ชมรมโรคระบบหายใจและเวชบําบัดวิกฤตในเด็กแหงประเทศไทยชมรมโรคระบบหายใจและเวชบําบัดวิกฤตในเด็กแหงประเทศไทย

รวมกับ ยูโรดรัก ลาบอราทอรีสรวมกับ ยูโรดรัก ลาบอราทอรีส

พญพญ มกดา หวังวีรวงศมกดา หวังวีรวงศพญพญ..มุกดา หวงวรวงศมุกดา หวงวรวงศ

หัวหนาหนวยโรคภูมิแพ หัวหนาหนวยโรคภูมิแพ

สถาบันสุขภาพเด็กแหงชาติมหาราชินีสถาบันสุขภาพเด็กแหงชาติมหาราชินี

DoxofyllineDoxofylline• Last generation methylxanthine• Last generation methylxanthine

derivative for airway obstructions

• Markedly lower affinity for adenosine treceptors

• As effective as the conventional methylxanthines being a bronchodilator y gwith lower risk of adverse reactions

DoxofyllineDoxofylline

• Shows favorable anti-inflammatory effects in the airwaysin the airways

• Retains the inhibitory action on PDE 4 due• Retains the inhibitory action on PDE-4 due to its chemical structure (methylxanthine + dioxolane substitution)

N d f it i l d l l• No need for monitoring plasma drug levels

Tolerability of doxofylline in the maintenance therapy of pediatric patients

with bronchial asthmawith bronchial asthma

• 806 patients, aged 3-16 yo.p , g y• Doxofylline (200mg sachets) 100-400

mg/d – 6 mg/kg/d q 12 hrmg/d 6 mg/kg/d q 12 hr• More than one-half of the patients

received 3 or more drugsreceived 3 or more drugs• Reported side-effects 11%

GI 76% CNS 16% l it ti 9%- GI 76%, CNS 16%, palpitation 9%

Bagnato GF. Eur Review Med Pharma Sci 1999; 3:255-60.

Doxofylline-Clinical effecacyin reducing weekly salbutamol consumptionin reducing weekly salbutamol consumption

In a multicentre,randomised trial on adult patient with COPD given either doxyfylline 400 mg b i dCOPD given either doxyfylline 400 mg b.i.d

or Theophylline 300 mg b.i.d for 28 days

Consumption of salbutamol

Theophylline - 38%Doxofylline - 47%

Theophylline - 38%

Doxofylline significantly decreased concurrent Salbutamol consumption

Doxofylline – Clinical efficacy

45

Asthma: overall clinical data on 806 children(age 3-16,mean 8;61%≤10 yrs)

54

50

60

35

41

35

40

45% %

29

40

25

30

35

29

20

30

13 1115

20

89

105

10

0

very good good fair poor

0

very good good fair poor

Doxofylline efficacy favorable in 91% Doxofylline safety was favorable in 89%Doxofylline efficacy favorable in 91% Doxofylline safety was favorable in 89%

Bagnoto GF. Eur Rev Med Pharmacol Sci 2000, in press

Doxofylline Safety ClinicalDoxofylline Safety - Clinical

• 48 studies, 1056 subjects• Total prevalence of side-effects : 15.2%• Overall risk for any adverse event :• Overall risk for any adverse event :

1.8 events per patient-year• Total dropouts : 3%• Treatment interruptions for any reason:• Treatment interruptions for any reason:

0.4 per patient-year

ConclusionConclusionConclusionConclusion• Inhaled steroids are the most effective

controller medications currently avaiabley

• Multicenter study :- Theophylline serumMulticenter study : Theophylline serum conc. <10mcg/ml provided nearly as much effect as an inhaled steroidsmuch effect as an inhaled steroids, beclomethasone, in controlling chronic

thasthma

ConclusionConclusion• Sustained-release theophylline can beSustained release theophylline can be

used as an alternative to inhaled steroids for maintenance therapy insteroids for maintenance therapy in mild persistent asthma

• Sustained-release theophylline can be added with a low dose inhaled steroids in asthma control

ConclusionConclusionD f lli i ff ti i th l t• Doxofylline is effective in the long-term treatment of obstructive pulmonary didiseases

• It is safer and has greater therapeutic index than theophylline orindex than theophylline or aminophylline

• Can be used in children, elderly, i i h CVS CNS d GI dipatients with CVS,CNS and GI diseases

ConclusionConclusionConclusionConclusion• There is no evidence that Doxofylline

effectiveness or adverse events areeffectiveness or adverse events are related to blood levels

• As a consequence there is no need for continued measurements blood level during long-term treatmentg g

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