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cholesterol

Court Rules That FDA Can Regulate Pharmanex’s Cholestin – (08-28-00)

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Court Rules That FDA Can Regulate Pharmanex’s Cholestin

This battle has been waging for awhile. A natural product derived from red Chinese yeast rice has been shown to lower cholesterol levels. Keep a close eye on this one–it could have major implications on the supplement market if the FDA and the pharmaceuticals win.

NEW YORK, Jul 25 (Reuters Health) – Pharmanex’s cholesterol-fighting formula Cholestin is subject to US Food and Drug Administration (FDA) regulation as a drug product, the 10th US Circuit Court of Appeals ruled on Friday. However, the FDA asserts that Cholestin is a drug because it contains a substance chemically identical to lovastatin, the active ingredient in Merck’s Mevacor, which is an approved prescription therapy for lowering cholesterol. As a drug, Cholestin cannot legally be marketed without an approved New Drug Application, the agency maintains. Pharmanex has argued that mevinolin, the ingredient that the agency equates with lovastatin, is actually a significantly different substance. Mevinolin is naturally occurring, while lovastatin is synthetically isolated, purified and crystallized, according to the company.

ApoB is inhibited by the flavonoids, naringenin and hesperetin – (05-31-01)

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ApoB is inhibited by the flavonoids, naringenin and hesperetin

This japanese sounding title refers to the ability of certain natural compounds found in various fruits, to lower cholesterol levels. Ironically, naringenin is the substance in grapefruit that leads to the recommendation of avoiding it (actually…only about 50% of patients on coumidin get this recommendation…) while on coumidin because of its ability to inhibit phase I detoxification in the liver.

J. Lipid Res. — Abstracts: Wilcox et al. 42 (5): 725

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Statins and risk of polyneuropathy – (05-23-02)

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Statins and risk of polyneuropathy

This article adds more weight to the clinical observation of statin drugs having polyneuropathy as a side effect. A few important things to consider here…the statins lower activity of HMG CoA reductase (one of the enzymes responsible for cholesterol synthesis). They also lower synthesis of CoQ10 at the same time. This is well documented. I’ve always been stumped at this one–CoQ10 is vital for high respiratory tissues such as the heart and skeletal muscle. Hence some of the side effects of the statins are muscle aches. I would guess that the polyneuropathy is also related to reduced CoQ10, which could easily be fixed with supplementation (which any patient on the statins should be put on). The other scary part is recent recommendations that are designed to increase the number of patients that should be on cholesterol lowering meds (three guesses as to who funded THAT study!!). This would increase the side effects we see in this class of drugs.

Neurology — Abstracts: Gaist et al. 58 (9): 1333

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Statin Plus Niacin Brings CAD Progression to A ‘Standstill’ – (12-07-00)

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Statin Plus Niacin Brings CAD Progression to A ‘Standstill’

It’s amazing that a supplement such as niacin, which has been used for decades longer than any cholesterol lowering medication with less side effects, is still relatively unheard of. The levels of niacin used are several grams per day, and only certain companies offer products with these levels. Side effects of niacin can include liver damage, and niacin should be used only under supervision by a practitioner knowledgeable in its use.

(article) The results of trial evaluating combined therapy in patients with coronary artery disease came as a surprise to researchers. Dr. B. Greg Brown, of the University of Washington, Seattle, reported at the American Heart Association meeting here that the combination of a statin to lower LDL cholesterol and niacin to raise HDL cholesterol “halted disease progression essentially to a standstill.” The study was designed to assess the effects of niacin 2 g to 4 g per day, simvastatin 10 mg to 20 mg per day and four antioxidant vitamins — E, C, beta-carotene and selenium — in various combinations. The investigators randomized 160 patients with documented coronary artery disease to one of four treatment arms: niacin plus simvastatin plus vitamins, niacin plus simvastatin plus placebo or placebo. Dr. Brown reported that the combination of niacin and simvastatin resulted in a 70% reduction in clinical events after 3 years of treatment compared with the rate in the rest of the patients. The reduction in events using statins alone is in the range of 25% to 35%, he noted. With simvastatin plus niacin, HDL levels increased 30% over baseline. Dr. Brown pointed out that statins alone increase HDL levels about 7% to 10%. Dr. Brown said that side effects with niacin were not significant, and that 90% of patients on combination therapy were still in the study at the end of 3 years. “With education, you can get virtually all patients to stay on [niacin]…You need to build up doses over a period of 1 to 2 months. Diabetic patients especially have difficulty adjusting.

Very-low–dose niacin on HDL in patients on long-term statin therapy – (06-10-02)

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Very-low–dose niacin on HDL in patients on long-term statin therapy

Remember that niacin is a well established (but hardly used) therapy for hypercholesterolemia. At therapeutic dosages (roughly 2-3 grams/day) the main side effect is skin flushing. This study uses low dose niacin (100 mg/day) to effect HDL levels. How about adding this to a natural approach to lowering overall cholesterol levels instead of statins?

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Use of Niacin in the Prevention and management of Hyperlipidemia – (05-17-01)

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Use of Niacin in the Prevention and management of Hyperlipidemia

With the use of niacin dating back long before the use of many of today’s common meds for high cholesterol levels, it is disappointing that it is not more widely used. This review article address the efficacy and safety of this time-tested treatment for hyperlipidemia. One side effect of niacin therapy, however, is the flushing that comes from the doses needed to achieve a clinical response (usually 1500-3000 mg). I have read that using one baby aspirin 1/2 hour before taking the niacin can de-activate the histamine release and prevent the flushing.

Prog Cardiovasc Nurs 6(1):14-20, 2001 Niacin is an inexpensive drug useful in treating various forms of hyperlipidemia. Cardiac doses of niacin are effective in lowering serum triglyceride, low density lipoprotein, and lipoprotein-a levels and in elevating high density lipoprotein levels. Adverse reactions to niacin are varied and dose-dependent and range from annoying cutaneous flushing to hepatic toxicity. Patients advised to use the drug should be carefully screened and monitored. This paper reviews the pathologic and pharmacologic basis for niacin as an antilipemic agent. The biochemical and physiologic effects of the drug and its mechanisms of action are discussed. Emphasis is placed on the importance of aggressive management of serum lipids and the therapeutic uses of niacin. The use of niacin in primary and secondary prevention of heart disease is stressed. A patient education guide is included. T he current decline in coronary heart disease (CHD) in the U.S. may be attributed more to the prolongation of life among those with existing disease than to a decrease in the absolute number of deaths. Further decline in the CHD death rate will most likely depend upon successful secondary prevention of heart disease. Single or combined drug therapies together with maintenance of a healthy lifestyle are central to successful prevention of recurrent thrombotic events in coronary arteries. Ultimate success in decreasing the incidence of CHD will depend upon primary prevention of new onset of the disease.The combination of lifestyle changes and drug therapy has been shown to be effective in both primary and secondary prevention of CHD. One of the oldest drugs in the CHD armamentarium is nicotinic acid, commonly known as niacin. First used as a hyperlipidemic agent in 1955, niacin is a readily available, inexpensive mainstay of adjunctive therapy for prevention and treatment of CHD. This paper briefly reviews the pathology of hyperlipidemia and discusses the use of plain and immediate-release niacin as well as a new, extended-release form of niacin in secondary and primary prevention of CHD. Emphasis is placed on the clinical impact of the adverse effects of niacin as well as the role of the primary care provider in recommending its use.

Nut Consumption and Decreased Risk of Sudden Cardiac Death – (07-01-02)

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Nut Consumption and Decreased Risk of Sudden Cardiac Death

Somewhere along the line nuts got a bad rap for being fattening and not good for us. Following the “as close to nature as possible” theory, nuts are really a very good food. This article adds to the increasing evidence that nuts are good for the cardiovascular system. Numerous studies already show lowering of cholesterol with nuts such as walnuts, pistachios and almonds. Nut and seed consumption should be a part of every healthy lifestyle.

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Flavonoids in grape juice protect the LDL from becoming oxidized – (12-05-02)

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Comparison of antioxidant effects of Concord grape juice flavonoids & alpha-tocopherol on markers of oxidative stress

While the findings that flavonoids in grape juice have potent antioxidant properties should not drop anyone’s jaw, this is a good time to remind everyone that, while we throw on our blinders and look only at cholesterol as the “bad guy” in CVD, the reality is that LDL cholesterol does not do any damage until the LDL itself gets damaged. The flavonoids in grape juice protect the LDL from becoming oxidized.

AJCN — Abstracts: O’Byrne et al. 76 (6): 1367

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