assigned to receive pembro + axi (n=432) or sunitinib (n=429). Median duration of follow-up, defined as time from randomization to the database cutoff date, was 42.8 mo (range, 35.6-50.6). At data cutoff, 418 pts had died: 193 (44.7%) of 432 pts in the pembro + axi arm vs 225 (52.4%) of 429 pts in the sunitinib arm. Compared with sunitinib, pembro + axi improved OS (median: 45.7 vs 40.1 mo; HR, 0.73 [95% CI, 0.60-0.88]; P<0.001) and PFS (median: 15.7 vs 11.1 mo; HR, 0.68 [95% CI, 0.58-0.80]; P<0.0001). The 42-mo OS rate was 57.5% with pembro + axi vs 48.5% with sunitinib; the 42-mo PFS rate was 25.1% with pembro + axi vs 10.6% with sunitinib. For pembro + axi vs sunitinib, ORR was 60.4% vs 39.6% ( P<0.0001); CR rate was 10.0% vs 3.5%; median DOR was 23.6 mo (range 1.4+ to 43.4+) vs 15.3 mo (range, 2.3-42.8+). Subsequent anticancer therapy was administered to 47.2% of pts in pembro + axi arm vs 65.5% of pts in sunitinib arm. Although a similar proportion of pts in each arm received VEGF/VEGFR inhibitors, only 10.2% of pts in the pembro + axi arm received subsequent treatment with a PD-1/L1 inhibitor compared to 48.7% of pts in the sunitinib arm. No new safety signals were observed. Conclusions: With a median follow-up of 42.8 mo, this is the longest follow-up of an anti-PD–1/L1 immunotherapy combined with a VEGF/VEGFR inhibitor for first-line RCC. These results show that pembro + axi continues to demonstrate superior efficacy over sunitinib with respect to OS, PFS, and ORR, with no new safety signals. Clinical trial information: NCT02853331.

scholarly journals Antibiotic Prescribing for Adults Hospitalized in the Etiology of Pneumonia in the Community Study

2017 ◽  
Vol 4 (2) ◽  
Author(s):  
Sara Tomczyk ◽  
Seema Jain ◽  
Anna M Bramley ◽  
Wesley H Self ◽  
Evan J Anderson ◽  
...  
Keyword(s):  
Antibiotic Use ◽  
Community Acquired Pneumonia ◽  
Community Study ◽  
Antibiotic Prescribing ◽  
Beta Lactam ◽  
First Line ◽  
Factors Associated ◽  
Admission Ward ◽  
Healthcare Associated ◽  
To Receive

Abstract Background Community-acquired pneumonia (CAP) 2007 guidelines from the Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) recommend a respiratory fluoroquinolone or beta-lactam plus macrolide as first-line antibiotics for adults hospitalized with CAP. Few studies have assessed guideline-concordant antibiotic use for patients hospitalized with CAP after the 2007 IDSA/ATS guidelines. We examine antibiotics prescribed and associated factors in adults hospitalized with CAP. Methods From January 2010 to June 2012, adults hospitalized with clinical and radiographic CAP were enrolled in a prospective Etiology of Pneumonia in the Community study across 5 US hospitals. Patients were interviewed using a standardized questionnaire, and medical charts were reviewed. Antibiotics prescribed were classified according to defined nonrecommended CAP antibiotics. We assessed factors associated with nonrecommended CAP antibiotics using logistic regression. Results Among enrollees, 1843 of 1874 (98%) ward and 440 of 446 (99%) ICU patients received ≥1 antibiotic ≤24 hours after admission. Ward patients were prescribed a respiratory fluoroquinolone alone (n = 613; 33%), or beta-lactam plus macrolide (n = 365; 19%), beta-lactam alone (n = 240; 13%), among other antibiotics, including vancomycin (n = 235; 13%) or piperacillin/tazobactam (n = 157; 8%) ≤24 hours after admission. Ward patients with known risk for healthcare-associated pneumonia (HCAP), recent outpatient antibiotic use, and in-hospital antibiotic use &lt;6 hours after admission were significantly more likely to receive nonrecommended CAP antibiotics. Conclusions Although more than half of ward patients received antibiotics concordant with IDSA/ATS guidelines, a number received nonrecommended CAP antibiotics, including vancomycin and piperacillin/tazobactam; risk factors for HCAP, recent outpatient antibiotic, and rapid inpatient antibiotic use contributed to this. This hypothesis-generating descriptive epidemiology analysis could help inform antibiotic stewardship efforts, reinforces the need to harmonize guidelines for CAP and HCAP, and highlights the need for improved diagnostics to better equip clinicians.

scholarly journals Sequential Treatment of Metastatic Adenocarcinoma of the Pancreatic Duct with Liver Metastasis Following the NAPOLI-1 Study Protocol with nal-Irinotecan plus 5-FU in the Second Line

2020 ◽  
Vol 13 (1) ◽  
pp. 79-84
Author(s):  
Dilara Akhoundova Sanoyan ◽  
Cäcilia S. Reiner ◽  
Panagiota Papageorgiou ◽  
Alexander R. Siebenhüner
Keyword(s):  
Systemic Treatment ◽  
Sequential Treatment ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Curative Surgery ◽  
To Receive

Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at an advanced or metastatic stage, when curative surgery is not recommended. Therefore, the prognosis is poor for this dismal disease, with only 1–2% of the patients reaching the 5-year survival follow-up. Current advances in systemic treatment with gemcitabine regimens, specifically polychemotherapy with gemcitabine plus nab-paclitaxel or other multidrug regimens such as FOLFIRINOX in the first line, have improved disease control over time. This higher efficacy of systemic treatment enables metastatic PDAC patients to receive second-line treatment more often nowadays. Currently, there is only one regimen for second-line treatment approved by the EMA, FDA, and Swissmedic, based on the phase III NAPOLI-1 study. In this case report, we present an outstanding response to sequential treatment with gemcitabine plus nab-paclitaxel followed by second-line treatment with nal-irinotecan plus 5-fluorouracil.

scholarly journals Efficacy of First-Third generation EGFR inhibitor combined with chemotherapy as first-line treatment for advanced lung adenocarcinoma in a real-world setting

2021 ◽  
Author(s):  
Ming-Wei Chen Ming-Wei Chen ◽  
An-Tai He . ◽  
Yi Pei .
Keyword(s):  
Lung Adenocarcinoma ◽  
Survival Time ◽  
Progression Free Survival ◽  
Egfr Mutations ◽  
Combination Group ◽  
First Line ◽  
Free Survival ◽  
Mean Survival Time ◽  
First Line Therapy ◽  
To Receive

Abstract BackgroundTo explore the optimal treatment strategy for patients who harbor sensitive EGFR mutations, a head-to-head study was performed to compare chemotherapy and gefitinib-erlotinip, osimertinib treatment in combination or with either agent alone as first-line therapy, in terms of efficacy and safety.MethodsA total of 200 untreated patients with advanced lung adenocarcinoma who harbored sensitive EGFR mutations were randomly assigned to receive gefitinib-erlotinip combined with pemetrexed and carboplatin group, gefitinib-erlotinip osimertinib combined with pemetrexed and carboplatin group, pemetrexed plus carboplatin alone group, or gefitinib-erlotinip alone group, osimertinib alone group.ResultsThe progression-free survival (PFS) of patients in the gefitinib-erlotinip combination group Mean Survival Time PFS 22.00 month,95%CI[16.29,27.70] and osimertinib gefitinib-erlotinip combination group Mean Survival Time PFS 40.00 month,95%CI[28.12,51.87]was longer than that of patients in the chemotherapy alone group PFS10,81 months, 95% CI,[ 8.99–12.64],gefitinib-erlotinip alone group PFS14.00 month.95%CI[11.98-20.01], osimertinib alone group PFS 26.66 month 95%CI[24.77-29.22].The gefitinib-erlotinip osimertinib combinational resulted in longer overall survival (OS) than chemotherapy alone (HR = 0.46, p = 0.016) or gefitinib-erlotinip alone (HR = 0.36, p = 0.01). osimertinib alone (HR = 0.26, p = 0.01).ConclusionsOur finding suggested that treatment with pemetrexed plus carboplatin combined with gefitinib-erlotinip and pemetrexed plus carboplatin combined with gefitinib-erlotinip osimertinib group could provide better survival benefits for patients with lung adenocarcinoma harboring sensitive EGFR mutations.

scholarly journals Evaluation of second line and subsequent targeted therapies in metastatic renal cell cancer (mRCC) patients treated with first line cediranib

2014 ◽  
Vol 8 (11-12) ◽  
pp. 398 ◽  
Author(s):  
Suzanne Richter ◽  
Jo-An Seah ◽  
Gregory R Pond ◽  
Hui K Gan ◽  
Mary J. Mackenzie ◽  
...  
Keyword(s):  
Renal Cell ◽  
Kinase Inhibitor ◽  
Cell Cancer ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Pivotal Phase ◽  
Line Therapy ◽  
To Receive

Introduction: Pivotal phase III trials have positioned angiogenesis inhibitors as first-line therapy for the management of most advanced or metastatic renal cell carcinomas (mRCC). Approaches to second-line therapy, however, remain more controversial with respect to drug selection and drug sequencing.Methods: In this study we evaluated mRCC patients who were initially treated on the first-line National Cancer Institute (NCI) trial with the highly potent vascular endothelial growth factor receptor tyrosine kinase inhibitor (TKI), cediranib, to determine the efficacy and tolerability of subsequent therapies.Results: Twenty-eight (65.1%) of the 43 patients enrolled on the first-line cediranib trial were known to receive second-line therapy, most commonly sunitinib (n = 21), with 4 (14%), 2 (7%) and 1 (3%) patients receiving temsirolimus, sorafenib, and interleukin, respectively. Of these, 14 (50%) went on to have 3 or more lines of therapy. The progression-free survival (PFS) proportion (PFS) at 1 year from starting second line was 30% (14.5%–47.9%). Longer duration of first-line cediranib treatment was modestly associated with longer duration of second-line treatment (Spearman rho 0.26). Patients who discontinued cediranib for toxicity were less likely to receive second-line sunitinib.Conclusion: In this real world evaluation, sequential use of TKIs for the management of mRCC was common. PFS with sequential TKIs was similar to observed and published results for any second-line therapy. Prior toxicity affected treatment patterns and the frequent use of at least 3 lines of therapy underscores the need for prospective sequencing trials in this disease.

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