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Category Archives: Hypothyroidism

IPE Kicks Off Phase-2 Clinical Trial for New Hypothyroid Drug

Kingsport, Tennessee (PRWEB) June 12, 2013 Intellectual Property Executives (IPE) announced today that it is now recruiting participants for the second phase of clinical trials for its new T3 drug to treat hypothyroidism, BCT303. BCT303 successfully completed Phase-1 in August 2012 at Georgetown University Hospital. BCT303, classified as a 505(b)(2) drug, is a formulation improvement to the active ingredient Liothyronine Sodium, which is already approved by the Food and Drug Administration (FDA). BCT303 utilizes IPEs patent-pending platform technology for sustained effects and improved stability. IPE utilized the same platform technology to formulate its T4 drug candidate, BCT304, and its Reverse-T3 drug candidate, BCT305, both of which are ready for IND submission. It has also identified additional 505(b)(2) applications, including treatments for pain-relief and anti-inflammation. The purpose of this Phase-2 study is to test the efficacy of BCT303, a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial. Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or “half-life” of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels. This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax. The investigators believe that in patients with hypothyroidism use of Thyromax in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy. Visit http://ipeamerica.com/bct303-clinical-trials to learn more about the Phase-2 clinical trial. ABOUT IPE: Intellectual Property Executives (IPE) is a pharmaceutical technology discovery and development corporation located in Kingsport, Tennessee, USA. For more info on IPEs portfolio of patented technology and pipeline of drug candidates, go to http://www.ipeamerica.com. Continue reading



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IPE Kicks Off Phase-2 Clinical Trial for New Hypothyroid Drug

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Sofia Vergara talks about thyroid cancer diagnosis, living with hypothyroidism

The vivacious star of Modern Family, Sofia Vergara, opened up about being diagnosed with cancer 10 years ago and how she adjusted her lifestyle to deal with hypothyroidism. Vergara sat down with The Huffington Post to talk about the scary diagnosis she received back in 2000. I was 28 years old, my son was really young so it was really scary, you know, when they tell you the word cancer. Of course it brought me down to earth to realize the important things. Vergara went through radiation treatments and had her thyroid removed to get rid of the cancer, but now she lives with hypothyroidism a condition in which the thyroid gland fails to release the hormones needed to regulate vital body functions. This forced the actress to be more diligent about her health. Vergara must take a pill every day to replace those necessary hormones. She also goes for a check-up every 3-6 months for blood tests. Vergara said, I started taking more care of my body, to be more healthyI believe its all about taking control of it [hypothyroidism]. In April, Vergara also talked with FOX News about her involvement with the awareness campaign, Follow the Script. Vergara told her personal story of how, at the time she was diagnosed, information about the thyroid and hypothyroidism wasnt as readily available as it is today. Follow the Script provides overwhelmed patients with a wealth of knowledge, tips, and procedures to handle hypothyroidism. It also provides a place for people to connect and share their stories. Vergara said about her proactive lifestyle, You realize that no matter how much beauty, money, success you have if you dont have health, you have nothing, because you cant do anything. Continue reading



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Sofia Vergara talks about thyroid cancer diagnosis, living with hypothyroidism

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Animal thyroid extract as effective as T4 in treating hypothyroidism

Public release date: 17-Jun-2013 [ | E-mail | Share ] Contact: Aaron Lohr alohr@endocrine.org 240-482-1380 The Endocrine Society San Francisco, CA Desiccated thyroid extract (DTE), derived from crushed preparations of animal thyroid glands, is a safe and effective alternative to standard T4 therapy in hypothyroid patients, a new study finds. The results will be presented Monday at The Endocrine Society’s 95th Annual Meeting in San Francisco. In adults, untreated hypothyroidism leads to poor mental and physical performance. It also can cause high blood cholesterol levels that can lead to heart disease. The condition is treated with Levothyroxine, a synthetic (laboratory-made) form of T4 that is identical to the T4 the thyroid naturally makes. Before the advent of synthetic thyroxine, patients with hypothyroidism were treated with DTE, which contains both T4 and the active thyroid hormone T3. Many patients claim they do not feel as well on T4 alone without the additional T3 hormone. “While thyroid experts recommend T4 alone for treatment of hypothyroidism, until now there have not been any randomized double-blind studies to compare the clinical effectiveness of synthetic T4 with DTE,” said Thanh Hoang, of the Naval Medical Center in Portsmouth, Virginia. “We found that DTE is a safe and effective alternative to the standard T4 therapy. Furthermore, DTE caused modest weight loss compared to T4 alone.” In this study, researchers investigated the effectiveness of DTE compared to Levothyroxine (L-T4) in 70 hypothyroid patients. Patients were randomized to either DTE or L-T4 for 16 weeks and then crossed-over for the same duration. Study subjects underwent biochemical and neurocognitive tests along with measurements of symptoms and mental health at baseline and at the end of each treatment period. DTE therapy did not result in a significant improvement in quality of life, but did cause modest weight loss and nearly half of the study patients expressed preference for DTE over L-T4. “Providers may now have an additional option for the treatment of hypothyroidism in patients who are not satisfied with standard T4 therapy,” said Hoang. “DTE could be considered for hypothyroid patients who still have symptoms despite normal thyroid blood tests while on T4 therapy.” ### Continue reading



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Animal thyroid extract as effective as T4 in treating hypothyroidism

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New Data Highlight Use of Tirosint® (levothyroxine sodium) Capsules in Patients with T4 Malabsorption Due to Gastric …

CRANFORD, N.J., June 20, 2013 /PRNewswire/ –Akrimax Pharmaceuticals, LLC, a privately-held, innovative specialty pharmaceutical company, today announced data that show a lower dose of Tirosint (levothyroxine sodium) capsules is required as compared with standard T4 tablets for hypothyroidism patients with impaired gastric acid secretion to reach their target thyroid-stimulating hormone (TSH) levels. The American Association of Clinical Endocrinologist (AACE) Guidelines for Clinical Practice for Evaluation and Treatment of Hypothyroidism call for physicians to treat hypothyroidism with oral levothyroxine replacement therapy. Careful dose titration and monitoring is necessary in order to maintain a euthyroid state, while avoiding adverse events due to overtreatment.1 TSH levels in patients receiving levothyroxine should be no more than 4.0 mU/L.2 Azeez Farooki, MD, Assistant Attending Physician, Endocrinology Service, Memorial Sloan-Kettering Cancer Center, said, “Dose titration can be cumbersome for patients with hypothyroidism who suffer from gastrointestinal disorders like H.pylori infection, lactose intolerance or celiac disease. These patients often require higher doses of T4 due to malabsorption issues. Such patients may endure frequent dose changing and lab tests, which is less than ideal. These data are encouraging because they suggest that, in many patients with malabsorptive disorders, Tirosint improves upon the absorption of traditional levothyroxine (T4) tablets.” The pilot study examined patients who had T4 malabsorption and were in T4 treatment for more than 5 years with the same brand of tablets. A total of 36 patients met the study criteria, and 30 (28 females / 2 males; median age=51 years; median T4 dose=2.05 mg/kg/day) completed the study. T4 treatment was switched from the usual tablets to a lower dose of the softgel T4 capsules (median T4 dose=1.77 mg/kg/day; p=0.0082). Thyroid function and TSH were measured before and after 3, 6, 12 and 18 months from the treatment switch. A slight serum TSH increase was observed in some patients after 3 months of treatment, with no change in Free T4 (FT4) levels. After 6 months, however, despite the reduced dose of T4, mean TSH values were similar (1.82 vs. 1.86 mU/l) in about two out of three patients (responders n=21) and so remained until the end of the study. In all of the remaining patients (non-responders n=9), TSH levels were significantly higher than baseline values throughout the study. In 4 of them, additional intestinal disorders were detected. Mean levels of FT4 and FT3 were in the normal range and not significantly modified throughout the study. These findings were recently presented during an oral session at ENDO 2013, the Endocrine Society’s 95th Annual Meeting, in San Francisco, CA. The abstract is available on the ENDO web site: https://endo.confex.com/endo/2013endo/webprogram/Paper6139.html. About Hypothyroidism Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism.3 Up to 13 million Americans have undiagnosed hypothyroidism.4 The condition is most common in women over 40 years of age and in the elderly of both sexes.3 The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, cold intolerance, coarse hair, dry skin, weight gain, delayed return phase of reflexes, and constipation.1, 5 Laboratory tests (TSH, FT3 and FT4) are the most common way hypothyroidism is detected. Treatment with levothyroxine sodium oral tablets is the standard of care in hypothyroidism. Studies in women taking levothyroxine sodium during pregnancy have not shown an increased risk of congenital abnormalities. Therefore, the possibility of fetal harm appears remote. Tirosint should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.6 About Tirosint (levothyroxine sodium) capsules Continue reading



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New Data Highlight Use of Tirosint® (levothyroxine sodium) Capsules in Patients with T4 Malabsorption Due to Gastric ...

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Mild hypothyroidism raises mortality risk among heart failure patients

Public release date: 22-May-2013 [ | E-mail | Share ] Contact: Jenni Glenn Gingery jgingery@endo-society.org 301-941-0240 The Endocrine Society Chevy Chase, MDPatients with underlying heart failure are more likely to experience adverse outcomes from mild hypothyroidism, according to a recent study accepted for publication in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM). Hypothyroidism occurs when an underactive thyroid does not produce enough hormones. More than 9.5 million people nationwide have hypothyroidism. People who have thyroid function at the low end of the normal range have subclinical hypothyroidism, also called mild hypothyroidism. “Our data suggest that mild hypothyroidism may, in fact, be harmful in specific populations, including people with heart failure,” said Connie Rhee, MD, MSc, of Brigham and Women’s Hospital in Boston. “A ‘one-size-fits-all’ approach may not be appropriate for assessing risk and determining whether treatment is required for subclinical hypothyroidism.” The retrospective cohort study used data from 14,130 participants in the Third National Health and Nutrition Examination Survey. Using laboratory data, researchers identified 749 participants with hypothyroidism, including 691 with the subclinical form. Researchers found the condition can have varying impacts on diverse racial and ethnic groups. “This study is the first to show that African-Americans who have hypothyroidism face a greater risk of death than patients of other racial and ethnic groups,” Rhee said. “This elevated risk exists despite the fact that hypothyroidism is less common in the African-American population compared to other groups. More research is needed to confirm these findings and to determine the underlying reasons why hypothyroidism has a differential impact on people of different race and ethnicity.” ### Other researchers working on the study include: G. Curhan, MD, ScM; E. Alexander, MD; I. Bhan, MD, MPH; and S. Brunelli, MD, MSCE of Harvard Medical School. Continue reading



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Mild hypothyroidism raises mortality risk among heart failure patients

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