FOR EVERY BEAT OF YOUR HEART!
Patented Olive leaf extract
Clinical study Indonesia _ M&S Meeting April 2010
Benolea® : Activity profile
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Hypertension trend
Hypertension affects
approximately 50 million
individuals in the United States
and approximately 1 billion
individuals worldwide. As the
population ages, the prevalence
of hypertension will increase
even further unless broad and
effective preventive measures
are implemented.
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Classification of Blood Pressure (BP)
Category
SBP* mmHg
DBP* mmHg
Normal
<120
and
<80
Prehypertension
120 – 139
or
80 – 89
Hypertension, Stage I
140 – 159
or
90 – 99
Hypertension, Stage II
≥160
or
≥100
*SBP (systolic blood pressure): pressure that blood exerts on vessels
while the heart is beating.
*DBP (diastolic blood pressure): pressure that blood exerts on vessels
while the heart is relaxed.
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New clinical study
Clinical study was conducted
• in human volunteers with Stage-1 hypertension
• in the Dr. Cipto Mangunkusumo National General
Hospital (Indonesia), in collaboration with the Faculty
of Medicine, University of Indonesia
• with financial support of Dexa Medica
Pharmaceuticals Manufacturers and Frutarom Ltd.
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Objective
Evaluation of
• blood-pressure reducing effect of Benolea®
• lipid-lowering effect of Benolea®
• safety and tolerability of Benolea®
in comparison with Captopril (= widely used
pharmaceutical for treatment of hypertension)
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Study design (I)
• Participants: 232 volunteers with stage-1 hypertension
(SBP 140-159 mmHg; DBP 90-99 mmHg)
• Active-controlled: 116 on Benolea; 116 on Captopril
• Randomized, double-blind, double-dummy method
Benolea Group
B
P
Captopril Group
P
C
P
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B
= Benolea
C
= Captopril
P
= Placebo
Study design (II)
• 4 weeks run-in period without treatment (placebo, dietary
advice)
• 8 weeks of treatment period
• Daily Dosage: Benolea group: 2 x 500mg Benolea/day
Captopril group: 2 x 12.5 mg Captopril/day
• Dietary advice
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Clinical study: Outcome measures
• Blood pressure was measured every week
• Lipid profile (total cholesterol and triglyerides)
were measured after 4 and 8 weeks.
• For safety evaluation changes in parameters
(routine hematology, serum electrolytes, liver and renal
function) were monitored.
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Result I – Effects on blood pressure
Blood pressure-reducing effect of Benolea® is similar to
Captopril
*p < 0.05
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Result I – Effects on blood pressure
Subgroup-analysis in subjects with higher SBP (> 145 mmgHg) at
the study begin: reduction of SBP was equal in Benolea group
and Captopril group
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Result II – Effects on lipid profile
Benolea® clearly reduced total cholesterol levels
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Result II – Effects on lipid profile
Benolea® clearly reduced triglyceride levels
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Result III – Safety assessment
All safety parameters (routine hematology, serum
electrolytes, liver and renal function), of the subjects in
the Benolea® group were within normal range.
No adverse events, related to the study medication,
occured
Benolea® is safe and well tolerated.
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Conclusion
• Benolea® shows similar blood pressure reducing
effect compared to standard antihypertensive
medicament (Captopril)
• Benolea® shows clear lipid-lowering effect, even more
effective than Captopril
• Benolea® is safe and well-tolerable
• Results are in agreement with the results from the
twin-study
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Thank You
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