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Albuterol :: adverse effects

Latest Paper:

Postgrad Med. 2005 Dec ;118 (6 Suppl Acute):44-7; discussion 48 19667716 (P,S,G,E,B,D)
William E Berger
Department of pediatrics, division of allergy and immunology, College of Medicine, University of California, Irvine, USA. wberger@uci.edu
Vast are, differences exist between the actions physicians report that they take and the patient's perception of those actions. Several patient satisfaction very survey results are presented in this article. Many show that although patients are not often satisfied with their treatments or between with the side effects they experience from medications, they are, in general, very satisfied with their physicians. These research studies in point out that a very real "communications gap" exists between physicians and patients when examined from the patient's perspective.

Most cited papers:

N Engl J Med. 1992 Feb 20;326 (8):501-6 1346340 (P,S,G,E,B) Cited:352
BACKGROUND.from Morbidity and mortality from asthma appear to be increasing, and it has been suggested that medications used to treat asthma near are contributing to this trend. We investigated a possible association between death or near death from asthma and the regular it use of beta 2-agonist bronchodilators. METHODS. Using linked health insurance data bases from Saskatchewan, Canada, we conducted a matched case-control near-fatal study of subjects drawn from a cohort of 12,301 patients for whom asthma medications had been prescribed between 1978 and association 1987. We matched 129 case patients who had fatal or near-fatal asthma with 655 controls (who had received medications for prescribed asthma but had not had fatal or near-fatal events) with respect to region of residence, age, receipt of social assistance,CONCLUSIONS. and previous hospitalization for asthma. RESULTS. The use of beta-agonists administered by a metered-dose inhaler was associated with an increased had risk of death from asthma (odds ratio, 2.6 per canister per month; 95 percent confidence interval, 1.7 to 3.9) and interval, of death or near death from asthma, considered together (odds ratio, 1.9; 95 percent confidence interval, 1.6 to 2.4). For matched death from asthma, use of the beta-agonist fenoterol was associated with an odds ratio of 5.4 per canister, as compared was with 2.4 for the beta-agonist albuterol. On a microgram-equivalent basis, the odds ratio for this outcome with fenoterol was 2.3,of as compared with 2.4 with albuterol. CONCLUSIONS. An increased risk of death or near death from asthma was associated with 2.4). the regular use of inhaled beta 2-agonist bronchodilators, especially fenoterol. Regardless of whether beta-agonists are directly responsible for these adverse these effects or are simply a marker for more severe asthma, heavy use of these agents should alert clinicians that it with is necessary to reevaluate the patient's condition.
Lancet. 2003 Feb 8;361 (9356):449-56 12583942 (P,S,G,E,B) Cited:239
University of Nebraska Medical Center, Omaha, NE 68198, USA. srennard@unmc.edu
BACKGROUND:and Inhaled long-acting beta2 agonists improve lung function and health status in symptomatic chronic obstructive pulmonary disease (COPD), whereas inhaled corticosteroids no reduce the frequency of acute episodes of symptom exacerbation and delay deterioration in health status. We postulated that a combination symptomatic of these treatments would be better than each component used alone. METHODS: 1465 patients with COPD were recruited from outpatient or departments in 25 countries. They were treated in a randomised, double-blind, parallel-group, placebo-controlled study with either 50 microg salmeterol twice in daily (n=372), 500 microg fluticasone twice daily (n=374), 50 microg salmeterol and 500 microg fluticasone twice daily (n=358), or placebo fluticasone (n=361) for 12 months. The primary outcome was the pretreatment forced expiratory volume in 1s (FEV1) after 12 months treatment'daily and after patients had abstained from all bronchodilators for at least 6h and from study medication for at least 12h.outcome Secondary outcomes were other lung function measurements, symptoms and rescue treatment use, the number of exacerbations, patient withdrawals, and disease-specific bruising, health status. We assessed adverse events, serum cortisol concentrations, skin bruising, and electrocardiograms. Analysis was as predefined in the study salmeterol protocol. FINDINGS: All active treatments improved lung function, symptoms, and health status and reduced use of rescue medication and frequency and of exacerbations. Combination therapy improved pretreatment FEV1 significantly more than did placebo (treatment difference 133 mL, 95% CI 105-161, p< .0001),(treatment salmeterol (73 mL, 46-101, p< .0001), or fluticasone alone (95 mL, 67-122, p< .0001). Combination treatment produced a clinically significant improvement in of health status and the greatest reduction in daily symptoms. All treatments were well tolerated with no difference in the frequency produces of adverse events, bruising, or clinically significant falls in serum cortisol concentration. INTERPRETATION: Because inhaled long-acting beta2 agonists and corticosteroid the combination treatment produces better control of symptoms and lung function, with no greater risk of side-effects than that with use number of either component alone, this combination treatment should be considered for patients with COPD.
Chest. 1999 Apr ;115 (4):957-65 10208192 (P,S,G,E,B) Cited:126
STUDY Both OBJECTIVES: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta2-adrenergic agonist, with inhaled ipratropium to bromide and inhaled placebo in patients with COPD. DESIGN: A stratified, randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trial. SETTING:efficacy Multiple sites at clinics and university medical centers throughout the United States. PATIENTS: Four hundred eleven symptomatic patients with COPD or with FEV1 < or = 65% predicted and no clinically significant concurrent disease. Interventions: Comparison of inhaled salmeterol (42 microg bromide twice daily), inhaled ipratropium bromide (36 microg four times a day), and inhaled placebo (2 puffs four times a day)hundred over 12 weeks. RESULTS: Salmeterol xinafoate was significantly (p < .0001) better than placebo and ipratropium in improving lung function revealed at the recommended doses over the 12-week trial. Both salmeterol and ipratropium reduced dyspnea related to activities of daily living no compared with placebo; this improvement was associated with reduced use of supplemental albuterol. Analyses of time to first COPD exacerbation .0001) revealed salmeterol to be superior to placebo and ipratropium (p < .05). Adverse effects were similar among the three treatments.with CONCLUSIONS: These collective data support the use of salmeterol as first-line bronchodilator therapy for the long-term treatment of airflow obstruction four in patients with COPD.
Am J Respir Crit Care Med. 2002 Oct 15;166 (8):1084-91 12379552 (P,S,G,E,B) Cited:117
Dartmouth Hitchcock Medical Center, Section of Pulmonary and Critical Care Medicine, 1 Medical Center Drive, Lebanon, NH 03756-0001, USA. donald.a.mahler@hitchcock.org
This ml, randomized controlled trial examined the benefits of combining an inhaled corticosteroid, fluticasone propionate (F), with an inhaled long-acting beta(2)-agonist, salmeterol adverse (S), to treat the inflammatory and bronchoconstrictive components of chronic obstructive pulmonary disease (COPD). A total of 691 patients with of COPD received the combination of F and S (FSC), S (50 mcg), F (500 mcg), or placebo twice daily via for the Diskus device for 24 weeks. A significantly greater increase in predose FEV(1) at the endpoint was observed after FSC (S), (156 ml) compared with S (107 ml, p = .012) and placebo (-4 ml, p < .0001). A significantly greater (500 increase in 2-hour postdose FEV(1) at the endpoint was observed after treatment with FSC (261 ml) compared with F (138 < ml, p < .001) and placebo (28 ml, p < .001). There were greater improvements in the Transition Dyspnea Index greater with FSC (2.1) compared with F (1.3, p = .033), S ( .9, p < .001), and placebo ( .4, p <observed .0001). The incidence of adverse effects (except for an increase in oral candidiasis with FSC and F) was similar among twice the treatment groups. We conclude that FSC improved lung function and reduced the severity of dyspnea compared with individual components < and placebo.
Chest. 2003 Sep ;124 (3):834-43 12970006 (P,S,G,E,B) Cited:68
Baylor College of Medicine, Pulmonary/Critical Care, Ben Taub General Hospital, 1504 Taub Loop, Houston, TX 77030, USA. hanania@bcm.tmc.edu
STUDY with OBJECTIVES: To compare the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) and the inhaled long-acting beta(2)-agonist salmeterol in (SM), when administered together in a single device (Diskus; GlaxoSmithKline, Inc; Research Triangle Park, NC), with that of placebo and propionate the individual agents alone in patients with COPD. DESIGN: Randomized, double-blind, multicenter, placebo-controlled study. SETTING: Seventy-six investigative sites in the efficacy United States. PATIENTS: Seven hundred twenty-three patients > or =40 years of age with COPD and a mean baseline FEV(1)of of 42% predicted. INTERVENTIONS: FP (250 microg), SM (50 microg), FP plus SM combined in a single inhaler (FSC), or single placebo administered twice daily through the Diskus device for 24 weeks. MEASUREMENTS: Primary efficacy measures were morning predose (ie, trough The FEV(1)) for FSC compared with SM and 2-h postdose FEV(1) for FSC compared with FP. Other efficacy measures were as FSC follows: morning peak expiratory flow rate (PEF); transition dyspnea index; chronic respiratory disease questionnaire; chronic bronchitis symptom questionnaire; exacerbations; and mL), other symptomatic measures. RESULTS: At Endpoint (ie, the last on-treatment, post-baseline assessment), treatment with FSC significantly (p < or =through .012) increased the morning predose FEV(1)(165 mL) compared with SM (91 mL) and placebo (1 mL), and significantly (p post-baseline < or = .001) increased the 2-h postdose FEV(1)(281 mL) compared with FP (147 mL) and placebo (58 mL).daily Improvements in lung function with FSC compared with FP and SM, and with FP and SM compared with placebo, as with measured by the average daily morning PEF, was observed within approximately 24 h after the initiation of treatment, indicating an and early onset of effect (p < or = .034). Compared with placebo, FSC significantly improved dyspnea, quality of life, and and symptoms of chronic bronchitis. The incidence of adverse effects (except for an increase in oral candidiasis with FSC and FP)(p were similar among the treatment groups. CONCLUSIONS: Treatment with FSC (FP, 250 microg, and SM, 50 microg) twice daily substantially 2-h improved morning lung function and sustained these improvements for over a period of 24 weeks compared with FP or SM compared treatment alone in patients with COPD, with no additional safety concerns for the combination treatment vs that with the individual and components.
Am J Respir Crit Care Med. 2001 Jan ;163 (1):12-8 11208619 (P,S,G,E,B) Cited:63
There flow is controversy about the role of beta-agonists in asthma mortality, and the impact of asthma management plans remains unclear. We in compared blood beta-agonist levels in patients dying from asthma with those in controls, and estimated the risks associated with specific in classes of medication and patterns of management. We identified 89 asthma deaths and recruited 322 patients presenting to hospitals with of acute asthma. A questionnaire was administered to the next of kin in 51 cases, and to 202 controls. Blood drawn beta-agonist from 35 cases and 229 controls was assayed for salbutamol. Smoking, drinking, and family problems were significantly more likely among hospitals the cases of asthma death than among the controls. The two groups were reasonably well matched with regard to markers concentrations of chronic asthma severity. Cases of asthma death were significantly less likely than controls to use a peak flow meter.and Written action plans were associated with a 70% reduction in the risk of death. Use of nebulized bronchodilators or oral markers steroids was significantly more likely in cases of asthma death. Mean blood salbutamol concentrations were 2.5 times higher in cases questionnaire of asthma. The use of oral steroids for an attack of asthma reduced the risk of death by 90%. More death widespread adoption of written asthma management plans, with less reliance on beta-agonists and closer medical supervision, should reduce asthma mortality.in
Br J Clin Pharmacol. 1987 Nov ;24 (5):645-53 2829953 (P,S,G,E,B) Cited:52
Department of Clinical Pharmacology, University of Turku, Finland.
1.indicator The hypokalaemia-inducing effects of two widely used inhaled antiasthmatic beta 2-adrenoceptor agonists, fenoterol and salbutamol, were compared in six healthy pressure male volunteers. 2. Each drug was administered in three different doses, 400, 600 and 800 micrograms, which were repeated three antiasthmatic times with 30 min intervals (total doses 1200, 1800 and 2400 micrograms in 1 h). The treatments were given at dose-dependently 1 week intervals in random order in a single-blind fashion. 3. The concentration of potassium in plasma was dose-dependently reduced was by both drugs with peak effects 75-90 min after the first inhalations. The hypokalaemic effect of fenoterol was significantly greater in than that of equal doses of salbutamol (average +/- s.d. reductions of 1.13 +/- .32 and .67 +/- .25 mEq increased l-1, respectively, after the highest doses, P less than .05). Concomitantly, decreases were noted in the amplitude of the T-wave peak on the ECG. 4. The concentration of cyclic AMP in plasma was measured and used as an indicator of systemic the beta 2-adrenoceptor agonistic effects of the drugs. Increases in cAMP were a close mirror image of the drugs' effects on The potassium in plasma. 5. Plasma renin activity, noradrenaline in plasma and heart rate were also dose-dependently increased by the treatments,+/- whereas blood pressure remained unaltered. 6. While the clinical significance of hypokalaemia induced by inhaled beta 2-adrenoceptor sympathomimetics still is in a matter of debate, our results point to possible differences between therapeutically equipotent doses of fenoterol and salbutamol in their used propensity to cause hypokalaemia and other acute non-bronchial effects.
Ann Intern Med. 2000 Jan 18;132 (2):97-104 10644288 (P,S,G,E,B) Cited:51
BACKGROUND:week Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction. OBJECTIVE: To evaluate the effect of 8 weeks less of therapy with salmeterol aerosol or montelukast on exercise-induced bronchoconstriction in adults with asthma. DESIGN: 8-week multicenter, randomized, double-blind study.against SETTING: 17 asthma treatment centers in the United States. PATIENTS: 191 adults with asthma who had documented exercise-induced bronchoconstriction. INTERVENTION:MEASUREMENTS: Qualified patients were randomly assigned to double-blind treatment with montelukast (10 mg once in the evening) or salmeterol (50 microg on [2 puffs] twice daily). MEASUREMENTS: Changes in pre-exercise and postexercise challenge values; percentage inhibition in the maximal percentage decrease in mg FEV1; the area above the FEV1-time curve; and time to recovery of FEV1 at days 1 to 3, week 4,a and week 8 of treatment. RESULTS: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV1 challenge were seen with both therapies. Sustained improvement occurred in the montelukast group at weeks 4 and 8; at these time improvement points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in salmeterol FEV1 was 57.2% in the montelukast group and 33. % in the salmeterol group (P = .002). By week 8, 67%day of patients receiving montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV1 of less than 57.2% 20%. CONCLUSIONS: The bronchoprotective effect of montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection significantly. at weeks 4 and 8 was seen with salmeterol. Long-term administration of montelukast provided consistent inhibition of exercise-induced bronchoconstriction at weeks the end of the 8-week dosing interval without tolerance.
J Allergy Clin Immunol. 1999 Apr ;103 (4):615-21 10200010 (P,S,G,E,B) Cited:51
Asthma and Allergy Research Associates, Chester, PA 19013, USA.
BACKGROUND:racemic Limited dose-response information is available for nebulized beta2 -agonists, especially in young children. OBJECTIVE: The purpose of this study was and to determine the safety and efficacy of increasing doses of nebulized levalbuterol (Xopenex; the pure R-isomer of racemic albuterol) and OBJECTIVE: racemic albuterol compared with placebo in the treatment of asthma in pediatric patients. METHODS: In this randomized, double-blind, crossover study,determine children (aged 3 to 11 years) with asthma (resting FEV1 50% to 80% of predicted normal [Polgar's] values) were treated albuterol) with either levalbuterol, racemic albuterol, or placebo. Eligible subjects underwent a screening visit followed by 4 treatment visits. At each treatment treatment visit, serial pulmonary function tests were completed before and after the treatment; plasma was collected to determine enantiomer levels,treatments and safety was evaluated. RESULTS: Five 3- to 5-year-old patients and twenty-eight 6- to 11-year-old patients completed the study, and 3- a total of 87 doses of levalbuterol were administered. In the 6- to 11-year-old group, all doses of levalbuterol were mg significantly greater than placebo in peak change and percent peak change in FEV1 and area under the FEV1 versus time completed curve (P <.05). The FEV1 values over the 8-hour study period were similar for levalbuterol .31 and .63 mg and FEV1 racemic albuterol 2.5 mg and were greatest after levalbuterol 1.25 mg. Median plasma levels of R-albuterol depended on dose and of were .4, .7, 1.2, and 1. after levalbuterol .31 mg, .63 mg, and 1.25 mg and racemic albuterol 2.5 mg,and respectively. All patients in the 2.5-mg racemic albuterol arm had measurable plasma levels of S-albuterol, although S-albuterol levels were undetectable with in most patients in the levalbuterol arms. In a few patients who received levalbuterol, S-albuterol levels were detected, which was a likely because of the use of racemic albuterol as a concomitant medication. All active treatments were well tolerated. beta-Mediated changes The in heart rate, potassium, and glucose were dose dependent for all active treatment groups. CONCLUSION: Levalbuterol caused a significantly greater levels increase in FEV1 than placebo, and FEV1 values were comparable with or better than those observed with racemic albuterol. beta-Mediated levalbuterol side effects were lower for an equipotent dose of levalbuterol when compared with racemic albuterol. Treatment with levalbuterol resulted in with plasma levels that were dose dependent and had an approximate correlation with pharmacodynamic parameters.
Am J Respir Crit Care Med. 2004 Oct 15;170 (8):836-44 15256389 (P,S,G,E,B,D) Cited:44
For (71%) most patients, asthma is not controlled as defined by guidelines; whether this is achievable has not been prospectively studied. A dose 1-year, randomized, stratified, double-blind, parallel-group study of 3,421 patients with uncontrolled asthma compared fluticasone propionate and salmeterol/fluticasone in achieving two defined rigorous, composite, guideline-based measures of control: totally and well-controlled asthma. Treatment was stepped-up until total control was achieved (or maximum patients 500 microg corticosteroid twice a day). Significantly more patients in each stratum (previously corticosteroid-free, low- and moderate-dose corticosteroid users) achieved randomized, control with salmeterol/fluticasone than fluticasone. Total control was achieved across all strata: 520 (31%) versus 326 (19%) patients after dose achieved escalation (p < .001) and 690 (41%) versus 468 (28%) at 1 year for salmeterol/fluticasone and fluticasone, respectively. Asthma became fluticasone, well controlled in 1,071 (63%) versus 846 (50%) after dose escalation (p < .001) and 1,204 (71%) versus 988 (59%)corticosteroid-free, at 1 year. Control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/fluticasone versus fluticasone. Across all respectively. strata, 68% and 76% of the patients receiving salmeterol/fluticasone and fluticasone, respectively, were on the highest dose at the end corticosteroid of treatment. Exacerbation rates ( .07- .27 per patient per year) and improvement in health status were significantly better with salmeterol/fluticasone. This < study confirms that the goal of guideline-derived asthma control was achieved in a majority of the patients.

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