Peg Strub

Adherence to Prescribed Treatment for Asthma: Evidence from Pharmacy Benefits Data

Background. Failure to use asthma controller medications as prescribed is associated with more asthma-related adverse events. Medication utilization may vary with ease of drug administration, efficacy, and tolerability as well as other factors. We hypothesized that in usual-care clinical practice settings, there would be greater adherence to oral controller than to inhaled controller asthma medications. Methods. We compared adherence to newly initiated asthma controller therapy among patients initiating monotherapy with leukotriene receptor antagonists (LTRAs), inhaled corticosteroids (ICS), or inhaled long-acting β-agonists (ILBA) from 03 1998 to 07 1999. We measured adherence as the sum of drug supply days between first and last fill dates divided by length of drug therapy. Analyses were stratified by the number of short-acting β-agonists (SBA) prescriptions per year to control for disease severity. Results. Pharmacy claims data from 48,751 subjects (6 to 55 years) were analyzed (mean age 30.4 years; 56% female). Mean adherence to new start monotherapy on LTRA was 67.7%, to ICS was 33.8%, and to ILBA was 40.0%. Adherence to all three controller agents increased with increasing SBA use. The percent of patients persistent to asthma controller monotherapy at both 6 and 9 months was significantly greater among those on LTRA monotherapy than on either ICS or ILBA. Conclusions. In clinical practice settings, patients initiating LTRA monotherapy have about twice the adherence as patients initiating ICS or ILBA monotherapy. Because adherence to treatment is a critical component of treatment response, it is important to consider this factor in the prescription of oral vs. inhaled asthma medications.

Behavioral Weight Loss and Physical Activity Intervention in Obese Adults with Asthma. A Randomized Trial

RATIONALE The effect of weight loss on asthma in obese adults warrants rigorous investigation. OBJECTIVES To examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control. METHODS The trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention. MEASUREMENTS AND MAIN RESULTS The primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m(2)) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, -4.0 ± 0.8 kg vs. control, -2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task-min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task-min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, -0.3 ± 0.1 vs. control, -0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72-8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from baseline). The effects of other weight change categories were small. CONCLUSIONS Moderately and severely obese adults with uncontrolled asthma can safely participate in evidence-based lifestyle intervention for weight loss and active living. The modest average weight and activity improvements are comparable to those shown to reduce cardiometabolic risk factors in studies of similar interventions in other populations but are not associated with significant net benefits for asthma control or other clinical asthma outcomes in the current population. Instead, weight loss of 10% or greater may be required to produce clinically meaningful improvement in asthma. Clinical trial registered with www.clinicaltrials.gov (NCT00901095).

The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: A randomized controlled trial

BackgroundObesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI) and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals.Methods/DesignBE WELL is a 2-arm parallel randomized clinical trial (RCT) of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324) are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke). The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical activity level and nutrient intake) and moderators (e.g., socio-demographic characteristics and comorbidities) of the intervention effects also will be examined.DiscussionThis RCT holds considerable potential for illuminating the nature of the obesity-asthma relationship and advancing current guidelines for treating obese adults with asthma, which may lead to reduced morbidity and mortality related to the comorbidity of the two disorders.Trial registrationNCT00901095

DASH for asthma: A pilot study of the DASH diet in not-well-controlled adult asthma

This pilot study aims to provide effect size confidence intervals, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy of Dietary Approaches to Stop Hypertension (DASH) as adjunct therapy to standard care for adults with uncontrolled asthma. The DASH diet encompasses foods (e.g., fresh fruit, vegetables, and nuts) and antioxidant nutrients (e.g., vitamins A, C, E, and zinc) with potential benefits for persons with asthma, but it is unknown whether the whole diet is beneficial. Participants (n = 90) will be randomized to receive usual care alone or combined with a DASH intervention consisting of 8 group and 3 individual sessions during the first 3 months, followed by at least monthly phone consultations for another 3 months. Follow-up assessments will occur at 3 and 6 months. The primary outcome measure is the 7-item Juniper Asthma Control Questionnaire, a validated composite measure of daytime and nocturnal symptoms, activity limitations, rescue medication use, and percentage predicted forced expiratory volume in 1 second. We will explore changes in inflammatory markers important to asthma pathophysiology (e.g., fractional exhaled nitric oxide) and their potential to mediate the intervention effect on disease control. We will also conduct pre-specified subgroup analyses by genotype (e.g., polymorphisms on the glutathione S transferase gene) and phenotype (e.g., atopy, obesity). By evaluating a dietary pattern approach to improving asthma control, this study could advance the evidence base for refining clinical guidelines and public health recommendations regarding the role of dietary modifications in asthma management.

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma

Rigorous research on the benefit of healthy eating patterns for asthma control is lacking. We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores <6 out of 9) to a 6-month DASH behavioural intervention (n=46) or usual-care control (n=44). Intention-to-treat analyses used repeated-measures mixed models. Participants were middle-aged, 67% female and multiethnic. Compared with controls, intervention participants improved on DASH scores (mean change (95% CI) 0.6 (0, 1.1) versus −0.3 (−0.8, 0.2); difference 0.8 (0.2, 1.5)) and the primary outcome, Asthma Control Questionnaire scores (−0.2 (−0.5, 0) versus 0 (−0.3, 0.3); difference −0.2 (−0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (−0.1, 1.0), emotions 0.4 (−0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant. The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted. A dietary programme has clinical benefits for asthma control and functional status in adults with uncontrolled asthma http://ow.ly/R8zUn

Abdominal and general adiposity and level of asthma control in adults with uncontrolled asthma.

RATIONALE Abdominal adiposity may be an important risk factor for uncontrolled asthma in adults, controlling for general obesity. Whether the relationship, if present, is explained by other factors (e.g., asthma onset age, sex, and/or coexisting conditions) is unclear. OBJECTIVES To examine whether clinically applicable anthropometric measures of abdominal adiposity--waist circumference and waist-to-height ratio (WHtR)--are related to poorer asthma control in adults with uncontrolled asthma controlling for body mass index (BMI), and whether the relationship (if present) is explained by gastroesophageal reflux disorder (GERD), sleep quality, or obstructive sleep apnea (OSA) or differs by age of asthma onset or sex. METHODS Patients aged 18 to 70 years with uncontrolled asthma (n = 90) participated in a 6-month randomized clinical trial. MEASUREMENTS AND MAIN RESULTS Baseline measures included sociodemographics, standardized anthropometrics, Asthma Control Test (ACT), GERD Symptom Assessment Scale, Pittsburgh Sleep Quality Index, and Berlin Questionnaire for Sleep Apnea. Participants (mean [SD] age, 52 [12] yr) were racially and ethnically diverse, 67% women, and 69% overweight or obese, and 71% reported their age of asthma onset was 12 years or older. Participants had uncontrolled asthma (mean [SD] ACT score, 14.9 [3.7]) and low GERD symptoms score (0.6 [0.4]); 67% reported poor sleep quality, and 42% had a high OSA risk. General linear regression results showed that worse ACT scores were significantly associated with every SD increase in waist circumference (β = -1.03; 95% confidence interval [CI], -1.96 to -0.16; P = 0.02) and waist-to-height ratio (β = -1.16; 95% CI, -2.00 to -0.33; P = 0.008), controlling for sociodemographics. Waist-to-height ratio remained correlated with ACT (β = -2.30; 95% CI, -4.16 to -0.45; P = 0.02) after further adjusting for BMI. The BMI-controlled relationship between WHtR and ACT did not differ by age of asthma onset or sex (P > 0.05 for interactions) and persisted after additional adjustment for GERD, sleep quality, or OSA scores. Poor sleep quality was associated with worse ACT scores (β = -0.87; 95% CI, -1.71 to -0.03; P = 0.045) controlling for waist-to-height ratio, BMI, and sociodemographics. CONCLUSIONS Abdominal adiposity by waist-to-height ratio and poor sleep quality correlated with poorer asthma control in adults with uncontrolled asthma, after controlling for BMI and sociodemographics. These results warrant replication in larger studies of diverse populations. Clinical trial registered with www.clinicaltrials.gov (NCT 01725945).

Asthma and Pregnancy

Asthma is one of the most common chronic diseases and affects up to 8 % of pregnancies. The “one-third rule” states that in pregnancies with asthma, a third of the patients will improve, a third will get worse, and a third will stay the same. In adverse pregnancy outcomes for patients with asthma, studies have shown that pregnant women with asthma are at increased risk for pregnancy-induced hypertension, preeclampsia, eclampsia, vaginal bleeding, perinatal mortalities, premature birth, low birth weights, and neonatal sepsis as well as pulmonary embolism and depression. In early pregnancy, 60–70 % of women feel dyspneic due to hyperventilation. As pregnancy progresses, an up to 50 % increase in minute ventilation occurs with a corresponding increase in oxygen consumption and carbon dioxide production. Together with the patient, providers should develop medication regimens that are effective and easy to follow. Providers need to be aware that pregnant patients with asthma may have difficulty following complicated treatment regimens. Optimal asthma control during pregnancy is very important for both the mother and the fetus.