Advice Pool - Health and Fitness

Previous studies conducted in United States have shown that patients with Type-2 diabetes and high bad cholesterol level are 3 o

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 4 times more likely to die from heart attack or stroke. Watching what to eat and having plenty of exercise are keys to help pe

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

Examples of combination products may in

ple reduce their bad cholesterol level. If one does all these but still fails to reduce the bad cholesterol level, he or she 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.

dvised to seek help from doctors for prescribed medication.

In 2004, the results of a 26-week study released at an internationa

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

meeting of cardiovascular specialists in Spain showed that Crestor (rosuvastatin) is more effective than any other in reducing

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

Combination pro

he bad cholesterol level in patients with Type-2 diabetes. The study compared rosuvastatin with another statin, atorvastatin (av

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

ailable under the brand Lipitor). Earlier studies had also shown that 10 mg of rosuvastatin is more potent than 10 mg of atorvas

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

atin.

Many diabetic patients were aware of their conditions but still had high levels of bad cholesterol. Despite they were tre

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

ted and monitored for diabetes and glucose control, the cholesterol remained outside the desirable range. Perhaps doctors have t

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

be more aggressive in getting all diabetic patients at the desirable cholesterol target with the help of appropriate medication

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

like Crestor.

Crestor is usually prescribed along with diet to lower cholesterol. It is known that taking 10 mg of Crestor alon

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

Following aspects would a

g with diet can actually lower bad cholesterol by up to 52 percent. Meanwhile, it can also raise the good cholesterol level by u

dd to the challenges in developing combination products:

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

to 14 percent. Nevertheless, results may vary among patients.

There is no doubt that lowering of bad cholesterol level and wel

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

-controlled diabetic conditions may help reduce the risk of developing heart disease, Crestor has not been determined to prevent

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

heart disease, heart attacks, or strokes.

Not everyone is suitable to take Crestor. Women who are nursing, pregnant, or who may

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

become pregnant or anyone with liver problems should not use Crestor. In fact, before and during treatment with Crestor, you sho

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

Professional from academic institutions, pharmaceutical industries, health care indust

uld ask your doctor to do blood tests to monitor your liver condition. Patients should inform their doctor if they are taking an

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

medication.

Patients may encounter side effects. Unexplained muscle pain and weakness are considered as a rare but serious sid

.

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

effect. If patients do experience this, they should report to their doctors immediately. Other infrequent side effects such as

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

Companies that provide selfless information through particip

uscle aches, nausea, abdominal pain, constipation and weakness are usually mild and tend to go away after a short period of time

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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Advice Pool - Is Crestor The Magic Treatment For Diabetes?

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