NaHA 40mg/2mL Sodium hyaluronate 2% ARTHRUM H AND ...

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P H A R M A C E U T I C A L

A TARGETED APPROACH TO PAINAND FUNCTIONAL MANAGEMENTA TARGETED APPROACH TO PAINAND FUNCTIONAL MANAGEMENT

P R O O F O F E F F I C A C YP R O O F O F E F F I C A C Y

TRAUMATIC AND DEGENARATIVEJOINT PATHOLOGIES

Primary tibiofemoral and patellofemoral knee osteoarthritis

Osteoarthritisand associatedfactors

• Inefficacy of common treatments

• Intolerance and orcontraindication toNSAIDs and orAnalgesics

• Patients over the age of 65 years onmultiple medication(Hypertension, Diabete,Obesity, Cardiovascularand Gastrointestinal problems)

• When a prosthesis iscontraindicated : young subjects,various contraindications to surgeryrelated to the patient's state of health.

Knee osteoarthritis secondary to trauma and or microtrauma

• Joint fractures, post-meniscectomy, laxity due to anterior cruciate ligament rupture

• Rotational osteoarthritis inyoung former sportsmen

• Arthroscopy and injection of ARTHRUM following washout, repair ofthe articular meniscus and cartilage (role as intra-articularlining and shock-absorber).

ARTHRUM H AND THERAPEUTIC INDICATIONS

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TRAUMATIC AND DEGENARATIVE JOINT PATHOLOGIESADJVANT IN THE ORTHOPAEDIC SURGERY

3 intra-articular injectionsthree weekly injections3 intra-articular injectionsthree weekly injectionsS o d i u m h y a l u r o n a t e 2 %

NaHA 40mg/2mL

S o d i u m h y a l u r o n a t e 2 %

NaHA 40mg/2mL

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9, allée Prométhée - F - 28000 Chartres - FranceEmail : [email protected] - Web : www.lca-pharma.com

L C A P H A R M A C E U T I C A L

FRENCH LABORATORY – MADE IN FRANCE

INTRA ART ICULAR INJECT IONINTRA ART ICULAR INJECT ION

THE SODIUM SALT OF NATURALHYALURONIC ACID

MOLECULAR WEIGHT (Da) : 2 800 000

THE HIGHEST CONCENTRATION OF HYALURONIC ACID SODIUM SALT (HA 2%)

HIGH MOLECULAR WEIGHTThe molecular weight of the Hyaluronic Acid used in ARTHRUM H is 2.8 million Daltons. It is one of the highest molecular weights currently available in genetic engineering. Molecular weight and concentration are essential factors for the effective treatment of osteoarthritis.

120 mg HA for a treatment of 3 intra-articularinjections

CONCENTRATION : 40 mg / 2 ml

PRODUCED BY GENETIC ENGINEERINGThe Hyaluronic Acid used in ARTHRUM H is a product of fermentationbiotechnology. It is therefore not of animal origin. It thereby avoids theproblems associated with extraction from animal tissues.

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HYALURONIC ACIDHyaluronic Acid is a high molecular weight polysaccharide, present in

large quantities in joints. It is found as a sodium salt in the synovial fluidand is one of the essential constituents of the extracellular matrix of

cartilage. It acts as a skeleton for proteoglycan aggregates and stabilisesthe collagen network. It serves as a lubricant and participates in cartilage

regeneration. It also has a role in shock absorption.

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P R O O F O F E F F I C A C YP R O O F O F E F F I C A C YS o d i u m h y a l u r o n a t e 2 %

NaHA 40mg/2mL0120

S o d i u m h y a l u r o n a t e 2 %

NaHA 40mg/2mL0120

IMPROVEMENT IN LEQUESNEFUNCTIONAL INDEX

S TAT I S T I C A L S T U D Y O N 3 3 4 9 PAT I E N T S *

6,0

7,0

8,0

9,0

10,0

11,0

12,0

D0 D15 D30 D60 D90

The index fell from a mean value of 11.2 (D0) to 6.2 (D90) (p<0.01).

Lequesne functional index

There was a gain in algofunctional performanceof 5 points.

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IMPROVEMENT IN LEQUESNE FUNCTIONALINDEX WITH THE BODY MASS INDEX

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D0 D15 D30 D60 D90

BMI < 22kg/m2

22 kg/m2 < BMI < 28 kg/m2

BMI > 28 kg/m2

The decrease in Lequesne functional index is observed in allstrata of the population and notably in patients with abody mass index greater than 28 Kg/m2.

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The value of Lequesne funtional index decreasessignificantly with each visit.

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11,2

8,9

7,6

6,76,2

* EVALUATION OF THE EFFICACY OF ARTHRUM H BY INTRA-ARTICULAR INJECTION IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE

P R O O F O F E F F I C A C YP R O O F O F E F F I C A C Y

S o d i u m h y a l u r o n a t e 2 %

NaHA 40mg/2mL0120

PATIENT’S GLOBAL IMPRESSION ATTHREE MONTHS OF TREATMENT

T H E B E N E F I T S F O R K N E E S O S T E O A R T H R I T I S PAT I E N T S

The percentage of patients who said they felt betterincreased significantly between D15 (59%) and D30 (68.2%)(p<0.01). On D90 65.9% of patients said they felt better.

FAIR / EXCELLENT

17%

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A REDUCTION IN NSAID ANDANALGESIC TREATMENTS

• On D0, 1888 patients(63.1%) were beingprescribed concomitanttreatments.

• On D90, only 546patients (29.9%) werein this situation(p<0.01).

The proportion of patients treated fell : NSAIDs :Diclofenac : D0 221 patients and at D90 only 52 Celecoxib : D0 157 patients and at D90 only 57ANALGESICS : Paracetamol : D0 689 patients and at D90 only 192 Dextropropoxyphene/Paracetamol : D0 403 patients and atD90 only 121

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65,9%

The concordance of the responses from patients and doctors regarding their assessment of the patient’s clinical condition was measured using the Kappa coefficient of concordance. Its value was 0.8132 (standard deviation 0.0053), whichmeans that the concordance was very high.

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D0 D15 D30 D60 D90

TotalCorticosteroidsNSAIDsAnalgesics

Change in the prescription of concomitant treatments

P R O O F O F E F F I C A C YP R O O F O F E F F I C A C Y