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

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