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1.
Article in English | MEDLINE | ID: mdl-38853099

ABSTRACT

BACKGROUND: Treatment recommendations for metastatic colorectal cancer (mCRC) do not differ by age group; nevertheless, aggressive multiagent chemotherapy comprising FOLFOXIRI+bevacizumab (triplet+bev) is routinely administered in younger patients. This study analyzed real-world data on index triplet+bev use and subsequent systemic therapies. MATERIALS AND METHODS: This retrospective, observational cohort study was conducted in patients aged ≥ 18 years with mCRC, who were initiated on triplet+bev. Data were derived from the Optum de-identified electronic health record dataset. RESULTS: Of 36,056 patients, 14%, 36%, and 50% were aged 18-49, 50-64, and ≥ 65 years, respectively. During the study period (2010-2021), triplet+bev use increased in patients aged 18-49 years (1%-4%) but remained at approximately 3% and 1% in patients aged 50-64 and ≥ 65 years, respectively. Patient demographics and clinical characteristics varied slightly; of patients receiving triplet+bev (n = 921) versus nontriplet+bev (n = 35,132) most were male (57% vs. 52%), resided in the Midwest (54% vs. 49%) and Northeast (18% vs. 14%) US regions, and had secondary malignancies (86% vs. 73%). Following triplet+bev, most patients received subsequent therapies (including continued triplet component therapies; 97%) or subsequent "new" therapies (therapies that did not include any agents comprising triplet+bev; 57%), most frequently EGFR inhibitors (28%) and regorafenib (21%), with a similar trend among all age groups. CONCLUSIONS: Overall, this study shows that younger patients with mCRC are more likely to receive first-line triplet+bev. These results also reveal that nonchemotherapy options are often used beyond first-line triplet chemotherapy for patients with mCRC.

2.
Cancers (Basel) ; 15(23)2023 Nov 22.
Article in English | MEDLINE | ID: mdl-38067235

ABSTRACT

Real-world (RW) evidence is needed to evaluate atezolizumab plus bevacizumab (atezo + bev) utilization for hepatocellular carcinoma (HCC) in clinical practice. This retrospective cohort study used administrative claims databases to evaluate treatment patterns in individuals with HCC ≥18 years of age who were initiated on atezo + bev between June 2020 and June 2022. The endpoints of this study were the proportion of individuals who discontinued atezo + bev and received subsequent systemic therapies, time to discontinuation (TTD), and time to next treatment. Overall, 825 individuals were eligible (median age 67 years; 80% male). Over a median follow-up of 15.3 months, most (72%) discontinued atezo + bev, with a median TTD of 3.5 months. A minority (19%) received subsequent therapies, with the most common second-line agents being lenvatinib (6%), cabozantinib (4%), and nivolumab (4%). The median time from index to next treatment post-atezo + bev was 5.4 months. Further research is needed to identify the patients who are most likely to benefit from atezo + bev as well as later-line HCC therapies to optimize overall survival.

3.
Future Oncol ; 2023 Sep 13.
Article in English | MEDLINE | ID: mdl-37701992

ABSTRACT

Aim: To evaluate temporal changes in metastatic colorectal cancer (mCRC), incidence, and use of chemotherapy treatment by age group using real-world data (RWD) from the USA. Methods: A retrospective, observational study describing temporal trends in mCRC incidence and FOLFOXIRI treatment by age group using a nationwide database of commercially and Medicare Advantage-insured patients from 2010 to 2019. Results: Incidence of mCRC increased by 22.1 and 14.9% in the 18-49 and 50-64 years cohorts, respectively, and decreased by 21.6% in the ≥65 years cohort. Overall, younger patients were more likely to receive FOLFOXIRI treatment versus older patients. Conclusion: The shifting age distribution of mCRC should be considered when recommending screening and treatment. Further research is needed to inform age-specific treatment guidelines.


What is this article about? This article reports the results of a study that used a US database of commercially and Medicare Advantage-insured adults to evaluate how the number of adults with metastatic colorectal cancer (mCRC) in three age groups (18­49 years, 50­64 years and 65 years and over) changed from 2010 to 2019. The study also looked at the use of an aggressive chemotherapy treatment, known as 5-fluorouracil, oxaliplatin, leucovorin calcium and irinotecan (FOLFOXIRI), by age group. What were the results? Overall, 23,970 adults with mCRC were included in the study. From 2010 to 2019, the number of adults with mCRC increased by 22.1% among those aged 18­49 years, increased by 14.9% among those aged 50­64 years, and decreased by 21.6% among those aged 65 years and over. There were some differences between age groups; a higher percentage of younger patients (18­49 years) were Hispanic or Asian, and from the South compared with the older age groups. In comparison, those aged 65 years and over were more likely to be from the West and Northeast of the USA. The study also found that a higher proportion of those aged 18­49 years received FOLFOXIRI (8.4%) compared with adults aged 50­64 years (4.4%) and 65 years and over (1.9%). What do the results of the study mean? Healthcare providers should be aware that early-onset mCRC is becoming more common and consider this when recommending screening and treatment.

5.
Clin Genitourin Cancer ; 21(1): 107.e1-107.e9, 2023 02.
Article in English | MEDLINE | ID: mdl-36180341

ABSTRACT

AIM: Estimate the effect of Radium-223 (Ra-223) on the incidence of bone fractures, prostate cancer death, and all-cause death compared with other standard treatments for metastatic, castration-resistant prostate cancer (mCRPC). METHODS: Using a cohort design, we estimated the effect of Ra-223 on the risk of bone fractures, all-cause and prostate cancer-specific mortality across different lines of treatment for mCRPC using Prostate Cancer data Base Sweden (2013-2018). The comparator group comprised other standard treatments for mCRPC. We used 36-month risk differences and hazard ratios (HRs) as effect estimates. RESULTS: The number of eligible individuals was 635, 453, 262, and 84 for the first-, second-, third-, and fourth-line cohorts, respectively. When compared Ra-223 to other standard treatments, the difference in the 36-month risk of fracture was 6% (95% confidence interval [CI], -7% to 18%) in the first-line cohort (n = 635) and 8% (95% CI, -7% to 18%) in the second-line cohort (n = 453). The number of fractures in the third-/fourth-line cohorts was too small for an adjusted comparison. The difference in 36-month mortality was higher in the first-line cohort 13% (95% CI, -3% to 31%), but lower in the second- and third-/fourth-line cohorts-8% (95% CI, -23% to 7%) and -14% (95% CI, -21% to 16%) respectively. Most deaths were due to prostate cancer. CONCLUSION: Results suggest that the difference in the risk of fractures is small, if any. A difference in the risk of mortality may be present in first-line treatment, but a decreased risk of mortality was observed in second and later lines of treatment. The results on mortality need to be considered in the context of potential unmeasured or residual confounding.


Subject(s)
Bone Neoplasms , Fractures, Bone , Prostatic Neoplasms, Castration-Resistant , Radium , Male , Humans , Prostatic Neoplasms, Castration-Resistant/drug therapy , Radium/therapeutic use , Sweden/epidemiology , Fractures, Bone/chemically induced , Fractures, Bone/drug therapy , Bone Neoplasms/radiotherapy , Bone Neoplasms/drug therapy , Retrospective Studies
6.
Future Oncol ; 16(25): 1889-1901, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32515225

ABSTRACT

Aim: This reports some of the first incidence rate (IR) estimates of second primary malignancies (SPMs) in men with metastatic castration-resistant prostate cancer (mCRPC) in three countries. Patients & methods: Claims data from the German Pharmacoepidemiological Research Database; registry data from the Prostate Cancer Data Base Sweden; and combined registry-claims data from the US Surveillance, Epidemiology and End Results-Medicare database were analyzed to obtain overall survival and incidence of SPMs in men with mCRPC. Results: SPMs occurred in 308 German (n = 2360), 273 Swedish (n = 2849) and 172 US (n = 2234) men with mCRPC. IRs of SPMs were 79.0 (95% CI: 70.4-88.4), 101.7 (95% CI: 90.3-114.5) and 59 (95% CI: 50-68) per 1000 person-years in German, Swedish and US cohorts, respectively. Conclusion: These studies report some of the first IR estimates of SPMs in men with mCRPC, providing a historical risk estimate of SPM in this patient population.


Subject(s)
Neoplasms, Second Primary/epidemiology , Neoplasms, Second Primary/etiology , Prostatic Neoplasms, Castration-Resistant/epidemiology , Aged , Aged, 80 and over , Germany/epidemiology , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Mortality , Prostatic Neoplasms, Castration-Resistant/diagnosis , Prostatic Neoplasms, Castration-Resistant/therapy , Public Health Surveillance , Registries , SEER Program , Sweden/epidemiology , Time Factors , United States/epidemiology
7.
PLoS One ; 15(2): e0227552, 2020.
Article in English | MEDLINE | ID: mdl-32084147

ABSTRACT

BACKGROUND: Among prostate cancer (PC) patients, over 90% of distant metastases occur in the bone. PC treatments may be associated with side effects, including second primary malignancies (SPM). There is limited information on the incidence of SPM among men with bone metastatic PC (mPC) and among men with bone metastatic castration-resistant PC (mCRPC). We estimated overall survival and the incidence of SPM in men with mPC and mCRPC. METHODS: In the Prostate Cancer data Base Sweden, the National Prostate Cancer Register was linked to other national health care registers, 15,953 men with mPC in 1999-2011 were identified. Further, 693 men with mCRPC were identified. Outcomes were evaluated using stratified incidence rates, Kaplan-Meier estimators and Cox models. RESULTS: The mean age among men with mPC was 73.9 years and in men with mCRPC 70.0 years. The median respective survivals were 1.5 (13,965 deaths) and 1.14 years (599 deaths), and average times since PC diagnosis 1.8 and 4.7 years. We observed 2,669 SPMs in men with mPC and 100 SPMs in men with mCRPC. The incidence rate of SPM per 1,000 person-years was 81.8 (78.8-85.0) for mPC and 115.6 (95.1-140.7) for mCRPC. High age, prior neoplasms, urinary tract infection, congestive heart failure, diabetes and renal disease were most strongly associated with increased mortality risk. Prior neoplasms and prior use of antineoplastic agents were most strongly associated with increased SPM risk. Several factors associated with increased mortality and SPM risks were more prevalent in the mCRPC cohort. CONCLUSIONS: Our results on mortality for men with mPC and mCRPC are in line with previous studies from the same time period. Investigation of factors associated with mortality and SPM in men with mPC and mCRPC can help to further understand these outcomes in the era prior to several new treatments have come available.


Subject(s)
Neoplasms, Second Primary/etiology , Prostatic Neoplasms, Castration-Resistant/mortality , Prostatic Neoplasms, Castration-Resistant/pathology , Adult , Aged , Aged, 80 and over , Bone Neoplasms/secondary , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasm Metastasis
8.
Prostate Cancer ; 2019: 5971615, 2019.
Article in English | MEDLINE | ID: mdl-31360552

ABSTRACT

BACKGROUND AND OBJECTIVE: Skeletal-related events (SREs) are common in men with bone metastases and have negative consequences for patients with castration-resistant prostate cancer (CRPC), including pain, reduced quality of life, and increased mortality. We estimated incidence rates of first SREs in a cohort of men with CRPC in the Surveillance, Epidemiology, and End Results-Medicare database. METHODS: We included men aged ≥ 65 years with a prostate cancer diagnosis in 2000-2011 if they had no prior malignancy (other than nonmelanoma skin cancer) and had surgical or medical castration with subsequent second-line systemic therapy, which was used to infer castration resistance. The first occurrence of an SRE (fracture, bone surgery, radiation therapy, or spinal cord compression) in Medicare claims was identified. Incidence rates of SREs were estimated in all eligible person-time and, in secondary analyses, stratified by any use of bone-targeted agents (BTAs) and history of SRE. RESULTS: Of 2,234 men with CRPC (84% white, mean age = 76.6 years), 896 (40%) had an SRE during follow-up, with 74% occurring within a year after cohort entry. Overall, the incidence rate of SREs was 3.78 (95% CI, 3.53-4.03) per 100 person-months. The incidence rate of SREs before any BTA use was 4.16 (95% CI, 3.71-4.65) per 100 person-months, and after any BTA use was 3.60 (95% CI, 3.32-3.91) per 100 person-months. The incidence rate in patients with no history of SRE was 3.33 (95% CI 3.01-3.68) per 100 person-months, and in patients who had such a history, it was 4.20 (95% CI 3.84-4.58) per 100 person-months. CONCLUSIONS: In this large cohort of elderly men with CRPC in the US, SREs were common. A decrease in incidence of SREs after starting BTA is suggested, but the magnitude of the effect may be confounded by indication and other factors such as age and prior SRE.

10.
Prostate Cancer ; 2019: 4387415, 2019.
Article in English | MEDLINE | ID: mdl-30886751

ABSTRACT

BACKGROUND: New therapies for castration-resistant prostate cancer (CRPC) may be associated with increased risk of second primary malignancies (SPM). We therefore estimated the population-based incidence of SPM among patients with CRPC in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We also estimated the proportion of men with CRPC with bone metastases and overall survival. METHODS: We conducted a retrospective cohort study of United States (US) men aged ≥ 65 years with CRPC. Cohort entry was from January 1, 2000, to December 31, 2011, with follow-up through December 31, 2013. Castration resistance was defined by treatment with second-line systemic therapy (after surgical or medical castration). SPM were diagnoses of primary cancers (other than prostate) in SEER or Medicare data. RESULTS: Altogether 2,234 patients met eligibility criteria. Most (1,887; 84.5%) had evidence of bone metastases in Medicare claims. SPM occurred in 172 patients (incidence rate 5.9 per 100 person-years; 95% confidence interval [CI], 5.0-6.8; standardized incidence ratio = 3.1, 95% CI, 2.8-3.6, based on SEER incidence rate of all malignancies except prostate cancer among men aged ≥ 65 years). The most common SPM were lung/bronchus (n = 29, 16.9%), urinary bladder (n = 22, 12.8%), and colon/rectum (n = 21, 12.2%). Median survival was 1.2 years (95% CI, 1.1-1.3); 5-year survival was 9% (95% CI, 7-11%). CONCLUSIONS: This study provides the first estimate of SPM risk in older men with CRPC in the US. The incidence rate is approximately threefold higher than the population-based cancer incidence among men without prostate cancer.

11.
Pharmaceut Med ; 33(3): 219-233, 2019 06.
Article in English | MEDLINE | ID: mdl-31933286

ABSTRACT

BACKGROUND: As part of the risk-management plan for aflibercept in the European Union, materials have been developed to educate physicians and patients in Europe on the safe use of aflibercept. OBJECTIVES: The objectives of this study were to measure receipt of the educational materials and to evaluate understanding of key safety information for aflibercept. METHODS: An observational cross-sectional study among physicians and patients with recent aflibercept experience in France, Germany, Italy, Spain, and the UK was conducted. Eligible physicians and patients completed a brief questionnaire regarding their knowledge of key safety information. RESULTS: Among the 8424 physicians invited to participate in the survey, 428 physicians were eligible, completed the questionnaire, and were included in this analysis. Most physicians reported having received the aflibercept summary of product characteristics (87%) and prescriber guide (77%); approximately half reported receiving the injection procedure video (50%) and patient booklet (54%). Physician knowledge of the most important topics (i.e., side effects; preparing patients for aflibercept injection) was high. Physician knowledge of dosing was high for neovascular (wet) age-related macular degeneration and lower for less commonly prescribed indications. Most physicians knew the contraindications for aflibercept and recognized possible side effects. Among the 874 patients approached about participation in the study, 773 patients were eligible, completed the questionnaire, and were included in the analysis. Patients' reported receipt was relatively low for the aflibercept patient booklet (38%) and the audio CD (23%). Patient knowledge of the health conditions to discuss with a doctor prior to injection was generally high; knowledge about possible side effects varied. Most patients knew that they should speak to a physician immediately if they experienced a possible side effect of aflibercept. CONCLUSION: Most physicians reported receiving the summary of product characteristics, prescriber guide, and patient booklet; half reported receiving the intravitreal injection procedure video. Patient receipt of the educational material was variable. Observed patterns of knowledge indicated the greatest knowledge of the most important risks emphasized in the educational material and lower knowledge of more complex or less salient aspects of safe use.


Subject(s)
Angiogenesis Inhibitors/administration & dosage , Health Education/methods , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Recombinant Fusion Proteins/administration & dosage , Adult , Aged , Aged, 80 and over , Angiogenesis Inhibitors/adverse effects , Clinical Competence , Contraindications, Drug , Cross-Sectional Studies , Europe , Female , Health Knowledge, Attitudes, Practice , Humans , Intravitreal Injections , Male , Middle Aged , Recombinant Fusion Proteins/adverse effects , Young Adult
12.
Pharmaceut Med ; 33(3): 235-246, 2019 06.
Article in English | MEDLINE | ID: mdl-31933288

ABSTRACT

BACKGROUND: As part of the risk-management plan (RMP) for aflibercept, materials have been developed to educate physicians in Canada on the key safety information and safe use for aflibercept. OBJECTIVE: The objectives of this study were to assess whether physicians in Canada received and reviewed the aflibercept educational materials (i.e. vial preparation instruction card, intravitreal injection procedure video, and product monograph) and to evaluate their knowledge of key safety information. METHODS: Retinal specialists and ophthalmologists who prescribe and/or administer aflibercept were recruited to complete a survey. Physicians could complete and return a paper questionnaire by mail or complete the questionnaire online via a study website. RESULTS: Of the 308 physicians invited to participate in the survey, 95 (31%) completed the questionnaire. Nearly all physicians (98%) reported receiving at least one of the educational materials. The proportion of correct responses to individual questions on storage and preparation of aflibercept ranged from 54 to 98%. Physician knowledge was high on the recommended dose of aflibercept (91%), dose preparation (91-96% on individual items), and dosing guidelines (75-95% on individual items). Most physicians knew the contraindications for aflibercept (89%) and that aflibercept should not be used in pregnancy unless clearly indicated by medical need in which benefits outweigh risks (60%); 21% responded more conservatively that aflibercept should never be used in pregnancy. Knowledge was high for most questions about injection procedures (91-99% on individual items); however, fewer physicians (24%) correctly reported that the eye should be covered with a sterile drape. Knowledge was high for possible side effects (89-100% on individual items) and actions to take in relation to the potential for increased intraocular pressure (86-93% on individual items). CONCLUSION: Nearly all physicians (98%) reported having received the product monograph, and most (82%) reported having received the vial preparation instruction card; nearly half (46%) reported having received the intravitreal injection procedure video. Physicians' knowledge of the most important topics was high. Knowledge varied for topics that are less frequently encountered (e.g. use in women of childbearing potential) and for recommendations that are not standard medical practice in Canada (e.g. use of sterile drape).


Subject(s)
Angiogenesis Inhibitors/administration & dosage , Clinical Competence/statistics & numerical data , Health Education/methods , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Recombinant Fusion Proteins/administration & dosage , Angiogenesis Inhibitors/adverse effects , Canada , Cross-Sectional Studies , Female , Humans , Intravitreal Injections , Male , Ophthalmologists , Practice Patterns, Physicians' , Recombinant Fusion Proteins/adverse effects , Risk Management , Surveys and Questionnaires
13.
Acta Ophthalmol ; 97(1): 91-98, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30238648

ABSTRACT

PURPOSE: To assess mean change in visual acuity (VA) overall and stratified by baseline VA after 1 and 2 years' treatment with aflibercept in a real-life setting. METHODS: This was an observational cohort study using nationwide data from the Swedish Macula Register. Treatment-naïve patient eyes with wet age-related macular degeneration and prescribed aflibercept from January 2013 to December 2014 were followed for 1 year (2478 eyes) or 2 years (831 eyes) to assess VA. Eyes were grouped by baseline VA. RESULTS: Mean number of injections in patients treated according to label (72%) versus patients treated not according to label was 8.0 ± 1.5 versus 4.4 ± 0.8 (p < 0.0001) at 1 year, and 12.5 ± 3.2 versus 7.3 ± 1.9 (p < 0.0001) at 2 years. Among all eyes, mean VA increased from 61.3 ± 13.4 Early Treatment Diabetic Retinopathy Study letters at baseline to 64.5 ± 15.6 at 1 year and 65.1 ± 15.1 letters at 2 years. At 2 years, eyes with good baseline vision (≥70 letters) lost a mean of 2.4 ± 11.3 to 72.3 letters, eyes with intermediate baseline VA (36-69 letters) gained 5.7 ± 14.1 to 62.7 letters, and eyes with poor baseline VA (≤35 letters) gained 13.2 ± 18.3 to 41.0 letters. Also at 2 years, 75% of treated eyes were stable or had improved VA. Among eyes with intermediate baseline VA, near vision was significantly better among those treated according to label versus not according to label at 3 (p = 0.019), 6 (p = 0.0002) and 12 months (p ≤ 0.0001). CONCLUSION: While gain in vision was especially pronounced in eyes with poor baseline VA, good baseline VA was important for best prognosis.


Subject(s)
Macula Lutea/pathology , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Recombinant Fusion Proteins/administration & dosage , Visual Acuity , Wet Macular Degeneration/drug therapy , Aged , Aged, 80 and over , Female , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Incidence , Intravitreal Injections , Male , Prognosis , Sweden/epidemiology , Time Factors , Tomography, Optical Coherence , Vascular Endothelial Growth Factor A , Wet Macular Degeneration/epidemiology , Wet Macular Degeneration/pathology
14.
Acta Ophthalmol ; 96(8): e942-e949, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29696809

ABSTRACT

PURPOSE: Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings. METHODS: POLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency. RESULTS: Outcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3-5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) µm, and the mean change in CRT was -115.2 µm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters). CONCLUSION: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.


Subject(s)
Diabetic Retinopathy/complications , Macula Lutea/diagnostic imaging , Macular Edema/drug therapy , Monitoring, Physiologic/methods , Ranibizumab/administration & dosage , Visual Acuity , Angiogenesis Inhibitors/administration & dosage , Diabetic Retinopathy/drug therapy , Diabetic Retinopathy/physiopathology , Dose-Response Relationship, Drug , Drug Administration Schedule , Europe , Female , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Intravitreal Injections , Macular Edema/diagnosis , Macular Edema/etiology , Male , Middle Aged , Retrospective Studies , Time Factors , Tomography, Optical Coherence , Vascular Endothelial Growth Factor A/antagonists & inhibitors
15.
Invest Ophthalmol Vis Sci ; 56(3): 1585-92, 2015 Feb 10.
Article in English | MEDLINE | ID: mdl-25670489

ABSTRACT

PURPOSE: Age-related macular degeneration (AMD) is the most common cause of legal blindness in Western patients over 65 years of age. We aimed to establish the incidence of AMD, and the association of diabetes, and cardiovascular and eye diseases with the risk of AMD, in a large cohort of primary care patients in the United Kingdom. METHODS: Using data from The Health Improvement Network database in the United Kingdom, all individuals with a first recorded diagnosis of AMD from 2004 to 2010 were identified (N = 10,516) and frequency-matched to 19,389 AMD-free individuals by age, sex, and calendar year of AMD occurrence. Logistic regression was used to examine comorbidities and risk factors for AMD. RESULTS: The incidence of AMD was 18.08 (95% confidence interval [CI], 17.74-18.43) per 10,000 person-years. A positive association with AMD was observed for smoking, a high frequency of primary care visits, and referrals. Diabetes and use of antidiabetic drugs were associated with an increased risk of AMD. Prevalence of cardiovascular diseases among AMD patients was slightly higher than in controls, with a small increased risk of AMD among patients with myocardial infarction, heart failure, or hyperlipidemia. Positive associations were observed between prior eye diseases and risk of AMD, in particular for chorioretinal disorders. CONCLUSIONS: The incidence of AMD in the United Kingdom is in line with previously reported incidence rates from population-based studies. The study suggests an association between diabetes, prior eye diseases, cardiovascular comorbidities and AMD risk, and a link between AMD and higher healthcare utilization.


Subject(s)
Cardiovascular Diseases/epidemiology , Diabetes Mellitus, Type 2/epidemiology , Macular Degeneration/epidemiology , Primary Health Care/statistics & numerical data , Aged , Aged, 80 and over , Cohort Studies , Comorbidity , Female , Health Surveys , Humans , Incidence , Male , Middle Aged , Risk , United Kingdom
16.
Expert Opin Drug Saf ; 9(2): 233-42, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20001764

ABSTRACT

IMPORTANCE OF THE FIELD: Over-the-counter (OTC) cough and cold medications have been used widely for years and continue to be a preferred choice for temporary relief of symptoms of upper respiratory tract infections in children. These medications are being placed under extraordinary scrutiny in the pediatric population due to the lack of conclusive evidence about their therapeutic efficacy and increased reports of associations with serious adverse events and even mortality. AREAS COVERED IN THIS REVIEW: A PubMed search was conducted to identify articles published up to August 2009 describing the efficacy and safety of OTC cough and cold medications in children. The objective was to provide an overview of the relevant literature and regulatory history and to comment on the available data on this important topic. WHAT THE READER WILL GAIN: The paper provides a detailed up-to-date review of the key efficacy and safety studies published on the subject. In addition, the reader is presented with an overview of the regulatory history and recent developments surrounding the use of OTC cough and cold medications in children in the US. TAKE HOME MESSAGE: This review confirms the lack of efficacy of OTC cough and cold products in children and reaffirms that although the overall incidence of related serious adverse events is low, such events continue to occur. The conclusions in this paper support a recommendation that OTC cough and cold medications should not be given to infants and very young children. Furthermore, additional research is needed to evaluate the safety and efficacy of these medicines in the broader pediatric population.


Subject(s)
Antitussive Agents/adverse effects , Common Cold/drug therapy , Cough/drug therapy , Nonprescription Drugs/adverse effects , Nonprescription Drugs/therapeutic use , Age Factors , Antitussive Agents/pharmacokinetics , Antitussive Agents/therapeutic use , Child , Common Cold/metabolism , Common Cold/mortality , Cough/metabolism , Cough/mortality , Humans , Nonprescription Drugs/pharmacokinetics , Treatment Outcome
17.
Am J Health Syst Pharm ; 66(5): 481-7, 2009 Mar 01.
Article in English | MEDLINE | ID: mdl-19233996

ABSTRACT

PURPOSE: The likelihood of hospitalization caused by adverse drug reactions (ADRs) from commonly implicated therapeutic groups is discussed. METHODS: A retrospective analysis of the computerized records of exposure cases involving pharmaceutical substances reported to the New Jersey Poison Information and Education System (NJPIES) was conducted from 2000 through 2007. The cases in the National Poisoning Data System that were categorized as an ADR were included in the study set. Only reports involving a single drug were selected for inclusion in the analyses. Characteristics of the ADRs, such as the sex and age of the patient, the therapeutic group involved, and the medical outcome of the exposure, were examined. Reports of ADRs with the most frequently implicated therapeutic groups were analyzed based on whether the patients were managed onsite, referred to a health care facility, or managed at a health care facility. The Adverse Drug Reaction Hospitalization (ADRH) index was calculated for all therapeutic groups, but the focus of the analyses was on the groups that were implicated in 5% or more of all ADRs. RESULTS: A total of 454,520 cases of human poisoning exposure were reported to NJPIES from 2000 through 2007. Of these cases, 162,105 were exposures implicating a single drug, of which 5,461 (3.4%) were classified as an ADR. Of the 5,461 cases, 385 patients were admitted into a health care facility. Antidepressants had the highest ADRH index (20.4%) among the therapeutic groups implicated, and antimicrobials had the lowest (2.2%). CONCLUSION: The analyses revealed a substantial variation in the likelihood of hospitalization associated with ADRs within different therapeutic groups. Among the groups that were most frequently implicated in ADRs, antidepressants showed the highest probability for an ADR-related hospitalization, followed by dietary supplements, herbals, and homeopathics and then by sedatives, hypnotics, and antipsychotics.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions , Hospitalization/statistics & numerical data , Poison Control Centers/statistics & numerical data , Adolescent , Adult , Aged , Antidepressive Agents/adverse effects , Child , Child, Preschool , Databases, Factual , Female , Humans , Infant , Male , Middle Aged , New Jersey , Retrospective Studies , Young Adult
18.
Prehosp Disaster Med ; 22(1): 55-8, 2007.
Article in English | MEDLINE | ID: mdl-17484364

ABSTRACT

INTRODUCTION: Poison Control Centers (PCCs) play an integral role in the preparation for and management of poison emergencies. Large-scale public health disasters, caused by both natural and human factors, may result in a drastic increase in the number of inquiries received and handled by PCCs in short periods of time. In order to plan and prepare for such public health emergencies, it is important for PCCs to assess their ability to handle the surge in call volume and to examine how the unusually large number of calls could affect the level of services. On 26 January 2006, the New York City Poison Center experienced a sudden loss of telephone service. The disruption in telephone service led to the need to reroute calls from that geographical catchment area to the New Jersey Poison Information and Education System (NJPIES) for several hours. METHODS: Data from the NJPIES was abstracted from the telephone switch's internal reporting system and the NJPIES's electronic record system and processed with a standard spreadsheet application. RESULTS: Compared to the same time and day in the previous week, the total number of calls received by the NJPIES during the four hours after the disruption increased by 148%. A substantial rise in the number of calls was observed in almost every 15-minute increment during this four-hour (h) time period (with some of these increments increasing as much as 525%). Meanwhile, the percentage of calls answered by the NJPIES decreased, and the percentage of calls abandoned during a 15-minute increment reached as high as 62%. Furthermore, the average time for handling calls was longer than usual in most of these 15-minute increments. CONCLUSIONS: Limitations of the telephone technology, which impacted the ability of the NJPIES to respond to the surge of calls, were observed. While the NJPIES was able to handle the unusual increase of incoming calls using available poison specialists and staff, the experience gained from this natural experiment demonstrates the need for PCCs to have a pre-planned surge capacity protocol that can be implemented rapidly during a public health emergency. A number of challenges that PCCs must meet in order to have adequate surge capacity during such events were identified.


Subject(s)
Hotlines/statistics & numerical data , Poison Control Centers/organization & administration , Humans , New Jersey , Organizational Case Studies
19.
J Toxicol Environ Health A ; 70(2): 107-10, 2007 Jan 15.
Article in English | MEDLINE | ID: mdl-17365570

ABSTRACT

While previous research suggests that poison control centers (PCCs) significantly reduce the number of emergency room visits and resultant health care costs for poisonings, little is known regarding the potential impact of the PCC on the length of hospital stay. The aim of this study was to examine whether assistance from a PCC is associated with a shorter length of hospital stay for patients admitted with poisonings. The cases reported to our PCC were matched over a period of 1 yr with the hospital admissions E-coded as poisonings in the Uniform Billing (UB) data maintained by the state health department. The length of hospital stay was then compared between the cases for which a PCC provided assistance (matches) and the cases for which a PCC was not contacted. During the study period, there were 32,245 hospitalizations for poisoning in the UB data and 52,498 poisonings reported to the PCC. The matching process yielded 1719 nonfatal cases. The length of hospital stay for patients who received assistance from a PCC ranged from 0 to 126 d (median = 2.0) and was significantly different compared to a range of 0 to 220 days (median = 5.0) for cases that were never called in to a PCC. The results of this study suggest that patients admitted to hospitals with poisonings who receive PCC assistance have measurable reductions in average hospital stay. Such a decrease may translate into substantial savings in health care costs and resources.


Subject(s)
Length of Stay/statistics & numerical data , Poison Control Centers/statistics & numerical data , Poisoning , Adolescent , Adult , Child, Preschool , Cost-Benefit Analysis , Drug-Related Side Effects and Adverse Reactions , Female , Humans , Length of Stay/economics , Male , New Jersey
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