I Advice - Health and Fitness

Heart disease treatment has made great strides in the past 50 years. Not only has there been an increase in information about risks, symptoms, and causes. There has also been an increase in the number of treatment options available for vario

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

us types of heart disease.

One treatment we now have for many coronary heart disease patients is the stent. Questions remain about the stent, though.

1. Are stents effective in heart disease?

2. Are stents effective in heart disease long

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

Examples of combination products may in

erm?

3. Are stents more effective in heart disease than other treatments?

What a Stent Is

A stent is a tiny tube made of wire metal mesh. This tube is inserted into a partially blocked artery to prop it open and allow blood to flow

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

more freely.

How a Stent Is Inserted

Surgery is not needed to insert a stent for heart disease. A stent is usually placed during angioplasty. In angioplasty without a stent, a small balloon at the tip of a catheter is inserted into

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

n artery (usually in the groin) and inflated to force open a blocked area inside the artery. If the physician believes the balloon is insufficient, and a stent is needed, the stent is collapsed to a small diameter and put over the balloon ca

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

Combination pro

theter. The doctor then moves the stent and balloon up the artery to the blocked section. The balloon is inflated, and as it inflates, it makes the stent expand. The expanded stent is locked in place, and forms a supportive framework that ho

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

ds the artery open. The balloon and catheter are removed.

Time a Stent Remains in Place

A stent is permanent. It is intended to remain in the artery, holding it open. The expectation is that it will improve blood flow to the heart a

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

d relieve heart disease symptoms for years.

Over those years, though, are stents effective in heart disease treatment? Or do they present potential problems?

Effectiveness of Stents

Within a few weeks of the time a stent is inserte

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

, the artery's inner lining begins to grow over the metal surface of the tiny tube. This growth tends to block the artery again. Additional plaque may also build. When this happens, the artery closes at the same place, and heart disease symp

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

toms return. The most notable symptom is probably chest pain.

In an effort to avoid this growth, pharmaceutical companies developed a new stent to replace the bare metal stent. The new stent is coated with drugs that release slowly. The dru

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

s help keep the artery from closing again. In either case, the patient must take anti-clotting medications, but it is hoped that the newer stents may be effective long term.

Stents Versus Other Treatments

The final question is, of c

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

Following aspects would a

urse: are stents more effective in heart disease than other treatments? Many prescription medications have been developed for the treatment of coronary heart disease. Suppose a patient opted to forego the stent and rely solely on medications

dd to the challenges in developing combination products:

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

What then?

A landmark study published in March 2007 showed that, after 5 years, heart disease patients who had stable angina, and were treated only with prescription medications and aspirin, did just as well as those who had a stent placed

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

in an affected artery. They survived at the same rate. Those with stent placement had more immediate relief from angina pain, but that playing field leveled over time.

The study discovered that more than half of heart disease patients who

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

et angioplasties - 1 million plus annually - have stable heart disease. That means they would do just as well with medications as they would with stents. The authors of the study said that as many as 85 percent of all stents placed are unnec

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

ssary. In the U.S., the cost per patient of placing unnecessary stents is between $30,000 and $40,000.

Stents are effective in heart disease treatment, but medication is just as effective in patients with stable angina.

The Decision Mak

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

Professional from academic institutions, pharmaceutical industries, health care indust

r

The decision maker is usually an interventional cardiologist. An interventional cardiologist is the one who performs angiography, the most prevalent test to see if an artery is blocked. He or she will require the patient's written per

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

mission, prior to angiography, to insert a stent immediately if blockage is found. In other words, the interventional cardiologist will be the decision maker for the heart disease patient.

The patient has no opportunity to discuss the sever

.

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

ty of the blockage or the possibility of treatment other than a stent. Unfortunately, interventional cardiologists are showing signs of reluctance to give up stents. The patient will have to make a firm decision before angiography, and withh

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

Companies that provide selfless information through particip

ld permission if treatment with medication is preferred.

Disclaimer: The author is not a physician, and shares this research for educational purposes only. Please ask your physician about whether stents are effective in heart disease

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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