E-Articles - Health and Fitness

One of the most important things that needs to be done once someone has been diagnosed as having type 2 diabetes, is to get everyone else in the immediate family tested too.

There are tw

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

o very compelling reasons for this suggestion. The first is the strong link between genetics and type 2 diabetes. Concordance studies (which involve identical twins who are brought up in

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

Examples of combination products may in

different family situations) have shown that there is an eighty percent chance of one twin getting type 2 diabetes if the other twin has it. Because the twins are generally brought up in

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

different environments, this risk is independent of lifestyle and dietary factors. It has also been shown that forty-five percent of first-degree relatives of an individual with type 2 di

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

betes will have insulin resistance. (First-degree relatives are defined as siblings, parents and children). And insulin resistance is the underlying cause of type 2 diabetes.

Having said

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

Combination pro

all this, the second reason for screening family members lies in the proven fact that type 2 diabetes is often preventable. And where it is too late to prevent someone from getting type

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

2 diabetes, the onset may be delayed by a significant number of years.

And diabetes is not the only condition to look out for in “diabetic families”. The underlying insulin resistance re

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

sponsible for the diabetic tendencies in these families also causes another, even more dangerous condition: Metabolic Syndrome.

Also known as Syndrome X, or Insulin Resistance Syndrome,

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

his condition is associated with a threefold increase in the risk of coronary heart disease, infarction and stroke. Metabolic syndrome is present in forty percent of people with impaired

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

glucose tolerance, and in a massive seventy percent of people with type 2 diabetes. It often precedes the onset of type 2 diabetes and is thought to be the reason why eighty percent of di

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

abetics die prematurely from cardiovascular disease (especially heart attacks and strokes).

The diagnosis of metabolic syndrome is fairly straightforward, and screening can be done by yo

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

Following aspects would a

ur general practitioner. I am, of course, making the assumption that the person who has already been diagnosed with type 2 diabetes has been tested for metabolic syndrome too. [If not, pl

dd to the challenges in developing combination products:

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

ase ask your doctor to do the relevant tests – this is something that could really prolong your life!]

Besides type 2 diabetes and metabolic syndrome, insulin resistance is also responsi

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

ble for a condition called Polycystic Ovarian Syndrome, or PCOS. This condition affects up to one in ten young women, and is the cause of much unhappiness, especially when it results in

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

infertility.

All of these conditions are important to diagnose, because they can be treated, and in some cases, even cured. Dietary modification and exercise play an extremely important

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

role in the management of insulin resistance and its resultant conditions. However, some problems often need medication. These include high blood pressure and cholesterol abnormalities (w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ich often occur in metabolic syndrome), as well as type 2 diabetes itself. Metformin, an “insulin sensitiser”, plays a vital role in many of the conditions caused by insulin resistance, a

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

s it targets the cause of the problem. It is particularly useful for type 2 diabetes and PCOS.

So if you are ever diagnosed as having type 2 diabetes, and you are quite fond of your fami

.

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

ly, get them screened too. It could mean that they are around for a lot longer!

Dr Guin Van Niekerk is the author of “Why Fat Sticks : An Introduction to Insulin Resistance” For more inf

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

Companies that provide selfless information through particip

ormation on insulin resistance, and a checklist for testing for metabolic syndrome, go to
www.insulinresistancesite.com

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 - Diabetics - Get Your Family Tested!

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