WASHINGTON (Sept. 30, 2014) -- Levothyroxine is considered the gold standard therapy for an underactive thyroid gland (hypothyroidism), and a new review of therapies for the condition -- including combining levothyroxine with another agent -- has not altered that assessment, say a team of investigators. 1Their analysis, published as a set of guidelines in the journal Thyroid, finds insufficient consistent data exist to recommend a change in use of levothyroxine -- whether generic, or sold under various trade names, such as Synthroid® -- as the only drug needed to treat hypothyroidism.
"Levothyroxine has been seen as a miracle drug that reverses symptoms of hypothyroidism in most individuals," says the guidelines study lead author Jacqueline Jonklaas, MD, PhD, an associate professor at Georgetown University Medical Center and a specialist in treating thyroid diseases at MedStar Georgetown University Hospital.
The American Thyroid Association asked Jonklaas and 10 other researchers from three countries to review existing data and prepare the new hypothyroidism treatment guidelines. Jonklaas served as clinical chair of the task force.
Hypothyroidism is common and is believed to affect up to 5 percent of the American population -- mostly middle-aged women, says Jonklaas. In the U.S. population, the disorder stems from an errant autoimmune response, but worldwide it is more likely to be due to iodine deficiency, she says.
Levothyroxine, developed in the 1950s, has been thoroughly tested and found to be very effective, Jonklaas says. Proper functioning of the thyroid involves two hormones, thyroxine (T4), and triiodothyronine (T3). Levothyroxine is a synthetic form of T4, which is then converted to T3 inside the body.
But because some patients have felt that the drug did not completely restore their health, a synthetic T3 preparation, that has already been developed and approved, is sometimes added to levothyroxine. Unlike levothyroxine, this T3 agent must be taken more than once a day.
The guidelines considered the preclinical and clinical evidence backing use of a T3 agent in combination with levothyroxine and found the data to be insufficient. "The studies were performed in many different ways, had some inconsistent findings, and none looked at use of a T3 agent for an extended period, which is necessary in order to uncover side effects," Jonklaas says. "Given that additional studies are needed, the task force did not feel that combination therapy should be recommended for routine use.
"All in all, our guidelines offer reassurance to physicians and their patients," she says. "No changes are needed in the current standard of care for hypothyroidism in the majority of patients."
Co-authors include Anthony Bianco, MD, PhD, and Brian Kim, MD, from Rush University Medical Center; Andrew Bauer, MD, from Children's Hospital of Philadelphia; Kenneth Burman, MD, from MedStar Washington Hospital Center; Anne Cappola, MD, from the University of Pennsylvania School of Medicine; Francesco Celi, MD, from Virginia Commonwealth University School of Medicine; David Cooper, MD, from Johns Hopkins University School of Medicine; Robin Peeters, MD, PhD, from Erasmus Medical Center in Rotterdam; M. Sarah Rosenthal, PhD, from the University of Kentucky College of Medicine; and Anna Sawka, MD, PhD, from University Health Network and University of Toronto in Canada.
Jonklaas is supported in part by grants from the National Institutes of Health (UL1TR000101 and R01AG033867).
About Georgetown University Medical Center
About Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health.