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If you have high cholesterol, the American Heart Association’s low-cholesterol, low-saturated fat diet will fail you. Even when applied conscientiously, it achieves a disappointingly modest reduction in LDL cholesterol of approximately 7%. Starting at an LDL cholesterol of

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

150 mg/dl, for instance, you would drop to 139. It’s no surprise that many people turn to alternative diets (Ornish, Pritikin, Zone, etc.) to get a bigger bang. And no surprise that many physicians go directly to statin agents for their nearly effortless 35% or greater redu

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

Examples of combination products may in

ction.

The Adult Treatment Panel-III (ATP-III) is a committee of experts charged with developing guidelines for cholesterol treatment for Americans. The latest ATP guidelines suggest the use of fibers for a nutritional advantage in lowering cholesterol. Despite the ATP-III

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

’s endorsement, however, there has been no ”real-world” data that documents the LDL-lowering effectiveness of combinations of fibers and other foods added to an AHA Step II low-fat diet (fat 30% of calories). Dr. David Jenkins from the Clinical Nutrition & Risk Factor Modif

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

ication Center at St Michael's Hospital, Toronto has therefore explored such a multi-ingredient program, reported in the Journal of the American Medicine Association1. He calls this program the “dietary portfolio,” highlighting the inclusion of several different healthy foo

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

Combination pro

s combined to achieve the goal of lowering cholesterol.

The study enrolled 46 adults (25 men, 21 post-menopausal women) with a mean age of 59 years. All participants were free of known heart disease, diabetes, and none were taking any cholesterol-lowering agents. Baseline

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

LDL cholesterol was 171 mg/dl for all participants. Three groups were designated: 1) Viscous fiber, phytosterols, and almond diet, the so-called “dietary portfolio”; 2) Control diet (AHA Step II); and 3) Control diet with lovastatin 20 mg/day (a cholesterol-lowering statin

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

drug). Cholesterol panels were reassessed after a four week period in each arm. All diets had equal calorie content.

The dietary portfolio provided 1.0 g of phytosterols (a soy bean derivative) per 1000 kcal; 9.8 g viscous fibers (as oat bran and oat products, barley, and

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

psyllium seed) per 1000 kcal; 21.4 g soy protein per 1000 kcal; and 14 g (around 12 almonds) per 1000 kcal. A typical 2400 kcal diet would therefore provide 2.4 g phytosterols (2 tbsp Take Control or Benecol), 24 g viscous fiber, 51 g soy protein, and 34 g of almonds (aroun

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

d 34 almonds). Average fiber intake for participants was an impressive 78 g/day. (The average American takes in a meager 14 g/day.)

The control diet was also abundant in fiber at 57 g/day, but contained little of the viscous variety, as the primary fiber sources were whole

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

wheat products which lack viscous fibers. The diet was otherwise very similar to the dietary portfolio in fat and cholesterol content, protein, and total calories.

The dietary portfolio achieved an impressive 28% reduction in LDL cholesterol. Unexpectedly, there was also a

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

Following aspects would a

30% reduction in C-reactive protein (CRP), a popular measure of inflammation. The results achieved with the dietary portfolio were virtually identical to the results obtained with lovastatin. The control diet achieved a paltry 8% reduction in LDL and a 10% reduction in CRP

dd to the challenges in developing combination products:

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

. Interestingly, a third of the participants in the dietary portfolio group reported that there was too much food (given the satiety-effect of fiber rich foods). This was the group that lost the most weight, though only a modest 1 lb.

Conclusion:

Dr. Jenkins’ portfolio of

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

fiber-rich foods had the same effects on LDL cholesterol and CRP as a moderate dose of lovastatin. This is quite remarkable, given the relative failure of the diets usually prescribed to improve cholesterol values. Conventional diets, in fact, have been so ineffective that

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

some physicians have abandoned the use of dietary recommendations in their practices.

The fiber-rich foods used in the dietary portfolio are readily available and inexpensive. Though the specific components used in the study have each been shown to lower LDL cholesterol w

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

en used independently, the combination has not been examined. Many would likely have predicted that, in view of the similar mechanisms of LDL-reduction among the various components of the portfolio, the LDL lowering effect would not exceed 15%. (Soy protein is the only comp

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

Professional from academic institutions, pharmaceutical industries, health care indust

onent with a significantly different mechanism of action—suppression of liver synthesis of cholesterol.)

Instead, this powerful combination achieved an impressive 28% reduction, as good as the prescription agent lovastatin. (In our experience with this approach, LDL choles

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

terol typically drops 30 to 50 points, sometimes more.)

The high-fiber approach of the dietary portfolio significantly exceeds the fiber intake of the average American. As a practical matter, people who elect to follow this program should introduce each component gradually

.

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

and drink plentiful water, as constipation can result if hydration in inadequate.

To reproduce the LDL and CRP benefits of the dietary portfolio, a practical combination would be:

• Oat bran—1/4 cup (uncooked) + 3 tsp psyllium seed
• Soy protein powder—6 tbsp/day

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

Companies that provide selfless information through particip

> • Almonds—34 or approximately 2 handfuls/day
• Take Control or Benecol 2 tbsp/day

Jenkins DJA, Kendall CWC, Marchie A, et al. Effects of a dietary portfolio of cholesterol-lowering foods vs. lovastatin on serum lipids and c-reactive protein. JAMA. 2003 290:502-10

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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