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Biomedical subjects

Gene R Pesola

Publications and source records attributed to Gene R Pesola.

At least 19 recordsLinked to original sources
PubMed2007

Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma.

RATIONALE: One-quarter to one-third of individuals with asthma smoke, which may affect response to therapy and contribute to poor asthma control. OBJECTIVES: To determine if the response to an inhaled corticosteroid or a leukotriene receptor antagonist is attenuated in individuals with asthma who smoke. METHODS: In a multicenter, placebo-controlled, double-blind, double-dummy, crossover trial, 44 nonsmokers and 39 light smokers with mild asthma were assigned randomly to treatment twice daily with inhaled beclomethasone and once daily with oral montelukast. MEASUREMENTS AND MAIN RESULTS: Primary outcome was change in prebronchodilator FEV(1) in smokers versus nonsmokers. Secondary outcomes included peak flow, PC(20) methacholine, symptoms, quality of life, and markers of airway inflammation. Despite similar FEV(1), bronchodilator response, and sensitivity to methacholine at baseline, subjects with asthma who smoked had significantly more symptoms, worse quality of life, and lower daily peak flow than nonsmokers. Adherence to therapy did not differ significantly between smokers and nonsmokers, or between treatment arms. Beclomethasone significantly reduced sputum eosinophils and eosinophil cationic protein (ECP) in both smokers and nonsmokers, but increased FEV(1) (170 ml, p = 0.0003) only in nonsmokers. Montelukast significantly increased a.m. peak flow in smokers (12.6 L/min, p = 0.002), but not in nonsmokers. CONCLUSIONS: In subjects with mild asthma who smoke, the response to inhaled corticosteroids is attenuated, suggesting that adjustments to standard therapy may be required to attain asthma control. The greater improvement seen in some outcomes in smokers treated with montelukast suggests that leukotrienes may be important in this setting. Larger prospective studies are required to determine whether leukotriene modifiers can be recommended for managing asthma in patients who smoke.

Acetates↗
PubMed2007

The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial.

BACKGROUND: Although guidelines recommend anti-inflammatory therapy for persistent asthma, recent studies suggest that 25% to 35% of patients with asthma may not improve lung function with inhaled corticosteroids. OBJECTIVE: To evaluate potential biomarkers of predicting short-term (6-week) response to inhaled corticosteroid with subsequent evaluation of responders and nonresponders to asthma control over a longer interval (16 additional weeks). METHODS: Eighty-three subjects with asthma off steroid were enrolled in this multicenter study. Biomarkers and asthma characteristics were evaluated as predictors of inhaled corticosteroid response over a 6-week trial for changes in FEV(1) and methacholine PC(20). After this, an additional 4-month trial evaluated asthma control. RESULTS: Although multiple baseline predictors had significant correlations with improvements for short-term inhaled steroid success, the only strong correlations (r >or= +/- 0.6) were albuterol reversibility (r = 0.83; P < .001), FEV(1)/forced vital capacity (r = -0.75; P < .001), and FEV(1) % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV(1) improvement) and nonresponders (<or=5%) determined the longer-term need for steroids. For the nonresponders, asthma control remained unchanged whether inhaled corticosteroids were continued or were substituted with a placebo (P = .99). The good short-term responders maintained asthma control longer-term only if maintained on inhaled steroids (P = .007). CONCLUSION: The short-term response to inhaled corticosteroids with regard to FEV(1) improvement predicts long-term asthma control. CLINICAL IMPLICATIONS: The decision to use long-term inhaled steroids could be based on a short-term trial. Different therapeutic strategies would need to be established for nonresponders.

Adult↗
PubMed2006

Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.

RATIONALE: Long-acting beta-agonists (LABAs) and inhaled corticosteroids administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABAs (improved lung function) and leukotriene receptor antagonists (LTRAs; protection against exacerbations) may be complementary as well. OBJECTIVE: We sought to determine whether the combination of the LTRA montelukast and the LABA salmeterol could provide an effective therapeutic strategy for asthma. METHODS AND MEASUREMENTS: In a randomized, placebo-controlled, crossover study of 192 subjects with moderate asthma, we compared the clinical efficacy of regular treatment over 14 weeks with the combination of montelukast and salmeterol to that with the combination of beclomethasone and salmeterol in moderate asthma. The primary efficacy outcome was time to treatment failure. MAIN RESULTS: Three months after the randomization of the last subject, the Data and Safety Monitoring Board determined that the primary research question had been answered and terminated the trial. The combination of montelukast and salmeterol was inferior to the combination of beclomethasone and salmeterol as judged by protection against asthma treatment failures (p = 0.0008), lung function (26 L/min difference in a.m. peak expiratory flow rate, p = 0.011), asthma control score (0.22 difference in Asthma Control Questionnaire score, p = 0.038), and markers of inflammation and airway reactivity. CONCLUSIONS: Patients with moderate asthma similar to those we studied should not substitute the combination of an LTRA and an LABA for the combination of inhaled corticosteroid and an LABA.

Acetates↗
PubMed2006

Abnormal predicted diffusion capacities in healthy Asians: an inequality with a solution.

BACKGROUND: Asian lung volumes are 10-15% less than those of Caucasians. OBJECTIVES: To test the hypothesis that healthy Asians might be labeled as abnormal using three commonly used Caucasian-derived prediction equation estimates (PEE) of DLCO currently used. In addition, a Chinese-derived PEE of DLCO was tested to determine its validity in non-Chinese Asians. METHODS: Forty-one healthy Asians underwent DLCO testing. Controls consisted of the PEE and 12 healthy Caucasians. Measured DLCO was compared with the Miller, Knudson, Crapo and one Chinese PEE. Abnormal was defined as a DLCO <80% predicted. Gas dilution and plethysmography estimated alveolar volume. Proportions in parentheses in the results below are DLCO adjusted for alveolar volume. RESULTS: The average Asian DLCO was 25.75 +/- 5.55 ml/min/mm Hg, no different than the predicted DLCO of 25.29 +/- 5.53 seen with Chinese PEE. This was different (p < 0.01) than the predicted DLCO of 27.82 +/- 5.09, 33.66 +/- 6.29, and 31.64 +/- 5.33 for the Miller, Knudson, and Crapo equations, respectively. This resulted in 4/41 (0/41), 27/39 (2/39), 21/41 (3/41) and 1/41 (0/41) DLCO measurements being defined as abnormal using Miller, Knudson, Crapo and Chinese PEE, respectively. In Caucasians, the measured DLCO was similar to the Miller but significantly lower than the Knudson and Crapo PEE. Measured lung volumes were significantly smaller compared to predicted for the three Caucasian PEE in Asians, with no difference in Caucasians. There was no difference in measured lung volumes and Chinese PEE. CONCLUSIONS: Current Caucasian PEE for DLCO when used in healthy Asians result in an abnormal reading that is incorrect from 10 to 50% of the time. This PEE failure is related to a reduction in lung volume not accounted for. The Chinese PEE for DLCO works for non-Chinese Asians and should replace Caucasian PEE in the US in all Asians.

Adult↗
PubMed2005

Daily versus as-needed corticosteroids for mild persistent asthma.

BACKGROUND: Although guidelines recommend daily therapy for patients with mild persistent asthma, prescription patterns suggest that most such patients use these so-called controller therapies intermittently. In patients with mild persistent asthma, we evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period. METHODS: In a double-blind trial, 225 adults underwent randomization. The primary outcome was morning peak expiratory flow (PEF). Other outcomes included the forced expiratory volume in one second (FEV1) before and after bronchodilator treatment, the frequency of exacerbations, the degree of asthma control, the number of symptom-free days, and the quality of life. RESULTS: The three treatments produced similar increases in morning PEF (7.1 to 8.3 percent; approximately 32 liters per minute; P=0.90) and similar rates of asthma exacerbations (P=0.24), even though the intermittent-treatment group took budesonide, on average, for only 0.5 week of the year. As compared with intermittent therapy or daily zafirlukast therapy, daily budesonide therapy produced greater improvements in pre-bronchodilator FEV1 (P=0.005), bronchial reactivity (P<0.001), the percentage of eosinophils in sputum (P=0.007), exhaled nitric oxide levels (P=0.006), scores for asthma control (P<0.001), and the number of symptom-free days (P=0.03), but not in post-bronchodilator FEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukast therapy did not differ significantly from intermittent treatment in any outcome measured. CONCLUSIONS: It may be possible to treat mild persistent asthma with short, intermittent courses of inhaled or oral corticosteroids taken when symptoms worsen. Further studies are required to determine whether this novel approach to treatment should be recommended.

Administration, Inhalation↗
PubMed2005

Sputum eosinophil counts predict asthma control after discontinuation of inhaled corticosteroids.

BACKGROUND: Although inhaled corticosteroids (ICSs) are effective in preventing deterioration in asthma control, at least half of subjects with mild-to-moderate asthma will remain stable when these agents are discontinued. OBJECTIVE: We sought to determine whether noninvasive markers of inflammation predict which individuals maintain asthma control after discontinuation of ICSs. METHODS: We analyzed data obtained from 164 subjects with mild-to-moderate asthma who participated in a 16-week trial comparing the effects of continued ICS use with the effects of a switch to salmeterol or placebo. RESULTS: In comparison with continued ICS use, a switch to salmeterol or placebo was associated with increased rates of asthma deterioration over 16 weeks (9.3% vs 24.1% and 37.5%, respectively; P = .04 and P < .001, respectively). We found that neither exhaled nitric oxide nor methacholine PC 20 , when measured at randomization or 2 weeks after randomization, were significant predictors of subsequent asthma control in subjects who discontinued ICSs. However, both induced sputum eosinophil counts measured 2 weeks after a switch from ICS to placebo and changes in sputum eosinophil counts from before cessation of ICSs to after a switch to placebo predicted subsequent asthma deterioration (area under the receiver-operating characteristic curve, 0.771 [ P < .001] and 0.825 [ P < .001], respectively). CONCLUSION: On the basis of a model treatment strategy, we estimate that allocating subjects to ICS therapy on the basis of changes in sputum eosinophil counts after a trial discontinuation could allow 48% of subjects with mild-to-moderate asthma to discontinue ICS therapy without an increased risk of asthma deterioration over a period of at least 14 weeks.

Administration, Inhalation↗
PubMed2004

The reuse of subjects in clinical studies: is a bias introduced? Is there a threat to study validity?

The reuse of subjects in clinical studies to answer specific research questions is a common practice. This reuse can take many forms and is at least partly related to study efficiency. It is much easier to reuse known subjects who know the system(s) or are easy to find than to recruit new ones. A hypothetical question is: Are there instances when such practices may not be scientifically valid? This question will be addressed from the perspective of the case-control and experimental study design.

Asthma↗
PubMed2004

Predicting asthma morbidity in Harlem emergency department patients.

OBJECTIVES: To determine predictors of asthma morbidity in African American patients with asthma. Proxies for asthma morbidity were emergency department (ED) visits for asthma and hospitalizations for asthma. METHODS: This was a prospective observational study that evaluated baseline predictors of asthma morbidity in adults in an urban, predominantly African American community in New York City. Potential predictors of asthma morbidity evaluated were education, gender, employment status, current smoking status, asthma severity, duration of asthma, daily use of a peak flow meter, presence or absence of pets at home, presence or absence of a significant other, presence or absence of medical insurance, and previous hospitalization for asthma in the past year. Follow-up consisted of a repeat questionnaire obtained between nine and 15 months after the baseline questionnaire. Follow-up data collection was limited to the last three-month history of ED visits or hospitalizations before the follow-up visit. At follow-up, the baseline predictors were related to the presence or absence of ED visits for asthma or hospitalizations for asthma. All predictors were evaluated individually (crude odds ratio [OR]) and simultaneously (adjusted OR) in a logistic regression model with the dichotomous outcome variable ED visits or hospitalization. RESULTS: Return ED visits on follow-up were more likely to occur in asthma patients hospitalized in the previous year (adjusted OR, 3.9; 95% confidence interval [CI] = 1.7 to 9.0) and were less likely to occur in asthma patients with pets (OR, 0.4; 95% CI = 0.2 to 0.9). Patients with moderate/severe asthma, relative to patients with mild asthma, were more likely to be seen in the ED on follow-up on initial analysis (crude OR, 2.4; 95% CI = 1.1 to 1.5), but the adjusted OR was not significant. Follow-up hospitalizations were significantly more likely to occur only in subjects reporting daily use of a peak flow meter (OR, 6.8; 95% CI = 1.3 to 34.5). Subjects hospitalized for asthma in the previous year were more likely to be hospitalized subsequently on initial analysis (crude OR, 2.9; 95% CI = 1.0 to 8.1), but the adjusted OR was not significant. CONCLUSIONS: It appears that African American patients with asthma who had previous hospitalizations for asthma within the past year or use a peak flow meter daily (a marker for more severe asthma) are more likely to visit the ED in the future or to be hospitalized for asthma, respectively. These patients need to be targeted and treated more aggressively to improve asthma care and decrease morbidity. The apparent protective effect of the presence of pets on reducing ED visits is unclear at this time, and the findings need to be replicated and evaluated further.

Adult↗
PubMed2003

Preferential distal radius fracture in right-handed individuals presenting to an ED.

The purpose of this study was to determine whether there is a lateralizing predisposition toward injury in right hand-dominant (RHD) individuals. The distal radius fracture was used as the injury for evaluation because it is easily defined and can be objectively documented by roentgenography. A prospective case-series design was used to include consecutive RHD patients with a distal radius fracture. There were 86 women with an average age of 63.1 +/- 17.9 years and 41 men with an average age of 44.0 +/- 17.6 years with a significant difference between ages (P <.01). Overall, there were 50 right and 77 left distal radius fractures, which was significantly different than a 50:50 split (P <.025). Stratification and logistic regression analysis revealed that age (dichotomized into age greater than 57 or other) and not gender was a significant factor in the determination of left versus right distal radius fracture. No interaction between age and gender was found. After adjustment for gender, the odds of developing a left compared with right distal radius fracture was 2.3-fold greater for the older compared with the younger age group (95% confidence interval, 1.0-5.2). Preliminary evidence suggests a lateralizing predisposition for left distal radius fractures in older compared with younger individuals who are RHD. If this data holds up, finding the etiology/mechanism of this predisposition might help in designing environments to minimize the impact of this injury pattern in the slightly older individual.

Adult↗
PubMed2002

Bupropion seizure proportion among new-onset generalized seizures and drug related seizures presenting to an emergency department.

Bupropion is a relatively new and popular medication with seizures as its major side effect. This drug can produce seizures with an overdose. The purpose of this investigation was to determine the relative importance of this medication as the etiology of new-onset seizures relative to other drugs and new-onset seizures in general. The study design was a retrospective case series. All new onset generalized seizures were evaluated over a 4-year period in subjects 16 years of age and older. Etiologic diagnosis was determined from the neurology consultation and all patients with new-onset seizures were admitted to the hospital as per hospital policy and received a routine chemistry screening and a neuroimaging study as a minimum. The results indicate that 17 of 279 or 6.1% of the new-onset seizures were drug related. After cocaine intoxication (6/279 or 2.2%) and benzodiazepine withdrawal (5/279 or 1.8%) seizures, bupropion (4/279 or 1.4%) was the third leading cause of drug related seizures. In addition, all the bupropion related seizures occurred in patients taking what was considered to be a therapeutic dose or 450 mg/day or less. Sleep deprivation, previous history of attention deficit disorder and bulimia, and previous heavy alcohol use were associated in three of the patients taking bupropion who had seizures. We conclude that although drug related new-onset seizures are not a common cause of seizures overall, bupropion might be a more common cause of drug related new-onset generalized seizures presenting to the Emergency Department than previously thought, occurring in more than one-fifth of this subgroup of cases. Possibly, greater exclusion criteria are needed than currently recommended for the use of bupropion at therapeutic doses.

Adult↗
PubMed2002

The normal difference in bilateral indirect blood pressure recordings in hypertensive individuals.

OBJECTIVE: If there is a significant dichotomy between bilateral systolic blood pressure determinations in both arms in hypertensive individuals, it is often taken as a sign of underlying pathology. The primary objective was to determine what the normal variation might be for a significant difference between blood pressures in both arms. A clinically significant difference was chosen as a systolic blood pressure value greater than 10 mm Hg between the upper extremities, as is commonly quoted at the bedside and in the literature. METHODS: Bilateral indirect blood pressure determinations were obtained in 100 subjects with hypertension in the sitting position. The blood pressure was obtained by two observers, one the recorder and the other who obtained the blood pressure but was blinded to the actual values taken. The order of blood pressure determination in the first arm was determined prior to the study from a table of random numbers. The coefficient of variation in obtaining the blood pressure in each arm was determined in 5 of the 100 subjects. The age, sex, and handedness of each individual were recorded as demographic variables. RESULTS: The average left and right systolic blood pressures were 139 +/- 22 and 141 +/- 22 mm Hg, respectively. The average left and right diastolic blood pressures were 78 +/- 12 and 79 +/- 13 mm Hg, respectively. There was no significant difference between left minus right systolic or diastolic differences (paired t-test). There was no significant difference between systolic or diastolic blood pressures between gender or between left- and right-handed individuals (nonpaired t-test). The average coefficients of variation for taking right and left arm systolic pressures were 2.90% and 1.32%, respectively. Eighteen subjects (18%) had differences in systolic blood pressure between both arms exceeding 10 mm Hg (10% to 26%, 95% confidence interval). CONCLUSIONS: Differences of more than 10 mm Hg in indirect systolic blood pressure recordings between arms are frequent in asymptomatic hypertensive individuals and do not per se indicate any pathologic condition. In the right clinical situation, differences that are noted should be repeated and should be added to the total clinical picture when used to determine whether a pathologic condition is present. Assuming no significant aortic or subclavian disease in the population tested, the specificity of the bilateral blood pressure test was 82%.

Aged↗