And the OPC Advantage New Clinical Evidence

Transcription

1 And the OPC Advantage New Clinical Evidence This presentation is based on clinical trials performed worldwide. The health claims in this presentation have not been approved or endorsed by TGA.

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4 Isotonix

5 HO O OH OH OH HO OH O OH OH HO OH OH OH HO O OH OH Copyright

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7 R1 OH HO O + R2 OH OH Bilberry has been shown to support night-time vision Effective for strengthening retinal capillaries

8 Resveratrol is a tri-hydroxy-stilbene HO OH OH

9 hesperitin OH OCH 3 sugar moiety HO O OH O hesperidin Shown to strengthen capillary walls and lower capillary filtration Lowering of total cholesterol and improved HDL to LDL was demonstrated

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11 BRAIN HEART Isotonix MUSCLES EYES BLOOD VESSELS SKIN

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13 Defend Your Blood Vessels: Veins Pycnogenol compared to European OTC for venous health

14 Example : Chronic Venous Insufficiency Pycnogenol vs. Antistax Ankle Swelling Resting Flux Ankle Circumference Pain Edema Compression -0% -0% -11% -2% -3% -6% -20% -27% -48% -48% -41% -86% p<0.05 vs baseline, N=166, Antistax 720 mg/day, Pycnogenol 100mg/day Belcaro, G. (2015). " International Journal of Angiology.

15 Pycnogenol more effective than Antistax Signs and symptoms of CVI Edema Capillary filtration Blood flow Microcirculation Oxidative stress And more Belcaro, G. (2015). " International Journal of Angiology.

16 Defend Your Blood Vessels: Arteries Pycnogenol helps stop progression of atherosclerosis: Part 1 Asymptomatic subjects (45-60) with non-stenosing atherosclerotic plaques (<50%) in at least one carotid or femoral bifurcation. 281 controls 167 Pycnogenol (50 mg) 206 Pycnogenol (100 mg) 235 Aspirin (100 mg)+ antiplatelet 202 Pycnogenol + Aspirin 30 month study

17 High resolution ultrasound Pycnogenol for atherosclerosis prevention Atherosclerosis can be assessed by evaluating the two carotids the two femoral arteries, by high-resolution ultrasound.

18 Rate of progression Atherosclerosis progression Atherosclerosis: the silent killer Stage I Stage II Stage III Stage IV Stage V Stage VI

19 Pycnogenol prevents atherosclerosis progression Belcaro, G., et al. Int. Journal Angiology, 2014

20 Pycnogenol for atherosclerosis: Part 1 1,363 asymptomatic subjects 30 month study

21 Pycnogenol Second for publication atherosclerosis: (in print) Part 2 Asymptomatic subjects with carotid or femoral stenosing plaques : 131 controls 122 Pycnogenol (50 mg) 125 Pycnogenol (100 mg) 129 Aspirin (100 mg)+ antiplatelets 131 Pycnogenol + Aspirin 42 month study

22 Rate of progression Atherosclerosis progression Atherosclerosis: the silent killer Stage I Stage II Stage III Stage IV Stage V Stage VI

23 Pycnogenol prevents atherosclerosis progression Pycnogenol prevents atherosclerosis progression p<0.05 Belcaro, G., et al. Int. Journal Angiology, 2015 In print

24 Pycnogenol reduces occurrence of cardiovascular events and need for treatment Pycnogenol prevents the occurrence of cardiovascular events and the need of treatment p<0.05 Belcaro, G., et al. Int. Journal Angiology, 2015 In print

25 Defend Your Brain Clinical Study with 77 subjects years of age with high oxidative stress Belcaro G. et al, J Neurosurg Sci submitted

26 Pycnogenol improves cognitive functions % improvement of cognitive functions (VASL) after 12 months 60.0% Cognitive function Attention Mental performance Sustained attention memory executive functions mood 50.0% 50.9% 55.8% 40.0% 30.0% 35.2% 41.2% 33.0% 37.7% 37.3% 20.0% 10.0% 0.0% -10.0% -1.8% 1.9% 1.9% 1.9% -9.8% -7.1% 3.8% -20.0% Pycnogenol Controls p<0.05 Belcaro G. et al, J Neurosurg Sci submitted

27 Defend Your Eyes Clinical Study with 77 subjects 9 months Aim prevention of a new retinal vein thrombosis episode Rodriguez, P., et al. (2015). " Panminerva Med 57(3):

28 Pycnogenol and retinal vein thrombosis 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% Pycnogenol in prevention of retinal vein thrombosis 17.39% 15.38% Diagnosed new RVT % in 9 months 3.56% p<0.05 Controls Aspirin Pycnogenol Rodriguez, P., et al. (2015). " Panminerva Med 57(3):

29 Pycnogenol effect on retinal edema 2.50 Pycnogenol decreases retinal edema Controls 1.00 Aspirin Pycnogenol 0.00 Baseline 9 months Retinal edema score Rodriguez, P., et al. (2015). " Panminerva Med 57(3): p<0.05

30 Pycnogenol effect on visual acuity Pycnogenol improves visual acuity 20/25 20/32 20/40 Baseline 9 months Vision Snellen Monoyer Controls Aspirin Pycnogenol p<0.05 Rodriguez, P., et al. (2015). " Panminerva Med 57(3):

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32 Pycnogenol Second improves publication performance (in print) in sport 2 Mile Run (women) control control Pycnogenol for exercise performance 2 Mile Run (men) Pycnogenol 1min 56 sec faster! Pycnogenol 1min 57 sec faster! Baseline 8 weeks Baseline 8 weeks Vinciguerra et al., J. Sport Medicine and Physical Fitness, 6: (2013)

33 PYC PYC control control Pycnogenol Second improves publication performance (in print) in sport Pycnogenol for exercise performance Push Ups (women) Push Ups (men) +14.3% +15% Pycnogenol Baseline 8 weeks Baseline 8 weeks Push Ups: Maximum in 2 minutes. Vinciguerra et al., J. Sport Medicine and Physical Fitness, 6: (2013)

34 Pycnogenol Second improves publication performance (in print) in sport Sit Ups (women) Sit Ups (men) +4,6% +9,3% Pycnogenol Pycnogenol control control Pycnogenol for exercise performance Baseline 8 weeks Baseline 8 weeks Sit Ups: Maximum in 2 minutes. Vinciguerra et al., J. Sport Medicine and Physical Fitness, 6: (2013)

35 Pycnogenol Second decreases improves publication oxidative performance (in print) stress in in sport sport Women Men control control Pycnogenol for exercise recovery Change in plasma free radicals after exercise Pycnogenol - 9,7% Pycnogenol - 8,8% Baseline 8 weeks Baseline 8 weeks Plasma free radicals [Carr units] Vinciguerra et al., J. Sport Medicine and Physical Fitness, 6: (2013)

36 Pycnogenol Second improves for publication fitness performance Part (in print) II: Triathlon in sport Pycnogenol for triathletes performance Controlled Clinical Evaluation Pycnogenol Controls n=38 male athletes n=22 male athletes Evaluation with the 100 minute triathlon model Swim distance of 750 meters Cycling distance of 20 km 5 km run Training for 4 weeks 1 triathlon every 3 days!

37 control Pycnogenol for exercise performance: triathletes Pycnogenol Pycnogenol Second improves improves publication performance performance (in print) trained sport athletes 100 Triathalon minute triathlon Time Pycnogenol controls 1:40:24 1:41: % Pycnogenol 10 min 48 sec faster! 1:29:44 1:36:08 Baseline baseline 4 weeks Vinciguerra et al., J. Sport Medicine and Physical Fitness, 6: (2013)

38 Pycnogenol for fitness Pycnogenol Second improves publication performance (in print) in sport Pycnogenol for fitness Lowers muscle pain Increases sport endurance Improves performance Controls oxidative stress

39 Build mass but don t lose it!

40 Defend Your Muscles NEW STUDY : Muscle Function / Sarcopenia 64 subjects with loss of muscle mass with age (sarcopenia) years of age with high oxidative stress (>320 Carr U) 2 months Belcaro G. et al, in submission

41 Pycnogenol improves muscular function 80% % improvement in muscular function in 8 weeks Hand grips [gram] 2kg weight [no. of lifts] Walking [meters] No. of stairs Time for feeling tired during activity [min] General fitness score (0-3) 70% 71% 60% 50% 40% 30% 38% 52% 43% 42% 20% 10% 17% 23% 17% 20% 20% 0% 5% Pycnogenol Controls -4% -10% Belcaro G. et al, in submission p<0.05 vs baseline and controls

42 Pycnogenol decreases proteinuria a marker of muscular loss in urine Proteinuria [mg/day] Control Group Pycnogenol -40% Baseline 8 weeks Belcaro G. et al, in submission p<0.05 vs baseline and controls

43 Defend Your Skin Clinical Study with 20 menopausal women Aged years, Skin type II or III Grether-Beck, S., et al. (2015). " Skin Pharmacol Physiol 29(1):

44 Pycnogenol effects on melanogenesis start 12 weeks UVA-1 radiation 100 J/cm 2 (area of 4 cm 2 ) Treatment regimen: 75 mg oral Pycnogenol for 12 weeks Biopsies at start and at 12 weeks before and after UV radiation mrna expression of MITF, TRP1, MART, Tyrosinase & Loricrin Grether-Beck, S., et al. (2015). " Skin Pharmacol Physiol 29(1):

45 Pycnogenol inhibits UVA induced hyperpigmentation 120.0% % increase in mrna following UVA irradiation before and after 12 weeks Pycnogenol p= % 80.0% p= % p= % 40.0% 20.0% 51.0% -67% 45.0% -51% -75% 17.00% 22.00% 27.00% 70.0% 0.0% MITF Tyrosinase TRP1 MART1 UVA Induction baseline 51.0% 45.0% 108.0% 70.0% UVA induction 12 weeks 17.00% 22.00% 27.00% 19.00% -67% 19.00% Grether-Beck, S., et al. (2015). " Skin Pharmacol Physiol 29(1):

46 Pycnogenol increases gene expression of loricrin Loricrin, a major component of the cornified cell in the stratum corneum accounts for much of cornified envelope mechanical resistance. X 2.5 P=0.017 Grether-Beck, S., et al. (2015). " Skin Pharmacol Physiol 29(1):

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