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Pranlukast

A Review of its Use in the Management of Asthma

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Summary

Abstract

Pranlukast (Onon®, Azlaire®), is an orally administered, selective, competitive antagonist of the cysteinyl leukotrienes (LT) C4, LTD4 and LTE4. It is indicated for the prophylactic treatment of chronic bronchial asthma in paediatric and adult patients.

The efficacy of pranlukast 225mg twice daily in adults with mild to moderate asthma was demonstrated in double-blind, placebo- or azelastine-controlled studies of 4 or 8 weeks' duration. The drug at this dosage was superior to both comparators in improving mean attack scores and morning and/or evening peak expiratory flow rates, and decreasing the use of rescue bronchodilators (p < 0.05). In limited clinical studies, pranlukast 225mg twice daily appeared to be as effective as montelukast 10mg once daily and zafirlukast 40mg twice daily in adults with mild to moderate asthma. Tachyphylaxis was absent when the drug was administered for up to 4 years. In patients requiring high-dose inhaled corticosteroid therapy, pranlukast 225mg twice daily plus a halved dosage of inhaled corticosteroid was as effective as the original dosage of inhaled corticosteroid. Pranlukast was also effective in patients with mild to severe asthma in a clinical practice setting. In a double-blind trial, greater improvements in most outcome measures were observed with pranlukast than with oxatomide in children and adolescents with asthma.

In clinical trials, pranlukast was well tolerated in adult and paediatric patients with asthma, with an adverse event profile similar to that of placebo. Gastrointestinal events and hepatic function abnormalities were the most commonly reported adverse events. No clinically significant differences in adverse event profiles between pranlukast, zafirlukast or montelukast were shown in limited comparisons. Although Churg-Strauss syndrome has been noted in pranlukast recipients, a direct causal relationship is unlikely.

Conclusions: Pranlukast is a well tolerated and effective preventative treatment in adult and paediatric patients with persistent asthma of all severities. In some patients, pranlukast may be beneficial when added to low-dose inhaled corticosteroids; it may also be a viable alternative to increasing inhaled corticosteroid dosages. The efficacy of pranlukast relative to placebo has been confirmed; its efficacy relative to other therapy awaits further investigation. Nonetheless, pranlukast is a useful therapeutic option (with as-required short-acting β2-agonists), either as preventative monotherapy for the treatment of mild persistent asthma or in conjunction with inhaled corticosteroids in the management of moderate or severe persistent asthma.

Pharmacodynamic Profile

Pranlukast is a selective, competitive antagonist of the cysteinyl leukotrienes, leukotriene (LT) C4, LTD4 and LTE4, antagonising binding at the cysteinyl leukotriene type 1 (CysLTi) receptor. Like the other commercially-available CysLTi receptor antagonists montelukast and zafirlukast, pranlukast inhibits antigen-induced contraction of human bronchial smooth muscle in vitro.

In patients with asthma, oral pranlukast at clinically relevant dosages generally inhibited eosinophil activity and the presence of eosinophils in sputum (in the late asthma response), reduced exhaled nitric oxide levels, improved allergen-induced decreases in forced expiratory volume in 1 second and reduced the magnitude of airway hyperresponsiveness.

Pranlukast attenuated bronchoconstriction induced by exercise (dosage of 450 mg/day for 14 days), LTD4 (pranlukast 10-60mg as a single intravenous dose), aspirin (pranlukast 450 mg/day for 7 days), and bronchial hyperresponsiveness induced by methacholine and cold air (clinically relevant dosages), but did not ameliorate the effects of histamine, alcohol or propranolol.

Pharmacokinetic Profile

At least 12.5% of a dose of pranlukast is absorbed after oral administration, and maximum plasma concentrations are achieved within 2-6 hours when the drug is administered after food. Steady-state plasma concentrations of pranlukast are achieved within 7 days of twice-daily oral administration. Bioavailability is increased when the drug is administered before or after a meal; in addition, the bioavailability of pranlukast is greater after evening than after morning administration. Pranlukast is approximately 99% bound to plasma protein.

The mean plasma elimination half-life of oral pranlukast ranged from 3-9 hours after repeated doses in pharmacokinetic studies. The drug is cleared through metabolic transformation (primarily glucuronic acid conjugation). The majority of an oral dose is excreted via the faecal route, chiefly as the unchanged drug, within 72 hours of administration.

The pharmacokinetics of a single dose of oral pranlukast were generally similar in adults with asthma, elderly (aged >65 years) or young (aged 18-35 years) volunteers and, on a mg/kg basis, in children aged 8-11 years with moderate asthma.

Although the drug is metabolised by cytochrome P450 (CYP) enzymes in vitro, in a clinical setting pranlukast appears to have low potential for drug-drug interactions via this system. Urinary 6β-hydroxycortisol excretion (a surrogate marker of CYP3A4 activity) was unchanged with oral pranlukast 112.5-675mg twice daily in healthy volunteers. Prior treatment with clinically relevant doses of oral pranlukast (225mg twice daily) had no effect on the pharmacokinetics of intravenous aminophylline administered 4 hours after the final dose of pranlukast in healthy young adults.

Therapeutic Efficacy

In Adults: In patients with mild to moderate asthma receiving bronchodilators and/or inhaled corticosteroids, pranlukast 225mg twice daily for 4 or 8 weeks was more effective in improving asthma symptoms than twice-daily administration of placebo or azelastine 2mg. Mean attack scores, morning or evening peak expiratory flow rate (PEFR) and frequency of bronchodilator use improved to a significantly greater extent (p <0.05) with pranlukast than with placebo or azelastine at each 2-week timepoint in two randomised, double-blind, multicentre 4- or 8-week trials (n = 197 and 177).

In randomised, double-blind trials in patients with mild to moderate asthma, pranlukast 225mg twice daily showed similar efficacy to zafirlukast 40mg twice daily for 6 weeks in 298 patients and montelukast 10mg once daily for 4 weeks in 368 patients.

A subgroup analysis of preliminary data from European and US efficacy trials demonstrated that pranlukast 75–450mg twice daily for 12 weeks was effective in patients (n = 941–949) with mild to moderate asthma complicated by rhinitis.

In small (n = 10–70), nonblind 4- to 16-week studies, pranlukast 225mg twice daily was generally effective in patients with moderate or severe asthma receiving a concomitant inhaled corticosteroid (but not in those also receiving oral prednisolone) and in patients with severe asthma refractory to corticosteroids.

Patients with mild to severe asthma who were responders to pranlukast (>15% increase in baseline PEFR after 16 weeks' treatment) have been effectively treated with pranlukast for up to 4 years. Patients receiving pranlukast had a significantly greater increase in percentage of predicted PEFR than patients receiving conventional therapy over the 4-year period.

Pranlukast allows for reduced inhaled corticosteroid dosages without deterioration in lung function in patients requiring high-dose inhaled corticosteroids. In a randomised, double-blind, placebo-controlled, 6-week trial in 79 patients with stable asthma who had been receiving inhaled beclomethasone ≥1500 µg/day, outcome measures did not change significantly from baseline values when inhaled corticosteroid doses were halved in patients receiving pranlukast 225mg twice daily. In contrast, a significant deterioration in outcome measures was demonstrated by patients receiving placebo. Similar results were observed in 8- and 16-week randomised trials.

Health-related quality of life (HRQOL) improved in adult patients with asthma receiving pranlukast 225–450mg twice daily in a placebo-controlled 12-week trial or nonblind 4- to 12-week trials.

In Children: Pranlukast was at least as effective as the H1 antihistamine oxatomide in a randomised, double-blind 4-week trial in 214 patients aged >1 year with mild to severe paediatric asthma. Pranlukast ≈7 mg/kg/day had a significantly better final global improvement rating than oxatomide ≈1 mg/kg/day (71.4% vs 37.2%) in both per-protocol and intention-to-treat analyses and was superior for several, but not all, other parameters.

In longer nonblind studies, treatment with pranlukast dry syrup for up to 24 months improved asthma control compared with baseline values.

Pranlukast dry syrup improved overall HRQOL, physical domain and emotional domain scores from baseline in children with mild to moderate asthma aged <4 years (n = 20; mean age 2.0 years) and ≥4 years (n = 36; mean age 6.6 years) in a nonblind, 4-week trial.

In Clinical Practice: Pranlukast was effective in the treatment of mild to severe asthma symptoms in the clinical practice setting, as shown by a large (completed by >2500 patients), nonblind, population-based study without specific inclusion and exclusion criteria. The efficacy of pranlukast was unaffected by concomitant use of inhaled corticosteroids, β2-agonists and/or theophylline.

Pharmacoeconomic Analyses

Preliminary data from retrospective Japanese pharmacoeconomic studies suggest that pranlukast may be a cost-effective addition to asthma treatment. Relative to placebo, pranlukast reduced the cost required to obtain an effectiveness increase of one point regardless of whether direct or overall costs were considered in a 4-week study in 166 patients with mild to moderate asthma (currency year 1995).

The initiation of pranlukast 225mg twice daily increased annual medication costs compared with the year before in 30 patients with moderate or severe asthma who responded to pranlukast, despite decreased asthma symptoms and signs.

Tolerability

Pranlukast was well tolerated in clinical trials in adults or children with asthma; most adverse events were experienced by <1 % of patients. In pre-approval clinical trials of pranlukast conducted in Japan, 7.4% of 472 evaluated adult patients and 5.6% of 320 evaluated paediatric patients with asthma reported an adverse event with pranlukast treatment. Gastrointestinal adverse events (e.g. nausea, diarrhoea, abdominal pain/stomach discomfort) and hepatic function abnormalities were the most commonly reported adverse events. In comparative trials, the frequency of adverse events with pranlukast was significantly less than with azelastine in adult patients (12.2% vs 26.4%), and similar to that with oxatomide dry syrup in paediatric patients (9.4% vs 11.1 %). Moreover, the frequency, severity and nature of adverse events with pranlukast 225–450mg twice daily were similar to those with placebo in clinical trials in Europe and the US.

In long-term treatment (for up to 4 years) in adult patients, pranlukast was well tolerated and laboratory data did not change significantly.

Comparative clinical studies have shown no clinically significant differences in adverse event profiles between pranlukast and zafirlukast or montelukast.

Churg-Strauss syndrome, a form of vasculitis, has been noted in patients receiving pranlukast; however, it is unlikely that there is a direct causal relationship between the drug and the emergence of this condition.

Dosage and Administration

Oral pranlukast is indicated for the prophylactic treatment of chronic bronchial asthma in Japan and for the prophylaxis and treatment of chronic bronchial asthma, including the prevention of exercise-induced asthma, in Latin America. It is approved for use in a capsule formulation in adult patients in Japan and in those aged ≥12 years in Latin America, and as a dry syrup formulation in paediatric patients aged ≥1 year (in Japan) or ≥2 years (Latin America). The recommended dosage of pranlukast is 450 mg/day in adult patients and 7 mg/kg/day (increasing to a maximum of 10 mg/kg/day according to age and symptoms, but not exceeding 450 mg/day) in paediatric patients, divided into two doses. As food affects the bioavailability of pranlukast, the drug is administered after breakfast and dinner. The manufacturer's prescribing information states that pranlukast should be withdrawn in patients with suspected liver dysfunction, interstitial or eosinophilic pneumonia, leukopenia, thrombocytopenia or risk of anaphylaxis. Close monitoring is required when the drug is administered in patients undergoing dosage reduction or withdrawal of oral corticosteroids. Dosage adjustments are recommended in elderly patients, and caution is required when prescribing pranlukast during pregnancy or when it is coadministered with drugs that are predominantly metabolised by or inhibit the activity of CYP3A4 enzymes.

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Notes

  1. Use of tradenames is for product identification purposes only and does not imply endorsement.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Ackland, 10, New Zealand

    Susan J. Keam, Katherine A. Lyseng-Williamson & Karen L. Goa

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  1. Susan J. Keam
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Correspondence to Susan J. Keam.

Additional information

Various sections of the manuscript reviewed by: P.E. Korenblat, Washington University School of Medicine, St Louis, Missouri, USA; R. F. Lockey, Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of South Florida, Tampa, Florida, USA; Y. Obase, Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan; G.E. Rovati, Department of Pharmacological Sciences, University of Milan, Milan, Italy; A.P. Sampson, Director, Respiratory Cell and Molecular Biology, University of Southampton School of Medicine, Southampton, UK; L.J. Smith, Northwestern University Medical School, Chicago, Illinois, USA; G. Tamura, First Department of Internal Medicine, Tohoku University School of Medicine, Sendai, Japan.

Data Selection

Sources: Medical literature published in any language since 1980 on pranlukast, identified using Medline and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were ‘pranlukast’ or ‘ONO-1078’ and ‘asthma’. EMBASE search terms were ‘pranlukast’ and ‘asthma’. AdisBase search terms were ‘pranlukast’ or ‘ONO-1078’ and ‘asthma’ and ‘pranlukast’ and ‘PK’ or ‘PD’. Searches were last updated 31 March 2003.

Selection: Studies in patients with asthma who received pranlukast. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Asthma, pranlukast, leukotriene antagonists, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Keam, S.J., Lyseng-Williamson, K.A. & Goa, K.L. Pranlukast. Drugs 63, 991–1019 (2003). https://doi.org/10.2165/00003495-200363100-00005

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