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1.
J Clin Oncol ; 40(4): 382-391, 2022 02 01.
Article in English | MEDLINE | ID: mdl-34730989

ABSTRACT

PURPOSE: In the phase III KEYNOTE-181 study (NCT02564263) of patients with advanced esophageal cancer (EC), pembrolizumab monotherapy prolonged overall survival versus chemotherapy as second-line therapy in patients with programmed death ligand 1 combined positive score (CPS) ≥ 10. We present the results of the prespecified health-related quality-of-life (HRQoL) analyses of the squamous cell carcinoma (SCC), CPS ≥ 10, and CPS ≥ 10 SCC populations. PATIENTS AND METHODS: HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC QLQ EC questionnaire (OES18), and EuroQol 5-dimension questionnaire (EQ-5D). Data were analyzed in patients who received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment. Key analyses included baseline to week 9 least squares mean change in global health status/quality of life, functional or symptom subscales, and time to deterioration (≥ 10-point deterioration) for specific subscales. RESULTS: The HRQoL population included 387 patients with SCC. Compliance and completion rates for all three questionnaires were similar in both treatment groups at baseline and week 9. No clinically meaningful differences in global health status/quality of life scores were observed between treatment groups from baseline to week 9 (least squares mean difference, 2.80; 95% CI, -1.48 to 7.08); patients in both treatment groups generally exhibited stable functioning and symptom scores of the QLQ-C30 and QLQ-OES18 from baseline to week 9. Time to deterioration for pain (hazard ratio [HR], 1.22; 95% CI, 0.79 to 1.89), reflux (HR, 2.38; 95% CI, 1.33 to 4.25), and dysphagia (HR, 1.53; 95% CI, 1.02 to 2.31) subscales were similar between treatment groups. These findings were generally similar in the CPS ≥ 10 (n = 218) and CPS ≥ 10 SCC (n = 166) subgroups. CONCLUSION: In patients with advanced EC, pembrolizumab monotherapy and chemotherapy maintained HRQoL in patients with SCC, CPS ≥ 10, and CPS ≥ 10 SCC.


Subject(s)
Adenocarcinoma/drug therapy , Antibodies, Monoclonal, Humanized/therapeutic use , Docetaxel/therapeutic use , Esophageal Neoplasms/drug therapy , Esophageal Squamous Cell Carcinoma/drug therapy , Immune Checkpoint Inhibitors/therapeutic use , Irinotecan/therapeutic use , Paclitaxel/therapeutic use , Quality of Life , Adenocarcinoma/diagnosis , Adenocarcinoma/mortality , Antibodies, Monoclonal, Humanized/adverse effects , Disease Progression , Docetaxel/adverse effects , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/mortality , Esophageal Squamous Cell Carcinoma/diagnosis , Esophageal Squamous Cell Carcinoma/mortality , Functional Status , Humans , Immune Checkpoint Inhibitors/adverse effects , Irinotecan/adverse effects , Paclitaxel/adverse effects , Surveys and Questionnaires , Time Factors , Treatment Outcome
2.
Cancer ; 127(6): 865-874, 2021 03 15.
Article in English | MEDLINE | ID: mdl-33231873

ABSTRACT

BACKGROUND: Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously received sorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. METHODS: Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. RESULTS: The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. CONCLUSION: Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously received sorafenib.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Carcinoma, Hepatocellular/therapy , Liver Neoplasms/therapy , Quality of Life , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/psychology , Humans , Liver Neoplasms/mortality , Liver Neoplasms/psychology , Patient Reported Outcome Measures
3.
Int J Gynaecol Obstet ; 137(2): 129-137, 2017 May.
Article in English | MEDLINE | ID: mdl-28190260

ABSTRACT

OBJECTIVE: To investigate the clinical and economic impacts of school-based administration of the quadrivalent HPV vaccine. METHODS: A retrospective health-economic analysis was conducted using data collected in Singapore between 2004 and 2005. A dynamic transmission model was adapted for universal vaccination that provided 80% coverage among students aged 11-12 years. Strategy 1 involved only girls, with a 5-year catch-up vaccination to provide 50% coverage among those aged 13-17 years. Strategy 2 included both girls and boys with no catch-up vaccination. Outcomes included the predicted incidence of HPV-related disease over 100 years. RESULTS: Current coverage was assumed to be 5%. Strategy 1 would reduce cervical intraepithelial neoplasia grade 1 (CIN1) by 63.8%, cervical intraepithelial neoplasia grade 2-3 (CIN2-3) by 62.9%, cervical cancer by 50.9%, and genital warts by 78.0% (female individuals) and 73.6% (male individuals). Strategy 2 would reduce CIN1 by 64.0%, CIN2-3 by 63.1%, cervical cancer by 50.7%, and genital warts by 79.9% (female individuals) and 80.1% (male individuals). The incremental cost-effectiveness ratio was S$12 464 for strategy 1 and $27 837 for Strategy 2. These values decreased to $7477 and $22 574, respectively, if a two-dose regimen was adapted. CONCLUSION: School-based quadrivalent HPV vaccination offered clinical and economic benefits, and is cost-effective in Singapore.


Subject(s)
Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Dysplasia/prevention & control , Child , Cost-Benefit Analysis , Female , Humans , Incidence , Male , Models, Theoretical , Papillomavirus Infections/economics , Papillomavirus Infections/epidemiology , Retrospective Studies , Singapore/epidemiology , Treatment Outcome , Vaccination/economics , Vaccination/statistics & numerical data , Women's Health , Uterine Cervical Dysplasia/economics , Uterine Cervical Dysplasia/epidemiology
4.
Viruses ; 6(3): 968-85, 2014 Feb 26.
Article in English | MEDLINE | ID: mdl-24576846

ABSTRACT

Human cytomegalovirus (HCMV) is a ubiquitous pathogen capable of causing life threatening consequences in neonates and immune-compromised individuals. HCMV inflicts site-specific double strand breaks (DSBs) in the cellular genome. DNA damage infliction raises the corollary question of virus modulation of DNA repair. We recently reported HDR was stimulated in wt human foreskin fibroblasts (HFFs) during fully permissive infection or expression of the HCMV protein IE1-72 (IE72). These studies have been extended into semi-permissive T98G glioblastoma cells. T98Gs encode a mutant p53, which may contribute to their high baseline rate of HDR. We fully expected HCMV infection to increase HDR in T98Gs, similar to its effects in HFFs. Surprisingly in T98Gs HCMV infection, or sole expression of IE72, decreased HDR by two-fold. Transient expression of wt p53 in T98Gs also reduced HDR by two-fold. Dual transient expression of wt p53 and IE72 restored high baseline HDR levels. GST pulldown experiments revealed that both IE72 and wt p53 bound the important HDR protein, Rad51. We conclude that the expression of certain HCMV proteins can modulate HDR in an infected cell, dependent upon p53 status. We propose a model of the protein interactions explaining this behavior.


Subject(s)
Cytomegalovirus/growth & development , DNA Repair , Host-Pathogen Interactions , Immediate-Early Proteins/metabolism , Rad51 Recombinase/metabolism , Tumor Suppressor Protein p53/metabolism , Cell Line, Tumor , Humans , Protein Binding
5.
J Virol Methods ; 198: 64-8, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24389128

ABSTRACT

This report describes the development of a novel dual color Southern protocol to visualize two distinct genomes or genic regions simultaneously on a single Southern blot. The blot is developed with IRDye-conjugated antibody (Ab) and streptavidin that recognize digoxigenin (Dig)- or biotin-labeled probes, respectively and visualized on an infrared imager. This protocol was validated by visualizing viral and host genomes of human cytomegalovirus (HCMV)-infected human fibroblasts. This technique utilizes extremely sensitive fluorescent imaging, allowing the detection of nanogram quantities of DNA, as opposed to microgram quantities needed in Southerns using radioactively labeled probes, and eliminates the inherent loss in signal after stripping and reprobing a Southern blot. The probes are labeled with non-radioactive Dig and biotin and can be stored for extended periods of time. This protocol will aid in studies of any system with two genomes, such as cells infected with numerous types of microorganisms (virus/parasites/bacteria), or studies of mitochondrial and nuclear DNA within the same cells.


Subject(s)
Blotting, Southern/methods , Genome/genetics , Cytomegalovirus/chemistry , Cytomegalovirus/genetics , DNA/genetics , Fibroblasts/chemistry , Fluorescent Dyes/chemistry , Humans
6.
BJU Int ; 109(4): 572-80, 2012 Feb.
Article in English | MEDLINE | ID: mdl-21777361

ABSTRACT

OBJECTIVE: • To determine the proportion of patients with overactive bladder (OAB) potentially at risk for adverse events by assessing their pre-existing central nervous system (CNS), cardiovascular (CV) and other co-morbidities. PATIENTS AND METHODS: • The GE Centricity Electronic Medical Record database was utilized to identify patients with a diagnosis of OAB using International Classification of Diseases, Ninth Revision (ICD-9) codes or a prescription between 1 January 1996 and 30 March 2007 for an OAB anti-muscarinic agent. • Matched non-OAB patients were assigned the same index date as the corresponding OAB patient. Based on the presence of ≥ one pharmacy claim for an OAB anti-muscarinic agent, the OAB cohort was stratified as treated or untreated. A random sample of age- and gender-matched patients formed a non-OAB control cohort. • An additional and separate analysis focusing on all co-morbidities was performed examining non-OAB patients who were matched to OAB patients on 1:1 propensity score matching, based on age, body mass index (BMI) and gender at baseline. • Charlson Comorbidity Index (CCI), using ICD-9 codes, and the Chronic Disease Score (CDS), using prescribed drugs, were calculated. RESULTS: • When compared with non-OAB patients (N= 77,272; 83.2% women; median age 64 years), OAB patients (N= 41,440; 83.6% women; median age 65 years) had more overall CNS co-morbidities (45.4 vs 29.0%; P < 0.001). • In addition, OAB patients had a higher use of medications with anti-muscarinic effects (39.6 vs 25.4%; P < 0.001). OAB patients were also more likely to have CV co-morbidities (57.6 vs 44.6%; P < 0.001). • CNS co-morbidities were slightly more common in untreated (n= 8 106) than in treated (n= 33 334) OAB patients (47.2 vs 45.0%; P < 0.001). CV co-morbidities were higher in treated OAB patients (58.8 vs 53.7%; P < 0.001). • In the additional separate analysis, which focused on all co-morbidities, patients with OAB had higher mean CCI and CDS scores than patients without OAB (CCI: 1.17 vs 1.11 [P < 0.001]; CDS: 2.95 vs 1.74 [P < 0.001]). • After controlling for other covariates, the linear regressions (n= 22,544) showed that OAB patients had higher CCI and CDS than patients without OAB. CONCLUSIONS: • Among OAB patients, CNS, CV and all co-morbidities were more prevalent than in non-OAB patients. • Prior exposure to CNS medications was more prevalent in OAB patients who received anti-muscarinic treatment than in those who did not. • Co-morbidities and concomitant medications affecting the CNS and the CV system should be taken into account when making the decision on the most appropriate OAB treatment option for each individual patient.


Subject(s)
Cardiovascular Diseases/epidemiology , Central Nervous System Diseases/epidemiology , Urinary Bladder, Overactive/epidemiology , Adolescent , Adult , Aged , Comorbidity , Cost of Illness , Female , Humans , Male , Middle Aged , Muscarinic Antagonists/adverse effects , Urinary Bladder, Overactive/drug therapy , Young Adult
7.
ISRN Cardiol ; 2011: 924343, 2011.
Article in English | MEDLINE | ID: mdl-22347663

ABSTRACT

Objective. To determine whether increases in heart rates (HRs) over time leads to adverse cardiovascular (CV) events among "healthy subjects." Methods. This retrospective cohort study used the GE Centricity EMR database. "Healthy subjects" were defined as those with Charlson Comorbidity Index (CCI) score = 0 and Chronic Disease Score (CDS) = 0 at baseline. Subjects were followed for 3 years post the first date of a clinical encounter between the patient and provider. Those aged ≥18 years old with baseline HR and ≥2 post-index HR readings were identified between 01/01/1996 to 03/30/2007. Results. There were 93,952 "healthy subjects" at baseline (median age 42 years; 67.2% women; mean HR was 75.8 (SD: 11) bpm); 20.7% with a mean HR at baseline of 76.3 (SD: 11.3) bpm (median age 45; 63 women) experienced a CV event during 3 years of follow-up. The mean HR was higher among those with a CV event (76.3 bmp) compared to those without a CV event (75.7 bpm). A Cox regression model indicated that an increase in HR by 5 bpm was associated with a 1% increase in CV event risk. Conclusions. Elevated HRs are associated with an increased likelihood of CV events among "healthy subjects".

8.
J Virol ; 84(7): 3528-41, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20071566

ABSTRACT

Congenital human cytomegalovirus (HCMV) infection is a leading cause of birth defects, largely manifested as central nervous system (CNS) disorders. The principal site of manifestations in the mouse model is the fetal brain's neural progenitor cell (NPC)-rich subventricular zone. Our previous human NPC studies found these cells to be fully permissive for HCMV and a useful in vitro model system. In continuing work, we observed that under culture conditions favoring maintenance of multipotency, infection caused NPCs to quickly and abnormally differentiate. This phenotypic change required active viral transcription. Whole-genome expression analysis found rapid downregulation of genes that maintain multipotency and establish NPCs' neural identity. Quantitative PCR, Western blot, and immunofluorescence assays confirmed that the mRNA and protein levels of four hallmark NPC proteins (nestin, doublecortin, sex-determining homeobox 2, and glial fibrillary acidic protein) were decreased by HCMV infection. The decreases required active viral replication and were due, at least in part, to proteasomal degradation. Our results suggest that HCMV infection causes in utero CNS defects by inducing both premature and abnormal differentiation of NPCs.


Subject(s)
Cytomegalovirus Infections/pathology , Neurons/pathology , Stem Cells/pathology , Cell Adhesion , Cell Differentiation , Cell Movement , Cells, Cultured , Down-Regulation , Ganciclovir/pharmacology , Gene Expression Regulation , Humans , Proteasome Inhibitors , Virus Replication
9.
BJU Int ; 106(2): 268-74, 2010 Jul.
Article in English | MEDLINE | ID: mdl-19922546

ABSTRACT

OBJECTIVE: To determine if cardiovascular (CV) comorbidity and treatment-associated antimuscarinic effects differ between patients with and without overactive bladder (OAB), and between treated and untreated patients with OAB, as OAB, CV disorders and exposure to medications with antimuscarinic effects are common in older patients. PATIENTS AND METHODS: Adults from the HealthCore Integrated Research Database with a diagnosis of OAB (International Classification of Diseases-9 codes; from 1 January 2000 to 31 December 2006) or a pharmacy claim for an antimuscarinic OAB medication, formed the OAB cohort, further stratified as treated and untreated. A random sample of patients with neither a diagnosis for OAB nor any urinary bladder dysfunction, nor a pharmacy claim for antimuscarinics, formed the non-OAB cohort. CV comorbidities and use of medications with antimuscarinic effects were assessed for the 12 months before OAB diagnosis/treatment. Information on heart rate (HR) on the day of the first OAB drug prescription was obtained from the GE Healthcare dataset. HR was assessed for patients aged > or =18 years with a diagnosis of OAB who were prescribed antimuscarinics (oxybutynin or tolterodine) at any dose or oral formulation between January 1995 and November 2006. RESULTS: The 6607 patients with OAB, with a substantial proportion with elevated HR at baseline, were more likely to have CV comorbidities (39% vs 21%; P < 0.001) and previous exposure to medications with antimuscarinic effects (33% vs 17%; P < 0.001) than the non-OAB patients. Rate of CV comorbidities (40% vs 38%; P = 0.326) did not differ between treated and untreated patients with OAB. However, there was a difference in previous exposure to medications with antimuscarinic effects (37% vs 29%; P < 0.001); 39.1% of patients with OAB had a HR of >80 beats/min before starting antimuscarinic treatment. CONCLUSION: In this study, the prevalence of CV comorbidities was significantly higher in patients with than without OAB; previous exposure to medications with antimuscarinic effects was also higher in patients with OAB. There was no difference in pre-existing CV comorbidities between the treated and untreated patients with OAB, but the high use of medications with antimuscarinic effects among these patients suggests that the presence of CV comorbidity might not be considered before using antimuscarinic agents for OAB.


Subject(s)
Cardiovascular Diseases/chemically induced , Heart Rate/drug effects , Muscarinic Antagonists/adverse effects , Urinary Bladder, Overactive/drug therapy , Aged , Cardiovascular Diseases/epidemiology , Epidemiologic Methods , Female , Humans , Male , Middle Aged , Muscarinic Antagonists/therapeutic use , United States/epidemiology , Urinary Bladder, Overactive/epidemiology
10.
J Dermatolog Treat ; 20(1): 48-51, 2009.
Article in English | MEDLINE | ID: mdl-18651301

ABSTRACT

This study assessed the need for a 'very severe (BSA > 20%)' category for psoriasis. Though impact on quality of life differs between severe (BSA 11-20%) and very severe groups, considerable overlap exists between them. BSA > 10% predicts severity sufficiently, deterring the need for a 'very severe' category. Severity was self-assessed and may not reflect true clinical severity.


Subject(s)
Psoriasis/diagnosis , Psoriasis/psychology , Quality of Life , Sickness Impact Profile , Adaptation, Physiological , Adaptation, Psychological , Adult , Age Factors , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/psychology , Arthritis, Psoriatic/therapy , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Interpersonal Relations , Interviews as Topic , Male , Middle Aged , Pain Measurement , Predictive Value of Tests , Probability , Psoriasis/therapy , Risk Assessment , Sampling Studies , Self Concept , Severity of Illness Index , Sex Factors , Statistics, Nonparametric , Stress, Psychological , Young Adult
11.
Expert Opin Pharmacother ; 9(2): 163-74, 2008 Feb.
Article in English | MEDLINE | ID: mdl-18201142

ABSTRACT

Parkinson's disease (PD) affects nearly 1 million Americans with a mean onset age of 60 years. Its progressive, neurodegenerative nature, causing motor complications and affecting mood, has a considerable impact on a patient's health-related quality of life. Pharmacologic therapies are the most widely utilized treatment. The broad range of drugs for treating PD warrants an assessment of each medication's health-related outcomes, which includes consideration of clinical, economic and patient-centered outcomes. This review seeks to explore the outcomes associated with drugs frequently appearing in the literature of the past 5 years and to comment on the direction of pharmacologic research and management of PD pharmacotherapy in the future.


Subject(s)
Antiparkinson Agents/therapeutic use , Parkinson Disease/drug therapy , Parkinson Disease/epidemiology , Animals , Health Status , Humans , Parkinson Disease/psychology , Quality of Life/psychology , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/trends , Treatment Outcome
12.
Mov Disord ; 23(3): 359-65, 2008 Feb 15.
Article in English | MEDLINE | ID: mdl-18074366

ABSTRACT

Maintenance of symptom control in Parkinson's disease (PD) requires continuous titration of medication and addition of multiple therapies over the course of the disease. Adherence to medication is vital to symptom control and key to maximizing the efficacy of existing therapies. However, adherence is compromised by a variety of factors, including motor symptoms, complex dosing regimens, multiple medications, and lack of patient/physician awareness of the impact and prevalence of suboptimal adherence. This retrospective, longitudinal cohort study assessed the prevalence of suboptimal adherence [measured as the medication possession ratio (MPR)] to PD medications, and its impact on the worsening of PD symptoms (measured as increase in monotherapy dose, augmentation of therapy, PD-related emergency department visit, or hospitalization), in a Medicare Health Maintenance Organization population in the United States. Irrespective of the MPR threshold chosen, a high percentage of patients were categorized as suboptimally adherent to their PD medications, and patients with suboptimal adherence to their PD medications had higher risks of worsening of PD symptoms, compared with those who were adherent. Increased awareness of both the magnitude and impact of suboptimal adherence to PD medications, coupled with dosage simplification and a unified effort by healthcare professionals and patients, may improve adherence to PD medications and ultimately improve symptom control.


Subject(s)
Antiparkinson Agents/therapeutic use , Geriatrics , Health Maintenance Organizations/statistics & numerical data , Parkinson Disease/drug therapy , Parkinson Disease/epidemiology , Age Factors , Aged , Aged, 80 and over , Antiparkinson Agents/economics , Female , Humans , Longitudinal Studies , Male , Retrospective Studies , Severity of Illness Index , United States/epidemiology
13.
J Dermatolog Treat ; 17(3): 162-6, 2006.
Article in English | MEDLINE | ID: mdl-16854758

ABSTRACT

OBJECTIVES: Actinic keratoses (AKs) are common skin lesions with the potential to progress to squamous cell carcinoma. Many effective treatment alternatives exist, yet the reasons for treatment choice have not been explored. This study examined which AK therapy was preferred among dermatologists and primary care physicians (PCPs), as well as potential determinants of therapeutic selection. METHODS: A random national sample of 534 dermatologists and PCPs selected from the American Medical Association database completed AK questionnaires. The final sample included 1184 AK patients treated by dermatologists and 559 AK patients treated and/or referred by PCPs. All analyses were weighted using the survey sampling weights. RESULTS: Patients who had new and recurring lesions as well as patients who had a mean duration of more than a year since the last AK episode treatment (all p<0.05) were more likely to receive pharmacotherapy. Patients being treated by a dermatologist, receiving pharmacotherapy treatment only, and having both new and recurring lesions (all p<0.05) were less likely to have a complete treatment success. CONCLUSIONS: This study identifies several patient and physician factors associated with treatment preference and related outcomes in patients being treated for AK.


Subject(s)
Dermatology , Keratosis/therapy , Outcome Assessment, Health Care , Practice Patterns, Physicians'/statistics & numerical data , Primary Health Care , Skin Neoplasms/therapy , Aged , Cryotherapy/statistics & numerical data , Drug Utilization/statistics & numerical data , Female , Health Care Surveys , Humans , Keratolytic Agents/therapeutic use , Keratosis/drug therapy , Keratosis/pathology , Male , Retrospective Studies , Skin Neoplasms/drug therapy , Skin Neoplasms/pathology , Surveys and Questionnaires , United States
14.
Cutis ; 77(4): 251-5, 2006 Apr.
Article in English | MEDLINE | ID: mdl-16706243

ABSTRACT

This study investigated the relationship among health status, costs linked with the treatment of acne in the United States, and other aspects related to medication use. The US Medical Expenditure Panel Survey (MEPS) database was analyzed for a cohort of people with acne. This cross-sectional study obtained costs, demographics, healthcare service utilization, and clinical patient variables from the MEPS database. The EuroQol Group's EQ-5D scores available in MEPS were used for health status information. Multivariate weighted analysis was performed for data for approximately 5 million patients (weighted sample size). Nearly 70% of the patients used some type of medication for acne. Acne-related medication accounted for approximately 36% of the total acne-related annual healthcare costs, with an average of 2 annual acne prescription refills per patient. Increased number of refills of acne-related medications was associated with an improvement in health status (P<.05). Increased physician office-based visits were the only predictors of higher acne-related annual healthcare costs (P<.01). Adherence to acne medications is an important component of better health status. Pharmacologic treatment of acne does not significantly add to acne-related annual healthcare costs.


Subject(s)
Acne Vulgaris/drug therapy , Acne Vulgaris/economics , Drug Utilization/statistics & numerical data , Health Care Costs , Outcome Assessment, Health Care , Acne Vulgaris/epidemiology , Adolescent , Adult , Aged , Anti-Bacterial Agents/therapeutic use , Child , Cohort Studies , Cross-Sectional Studies , Drug Prescriptions , Female , Humans , Male , Middle Aged , Multivariate Analysis , Retinoids/therapeutic use , United States/epidemiology
15.
Manag Care Interface ; 19(1): 33-6, 39, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16453993

ABSTRACT

The cost of treating severe psoriasis has risen dramatically, and treatment options vary widely in terms of cost and efficacy. However, little information is available on the relative costs of home phototherapy and other long-term management options, specifically in the context of managed care. A payer-perspective cost model was developed to estimate and compare the direct expenditures associated with a 30-year course of various treatments for severe psoriasis. Within two years of treatment initiation, home-administered ultraviolet B phototherapy was less costly than any of the other treatments examined, including methotrexate, psoralen plus ultraviolet A, the retinoid acitretin, and new biologic agents. In addition, the efficacy and safety profile of home ultraviolet B phototherapy make it an excellent choice for extended management.


Subject(s)
Home Care Services , Psoriasis/radiotherapy , Ultraviolet Therapy/economics , Acute Disease , Cost-Benefit Analysis , Health Maintenance Organizations , Humans , Models, Economic , United States
16.
Indian J Exp Biol ; 44(1): 7-13, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16430084

ABSTRACT

UV-sensitive mutant strain of Haemophilus influenzae Rd MBH3, is 20 times more sensitive to UV irradiation than the wild type strain. The mutation responsible for increased UV sensitivity of the strain was identified as G --> A transition predicting synthesis of truncated UvrAdeltaC44 protein (Balsara & Joshi). Recombinant UvrAdeltaC44 protein was purified for the first time under denaturing conditions. The molecular weight of the recombinant protein was estimated as approximately100 kDa. Recombinant UvrAdeltaC44 protein was found to be less efficient in its ATPase and DNA binding activity as compared to the wild type protein. Recombinant plasmid carrying uvrAdeltaC44 gene could partially complement the UvrA deficiency in E. coli UvrA mutant.


Subject(s)
Bacterial Proteins/genetics , Bacterial Proteins/metabolism , Haemophilus influenzae/genetics , Haemophilus influenzae/metabolism , Adenosine Triphosphatases/chemistry , Adenosine Triphosphatases/genetics , Adenosine Triphosphatases/metabolism , Bacterial Proteins/chemistry , Base Sequence , Cloning, Molecular , DNA Repair , DNA, Bacterial/genetics , DNA, Bacterial/metabolism , DNA-Binding Proteins/chemistry , DNA-Binding Proteins/genetics , DNA-Binding Proteins/metabolism , Escherichia coli/genetics , Escherichia coli/metabolism , Escherichia coli Proteins/genetics , Escherichia coli Proteins/metabolism , Genes, Bacterial , Genetic Complementation Test , Haemophilus influenzae/radiation effects , Molecular Weight , Radiation Tolerance , Recombinant Proteins/chemistry , Recombinant Proteins/genetics , Recombinant Proteins/metabolism , Sequence Deletion , Ultraviolet Rays
17.
J Drugs Dermatol ; 4(6): 699-706, 2005.
Article in English | MEDLINE | ID: mdl-16302555

ABSTRACT

Of the topical preparations available, the ultra-high potency corticosteroids have an important role in treating psoriasis. However, the use of these agents in many other conditions and patient populations may not be appropriate. This study examines the prescribing patterns of Class I topical corticosteroids in patients with skin disease by analyzing data from the National Ambulatory Medical Care Survey (1990-2000). Of the nearly 718 million visits for skin disease, Class I topical corticosteroids were prescribed in nearly 3% of all skin disease-related visits, with prescription rates being highest in psoriasis (22%). The study found greater prescription rates of Class I topical steroids by dermatologists compared to non-dermatologists [Odds Ratio (OR) = 4.39 (95% CI: 2.15, 8.99)]. However, there were also a large number of questionable prescriptions for other conditions, which could be construed as misuse of these medications. Despite limitations and the potential dubious use seen here, Class I topical corticosteroid use is relatively commonplace. Education efforts and novel preparations of Class I agents will help to ensure the best possible care for patients suffering from significant skin diseases like psoriasis.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Drug Prescriptions/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Psoriasis/drug therapy , Administration, Cutaneous , Adolescent , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Adult , Ambulatory Care/statistics & numerical data , Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/adverse effects , Child , Dermatology/statistics & numerical data , Dose-Response Relationship, Drug , Family Practice/statistics & numerical data , Health Care Surveys , Humans , Internal Medicine/statistics & numerical data , Male , Office Visits/statistics & numerical data , Pediatrics/statistics & numerical data , Practice Patterns, Physicians'/trends , Psoriasis/diagnosis , Psoriasis/epidemiology , Skin Diseases/drug therapy , United States/epidemiology
19.
J Asthma ; 42(1): 35-40, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15801326

ABSTRACT

BACKGROUND: Outcomes in asthmatic patients may vary depending on the controller medication used. Observational studies of outcomes of asthma therapy are needed to understand the implications of choice of controller in different populations. OBJECTIVES: To determine whether there are differences in health care use and costs of asthma treatment in asthma patients treated with montelukast compared with fluticasone proponiate 44 microg. METHOD: Using data from the North Carolina Medicaid program, we compared continuously enrolled asthmatic patients starting either fluticasone propionate 44 microg (FP44), an inhaled corticosteroid (ICS) (n = 312), or montelukast 5 and 10 mg, an oral leukotriene modifier (LM) (n = 398) between the years 1998 and 1999. A secondary analysis compared continuously enrolled asthmatic patients already using ICS as controller therapy initiating either salmeterol (long-acting beta-agonist) (n = 97) or montelukast (n = 101) in the year 1998. Patients were followed for 1 year pre- and postcontroller or additional controller initiation for health care service use, medication refill patterns, and costs. RESULTS: There were no significant differences in the adjusted asthma-related health care costs between the montelukast and FP44 groups. In both groups, physician visits were significantly higher in year 2 (p < 0.01) than in year 1. We found montelukast users to be more adherent with prescription refills (using measures of medication possession) even after allowing for a wider adherence range for FP (RR = 2.53; 95% CI = 1.50-4.26), although patients using montelukast were more likely than patients with fluticasone to switch controller pharmacotherapy (RR = 1.53; 95% CI = 1.12-2.09). Similarly, there were no differences in health care service use and costs between the montelukast and salmeterol groups, with the exception of a 33% reduction (p < 0.01) in number of inhaled corticosteroid refills in the second year in the salmeterol group. CONCLUSION: There were no cost and major health care use differences between the two primary or secondary controller therapies in the postinitiation year. Although FP was associated with lower rate of controller switch, montelukast use was associated with significantly better treatment adherence in patients with treatment persistence in this population of Medicaid-enrolled asthmatic patients. The addition of salmeterol as additional controller was associated with a significant decrease in inhaled corticosteroid use, suggesting decreased adherence in patients on the two-drug regimen.


Subject(s)
Albuterol/analogs & derivatives , Anti-Asthmatic Agents/therapeutic use , Asthma/drug therapy , Acetates/economics , Acetates/therapeutic use , Adolescent , Adrenergic beta-Agonists/economics , Adrenergic beta-Agonists/therapeutic use , Adult , Albuterol/economics , Albuterol/therapeutic use , Androstadienes/economics , Androstadienes/therapeutic use , Anti-Asthmatic Agents/economics , Asthma/economics , Cohort Studies , Cyclopropanes , Drug Therapy, Combination , Female , Fluticasone , Health Care Costs , Humans , Leukotriene Antagonists/economics , Leukotriene Antagonists/therapeutic use , Male , Medicaid , Patient Compliance , Quinolines/economics , Quinolines/therapeutic use , Retrospective Studies , Salmeterol Xinafoate , Sulfides , Treatment Outcome
20.
J Am Acad Dermatol ; 52(1): 27-31, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15627077

ABSTRACT

BACKGROUND: The impact of psoriasis medication therapy on costs and patient outcomes in large nationally representative samples needs further examination. OBJECTIVE: This study examined the association between factors related to medication use, health status, and health care costs associated with psoriasis in the United States. METHODS: A cross-sectional cohort study was performed using the 2000 Medical Expenditure Panel Survey database. Information on health care service use, health status (EuroQol-5D instrument), and patient demographics were obtained from the database representing approximately 1.1 million patients with psoriasis. EuroQol was used in the Medical Expenditure Panel Survey. RESULTS: Weighted multiple linear regression analysis indicated that use of topical corticosteroid therapy was associated with a decrease in psoriasis-specific health care costs (53.2% lower than average costs vs patients using no medications, P = .022) and better health status (34.0% higher than average scores vs patients using no medications, P = .006). CONCLUSIONS: We observed an association with topical corticosteroids for treatment of psoriasis on health care outcomes and costs.


Subject(s)
Dermatologic Agents/therapeutic use , Glucocorticoids/therapeutic use , Psoriasis/drug therapy , Psoriasis/economics , Administration, Topical , Adolescent , Adult , Aged , Child , Cross-Sectional Studies , Dermatologic Agents/economics , Female , Glucocorticoids/economics , Health Care Costs , Humans , Male , Middle Aged , Morbidity , Multivariate Analysis , Severity of Illness Index , Treatment Outcome , United States
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