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The story of Metabolic syndrome and cardiovascular diseases.

In the Beginning, it was only weight gain, which soon turned into Obesity. And it was

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

predominat in the abdomen. There was no problem felt. Life was all fun with rich food, drinks and associated life styles.

Insulin Resistance (Pre-d

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

abetic condition) and increase in blood pressure had joined the chorus,subsequently. Even then, there were no visible symptoms to stop the junk food

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

, drinks and life style. What was not seen and felt was non-existent!

Now, things have dramatically changed.The doctor's report states in no uncer

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ain terms that the individual is affected by Metabolic syndrome, which is a cluster of all the three elements stated above, to create and unleash se

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ious health hazards of cardiovascular diseases, which include heart attack and stroke!

Lessons to learn:

If your waist measurements exceed 36", th

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

e time has come for serious action. You have, without doubt, increased abdominal weight and higher BMI. It MUST be reduced, without further delay.

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

bdominal obesity causes Insulin Resistant conditions,(Pre diabetic) and increases blood pressure. If your fasting sugar levels , blood pressure and

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

lood cholesterol levels increase beyond prescribed levels, the condition points to only one direction- Cardiovascular Disease! The cluster of these

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

elements are known as Metabolic syndrome.

Approximately 47 million people in USA suffer from Metabolic syndrome. Origin of this disease, causing ob

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

sity, are Nutritional Disorders and lack of physical exercises.

All patients diagnosed with this condition should be encouraged to change their sen

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

entary life style habits, diet and exercise habits as primary therapy. Weight loss improves all aspects of the syndrome as well as cause and cardiov

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ascular mortality.

Regular exercise lowers blood pressure and improves lipid levels thus reversing insulin resistant conditions.

Skeletal muscle i

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

the most insulin sensitive tissue in the body and therefore, the primary target for impacting insulin resistance. Physical exercise has a higher im

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

act and must be the major activity to reverse the effect of insulin resistant condition.

Diet

Sustained dietary changes to include adequate micron

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

utrients (Calcium, iron, folate) and to reduce intake of calories. Low fat,low carbohydrate and low sodium diet reduce blood pressure. Increasing di

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

tary fiber lowers the risk of developing cardiovascular disease.

Alcohol consumption is closely associated with elevation of serum triglyceride lev

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ls, and therefore, consumption should be reduced to moderate levels.( 1 drink/day for women and 2 drinks/day for men would be OK )

WARNING!

Men wi

.

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

th all the three factors of this sysndrome viz- abdominal obesity,Insulin resistance and high blood pressure face a real serious risk of heart attac

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

or stoke, which comes without warning!

Give due recognition and respect to your internal body system- Feed them only what they need!

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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E-Articles - Metabolic Syndrome Unleashes Cardiovascular Diseases

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