Monaco 020909

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Epidemiologie sociale de la maladie veineuse Pr Francois André ALLAERT Président de la Société Française d'Angiologie. Vice Président de la société Française de phlébologie Secrétaire général de la Société Française Des docteurs en pharmacie Pr CHRU Dijon & McGill University Montreal. Canada. Pr Francois André ALLAERT Président de la Société Française d'Angiologie. Vice Président de la société Française de phlébologie Titulaire de la Chaire d’Evaluation des allégations de santé Ceren ESC Dijon Evaluation tools for venoactive drug : Does the future lies in patients’ satisfaction evaluation ?

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Transcript of Monaco 020909

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Epidemiologie sociale de la maladie veineuse

Pr Francois André ALLAERT

Président de la Société Française d'Angiologie. Vice Président de la société Française de phlébologie

Secrétaire général de la Société Française Des docteurs en pharmacie

Pr CHRU Dijon & McGill University Montreal. Canada.

Pr Francois André ALLAERT

Président de la Société Française d'Angiologie.

Vice Président de la société Française de phlébologie

Titulaire de la Chaire d’Evaluation des allégations de santé Ceren ESC Dijon

Evaluation tools for venoactive drug : Does the future lies in patients’ satisfaction evaluation ?

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INTRODUCTION

De-reimbursement has discredited the efficacy of the venoactive drugs

For most of them their efficacy was not in question

According to the evidence based standards, one of them was able to claim for a level A evidence of efficacy and some other a level B

It was the medical utility which appeared insufficient to the French Health authorities

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An evolution of the drug registration

A new approach of the drug registration

Where efficacy is a sine qua none condition

But which is not sufficient by itself

To allow its registration and its reimbursement by the social insurance system.

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The added medical value : a flexible paradigme

Its fuzzy definition lets the commissions to interpret it as they whish by associating depending on the circumstances :

« Effectiveness » « Efficacy »

« Efficiency » 

«Utility»

«  Safety »

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An anglosaxon terminology« Efficacy » measures how well it works in clinical trials or laboratory studies.

« Effectiveness  »» relates to how well a treatment works in practice

« Efficiency  »» is doing things in the most economical way

« Safety » is the security in use

«Utility» is a measure of the relative satisfaction from, consumption of various goods and services

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Efficacy evaluation tools

Indirect evidences :

an explanatory approach

Direct evidences :

a conclusive approach

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Efficacy evaluation tools

Explanatory approach

in vitro studies or animal studiesOn microcirculation On N0 production

On inflammatory markerOn pain mediator

Interest : to explain the effects on functional and physical symptoms

Difficulty : to démonstrate the link with the venous disease

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Conclusive approach

Clinical studies

56 studies fulfilling the criteria to get a level A evidence were analysed in the cochrane 2005 review and that we complete with a personal bibliography review after 2005 using the same key words

Frequencyof evaluation criteria54/56 Symptoms evaluation 96,4%28/56 ankle or calf circumference 50,0%13/56 Pléthysmographies 23,2%4/56 leg volume measure using water displacement 7,1%4/56 Venous reflux with doppler 7,1%4/56 Venous pressure measure 7,1%3/56 PO2 et PCO2 measure 5,4%2/56 Echodoppler measure of oedema 3,8%

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Conclusive approach

Functional symptoms Visual analogic scales are better than qualitative or semi quantitative scales

Oedema measures : Measure with measuring tape must be conducted with constant force and attention must be paid to do the measure at the exact same level.

Pléthysmography :The most valuable measure except the photoplethysmography. Plethysmography using mercury strain-gauge are forbidden in many countries do to the restriction of using mercury. The most frequent is now air Plethysmography. Volume measurement and venous refilling time.

Water displacement: The best way to measure oedema but only oedema.

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Conclusive approach

Reflux measure with echodopplerDemonstrate the reflux and its duration But some studies shows that only 20% of patients with a chronic venous disease avec a deep venous reflux Deep venous reflux are not very sensitive to medical treatment..

Mesure of the venous pressure at the ankle . Lack of standard or definition of a pathological threshold. Not very sensitive to medical treatment..

PCO2 et PO2 Measure Reflect the tissular stress induced by the venous stase But what is the correlation with the clinical symptoms?

Oedema measure with echodpoppler. Requires a mathematical 3 dimensional reconstruction of the oedema and only gives a measure of oedema.

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Conclusive approach

Quality of life scales

Generic scale : SF12

Specific scales : CIVIQ

Show a patients’ quality of life benefit

Health authorities do no pay a great attention to their results

May re-enforce the opinion of health authorities that venous disease is a comfort troubles

It could have been more interesting to compare the

quality of life decrease induced by venous disease and those induced by some more « recognized » pathology

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A lack of recognition

Its a disease without real pathological status till some complications appear.

Trophic troubles

Varicose

Ulcer

Even not recognised as a risk factor of complications as phlebitis

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Venous disease status

A painful heaviness Whose physiopathological mechanisms have

been partially elucidated

whose symptoms are relieved by venoactive drugs

But its severity is not perceived by authorities in the same

manner than arthritic pain

or headache.

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What should we do ?

Studies must be targeted in two directions.

Health authorities

Patients

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To convince health authorities

Long term clinical trials Long term cohorts studies

Targeting new indications Not making reference to the venous disease

But to the prevention of its complication who are acknowledge as « real » pathologies

Requires many years

A willingness to pay of the health authorities

But what happens in italy is interesting :

After venoactive de-reimbursement : frequency of varicose and ulcer increases inducing heath costs increase

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To convince patients

Because patients become consummersWhen they are paying for their own health

expenses

To bring evidence of their venous disease relief

Functional symptoms +++

Physical symptoms (oedema)

Quality of life

And in the next future

Patients’ satisfaction

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To evaluate patients’ satisfaction

VAS or Lickert scalesbut

Some specific questionnaire Already exist in some other disease and

especially in rheumatology

They concern 1) The answer to the patients’ expectations

2) Its posology3) Its safety

4) The patients decision to buy it again5) Its satisfaction/price

A questionnaire should be soon validated In the venous disease

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CONCLUSION

Perhaps are we faced to a turning point of the evaluation of venoactive drugs?

Because patients are now paying the venoactive drugs, should we pay more attention to the patienst satisfaction?

Perhaps the consumer patient will require a specific metrology for OTC drug in general and venoactive particularly ?

Utility is a measure of the relative satisfaction from,

consumption of various goods and services