Ryan Ziemiecki

A Population-Based Study of Peyronie's Disease: Prevalence and Treatment Patterns in the United States.

Purpose. To estimate the US prevalence of Peyronies disease (PD) from patient-reported data and to identify diagnosis and treatment patterns. Methods. 11,420 US males ≥18 years old completed a brief web-based survey regarding the presence of PD, past treatments, and penile symptoms (Phase 1). Phase 1 respondents with PD diagnosis, history of treatment, or PD-related symptoms then completed a disease-specific survey (Phase 2). Results. Estimated prevalence of PD ranged from 0.5% (diagnosis of PD) to 13% (diagnosis, treatment, or penile symptoms). Thirty-six percent of Phase 2 participants reported that penile symptoms interfered with sexual activities. Of participants who sought treatment for penile symptoms (n = 128), 73% initially saw a primary care physician, 74% did not receive treatment from their first doctor, and 92% were not diagnosed with PD. Conclusions. PD may be underdiagnosed/undertreated in the US. Improved awareness is needed of PD symptoms and treatment options among health care professionals.

Predictors of Uncontrolled Asthma in Adult and Pediatric Patients: Analysis of the Asthma Control Characteristics and Prevalence Survey Studies (ACCESS)

Background. Despite the availability of effective asthma treatments and evidence-based management guidelines focusing on asthma control, many patients have asthma that is inadequately controlled. The objective of this analysis was to identify risk factors for uncontrolled asthma among adult and pediatric patients. Methods. Two cross-sectional surveys assessing asthma control status were conducted between January 25 and May 2, 2008, among adult and pediatric patients with asthma. Participants completed a self-administered questionnaire including demographics, medical history, and current asthma medication use. In addition, participants completed either the Asthma Control Test (ACT) or Childhood ACT (C-ACT). Uncontrolled asthma was defined as a score of ≤19 on the ACT or C-ACT. Multiple logistic regression was used to identify factors related to uncontrolled asthma. Results. A sample of 64 primary care provider sites (35 for adults and 29 for pediatric patients) across the United States enrolled. One study enrolled 2238 adults (aged ≥18 years) and the other 2429 children (aged 4–17 years) with asthma. The patients were visiting their health care provider for a scheduled appointment for any reason. The overall prevalence of uncontrolled asthma was 58% and 46% in adult and pediatric patients, respectively. Multivariate analysis identified predictors of uncontrolled asthma in both adults and children including self-reported asthma severity, lack of adherence, and recent history of cold, flu, or sinus infection. The predictors of uncontrolled asthma seen only in adults were less education, insurance status, current smoker, body mass index (BMI) >30 kg/m2, and history of gastroesophageal symptoms. The predictors of uncontrolled asthma seen only in children were female aged 12–17 years, caregiver unemployment, and history of asthma exacerbation. Conclusions. A high proportion of patients with asthma seen in primary care settings are not well controlled. Recognition of specific predictors can signal who may be at higher risk of uncontrolled asthma and provide the opportunity for early interventions.

Status of Asthma Control in Pediatric Primary Care: Results from the Pediatric Asthma Control Characteristics and Prevalence Survey Study (ACCESS)

OBJECTIVE To estimate the prevalence of uncontrolled asthma in pediatric patients with asthma visiting their primary care provider for any medical reason. STUDY DESIGN This was a cross-sectional survey conducted at 29 pediatric care sites across the United States. Children age 4-17 years with self- or caregiver-reported asthma completed the Childhood Asthma Control Test (C-ACT) or the Asthma Control Test (ACT) and responded to demographic and health-related questions. Uncontrolled asthma was defined as a C-ACT or ACT score <or=19. RESULTS A total of 2429 children with a diagnosis of asthma (or caregivers) completed the survey. The prevalence of uncontrolled asthma was 46%. The prevalence of uncontrolled asthma was 35% in patients seen for a nonrespiratory complaint versus 54% in those seen for a respiratory complaint. Children seen for a non-respiratory-related complaint with uncontrolled asthma were more likely to have missed 1 or more school days in the previous 4 weeks compared with children with controlled asthma (53% vs 24%). CONCLUSIONS These findings highlight the impact of uncontrolled asthma not only in children seen for respiratory complaints, but also in those seen for nonrespiratory complaints. Pediatric care providers should consider evaluating asthma control on a regular basis regardless of the reason for the visit.

Assessment of asthma control in primary care

Abstract Objective: To determine the prevalence of uncontrolled asthma in patients who are visiting their primary care provider for any reason. Research design and methods: This multisite, cross-sectional survey was conducted between January 25 and May 2, 2008. Participants aged ≥18 years were recruited from 35 primary care provider sites. Eligible participants presented to the office for any acute medical, routine, follow-up, or nonmedical reason; had a self-reported physician diagnosis of asthma; used medication to treat asthma in the past year; and had no history of COPD. They completed the Asthma Control Test† (ACT) and provided information including demographics, health behaviors, medical history, and asthma medication use. Uncontrolled asthma was defined as ACT score ≤19. † Asthma Control Test is a trademark of QualityMetric, Inc., Lincoln, RI, USA. Results: The overall weighted prevalence of uncontrolled asthma in 2238 patients in primary care was 58% (95% confidence interval [CI], 0.56–0.60). Among asthma patients seeking care for a respiratory complaint, 72% (95% CI, 0.68–0.75) had uncontrolled asthma compared to 48% (95% CI, 0.45–0.51) of asthma patients presenting for a non-respiratory reason. Conclusions: At the population level, over half of patients with asthma under primary care management had uncontrolled asthma at the time of an office visit. Surprisingly, nearly 50% of patients with asthma who presented for office visits not associated with respiratory-related complaints had uncontrolled asthma. The study results may be influenced by a seasonal effect of upper respiratory infections and by the insurance status of the study respondents. However identifying patients with uncontrolled asthma is important and remains a challenge. Therefore, health care providers should consider evaluating asthma control on a regular basis, regardless of reason for visit.

Comparison of the effectiveness of frontline chemoimmunotherapy regimens for follicular lymphoma used in the United States

Abstract To compare the effectiveness of frontline rituximab-chemotherapy regimens in clinical practice, we examined outcomes for patients with low-grade, stage III/IV follicular lymphoma receiving rituximab (R) with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), R with cyclophosphamide, vincristine and prednisone (R-CVP) or R with a fludarabine-based regimen (R-Flu) as frontline therapy. In total, 611 patients meeting these criteria were identified in the National LymphoCare Study: 47% receiving R-CHOP (n = 287), 31% receiving R-CVP (n = 187) and 22% receiving R-Flu (n = 137). Overall response rates were high (R-CVP 87%, R-CHOP 93%, R-Flu 94%; p = 0.017). Median follow-up was 7.4 years. R-CVP was associated with lower 5-year overall survival (R-CVP 76%, R-CHOP 86%, R-Flu 86%; p = 0.021) and progression-free survival (R-CVP 49%, R-CHOP 58%, R-Flu 64%; p = 0.029). There were no significant differences in survival in Cox models adjusted for baseline clinical factors, practice region/setting and post-treatment R maintenance/observation.

Health-related quality of life and disease symptoms in postmenopausal women with HR+, HER2− advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy

Abstract Objective: Everolimus (EVE)+exemestane (EXE; n = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (n = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR+) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE + EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL. Research design and methods: HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall. Clinical trial registration: Clinicaltrials.gov: NCT00863655. Main outcome measures: Progression-free survival, survival, response rate, safety, and HRQOL. Results: Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE + EXE and PBO + EXE for QL2 (LSM difference = −1.91; 95% CI = −4.61, 0.78), BRBS (LSM difference = −0.18; 95% CI = −1.98, 1.62), or BRAS (LSM difference = −0.42; 95% CI = −2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE + EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO + EXE. Key limitations: HRQOL data were not collected after disease progression. Conclusions: These analyses confirm that EVE + EXE provides clinical benefit without adversely impacting HRQOL in patients with HR+ ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.

Outcomes following watchful waiting for stage II-IV follicular lymphoma patients in the modern era

To examine the effectiveness of an initial management strategy of watchful waiting for follicular lymphoma (FL) in clinical practice, we compared outcomes for patients diagnosed 2004–2007 in the United States initially managed with watchful waiting with outcomes following initial rituximab monotherapy and chemoimmunotherapy. In total, 1754 stage II–IV patients in the National LymphoCare Study underwent watchful waiting (n = 386), rituximab monotherapy (n = 296) or rituximab plus chemotherapy (n = 1072) as initial management strategy. Female patients and those who received treatment in the Northeast or in an academic setting more commonly underwent watchful waiting versus initial chemoimmunotherapy; whereas patients with grade 3 histology, anaemia, elevated lactate dehydrogenase, extranodal involvement, B symptoms or performance status ≥1 more commonly received chemoimmunotherapy. Although time to new treatment and progression‐free survival following first‐ and second‐line therapy were improved with chemoimmunotherapy, and time to chemotherapy was improved with rituximab monotherapy, there were no differences in overall survival between watchful waiting and chemoimmunotherapy or rituximab monotherapy. With 8‐year overall survival estimates of 74%, initial management with watchful waiting in the context of sequential therapy remains a viable option for FL patients in the modern era. This trial was registered at www.clinicaltrials.gov (NCT00097565).

Patterns of delivery of chemoimmunotherapy to patients with follicular lymphoma in the United States: results of the National LymphoCare Study.

Drug choice and delivered dose of treatment potentially influence outcome in patients treated for follicular lymphoma (FL). Historically, observational studies have evaluated drug choice. The National LymphoCare Study (NLCS) is a prospective, observational study of patients with FL who were enrolled at academic and community practice sites in the United States between 2004 and 2007. In the current study, the authors report on measures of delivered dose and its impact on outcomes for the most common first‐line regimens.

Variation in cardiovascular risk related to individual antimuscarinic drugs used to treat overactive bladder: A cohort study in the UK

Blocking muscarinic receptors could have an effect on cardiac function, especially among elderly patients with overactive bladder (OAB).