Microsoft word - drugs and supplements.doc

Treatment of ALS is primarily a process of managing symptoms. As PALS get weaker, their symptoms change, their needs change, and consequently their treatments are always being modified. Treatment involves managing ALS symptoms through drugs, therapies, nutrition, dietary supplements, and adaptive equipment. FDA approved drugs to slow ALS progression Rilutek (available by prescription) is the only drug approved by the Food and Drug Administration for treatment of ALS patients. Two randomized and placebo-controlled trials performed in both Europe and North America found a difference of about 2 to 3 months in the time to tracheostomy or death in favor of patients treated with Rilutek as compared to those receiving placebo. However, there was no statistical significant difference in mortality at the end of the trial. Measures of muscle strength and neurological function did not show improvement. Potential side effects include fatigue, nausea, dizziness, diarrhea, anorexia, vertigo, and somnolence. While the effect of Rilutek is modest, it is a significant development in that is the first ALS drug proven to be effective in over 130 years of research. Because the effect is modest, one must weigh the financial cost versus the benefit when electing to use Rilutek. Rilutek is expensive, over $600 for a 30-day supply, but it is covered under most health insurance policies. The National Organization for Rare Disorders (NORD) may be able to assist you with purchasing Rilutek if you do not have insurance. You can get more information at http://www.rarediseases.org/ Prescription and OTC Drugs for ALS Symptoms Potential Treatment Drugs - Generic (Brand Name) Baclofen (Lioresal), Tizanidine (Zanaflex), Memantine, Tetrazepam, Carisoprodol (Soma), Dantrolene, Marinol Quinine Sulfate, Baclofen (Lioresal), Clonazepam (Klonopin), Carbamazepine (Tegretol), Phenytoin (Dilantin), Magnesium, Verapamil (Calan) Fluoxetine (Prozac), Sertraline (Zoloft), Paroxetine (Paxil), Amitriptylene (Elavil), Imipramine (Tofranil), Nortriptyline (Pamelor), Fluvoxamine (Luvox) Amitriptylene (Elavil), Fluvoxamine (Luvox), Lithium; Guaifenesin, Robitussen, Propranolol (Inderal), Metoprolol (Toprol) Amitriptylene (Elavil), Trihexyphenidyl Hydrochloride (Artane), Clonidine (Catapres), Propantheline (Pro-Banthine), Benztropine (Cogentin), Glycapyrrolate (Robinul), Transdermal Hyoscine (Scopolamine), Benadryl, Atropine (Sal-Tropine) Potential Treatment Drugs - Generic (Brand Name) Bulk-forming fiber laxative (FiberCon, Citrucel, Metamucil, etc.), Docusate Sodium (Correctol, Colace, Dulcolax), Lactulose (Constulose, Duphalac, Chronulac, Constilac) Morphine (Roxanol), Lorazepam (Ativan), Midazolam (Versed) Antioxidants and Supplements Antioxidants - It is thought that antioxidants such as vitamin E, vitamin C, and beta-carotene may protect nerve cells from damage by toxic free radicals. However, the specific benefits of these compounds have not been tested scientifically in patients with ALS. A recent experiment using an animal model shows that adding vitamin E to their food delays onset of clinical disease and slows progression, but does not prolong survival. The Muscular Dystrophy Association gives ALS patients the following dosage recommendations for vitamins A, C, and E: 1,000 mg 3 times a day ( 3 grams daily ) 800 units 3 times a day ( 2,400 units daily ) 10,000 units 3 times a day ( 30,000 units daily ) Foods rich in antioxidants include alfalfa sprouts, beets, blueberries, brussel sprouts, broccoli, garlic, grapes, kale, spinach and strawberries. Foods rich in vitamin C include citrus fruits, green peppers, broccoli, tomatoes and strawberries. Other antioxidants that may be beneficial include coenzyme Q10, grape seed extract, green tea, melatonin, NAC, DHEA, and alpha lipoic acid. Steve Shackel, a PALS, has an excellent website (http://www.goulburn.net.au/~shack/welcome.htm) that describes most anti-oxidents and their possible benefit in treating ALS. Patients should always seek the advice of their physician before making any dietary changes or taking any vitamins or supplements. Experimental Drugs and Supplements The good news about ALS research is that there are a number of drugs and supplements currently being studied. Every ALS patient should consider participating in clinical research trials. All clinical trials have an experimental group and a control group. The experimental group receives the active medication and the control group receives the placebo, a pill with no active medication. Neither the doctor nor the patient knows whether or not they are receiving the active medication or the placebo. This is called a “double blind study.” For more information on drug development and current clinical trials of experimental drugs, call our office. There are a number of drugs and supplements that have shown promise in the treatment of ALS. Most have been studied in mouse trials and have been shown to delay disease onset or increase survival. Clinical trials of most are either planned or underway. Since most of the studies were done on mice, the results cannot be assumed to be the same for humans. Regardless, many ALS patients, who are unable to participate in these trials or are unwilling to wait for them to be completed, are taking these drugs and supplements. This is possible for supplements, since they are available over the counter without a prescription, and for drugs that are FDA approved for another condition, if the patient’s physician is willing to prescribe it “off label”. The experimental drugs and supplements most commonly being taken by ALS patients are listed below. As with any supplement or medication, please consult your physician before trying them. Patients are also encouraged to refer to the sources of information in the Research section for the latest information and study results. Drugs/Supplements Commonly Taken by ALS Patients The following table lists the drugs, supplements and vitamins commonly being taken by ALS patients. It is based on the number of patients reporting taking them for over 6 months as part of the ALS PINpoint Survey of 154 patients as reported May 18, 2002. For more information visit the ALS PINpoint website at http://members.aol.com/alspinpoint/results.html. Research Information on Various Experimental Drugs and Supplements Caution: Many of the research studies reported on below were done on mice, so the results cannot be assumed to be the same for humans with Amyotrophic Lateral Sclerosis. As with any supplement or medication, please consult your physician before trying them. Coenzyme Q-10 - Researchers at Massachusetts General Hospital and Harvard Medical School in Boston have found that coenzyme Q10, a widely available over-the-counter supplement, can combat nerve-cell degeneration in mice with ALS. The study is in the July 21, 1998 issue of Proceedings of the National Academy of Sciences. M. Flint Beal of the Department of Neurology at Massachusetts General and also at Cornell University Medical Center in New York was part of the research team. “I'm not as yet recommending that people with ALS take coenzyme Q10,” Beal said. “In order to make this recommendation, it will be necessary to do a clinical trial. I don't believe it would be harmful, but there is no evidence as yet that it will be beneficial.” Oral coenzyme Q10 significantly prolonged the lives of mice with mutated SOD1 genes and a disorder that closely resembles human ALS (which also sometimes results from mutations in this gene). Coenzyme Q10, even when given by mouth, was found to penetrate into brain tissue in general and into the mitochondria of brain cells. “Both antioxidant effects and preservation of mitochondrial function may contribute to the observed neuroprotection,” the authors say. “Although vitamin E supplementation delays disease onset in [such] mice, it has no effect on survival,” the report continues. “This finding suggests that coenzyme Q10 may be more effective than vitamin E in the treatment of neurodegenerative diseases.” The Eleanor and Lou Gehrig ALS Center at Columbia University conducted a clinical trial of Co-Q10 enzyme in 16 patients with ALS. The study began in spring 1999 and results were released as of July, 2001. The therapeutic benefit of high doses of CO-Q-10 was difficult to assess in an open-label study with a small sample size. However, the positive trends seen in the completers strongly justify a larger double blind study of CoQ10 in ALS. There have been no significant studies that have suggested a recommended dose of CoQ10 for ALS patients. Data gathered from patients by the ALS Therapy Development Foundation, shows the dosage of CoQ10 that they chose was from 100-200mg/day while under the care of their physician. ALS patients are taking up to 600mg per day. CoQ10 is seen as generally well-tolerated, however nausea is cited as the reason for discontinuation. Insomnia and hepatic enzyme elevations have also been noted with higher dosages. It is recommended that CoQ10 be taken with a fatty meal to maximize absorption. CoQ10 is available over the counter at any store selling dietary supplements. Creatine - Researchers have reported that Creatine, an over-the-counter supplement popular as a muscle builder among athletes, works twice as well in diseased mice as the only approved prescription drug available for treating Lou Gehrig's disease. The study,done by researchers at Harvard Medical School and Cornell University Medical College in Manhattan, was reported in March of 1999 in the science journal Nature Medicine. The research studied mice with a genetic mutation that normally leads to the same type of motor neuron destruction as is seen in amyotrophic lateral sclerosis, which is also called Lou Gehrig's disease or ALS. The study found that animals given a diet high in creatine had the same amount of healthy muscle-controlling nerve cells as mice in the control group. The animals on the creatine supplements showed complete protection up to four months, when the disease would normally have begun to take hold, said Dr. Flint Beal, chairman of neurology at Cornell. And the creatine worked twice as well as Riluzole, the only federally approved drug for Lou Gehrig's disease. Unfortunately, two recent large-scale human studies concluded creatine showed no benefit in the treatment of ALS. A study of 175 patients, conducted in the Netherlands and published in the March, 2003 Annals of Neurology, found that creatine provides no significant benefit in humans with the disorder, which is also known as Lou Gehrig's disease. A separate study of 104 patients in the United States was conducted by the Northeast ALS Coalition of ALS Research. They released an official summary on July 28, 2003 after preliminary analysis of thier Creatine study data and stated “The initial analysis of the creatine/ALS clinical trial has been completed. Although further analysis is ongoing, the major results are clear. Creatine was safe and well tolerated, but our trial showed no hint that there was any therapeutic benefit, at the dose used in this study.” Celebrex – Researchers at Johns Hopkins University report that tests of Celebrex in the SOD mouse model have shown that it extends the life of the mouse by approximately 25-30% (Rothstein et al, unpublished data). In addition in rat spinal cord slices that are a model used to measure protection of motor neurons, Celebrex significantly protected neurons against chronic injury by glutamate according to a report in the November, 2000 Annals of Neurology. Celebrex is a cyclooxygenase-2 (COX-2) inhibitor that is FDA approved for the treatment of arthritis. This mechanism results in inhibition of both glutamate release from astrocytes and free radical production. Recent genetic and biochemical studies implicate glutamate excitotoxicity and free radical toxicity in the pathogenesis of sporadic and familial ALS. The active ingredient Celecoxib is a nonsteroidal anti-inflammatory drug (NSAIDS) that specifically targets COX-2. Celebrex is similar in action to Vioxx. Celebrex is a capsule taken by mouth. In general, Celebrex is well tolerated. Possible side effects include gastrointestinal disturbances, kidney problems and allergic reactions. People with known allergic sensitivity to sulfa antibiotics should not take Celebrex. Drug interactions include but are not exclusive to ACE inhibitors corticosteroids diuretics and other nonsteroidal anti-inflammatory drugs. If stomach upset is noted it may be taken with food or milk. Do not take double or extra doses if one is missed. The recommended dosage for Celebrex is from 100mg-200mg orally twice per day. The maximum dose recommended is 400mg twice per day. There is no data at this time that recommends a dosage for ALS patients although current clinical trials are reportedly studying doses up to 800mg per day. Celebrex is available by prescription from your physician. Minocycline - Researchers led by Robert M. Friedlander, M.D., of Brigham and Women's Hospital in Boston, reported study results show the antibiotic minocycline delays onset by several weeks and slows progression of symptoms slightly in a mouse model for ALS. The effect of minocycline on survival in the SOD1 mice was roughly equivalent to that of riluzole. The study results were published in the May 2, 2002 issue of Nature. The researchers also tested the effects of minocycline on neurons in culture and on isolated mitochondria. These studies indicate that minocycline inhibited cell death by preventing release of cytochrome c. Once cytochrome c is in the cytoplasm, it is known to activate the enzyme caspase-3. When activated, the caspase-3 enzyme enables cells -- especially motor neuron cells in the brain -- to commit suicide. Minocycline also significantly inhibited release of cytochrome c in the SOD1 mice. A previous report had shown that release of cytochrome c in spinal cords of these mice correlates with progression of the disease. More evidence about the potential of minocycline as a treatment for ALS is contained in the results of a Canadian study at McGill University of minocycline in an ALS mouse model being published in the June, 2002 issue of Neurobiology of Disease. While the mechanism of how minocycline slowed disease progression was unclear, the McGill study team found the mice fed the minocycline lived substantially longer, had a delayed onset of neuronal and muscle deterioration, and a noticeably reduced inflammation of their brains. “The analysis clearly demonstrates that minocycline delays the onset of neuronal loss and prolongs life in ALS-mice,” says Professor Jean-Pierre Julien, principal investigator of this study. “Minocyline is potentially more effective than other treatments currently available and it has no adverse side effects. Our results clearly indicate that the next step is to commence clinical trials.” Minocycline, a semisynthetic derivative of tetracycline, is an antibiotic used to treat a wide variety of bacterial infections including acne. is a pill, available in 50mg and 100mg capsules, taken by mouth. There have been no significant studies that have suggested a recommended dose for ALS patients. The usual dosage of minocycline capsules prescribed for bacterial infections and acne is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily This medication may cause stomach upset, diarrhea, dizziness, unsteadiness, drowsiness, headache or vomiting. Use of this medication for prolonged or repeated periods may result in a secondary infection (e.g., oral, bladder or vaginal yeast infection). Tamoxifen - Interest in Tamoxifen began when clinicians at the University of Wisconsin-Madison noted that an ALS patient receiving Tamoxifen for breast cancer had an unusually mild form of ALS. Other ALS clinicians have recently informed Dr. Brooks that they may have seen similar rare occurrences. This clinical observation led to laboratory work using a mouse model of motor neuron degeneration. Mice infected with a virus show initial signs of motor neuron degeneration at 28 days post infection. Disease progresses to a moribund condition at 36 days. Treatment of the mice with Tamoxifen delayed onset of symptoms until 36 days, and mice became moribund at 48 days post viral infection. A possible disease mechanism being investigated in this clinical trial is that Tamoxifen is a protein kinase C inhibitor that could produce an anti-glutamate effect. An excess of glutamate is believed to play a role in ALS due to its toxic effect on motor neurons. Rilutek has been demonstrated to have a similar effect on glutamate as is theorized for Tamoxifen. Tamoxifen is a drug that blocks the action of the hormone estrogen. It is used in the treatment of breast cancer. Adverse reactions to tamoxifen citrate are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients. In patients treated with Tamoxifen for metastatic breast cancer, the most frequent adverse reaction is hot flashes. Adverse effects of Tamoxifen seen in some breast cancer patients with long-term high doses of the drug include increased incidence of uterine cancer, stroke and venous thrombosis (blood clots). Tamoxifen is a pill, available in 10mg and 20mg tablets, taken by mouth. For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening).

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Laura Benjamin www.laurabenjamin.tv Cell: (917) 297-8064 [email protected] Freelance Ad Agency Producer Integrated Marketing Experience DraftFCB – AARP/United Health Coca-Cola/Vault Webisode – Agency/Line producer, Publicis Common Health - Novartis Flu Vaccine Heineken/DefJam/MTV Promotional Event – Talent Coor. CMMB – Turning Stone Resort and Casino

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