Low frequency of adverse events reported through postmarketing surveillance for pulmicort respulesTM (budesonide inhalation suspension) in the US adult population

2002 ◽  
Vol 109 (1) ◽  
pp. S292-S293 ◽  
Author(s):  
Mario Cruz-Rivera ◽  
Ewa Lyzell ◽  
Sherahe Fitzpatrick
2021 ◽  
Vol 12 ◽  
pp. 215013272110165
Author(s):  
Elaine Seaton Banerjee ◽  
Kyle Shaak ◽  
Nicole Burgess ◽  
Melanie Johnson ◽  
Beth Careyva

Introduction/Objectives: Diabetes and prediabetes impact nearly half of the US adult population and are associated with significant health risks but may be underdiagnosed. Effective screening may improve diagnosis and give patients opportunity to manage their disease. The purpose of this study was to determine screening rates, identify characteristics predictive of screening, and evaluate correct diagnosis of diabetes and prediabetes. Methods: Retrospective chart review of 71 433 patients eligible for diabetes screening, defined by completing A1c test within the 3-year study period. Results: A total of 31.3% of eligible patients received diabetes screening. Factors associated with screening include older age, female sex, non-white race, Hispanic ethnicity, Medicare or Medicaid insurance, higher BMI, and having a medical comorbidity. History of prediabetes or gestational diabetes were the strongest predictors for diabetes screening, but history of gestational diabetes was under-documented. Of those screened, 10.4% had a result consistent with diabetes and 51.8% had a result consistent with prediabetes. However, 52.9% of these patients had a missed diagnosis. Conclusions: Findings of this study indicate the need for uniform coverage for diabetes screening for all insurances, increased documentation of gestational diabetes to improve screening for patients with this history, and improving accurate diagnosis after screening is completed.


Obesity ◽  
2017 ◽  
Vol 25 (9) ◽  
pp. 1540-1548
Author(s):  
Sandra A. Tsai ◽  
Lan Xiao ◽  
Nan Lv ◽  
Ying Liu ◽  
Jun Ma

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Cheng KKF ◽  
S. A. Mitchell ◽  
N. Chan ◽  
E. Ang ◽  
W. Tam ◽  
...  

Abstract Background The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. Methods All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. Results A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. Conclusions PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.


Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Dianjianyi Sun ◽  
Tao Zhou ◽  
Xiang Li ◽  
Yoriko Heianza ◽  
Xiaoyun Shang ◽  
...  

Background: Cardiovascular disease (CVD) has been the number one cause of death and disability in the US and globally for decades, and its comorbidity complicates the management of CVD. However, little is known about the secular trend of CVD comorbidities in national representative populations in the last 20 years. Methods: Prevalence of CVD and nine major chronic comorbidities was estimated using data from 1,324,214 adults aged 18 years and older in the National Health Interview Survey (NHIS) from 1997 through 2016, with age-standardized to the U.S. population in the year 2000. Results: CVD prevalence in the US adult population significantly declined in the past twenty years (from 6.6% in 1997 to 5.9% in 2016, P trend <0.01in Figure a). And such trend was shown in women and whites (P trend <0.01), but not in men and blacks (P trend >0.05). We ranked the nine major chronic comorbidities (high to low) in the CVD patients (Figure b.), including (1) hypertension, (2) respiratory conditions, (3) nervous system conditions, (4) digestive conditions, (5) diabetes, (6) cancer, (7) genitourinary conditions, (8) circulatory conditions, and (9) endocrine/nutritional/metabolic conditions. From 1997 to 2016, the prevalence of CVD comorbidities including hypertension (38.8% to 50.2%), digestive conditions (17.0% to 27.1%), diabetes (10.0% to 19.2%), cancer (9.4% to 12.8%), and genitourinary conditions (4.1% to 5.2%) continuingly increased (all P trend <0.01), while respiratory conditions declined (35.9% to 27.6%, P trend <0.01). Similar trends of CVD comorbidities were observed among subgroups stratified by gender or by race. Conclusions: CVD prevalence in the U.S. adults have declined significantly in the past two decades, but rates of CVD comorbidities including hypertension, digestive conditions, diabetes, cancer, and genitourinary conditions increased substantially.


2020 ◽  
Vol 23 (2) ◽  
Author(s):  
Patrycjusz Kołodziejczyk ◽  
Katarzyna Baranowska-Kempisty ◽  
Piotr Bernat ◽  
Piotr Tutka

Tobacco smoking is one of the leading causes of death among people. Cytisine, a plant alkaloid considered to be the oldest medication for smoking cessation, has been used in Poland since the 1970s. The drug is a partial nicotinic receptor agonist, with pharmacological actions close to those of nicotine and varenicline (a synthetic cytisine derivative and most expensive smoking cessation medication currently available). Cytisine has several advantages compared to existing smoking cessation drugs, including: 1) it is more effective than placebo and nicotine replacement therapy, and at least as effective as varenicline, 2) its use is associated with a low frequency of adverse events, 3) it is available as over the counter medicine and is much cheaper than other smoking cessation drugs that are cost-prohibitive, 4) it derives from a natural plant and may be preferred by smokers who do not want to use other treatments, 5) it has shorter duration of treatment (i.e. 25 days) compared to other medicines for smoking cessation. This review describes the use of cytisine for nicotine addiction treatment, mechanism of anti-smoking action, pharmacokinetics, efficacy, tolerability and safety.


2018 ◽  
Vol 34 (4) ◽  
pp. 144-148
Author(s):  
Hannah Mohammad ◽  
Nancy Borja-Hart

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.


JAMA ◽  
2017 ◽  
Vol 318 (4) ◽  
pp. 325 ◽  
Author(s):  
Rita F. Redberg ◽  
Alison F. Jacoby ◽  
Joshua M. Sharfstein

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