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E-Articles - Obesity Paradox- Excess Body Fat Helps in Heart Failure Recovery
We have all known for a fact, and for some time now that obesity is one of the risk factors for developing heart disease and heart failure.
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
We have also in the last few decades been very upbeat, to say the least, in encouraging weight loss.
Particularly, BMI or Body Mass Index h
Particularly, BMI or Body Mass Index h
; 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
as been used to show increasing risk for heart condition as it increases. BMI is a number that indicates the extent of body fat in an indivi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
dual. A higher BMI has often, if not always, been associated with adverse outcome; until now.
Evidently, the excess body fat may cause hear
Evidently, the excess body fat may cause hear
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
failure, but it also helps one recover better. There are indications that the obese fare better after heart failure compared to their healt
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hy counterparts. This is according to a study by Dr. Gregg C. Fonarow of the David Geffen School of Medicine at the University of California
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
at Los Angeles U.S.A and colleagues. This study has been backed up by another led by Dr. Jeptha P. Curtis of Department of Medicine section
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
of cardiovascular medicine, Yale University School of Medicine.
Both studies came to the counter-institute conclusion that higher BMI is w
Both studies came to the counter-institute conclusion that higher BMI is w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ll associated with lower mortality risk. Overweight and obese patients had lower risks of death in case of a heart failure compared to healt
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
hy and underweight individuals.
Fonarow tries to explain this unusual finding, "the study suggest that overweight and obese patents may hav
Fonarow tries to explain this unusual finding, "the study suggest that overweight and obese patents may hav
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e greater metabolic reserves to call upon during an accuse heart failure episode which may lessen in-hospital mortality risks"
The studies
The studies
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
found that in-hospital mortality rate in patients that had heart failure reduced as their BMI increased. Mortality rate in the hospital was
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
ighest at 6.3 percent for underweight 4.6 percent for healthy weight, 3.4 percent for the overweight and only 2.4 percent for obese patients
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
.
The studies seem to point to the existence of what has now come to be know as the "obesity paradox". Many researchers and doctors are stu
The studies seem to point to the existence of what has now come to be know as the "obesity paradox". Many researchers and doctors are stu
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
mped y the phenomena, but not everyone is buying into the paradox. A. Habbu and colleagues at the University of Texas School of Public healt
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
h Huston think the obesity paradox may be a bunch of baloney. They comment on one of the studies, "closer examination of these studies raise
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
important questions on the validity of the paradox". They have issue with the quality of data used in the studies implying they could be in
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
herently skewed.
But whether the obesity paradox exists or not, these is not doubt you still need to lose excess weight. Remember although
But whether the obesity paradox exists or not, these is not doubt you still need to lose excess weight. Remember although
.
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
excess weight may help you recover from heart failure; it is the one that increased your chances of the heart failure in the first place. So
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
having to make a choice between successful recovery from a heart failure and not having any heart failure, we suggest you choose the latter
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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