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Advice Pool - High Blood Pressure - The Silent Heart Killer
“High blood pressure is a silent killer.” American Heart Association
According to recent estimates, almost 65 million American adults—nearly 1 in 3—have high blood pressure. It is more common and often more serious in African Americans than in Cuacasions. High blood pressure is also prevalent in other parts of the world - this silent kille
According to recent estimates, almost 65 million American adults—nearly 1 in 3—have high blood pressure. It is more common and often more serious in African Americans than in Cuacasions. High blood pressure is also prevalent in other parts of the world - this silent kille
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
r affects almost one billion people worldwide. And its prevalence is rising.
Blood pressure is measured as systolic and diastolic pressures. Systolic pressure is the force in the arteries when the heart beats, while diastolic pressure is the pressure in the arteries when the heart is at rest. It's measured in millimeters of mercury (mm Hg).
Blood pressure is measured as systolic and diastolic pressures. Systolic pressure is the force in the arteries when the heart beats, while diastolic pressure is the pressure in the arteries when the heart is at rest. It's measured in millimeters of mercury (mm Hg).
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
Ideal blood pressure is less than 120/80. Pre-hypertension is blood pressure of 120-129/80-89 mm Hg. Blood pressure is high when it is greater than or equal to 140 mm Hg systolic pressure or greater than or equal to 90 mm Hg diastolic pressure. Physicians classify high blood pressure in two stages: Stage I is 140-159/90-99 and Stage II is
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
60/100 or higher. Blood pressure readings need to be taken properly. Ideally one should be resting for 5 minutes and should not have drunk coffee or smoked cigarettes for 30 minutes prior to the measurement. A full bladder can also affect the numbers.
The cause of high blood pressure is not known in about 90-95 percent of the cases and this
The cause of high blood pressure is not known in about 90-95 percent of the cases and this
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is labeled as essential hypertension. In the remaining 5-10 percent, the blood pressure is elevated due to a kidney disease or structural abnormality of the aorta or certain arteries. Oral contraceptives can also contribute to the development of high blood pressure. This latter category is called secondary hypertension. We do however know c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ertain risk factors that increase your risk of developing hypertension. These include modifiable risk factors like obesity, high salt intake, excessive alcohol intake, lack of physical activity and stress. The non-modifiable risk factors include African American race, advancing age and heredity.
High blood pressure is dangerous and often c
High blood pressure is dangerous and often c
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
eeps up without producing any symptoms. It contributes to stroke, heart attacks, kidney failure, heart failure, erectile dysfunction and atherosclerosis. It can also cause blindness. The risk of heart disease and stroke doubles for every 20 mm Hg increase in systolic blood pressure or for every 10 mm Hg increase of diastolic blood pressure.
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
The higher the blood pressure, the greater is the risk of getting complications. This has been repeatedly confirmed by the Framingham Study, which was begun in 1948 and has monitored several thousand people for high blood pressure and cardiovascular events. Recent data suggests that the risk of cardiovascular complications are even elevated
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in people with ‘prehypertension’. The research indicates that the approximately 23 million adults in the U.S. with high-normal blood pressure levels (systolic pressure of 130-139 mmHg and/or a diastolic pressure of 85-89 mmHg) are 1.5 to 2.5 times more likely to have a cardiovascular event or to die within 10 years, compared to those with op
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
imal blood pressure (systolic pressure of less than 120 mmHg and diastolic pressure of less than 80 mmHg).
Hundreds of clinical trials have shown the beneficial effects of lowering blood pressure to acceptable levels. This benefit has been repeatedly confirmed in all ethnic groups, at all ages and in both males and females. Bringing down th
Hundreds of clinical trials have shown the beneficial effects of lowering blood pressure to acceptable levels. This benefit has been repeatedly confirmed in all ethnic groups, at all ages and in both males and females. Bringing down th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e blood pressure to ideal levels reduces the incidence of stroke is by about 40%, heart attack by 25% and heart failure by more than 50%.
"He who cures a disease may be the skillfullest, but he that prevents it is the safest physician." Thomas Fuller. Non-drug lifestyle changes can not only reduce elevated blood pressure but may also preven
"He who cures a disease may be the skillfullest, but he that prevents it is the safest physician." Thomas Fuller. Non-drug lifestyle changes can not only reduce elevated blood pressure but may also preven
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
t or delay the onset of the disease. These include reducing weight to a BMI of 18.5-24.9 kg/m2, adopting a diet rich in fruits, grains, vegetables and low-fat diary products, reducing dietary sodium intake to less than 6 gm sodium chloride per day, engaging in regular physical activity such as brisk walking for 30 minutes most days of the we
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
k, and limiting alcohol consumption to no more than 2 drinks (0.5 oz or 15 mL ethanol; e.g., 12 oz beer, 5 oz wine, or 1.5 oz 80-proof whiskey) a day in men and no more than 1 drink a day in women. Combined, these lifestyle changes can reduce your systolic blood pressure by almost 50 mm Hg.
Pharmacologic treatment is needed if your initial
Pharmacologic treatment is needed if your initial
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
blood pressure is very high, if you have complications or if you do not respond to lifestyle changes. The common classes of drugs used to treat high blood pressure are:
Diuretics are also called water pills. They work by helping your kidneys remove excess water and salt from your body.
Beta blockers help your heart beat slower and with le
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ss force.
Angiotensin converting enzyme (ACE) inhibitors block the production of a hormone called angiotensin II, which normally constricts your arteries and raises the blood pressure.
Angiotensin II receptor blockers (ARBs) protect your blood vessels from angiotensin II. The blood vessels relax and become wider, lowering the blood pressu
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
e.
Calcium channel blockers (CCBs) relax the blood vessels by preventing the calcium from entering the muscle cells of your heart and blood vessels.
Alpha blockers also relax the blood vessels by reducing nerve impulses that constrict blood vessels.
Alpha-beta blockers, besides reducing nerve impulses to blood vessels also slow the he
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
artbeat, as beta blockers do.
Nervous system inhibitors relax blood vessels by controlling constricting nerve impulses from the brain.
Vasodilators directly relax the muscle in the vessel walls.
In 2003 the Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure was publi
In 2003 the Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure was publi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
shed in the Journal of the American Medical Association. Physicians use this as a guide to treat high blood pressure. The initial choice is usually a diuretic. Other drugs are added for further reduction, if needed. If the initial readings are high or if there compelling other risk factors, combination drugs may be used as the first choice.
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ost people need more than one class of medication to adequately control their blood pressure.
“Variability is the law of life, and as no two faces are the same, so no two bodies are alike, and no two individuals react alike and behave alike under the abnormal conditions which we know as disease.“ William Osler (1849 - 1919). You may be on a
“Variability is the law of life, and as no two faces are the same, so no two bodies are alike, and no two individuals react alike and behave alike under the abnormal conditions which we know as disease.“ William Osler (1849 - 1919). You may be on a
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
completely different combination of blood pressure reducing pills compared to someone you know. Your physician is the best judge of what treatment combination is the best for you. Adopt the lifestyle changes, take your medication and monitor your blood pressure regularly, and you will stop the silent killer from taking your life prematurely
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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