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RP Community› RP Articles› New Treatment Regimen for Patients with RP
| New Treatment Regimen for Patients with RP |
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| Written by Wiggy | |
| 07 December 2009 | |
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September 23, 2004 (Page 1 of 3); Revised March 20, 2007
HARVARD MEDICAL SCHOOL , MASSACHUSETTS EYE & EAR INFIRMARY
In June 1993, we reported in the Archives of Ophthalnology that vitamin A palmitate15,000
In September 2004, the Archives of Ophthalmology has just published two reports that summarize
the results of 8 years of work to evaluate the effects of docosahexaenoic acid (DHA) for adults with typical RP also receiving vitamin A palmitate15,000 Iu/day. The results are complex. The first new report on all participants taken together showed that DHA supplementation by capsules (600 mg twice each day) did not, on average, slow the course of RP over a four-year interval. Therefore, we cannot make any general recommendation for DHA supplementation by capsules for patients already taking vitamin A palmitate. The second new report describes the results in subgroups of the participants. Here l've observed that DHA supplementation did provide a benefit. However, the benefit was limited to the subgroup of patients starting vitamin A palmitate for the first time. ln a comparison among randomized patients in this subgroup, DHA supplementation by capsules slowed the course of RP for two years. In addition, a dietary benefit of omega-3 rich food became evident as stated in the second report. We observed that patients taking vitamin A palmitate (but not on DHA capsules) with a higher omega-3 rich diet iniake (i.e.,equivalent to eating 1 to 2 three-ounce servings per week of omega-3 rich fish, such as salmon, tuna, mackerel, herring, or sardines,which contain among other constituents considerable DHA) had, on average, a 4O to 5O% slower annual rate of loss of visual field than patients with a lower omega-3 rich diet intake. Re: New treatment regimen for RP Page2 of 3, 9/23/04 The results in the second report lead us to offer the following general recommendations. (1) For adults with typical RP already on or who have ever taken vitamin A palmitate 15,000 Iu/day in the past, we advise that they continue vitamin A palmitate and eat 1-2 three-ounce servings per week of omega- 3 rich fish. Including this amount of fish in the diet is consistent with current American Heart Association recommendations. About three months after starting omega-3 rich fish, we advise a measurement of fasting red blood cell (RBC) DHA through their physician to confirm that the RBC DHA level is at least 4% of total RBC fatty acids, as we reported that such patients have, on average, a slower rate of decline of visual field than patients with lower levels. If the RBC DHA level is not at least 4%, we advise patients to consult with their physcian on how best to reach this level through food. lf the level is 4% -7% (no higher or lower), this test could be repeated annually thereafter. (2) For adults with typical RP who plan to start vitamin A palmitate 15,000 lu/day for the first time, the results support the following. If fasting serum vitamimin A and liver function profile are normal, we advise that they take this dose of vitamin A palmitate and also supplement with DHA capsules 600 mg twice each day (i.e., three 200 mg capsules in both the AM and PM with meals) for two years. After two years patients should discontinue DHA supplementation by capsules because no evidence was fould for continued benefit and because a slight tendency toward adversity on ocular function was observed over the longer term among patients concurrently on vitamin A palmitate. After stopping DHA capsules after two years, patients should continue vitamin A palmitate15,000 iu/day and also eat l-2 three-ounce servings of omega-3 rich fish each week. Then, about three months after starting omega,3 rich fish, we advise measurement of fasting RBC DHA as described above. It should be noted that combining an omega-3 rich fish diet wirh DHA capsules did not provide any additional benefit. The Study results reported in the second paper show that the potential benefit of combining vitamin A palmitate with dietary intake of l-2 servings of omega-3 rich fish per week is substantial: the rate of decline of loss of visual field sensitivity was reduced by 40 -50% per year. Therefore, combining vitamin A palmitate with this diet regimen could achieve a gain of almost two decades of visual preservation. For example, we have estimated that an average patient age 37 with typical RP already on vitamin A palmitare15,000 Iu/day who maintains an omega-3 fatty acid food intake of at least 0.2 grams per day (i-e.,equivalent to eating l-2 three ounce servings of omega-3 rich fish per week) would be expected to lose virtually all central visual field sensitivity by age 78, whereas an average patient who eats less than 0.2 grams per day would be expected to lose all central visual field sensirivity by age 59.
Re: New treatment regimen for RP 9/23/04 P. 3 of 3
It should be noted that beta-carotene is not vitrmin A. lt is the precursor of vitamin A, but it is not predictably converted into vitamin A. Therefore beta carotene is not a suitable substitute for vitamin A palmitate in the context of this treatment regimen. Although no toxic side effects have been observed among adults with RP in good general health on vitamin A palmitate15,000 lU per day (Sibulesky et al., Safety of Less Than 25,000 IU Vitamin A Daily in Adults with Retinitis Pigmcntosa, Am J Clin Nutr 69:656-663 1999), we continue to advise that patients obtain a fasting serum vitamin A and liver function profile annually and continue vitamin A palmitate only if these tests are normal. We have observed no toxic side effects among adults with RP in good general health on DHA supplementation by capsules. The results apply to most adult patients with typical RP including those with partial hearing loss. The results do not apply to patients with RP and profound congenital deafness, RP as part of the Bardet-Biedl syndrome,or atypical or rare forms of RP as such parients were not included in this study. Women with RP who are pregnant or planning to be pregnant should not take the combination of vitamin A palmitate and DHA by capsules because high vitamin A intake has been associated with an increased risk of birth defects. We did not study patients under age l8 or patients with best-corrected visual acuity of less than 20/100 in both eyes; therefore, we cannot make any formal recommendation for such patients. Our conclusions are based on group averages and, therefore, we cannot provide assurance that this regimen will benelit a specific patient or that it is appropriate for any particuliar patient. Sources of vitamin A palmitate15,000 lU as well as DHA in 200 mg gelcaps and the procedure for obtaining a RBC DHA level are attached. Please share this informatior with your ophthalmologist and family physician to determine if this regimen is appropriate for you. This treatment regimen should be done only under medical supervision. you are referred to the Archives of Ophthalmology Volume 122, pages l297-1305 and pages 1306-1314, 2004 if you or your doctor wish to review the details of our research. If you still have questions, please write to us at the above letterhead address. EliotL. Berson, M.D. ELB/jbq Attachments:(3) September23, 2004 Attachment I of 3 Known Sources of Vitamin A Palmitate October 2006 Consult with your doctor concerning dose the appropriate before ordering these supplements. Sources of 10,000 lU (for children with RP age 10-15 years old) FREEDA VITAMINS, INC. BRONSON 47-25 34rh Street,3rd Floor 350 South 400 West #102 Long lsland City, NY 11101 Lindon, UT 84042 1-800-777-3737 (outside NY) or 1-800-235-.3200 1-718-433-4337, FAX 1-718-433-4373 100 Tablets $6.95/bottle 250 Soft-gels $6.98/bottle 250Tablets 10.90/bottle Order ltem No. 24 Shipping& Handling 5.25 Shipping & Handling 4.90 Tablets are scored and can be easily halved for a 5,000 lU dosage for children 6-10 years old Sources ol 15,000 lU (for adults with RP) FREEDA VITAMINS, INC. J.R. CARLSON LABOFATORIES, INC 47-25 34th Street, 3rd Floor 15 College Drive Long lsland City, NY 11101 Arlington Heights, lL 60004-1985 1-800-777-3737 (outside NY) or 1-888-234-5656 (outsideChicago) or 1-718-433-4337; FAX 1-718-433-4373 1-847-255-1600 Products #1101 and1102A-Palmitate-15 100 Tablets $6.95/bottle 120 Gel-caps $6.90/bottle 250 Tablets 13.90/bottle 240 Gel-caps 12.90/bottle Shipping & Handling 5.25 Shipping & Handling $5.00 Will ship outside USA for extra postage Will ship outside USA for extra postago Disclalmer: The products described above have not been tested or evaluated to determine their safety or effectiveness in children or adolescents wilh RP. The listing of these suppliers and their products should not be misinterpreted as a recommedation or indication of propietary interest any of these companies. September 23, 2004 Attachment 2 of 3 Known Sources of Neuromins DHA 200mg DHA in a dose of 600 mg twice a day has been recommended for most adult patients with typical retinitis pignentosa who are starting vitamin A palmitate15,000 lU/day for the first time (see Berson et al; Archives of Ophthalmology 122: 1306-1314,2004). Patients with retinitis pigmentosa should consult with their doctor concerning whether DHA is appropriate for them before ordering this supplement. Neuromins(R) DHA 200 was the form of DHA used in this study. Neuromins(R) DHA 200 is available in many health food stores across the country. Brands of Neuromins(R) DHA 200 include Nature's Way, Source Naturals,Solaray, Natrol, and Solgar. The above brands are sold directly to retail stores and clearing houses (two listed below) rather than to individual consumers. However, both Nature's Way (l-800-962-8873 or www.naturesway.com) and Natrol ( l-800-262-8765 or www.natrol.com) will help you locate a local supplier. The dose recommended is 600 mg twice each day (3 in the AM and 3 in the PM with meals) only for 2 years. Therefore, patients ordering Neuromins(R) DHA will be taking six softgels per day. For example,a one-month supply would be 180 softgels and patients should plan accordingly. The following are sources of Neuromins(R) DHA 200 readily acccssible by toll-free phone or via their websites. SWANSON HEALTH PROOUCIS THE VITAMIN SHOPPE P.O. Box 6003 CustomerCare Department Fargo,ND 58108-6003 2101 91st Street 1-800-437-4148 North Bergen, NJ 07047 www.swansonvitatmins.com 1-800-223-1216 (searchNeuromins(R) on the homepage) (searchNeuromins(R) on the homepage) 30 softgels(SWU092) 200mg www.vitaminshoppe.com $12.49/bottle Shipping& Handling 4.95 60 softgels (SR-5558) 200mg Ship abroad for additional fee. $30.80/bottle 120 softgels (SR-5559)200mg $59.98/bottle Shipping and Handling $4.99 Ship abroad with restrictions for added fee Precautions: Please be reminded that DHA supplcmentation in a dose of 600 mg twice a day for adults with typical retinitis pigmentosa (RP) on vitamin A palmitate was reported to be effective for only two years and only in patients starting vitamin A for the first time. The products described above in this dose have not been tested or evaluated to determine their safety or effectiveness in children or adolescents with RP. Stopping instructions: This dose of DHA should not be continued beyond two years because no evidence was found of a continued benefit and also because a slight tendency toward adversity on ocular function was observed over the longer term among patients on vitamin A palmitate 15,000 IU/day (see Archives of Ophthalmology, Volume 122, pages 1306-1314,1004). This supplement in combination with vitamin A palmitare should not be taken by women who are pregnant or planning to become pregnant because of an increased risk of birth defects among women on high dose vitamin A intake. Disclaimer: The listing of these suppliers and their products should not be misinterpreted as a recommendation or indication of proprietary interest in any of these companies. September 23, 2004 Attachment 3 of 3 Revised September17, 2008 PROCEDURE FOR MEDICAL DOCTOR TO OBTAIN A RED BLOOD CELL DOCOSAHEXAENOIC ACID (DHA) LEVEL KIT 1. Patients should fast ovemight. If not feasible, fast at least 4 hors prior to the blood draw. 2. Use a 5 ml EDTA - Lavender top vacutainer tub (Becton Dickenson Catalog # DB 366452 or #DB367863). Collect about 3 ml of blood in an EDTA tube.The tube should be labeled with the PATIENT'S NAME and the DATE THE BLOOD WAS DRAWN. 3. The patient's blood should be packaged in a Specimen Collection Kit provided by the laboratory below only on request from your physician. Your physician should fill in the required information on a Test Requisition Form, available at the website of the laboratory listed below, and request a RBC DHA level which is part of a RBC total lipid fatty acid profile. The goal is to have a fasting RBC DHA level of 4 - 7% of total RBC fatty acids. 4. Send the lavender EDTA tube of whole blood at room temperature by same day courier on the day collected (Mondays through Thusdays only) in a Specimen Collection Kit following kit instructions for packaging and shipping along with the Test Requisition Form to the labontory listed below to arrive within 24 hous after the specimen was drawn via DHL or Federal Express: Send to: Peroxisomal Diseases Labontory Kennedy Krieger Institute 707 North Broadway, Room 530 Baltimore, MD 21205 Tel # 443-923 -2188 Fax # 443-923-2755 www.genetics.kennedykieger.org $185.00 with specimen (pre-pay) A report will be sent within about 1 month. Adults with typical retinitis pigmentosa on vitamin A palmitate15,000 Iu/day and an omega-3 rich diet should strive to have a RBC DHA level of 4% or greater of total RBC fatty acids. If the level is 4% or greater, the level could be rechecked annually. Patients who have not achieved this level should consult with their physician on ways to incrcase their RBC DHA level through food intake and then recheck their level about 3 months after changing their food intake (See Archives of Ophthalmology 122:1306-1314,2004). Disclaimer:The listing of these suppliers and their tests should not be misinterpreted |
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