Utilization of bronchodilators in ventilated patients without obstructive airways disease.
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OBJECTIVE: To examine physician practice in, and the costs of, prescribing inhaled bronchodilators to mechanically ventilated patients who do not have obstructive lung disease. METHODS: This was a prospective cohort study at 2 medical intensive care units at 2 tertiary-care academic medical centers, over a 6-month period. Included were the patients who required > or = 24 hours of mechanical ventilation but did not have obstructive lung disease. Excluded were patients who had obstructive lung disease and/or who had undergone > 24 hours of mechanical ventilation outside the study intensive care units. RESULTS: Of the 206 patients included, 74 (36%) were prescribed inhaled bronchodilators without clear indication. Sixty-five of those 74 patients received both albuterol and ipratropium bromide, usually within the first 3 days of intubation (58 patients). Patients prescribed bronchodilators were more hypoxemic; their mean P(aO(2))/F(IO(2)) ratio was lower (188 mm Hg versus 238 mm Hg, p = 0.004), and they were more likely to have pneumonia (53% vs 33%, p = 0.007). The mean extra cost for bronchodilators was 449.35 dollars per patient. Between the group that did receive bronchodilators and the group that did not, there was no significant difference in the incidence of ventilator-associated pneumonia, tracheostomy, or mortality. The incidence of tachyarrhythmias was similar (15% vs 22%, p = 0.25). CONCLUSION: A substantial proportion of mechanically ventilated patients without obstructive lung disease received inhaled bronchodilators. (+info)
Early prognosis of acute asthma in the emergency room.
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OBJECTIVE: To evaluate clinical and pulmonary function measurements taken in the first fifteen minutes of the assessment of acute asthma in the emergency room and used for prognostic purposes. METHODS: A prospective cohort study involving consecutive patients with acute asthma. Only patients who were between the ages of 12 and 55 and presented peak expiratory flow rates < or = 50% of predicted were included. Evaluations were performed upon admission, then again at 15 minutes and 4 hours after the initiation of treatment. Treatment included albuterol and ipratropium delivered by metered-dose inhaler with a spacer, together with 100 mg of intravenous hydrocortisone. Favorable outcomes were defined as peak expiratory flow > or = 50% of predicted after 4 hours of treatment, and unfavorable outcomes were defined as peak expiratory flow < 50% after 4 hours of treatment. RESULTS: Favorable outcomes were seen in 27 patients, and unfavorable outcomes were seen in 24 patients. In the multivariate analysis, peak expiratory flow as percentage of predicted was identified as the variable with the highest predictive value. A peak expiratory flow > or = 40% after 15 minutes of treatment showed significant power in predicting a favorable outcome (sensitivity = 0.74, specificity = 1.00, and positive predictive value = 1.00). A peak expiratory flow < 30% after 15 minutes of treatment was predictive of a poor outcome (sensitivity = 0.54, specificity = 0.93, and positive predictive value = 0.87). CONCLUSION: Our results suggest that measuring peak expiratory flow after 15 minutes of management in the emergency room is a useful tool for predicting outcomes in cases of acute asthma. (+info)
Pharmacological modulation of gut mucosal and large vessel blood flow.
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BACKGROUND: Constipation, diminished gut blood flow, ischaemic colitis and drug therapy may be associated. AIM: To study the effect of constipating medication on, and the regulation of, gut blood flow. METHODS: 24 healthy females (mean age 30) received, in a double-blind, three-way crossover study: (i) placebo, (ii) ipratropium 40 microg by inhalation (positive control known to reduce rectal mucosal blood flow) and (iii) oral loperamide 4 mg. Mucosal blood flow was measured at the splenic flexure and rectum using laser Doppler flowmetry. Blood flow in the superior and inferior mesenteric arteries was measured by trans-abdominal Doppler ultrasound. RESULTS: Ipratropium decreased rectal mucosal blood flow by 16% (P=0.009) and splenic flexure mucosal blood flow by 8% (P=0.075). Loperamide caused no change in rectal (P=0.40) or splenic flexure mucosal blood flow (P=0.73). Neither treatment changed superior or inferior mesenteric artery blood flow. Splenic flexure mucosal blood flow showed a positive correlation with rectal mucosal blood flow (r=0.69; P<0.0001). CONCLUSIONS: Vasoactive agents may reduce gut mucosal blood flow in the absence of reduced large vessel flow. Constipating drugs do not necessarily reduce gut blood flow. Rectal mucosal blood flow correlates with splenic flexure mucosal flow, and potentially may be used as a more convenient surrogate for studying splenic flexure blood flow. (+info)
Treatment persistence and compliance with medications for chronic obstructive pulmonary disease.
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BACKGROUND AND OBJECTIVE: Inhaled beta-agonist, anticholinergic and glucocorticoid medications are used to treat asthma and chronic obstructive pulmonary disease (COPD). The present study assessed the patterns of persistence with the above mentioned inhaled medications. METHODS: Prescription claims data from the Ontario Drug Benefit Program were analyzed to assess persistence (time to discontinuation) and compliance (percentage of days with doses available divided by days to last refill) of patients prescribed inhaled medications. Patients were grouped as naive (no inhaled medication in the previous year) or experienced (previous or current treatment), and by age (18 to 65 years of age and older than 65 years of age). Medications included ipratropium, ipratropium plus salbutamol, formoterol, formoterol plus budesonide, salmeterol, salmeterol plus fluticasone, and tiotropium. RESULTS: The database included 31,368 patients (4888 naive and 26,480 experienced) who were prescribed at least one of these medications. Fifteen per cent to 63% of patients continued on the index drug for more than six months, which decreased to 7% to 53% at 12 months, and 5% to 47% at 18 months. At 12 months, patients taking tiotropium had significantly longer persistence compared with other therapies (53% versus 7% to 30%; all P<0.0001), and fewer switches to alternative medications. Most naive patients had significantly shorter treatment persistence than experienced patients for all drugs (all P<0.0001), including tiotropium (27% versus 55%, P<0.0001). Compliance rates were similar for all drugs (ie, 76% to 94%) but were highest for tiotropium. CONCLUSIONS: These data demonstrated that persistence with inhaled treatment was low overall, but patients treated with tiotropium remained on therapy significantly longer than when treated with other medications, and patients naive to inhaled treatment had shorter treatment persistence than experienced patients. (+info)
Overcoming beta-agonist tolerance: high dose salbutamol and ipratropium bromide. Two randomised controlled trials.
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BACKGROUND: Asthmatics treated with long-acting beta-agonists have a reduced bronchodilator response to moderate doses of inhaled short acting beta-agonists during acute bronchoconstriction. It is not known if the response to higher doses of nebulised beta-agonists or other bronchodilators is impaired. We assessed the effect of long-acting beta-agonist treatment on the response to 5 mg nebulised salbutamol and to ipratropium bromide. METHODS: Two double-blind, placebo-controlled, crossover studies of inhaled formoterol 12 mug twice daily in patients with asthma.High-dose salbutamol: 36 hours after the last dose of 1 week of formoterol or placebo treatment, 11 subjects inhaled methacholine to produce a 20% fall in FEV1. Salbutamol 5 mg was then administered via nebuliser and the FEV1 was monitored for 20 minutes. Ipratropium: 36 hours after the last dose of 1 week of formoterol or placebo treatment, 11 subjects inhaled 4.5% saline to produce a 20% fall in FEV1. Salbutamol 200 mug or ipratropium bromide 40 mug was then inhaled and the FEV1 was monitored for 30 minutes. Four study arms compared the response to each bronchodilator after formoterol and placebo. Analyses compared the area under the bronchodilator response curves, adjusting for changes in pre-challenge FEV1, dose of provocational agent and FEV1 fall during the challenge procedure. RESULTS: The response to nebulised salbutamol was 15% lower after formoterol therapy compared to placebo (95% confidence 5 to 25%, p = 0.008). The response to ipratropium was unchanged. CONCLUSION: Long-acting beta-agonist treatment induces tolerance to the bronchodilator effect of beta-agonists, which is not overcome by higher dose nebulised salbutamol. However, the bronchodilator response to ipratropium bromide is unaffected. (+info)
Enhanced persistence with tiotropium compared with other respiratory drugs in COPD.
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BACKGROUND: Tiotropium is a once-daily inhaled anticholinergic maintenance treatment with demonstrated effectiveness in chronic obstructive pulmonary disease (COPD). OBJECTIVE: To compare persistence of tiotropium-use with other inhaled respiratory drugs in COPD in current clinical practice. METHODS: The PHARMO database includes, among others, drug-dispensing and hospital discharge records for 2> or = million subjects in the Netherlands. All probable COPD-patients were identified by new respiratory drug use (age >54 years) or COPD-hospitalisations. New users of tiotropium, ipratropium, long-acting beta-agonists (LABAs), or fixed combination of LABA and inhaled corticosteroids (LABA+ICS), in 1998-2003, were included in the study. Persistence was assessed quarterly during the first year of follow-up. Patients with a proportion of days covered (PDC) > or =80% were considered persistent. Persistence was analysed using generalised estimating equations model. RESULTS: About 37% of new users of tiotropium continued treatment for 1 year, compared with 14% for ipratropium, 13% for LABA, and 17% for LABA+ICS. Multivariate analyses showed that tiotropium-users were 2-3 times more persistent with their therapy than patients using ipratropium (relative risk [RR]: 2.0; 95% confidence interval [CI]: 1.8-2.3), LABA (RR: 2.9; 95% CI: 2.4-3.6), or LABA+ICS (RR: 2.4; 95% CI: 2.1-2.8), respectively. Sub-analyses in patients with a prior hospitalisation for COPD showed that 1-year persistence rates were increased for all treatments (varying from 33% for patients using LABA+ICS to 61% for patients using tiotropium), while persistence with tiotropium was again 2-3 times higher compared with other treatments. CONCLUSION: Persistence with tiotropium was higher compared to other inhaled respiratory drugs in COPD in clinical practice. (+info)
Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain.
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Our objective was to assess the 5-year cost effectiveness of bronchodilator therapy with tiotropium, salmeterol or ipratropium for chronic obstructive pulmonary disease (COPD) from the perspective of the Spanish National Health System (NHS). A probabilistic Markov model was designed wherein patients moved between moderate, severe or very severe COPD and had the risk of exacerbation and death. Probabilities were derived from clinical trials. Spanish healthcare utilisation, costs and utilities were estimated for each COPD and exacerbation state. Outcomes were exacerbations, exacerbation-free months, quality-adjusted life years (QALYs), and cost(-effectiveness). The mean (SE) 5-year number of exacerbations was 3.50 (0.14) for tiotropium, 4.16 (0.40) for salmeterol and 4.71 (0.54) for ipratropium. The mean (SE) number of QALYs was 3.15 (0.08), 3.02 (0.15) and 3.00 (0.20), respectively. Mean (SE) 5-year costs were 6,424 euro (305 euro) for tiotropium, 5,869 euro (505 euro) for salmeterol, and 5,181 euro (682 euro) for ipratropium (2005 values). Ipratropium and tiotropium formed the cost-effectiveness frontier, with tiotropium being preferred when willingness to pay (WTP) exceeded 639 euro per exacerbation-free month and 8,157 euro per QALY. In Spain, tiotropium demonstrated the highest expected net benefit for ratios of the willingness to pay per QALY, well within accepted limits. (+info)
Use of ozone-depleting substances; removal of essential use designations; confirmation of effective date. Direct final rule; confirmation of effective date.
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The Food and Drug Administration (FDA) is confirming the effective date of April 23, 2007, for the direct final rule that appeared in the Federal Register of December 7, 2006 (71 FR 70870). The direct final rule amends the regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, used in oral pressurized metered-dose inhalers, from the list of essential uses of ozone-depleting substances. None of these products is currently being marketed. This document confirms the effective date of the direct final rule. (+info)