dr.roger ebastinefdt lisboa2006 - alergomurcia · -along the same line, 87% stated that the new fdt...

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Ebastine FDTFast Dissolving Tablet

An opportunity to meet patient needs

Dr Albert RogerAllergy Unit. H.U. Germans Trias i Pujol

Barcelona, Spain

www.alergomurcia.comDr Roger

Marzo 2006

Good afternoon, Mr. Chairman, ladies and gentlemen, it´s nice for me to be back in Lisbon again.The last time I was here, I was doing my favourite hobby.

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As Dr. Valovirta said in his previous presentation, the prevalence of allergyhas beeen increasing in recent years.For example, in this European Academy of Allergy campaign, it is stated that 1 in every 4 children is allergic, and children is the future!.Therefore, the first thing we have to do to meet the patients needs is toperform allergy tests to diagnose them.

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Immunotherapyeffectiveness

specialist prescription may alter the natural course of the disease

pharmacotherapysafety

effectiveness easy to be administered

allergen avoidance

indicated when possible

patient’s education

alwaysindicated

COSTS

Treatment of allergic rhinitis ARIA Guidelines


Marzo 2006

Once our patients have been diagnosed, they can be treated accordingto current therapeutic guidelines.For example, regarding allergic rhinitis, ARIA guidelines remind us pharmacotherapy should not only be safe and effective, but should alsobe easy to administer.

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Patient-centred managementin allergic rhinitis

• Guidelines provide the template for patient management

• Significant issues about how we meet patient needs– Adherence to treatment *

• pharmaceutical formulation

• Patients are increasingly demanding in what they want and expect from their treatments– Efficacy– Tolerability– Convenience

* Nolte H. Unawareness and undertreatment of asthma and allergic rhinitisin a general population. Respir Med 2005.


Marzo 2006

In summary, guidelines provide the template for patient management, and this management should be patient-centred.Despite the presence of these guidelines, there are still significant issues about how we meet patient needs.For example, non-adherence, or non-compliance to treatment is an ongoing problem. One area where adherence might be improved is pharmaceutical formulation.Patients are increasingly demanding in what they want and expect from their treatments.This is why treatments must meet patient needs.For the management of allergic rhinitis efficacy is expected; good tolerability is expected.New formulations provide the potential to offer the convenience that patients also want from their treatments.This presentation will focus on the large studies that have assessed whether new Ebastine FDT meets those patient needs

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M. Salvà. Phase I, single dose, open-label, randomised, crossover bioequivalence studies of Ebastine 10 and 20 mg regular tablets versus 10 and 20 mg of fast-dissolving tablets in healthy male volunteers. Interasma-EAACI, Bilbao 2004

Ebastine FDT Bioequivalence

•REGULAR TABLETS (RT) vs FAST DISSOLVING TABLETS (FDT)

•0 •8 •16 •24 •32 •40 •48 •56 •64 •72•0

•25

•50

•75

•100

•125

•150

•175

•200

•RT 10 mg•FDT 10 mg

•FDT 20 mg•RT 20 mg

•TIME (h)

Mea

n ca

reba

stin

epl

asm

a co

ncen

trat

ions

(ng/

mL)


Marzo 2006

As I have mentioned in the previous slide, I am going to speak to you aboutthe new FDT formulation of ebastine.But, f.irst of all, it must be pointed out that the efficacy and safety of the newFDT formulation is the same as that of the traditional ebastine tablet.To demonstrate the bioequivalence of the 2 formulations, this graph shows theresults of 2 phase I, single dose, randomized, crossover bioequivalencestudies of Ebastine 10 and 20 mg regular tablets versus 10 and 20 mg FDT performed in healthy volunteers.You can see that the mean plasma concentrations of carebastine, the active metabolite of ebastine, did not significantly differ in the 2 formulationsadministered, independently of the dose (10 or 20 mg)

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Relevant attributes for anti-H1(patients and physicians)

What can the new FDT improve?

• Efficacy• Fast onset of action• Long term effect

• Good side effect profile

• Once daily administration

• Easy to use


Marzo 2006

Going back to fullfilling patient needs, what we first need to know is what theseneeds are and which are the most important to the patient.In a recent IMR study carried out in several European countries, patients andphysicians were asked about what they considered to be the most relevantattributes required for an anti-H1.It was found that the main characteristics demanded were:-Efficacy, including a fast onset of action and a long term effect-A safe side effects profile-Once daily administration-And easy to useWhat can the new FDT improve with respect to other anti-H1 or formulations?I will focus on 2 of these attributes: fast onset of action and ease (is) of use, which are the characteristics which most differentiate the new FDT from theconventional ones.

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Ebastine FDT studies

EBAFLAS studyRoger A, Galván J, Plazas MJ, et al. Ebaflas Doctors study. Barometer survey of acceptance of an oral freeze-driedpharmaceutical form in allergic patients. Patient satisfactionand expecations. Pharmaceutical Care (Spain) 2005; 7:159.

INTERNATIONAL PATIENT’S PREFERENCE SURVEYRoger A, Fortea J, Artés M, Montilla L. Acceptability andpreference of the placebo fast dissolving tablet vs placebo regular tablets of ebastine in consumers of oral antihistamines with allergic rhinitis. Pharmaceutical Care(Spain) 2005; 7:159.


Marzo 2006

To comment this characteristics, I will focus on 4 recent studies in which I haveparticipated.In this slide the first 2 references.

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Ebastine FDT studies

EMPRAE studyRoger A. Fortea J, Artes M, Montilla L. Perception of the fastonset of action with Ebastine in fast dissolving tabletformulation in patients with allergic rhinitis. IV Congress ofPharmaceutical Care Spain 2005; 7 (special number): 157.

EUROPEAN PREFERENCE SURVEYRoger A, Fortea J, Artés M, Montilla L. Attributes forpreference of new fast dissolving tablet (FDT) formulation ofebastine in patients with allergy. Value in Health 2005; 8(6):A23.


Marzo 2006

And in this slide, the other 2.Let´s have a look at them.

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EBAFLAS study

• Evaluation of convenience(the quality of being suitable to one's comfort, purposes, or needs)

• 2,849 Spanish doctors assessed satisfaction withthe new FDT formulation in 7,686 adult patients

• Diagnosis: Rhinitis, Urticaria, Dermatitis

• Convenience was evaluated witha questionnaire


Marzo 2006

The first study was called Ebaflas (from Ebastel Flas).The aim of the study was to evaluate the convinience of the new FDT

formulation.Convenience is defined as the quality of being suitable to one's comfort,

purposes, or needsAlmost 3 thousand Spanish doctors assessed satisfaction with the new FDT

formulation in more than 7600 adult patientsThese patients had been diagnosed previously with rhinitis or urticaria or

dermatitis. Rhinitis accounted for 71% of these diagnosesThe methodology used to evaluate patient convenience was a questionnaire

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Degree of patient satisfaction

Quite or very satisfied

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Initial Taste

90%

Size

82%

Disintegrationtime

95%100%


Marzo 2006

The degree of patient satisfaction with the FDT formulation, assessed by thephysicians, was very high in general. For example, 95% of patients were quite or very satisfied with the disgregation time, 90% with the initial taste and 82% with the size of the tablet.

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Patients considered .... FDT formulation

Quite or very important

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100%

Can be takenwithout water

87%93%

Can be takenanytime and

anywhere

It leaves no residue

93%


Marzo 2006

Likewise, the patients considered it to be quiet or very important that EbastineFDT can be taken anytime and anywhere in 93% of the cases, that it leaves no residue in 93% of the cases, that the disgregation is fast in 91% and finally thatit can be taken without water in 87% of the patients

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International Patient’s Preference Survey

Evaluation of formulation preferences

• Randomised, multicentre, crossover study (Germany, Italy, Mexico)

• 420 adult patients with allergic rhinitis (70% IAR and 30% PAR)

• Placebo FDT and placebo regular tablet

• Multiple choice scoring system and visual analogue scores


Marzo 2006

Here I present you the second study, an international market research.The aim of the study was to evaluate formulation preferences.This was a randomised, multicenter, crossover study carried out in Germany, Italy and MexicoA total of 420 adult patients with AR were included, 70% having IAR and the remaining 30% PARThese patients were given either placebo regular tablets or placebo FDTThe methodologies used to evaluate patient preference were:

-Multiple choice scoring system-Visual analogue scores-And spontaneous likes/dislikesProfessional interviewers made these assessments.

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Patients prefer FDT Formulation

47,6

84,3

89,8

86,9

72,1

74,1

77,4

52,4

15,7

10,2

13,1

27,9

25,7

22,6

Suitable size

Has a pleasant taste

Suitable for taking whithout water

Suitable for taking anytime and anywhere

Easy to carry about in a bag or pocket

Suits my lifestyle

Facilitates treatment compliance

RTFDT

TOTAL BASE: (420)% of measurements


Marzo 2006

When patients were asked to rate specific attributes, they only had to choose which of the 2 formulations best fullfied their needs, and FDT was clearly preferred.-52% of the patients considered the size of the FDT tablet to be more suitable than the traditional formulation.-84% of the patients found the taste of FDT to be much more pleasant.-Almost 90% of the patients considered the FDT formulation suitable for taking without water.-Along the same line, 87% stated that the new FDT was suitable for taking anywhere/anytime.-Almost ¾ of the patients indicated that they preferred the FDT to carry about in the bag-Keeping in mind the different lifestyles of the patients, its important to underline that 3 out of 4 patients said that FDT suited their lifestyle.-And lastly, and perhaps the most important from the physicians point of view, 77% of the patients considered that the FDT facilitated treatment compliance.

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Patients prefer FDT Formulation

47,6

84,3

89,8

86,9

72,1

74,1

77,4

52,4

15,7

10,2

13,1

27,9

25,7

22,6

Suitable size

Has a pleasant taste

Suitable for taking whithout water

Suitable for taking anytime and anywhere

Easy to carry about in a bag or pocket

Suits my lifestyle

Facilitates treatment compliance

RTFDT

TOTAL BASE: (420)% of measurements

8,217,05General Assessment

TOTAL BASE: (420)MEAN (scale from 0 to 10)


Marzo 2006

After asking the patients about these different specific attributes, the patients were also asked to give a global evaluation of the 2 formulations. The mean score for the FDT was 8.2 and for tablets was 7.

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EMPRAE study

Perception of fast onset of action and satisfaction

• 100 adult patients with allergic rhinitis (41% Intermittent, 57% persistent)

• Multicentre Spanish study

• With prescriptions for 10 or 20 mg Ebastine FDT

• Retrospective phone interview(comparison with anti-H1)


Marzo 2006

The third study, the EMPRAE study (Estudio de mercado retrospectivo sobrepercepción rapidez de acción ebastina liofilizado oral) was designed to evaluate the perception of fast onset of action and satisfaction with the FDT

100 adult patients with allergic rhinitis: 41% intermittent and 57% persistent were included in this multicenter Spanish studyPatients were recruited when they went to the pharmacy with a FDT prescription. Later a professional interviewer telephoned them. Patients wereasked to evaluate the product characteristics compared to the previous experience with other antihistamines or formulations

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Perception of Onset of Action

75%

10%

Fast

Very fast

+

1%

14%

Slow

Neither fastnor slow-

85%


Marzo 2006

As you can see here, 10% of patients considered that FDT had a very fast onset of action and another 75% stated that the action was fast.Therefore we can say that 85% of patients felt that the new Ebastine FDT was a quick acting anti-H1.

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Perception of Fast Onset of Action

Begins to notice relief of the predominant symptom

35

30

25

20

15

10

5

0

4043

From 15 to 30

minutes

From 90 to 120

minutes

From 30 to 45

minutes

15

From 60 to 90

minutes

1

Dk/Na

2

More than 120 minutes

or 2 hours

13

From 45 to 60

minutes

18

% s

ymto

mre

lief

5

Less than15

minutes

45

3


Marzo 2006

If we focus the perception of the rapid onset of action on the most worrisomeor predominant symptom, which may vary from patient to patient, 48% of thepatients (the first 2 left bars) noticed alleviation within just 30 min, whileanother 33% of patients (the second 2 left bars) recognised improvementwithin 60 min.In total 81% of patients felt better within the first hour.

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Overall Satisfaction Rating

-16

24

13

Satis

fact

ion

+ 2410

269

368

107

96%

98% of patients were quite or totally interested in continuing to take Ebastine FDT


Marzo 2006

On a scale from 1 to 10 rating overall satisfaction, 7 was considered the minimum level expressed by the patient to indicate satisfaction with the treatment.Taking into account this rating, 96% of the patients felt satisfaction.The mean score of the 100 patients included was 8.5It is therefore not surprising that when patients were specifically asked, 98% were quite or totally interested in continuing to take Ebastine FDT.

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European Preference Survey

Understand the strengths of FDT

• European, multicentre, questionnaire based study

• 60 adult allergic patients and 82 physicians

• Assessment of placebo FDT

Poster presentation, ISPOR, Italy, 2005


Marzo 2006

Last, the fourth study, an European Market Research, was designed to know the strengths of the new FDT formulation.This was a multicentre, questionnaire based study carried out in France, Germany, Belgium, Italy and FinlandA total of 60 adult allergic patients who regularly take anti-histamines (30 men and 30 women) and 82 physicians who were used to prescribing antihistamines (a mixture of specialists and GPs) were included in the studyAll the subjects were given Placebo FDT

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What does the new Ebastine FDT offer?

• Strengths– Fast Dissolving– Easy to use– No need for water– Pleasant taste– Easy to take around

(good for acute allergies / active people)

• Controversial Aspects– Handling of the blister (not easy to open)

Disappeared once subjects were instructed


Marzo 2006

The greatest strengths reported by both, patients and physicians, were:-Fast dissolving-Easy to use-No need for water-Pleasant taste-And easy to take around, in special good for acute allergies and active peopleOn the other hand, the most commented controversial aspect was the handling of the blister (not easy to open), but this aspect disappeared once subjects were instructed how to do it.

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• FDT was preferred by the majority of both patients and physicians …

• … Patients views on FDT were very similar to those of physicians interviewed

75% of patients stated that the new formulation will improve their compliance



Marzo 2006

It is of mention that FDT was preferred by the majority of both patients and physicians and….…. that patients views on FDT were very similar to those of physicians interviewed.I will give you 3 specific data as examples of these remarksMost patients (45 out of 60, 75%) considered that the new formulation can improve their compliance

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9

8

7

6

5

4

3

2

1Germany Belgium Italy

7,5

6,9

8,8 8,6

Likelihood of taking EbastineFDT - Patients

Likelihood of prescribingEbastine FDT - Physicians

Ave

rage

France

7,4 7,4 7,97,6

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Most of the patients preferred FDT: they will ask the doctor for FDTThe majority of physicians would be very likely to prescribe FDT



Marzo 2006

In this graph, it is shown, in white bars, the likehood of patients for taking Ebastine FDT, and in orange bars, the likehood of physicians for prescribing Ebastine FDTAlthough there was a high level of satisfaction with current antihistamine formulations, 78% (47 out of 60) of patients preferred the new FDT formulation, thus these patients indicated that they would definitely ask their doctor for FDT.Similarly, the majority of physicians reported that it would be very likely that they would prescribe Ebastine FDT. You can see that on a scale from 0 to 10, the mean average for prescribing FDT in the different countries rates between 7.4 and 8.1

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The effect of formulation:FDT advantages

• Virley P. A novel, fast-dissolving dosage form. Manuf Chem. 1990; 61:36-37.

• Andersen. Problems when swallowing tablets: a questionnairestudy from general practice. Tidsskr Nor Leageforen 1995;155(8):947-949.

• Seager H. Drug-delivery products and the Zydisfast-dissolving dosage form. J Pharm Pharmacol 1998; 50:375-382.

• Habib W. Fast-dissolving drug delivery systems, critical reviewin therapeutics. Drug Carrier Systems. 2000; 17 (1):61-72.


Marzo 2006

Up to now, I have given you the Ebastine FDT studies that I wanted to present to you.Now, 2 small reflexions to discuss the results presented.First of all: Are the results you have listened in my speech in accordance withthe medical literature?These FDT formulation advantages should not surprise us, because prior toebastine, other drugs have been developed in the same way.The importance of not having to swallow and not needing water has beenreported in several studies such as those cited here.

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Marzo 2006

Second, I want to highlight this study comparing 5 new anti-histamines.It concluded that for the newer nonsedating anti-histamines, there appears tobe no clinically relevant differences in activities (but let me say that it seems different after listening Dr.Valovirta presentation)But, what it´s more important to underline, the conclusions of this study end with the following phrase: preference of the patient may be one the mostimportant factors in making a choice between these drugs.

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Improved formulation preferred by patients and physicians:

• Ease of use and easy to take around

• No need for water

• Perception of rapid onset of action

• Desire to continue or start with Ebastine FDT

Ebastine FDT meets patients needs

Improved treatment compliance,and thus improve management

Same efficacy and safety profile as Ebastineregular tablets


Marzo 2006

To conclude, we can state that Ebastine FDT meets patients needs.Ebastine FDT possesses the same efficacy and safety profile as traditional Ebastine regular tablets.This improved formulation is preferred by both, patients and physicians.Pan European studies have consistently shown that Ebastine FDT’s key attributes include:-Ease of use and easy to take around-No need for water-Perception of rapid onset of action-And desire to continue or start with Ebastine FDTSo, by meeting patient’s needs, Ebastine FDT offers the opportunity to improve treatment compliance, and thus improve management.

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Remember …..

The main objective of medical practiceis to ensure that the quality of life of ourpatients is not affected by the diseaseitself or the treatments we prescribe.

We need to offer patients treatmentsthat they prefer and that can help toimprove their quality of life.

..... meeting patient´s needswww.alergomurcia.com

Dr Roger

Marzo 2006

And last, but not least, remember that the main objective of medical practice isto ensure that the quality of life of our patients is not affected by the diseaseitself or the treatments we prescribe.So, we need to offer patients treatments that they prefer and that can help toimprove their quality of lifeDoctors, you can make such things happen ……. just by thinking aboutmeeting patient´s needsThank you for your kind attentionMoito obrigao per la sua atencio

dr.roger ebastinefdt lisboa2006 - alergomurcia · -along the same line, 87% stated that the new fdt...

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