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Pharmacoeconomic Analysis Examines the Additional Cost to Prevent
Gastrointestinal Side Effects and Complications
Theramine® Lowered C-reactive protein (CRP) in Clinical Trial
Los Angeles, October 23, 2012 – Medical food Theramine® should be the preferred treatment for pain when compared to NSAIDs (non-steroidal anti-inflammatory drugs) in elderly patients 65 years and older, according to a pharmacoeconomic analysis conducted by Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM) published in the May issue of the Journal of Pharmacy Research.
The scientific economic paper, “Theramine (A Medical Food) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis,” examines the additional cost burden of the strategies to prevent gastrointestinal side effects and complications. A PDF of the full pharmacoeconomic analysis can be viewed by visiting http://bit.ly/TheramineVsNSAIDs.
“Non-steroidal anti-inflammatory drugs are the leading cause of drug induced morbidity and mortality in the United States,” said David S. Silver, M.D., corresponding author of the pharmacoeconomic analysis, and executive VP of medical and scientific affairs at Targeted Medical Pharma, Inc., which develops and distributes prescription medical foods to physicians, pharmacies and skilled nursing facilities. “Gastrointestinal hemorrhage is the most common concern when using NSAIDs, along with hypertension, edema, renal complication and cardiovascular risk, all which occur at higher rates in elderly patients. Patients over the age of 65 with concomitant medications and disease states are the most likely to suffer serious consequence side effects of NSAIDs.”
The analysis found that the actual cost of using Theramine is considerably lower when compared to the total impact of NSAIDs. Excluding the treatment for hepatic, renal and cardiovascular side effects, the annual cost of generic NSAIDs per 100 pain and inflammation patients is $241,500, compared to an annual cost of $211,200 per 100 patients using Theramine.
“Theramine is a prescription only medical food that is used to treat fibromyalgia, acute and chronic neuropathic or inflammatory pain without risk of gastrointestinal or other side effects,” added Dr. Silver. “The higher acquisition costs for Theramine are offset by the reduction in side effects and need for testing and other protective medications in patients over the age of sixty-five taking NSAIDs, making Theramine a preferred choice over non-steroidal anti-inflammatory drugs in elderly patients.”
Safety and efficacy data were derived from two large double-blind controlled trials that compared Theramine to low dose naproxen and ibuprofen, as well as other industry published literature. A total of 256 patients across 12 independent sites were randomized for treatment to receive Theramine alone (two capsules twice daily), NSAID or a combination of both. In both studies, Theramine showed statistically significantly greater pain relief than either naproxen at 250mg daily or ibuprofen at 400mg daily. The studies also revealed that Theramine, when administered as a standalone medication and in combination with an NSAID, lowered a statistically significant amount of CRP (C-reactive protein), while an increased CRP level was seen in the naproxen and ibuprofen groups. No side effects from Theramine were reported in the trials and observational reporting after 38,000,000 doses of Theramine showed no gastrointestinal bleeds.
Risk data and rates of gastrointestinal bleeding, morbidity and mortality data were derived from the Medicare database and peer reviewed literature. Medication acquisition costs were determined based on listed average wholesale pricing (AWP). Procedural and hospitalization rates were obtained from the Medicare fee schedule. A cost per life saved analysis was not performed since there is no incremental overall cost increase to the use of Theramine.
“Theramine (A Medical Food) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis.” David S. Silver, M.D.; Elizabeth H. Charuvastra, RN; Lawrence May, M.D.; Stephanie L. Pavlik, CRA; William E. Shell, M.D. Journal of Pharmacy Research (Volume 5, Issue 5); Published online: May 2012.
About Targeted Medical Pharma, Inc.
Targeted Medical Pharma’s medical foods are amino acid based, FDA-regulated medications specially formulated to meet the body’s increased nutritional requirements of disease. They are a safe and effective option for treating pain syndromes, sleep disorders and obesity without harmful side effects. Physician Therapeutics’ medical food products are available by prescription only and must be administered under the ongoing supervision of a physician.
About Targeted Medical Pharma’s Medical Foods
Targeted Medical Pharma, Inc. is a specialty pharmaceutical company that develops and sells prescription medical foods to physicians, pharmacies and skilled nursing facilities for the treatment of chronic disease including pain syndromes, obesity, and sleep and cognitive disorders. Based in Los Angeles, the company’s proprietary pharmaceutical therapeutic systems are sold in the United States and Japan. The company manufactures nine proprietary medical foods, as well as 48 convenience packed kits, which pair a medical food and branded or generic pharmaceutical. These prescription medical food products and therapeutic systems represent a novel approach to the management of certain disease states, focusing on safety and efficacy without the deleterious side effects of traditional, high dose prescription drugs.
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