The Effect of Maximal Doses of Formoterol and Salbutamol from a Metered Dose Inhaler on Pulse Rates, ECG, and Serum Potassium Concentrations

Maesen, F. P. V.; Costongs, Robert; Smeets, J. J.; Brombacher, P. J.; Zweers, Petra G.M.A.

doi:10.1378/chest.99.6.1367

Cited by 47 publications

(30 citation statements)

References 10 publications

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“…In this study, the pattern of adverse events was not different from that in the previously mentioned high-dose studies [13,17], and represents expected b 2 -agonist effects. When comparing the treatments regarding adverse events, the differences were generally small and in favour of formoterol.…”

Section: Discussionsupporting

confidence: 50%

“…Additionally, its bronchodilating effect is sustained for up to 12 h after inhalation [10,16]. MAESEN et al [17] have shown that formoterol at doses of up to 228 mg, inhaled via a pressurized Metered Dose Inhaler (pMDI) , is safe in terms of known b 2 -agonist side effects i.e. pulse rate, ECG and serum potassium concentrations, in patients with asthma.…”

Section: Discussionmentioning

confidence: 99%

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Safety of formoterol Turbuhaler(R) at cumulative dose of 90 g in patients with acute bronchial obstruction

Małolepszy¹,

Nagy²,

Selroos³

et al. 2001

European Respiratory Journal

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Safety of formoterol Turbuhaler1 at cumulative dose of 90 mg in patients with acute bronchial obstruction. J. Malolepszy, G. Böszörményi Nagy, O. Selroos, P. Larsson, R. Brander. #ERS Journals Ltd 2001. ABSTRACT: This study compared the safety of formoterol (Oxis1 Turbuhaler1; 90 mg delivered dose; 120 mg metered dose) with terbutaline (Bricanyl1 Turbuhaler1; 10 mg), in patients with acute bronchoconstriction.Forty-eight patients (31 females) with a mean age of 45 yrs, were randomized into two parallel groups (double-blind design). Mean baseline forced expiratory volume in one second (FEV1) was 0.98 L (33% of predicted normal). Study drugs were administered on six occasions during 3 h (formoterol 4.5 mg or terbutaline 0.5 mg?inhalation -1 , 20 inhalations). Patients received intravenous prednisolone after 1.5 h and oxygen during the first 3 h. Pulse rate, serum potassium, 12-lead electrocardiogram (ECG), Holter ECG, arterial blood gases and FEV1 were assessed during 12 h after the first dose.Four patients (one formoterol, three terbutaline) discontinued. The 12-h mean values of serum potassium decreased from 4.02 to 3.89 mmol?L -1 for formoterol and from 4.22 to 3.76 mmol?L -1 for terbutaline. Mean 12-h pulse rate was significantly (pv0.01) higher in the terbutaline group (101.7 beats per minute (bpm)) than in the formoterol group (93.5 bpm). No individual patient value was considered clinically important or alarming. FEV1 improved in both groups but with no statistically significant difference between treatments.Oxis1 Turbuhaler1 (90 mg) was at least as safe and well tolerated as terbutaline (110 mg) in patients with acute bronchoconstriction. Eur Respir J 2001; 18: 928-934.

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Section: Discussionsupporting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Safety of formoterol Turbuhaler(R) at cumulative dose of 90 g in patients with acute bronchial obstruction

Małolepszy¹,

Nagy²,

Selroos³

et al. 2001

European Respiratory Journal

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“…A severe acute episode of asthma may lead to taking high-doses of b 2 -agonists over a short time. A previous tolerability study showed no difference in safety between equivalent high doses of formoterol and salbutamol [20]. Clinically relevant cardiovascular and hypokalaemic side-effects were not observed during administration of high-doses of formoterol (up to 228 mg) and salbutamol (up to 3,800 mg) [20].…”

Section: Discussionmentioning

confidence: 82%

“…A previous tolerability study showed no difference in safety between equivalent high doses of formoterol and salbutamol [20]. Clinically relevant cardiovascular and hypokalaemic side-effects were not observed during administration of high-doses of formoterol (up to 228 mg) and salbutamol (up to 3,800 mg) [20]. However, additional safety studies with long-term treatment of formoterol "as needed" are required, before considering changing asthma management strategies.…”

Section: Discussionmentioning

confidence: 95%

Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction

Politiek¹,

Boorsma²,

Aalbers³

1999

Eur Respir J

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Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction. M.J. Politiek, M. Boorsma, R. Aalbers. #ERS Journals Ltd 1999. ABSTRACT: The onset of the bronchodilating effect of formoterol (12 mg by Turbuhaler1) was compared with that of salbutamol (50 mg by Turbuhaler), salmeterol (50 mg by Diskhaler1) and placebo in methacholine-induced severe bronchoconstriction.Seventeen subjects with mild-to-moderate asthma completed this randomized, double blind, cross-over, double-dummy study. On four study days, baseline forced expiratory volume in one second (FEV1) was recorded and the subjects were challenged with methacholine until FEV1 fell by at least 30%. Immediately thereafter, the study drugs were inhaled and lung function was assessed for 60 min.The geometric mean time for FEV1 to return to 85% of baseline was 7.2 min with formoterol, 6.5 min with salbutamol, 14.1 min with salmeterol and 34.7 min with placebo (p=0.0001, overall ANOVA). The difference between formoterol and salmeterol was statistically significant (p=0.01); there was no difference between formoterol and salbutamol (p=0.69).In conclusion, formoterol reversed methacholine-induced severe bronchoconstriction as rapidly as salbutamol and more rapidly than salmeterol. Classifying b 2 -agonists as "fast"-and "slow"-acting may be supplemental to "short"-and "long"-acting. Eur Respir J 1999; 13: 988±992.

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“…Long-acting β 2 -agonists administered at higher than recommended doses have previously been associated with changes in heart rate, QTc interval and serum potassium and glucose levels, in patients and healthy volunteers [17][18][19][20][21][22][23]. The current study was therefore specifically designed to monitor and assess changes in these variables.…”

Section: Accepted Manuscript 29 August 2006mentioning

confidence: 99%

Safety, tolerability and efficacy of indacaterol, a novel once-daily β2-agonist, in patients with COPD: A 28-day randomised, placebo controlled clinical trial

Beier

Chanez

Martinot

et al. 2007

Pulmonary Pharmacology & Therapeutics

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The Effect of Maximal Doses of Formoterol and Salbutamol from a Metered Dose Inhaler on Pulse Rates, ECG, and Serum Potassium Concentrations

Cited by 47 publications

References 10 publications

Safety of formoterol Turbuhaler(R) at cumulative dose of 90 g in patients with acute bronchial obstruction

Safety of formoterol Turbuhaler(R) at cumulative dose of 90 g in patients with acute bronchial obstruction

Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction

Safety, tolerability and efficacy of indacaterol, a novel once-daily β2-agonist, in patients with COPD: A 28-day randomised, placebo controlled clinical trial

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