Armour Thyroid vs Synthetic T4 for Hypothyroidism
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: AbbVie
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.
Do I have to stop taking my current medications?The trial requires you to stay on your current synthetic T4 medication at a stable dose to determine dose conversion to Armour Thyroid.
Is the drug Armour Thyroid a promising treatment for hypothyroidism?Yes, Armour Thyroid, which is a natural desiccated thyroid drug, shows promise for people with hypothyroidism who do not respond well to the usual synthetic treatment. It may improve quality of life and reduce thyroid symptoms for these individuals.2351011
What safety data exists for Armour Thyroid and similar treatments for hypothyroidism?Existing safety data for Armour Thyroid and similar natural desiccated thyroid (NDT) treatments indicate that they are used for patients unresponsive to levothyroxine. A study showed no difference in thyroid-stimulating hormone (TSH) stability between NDT and synthetic levothyroxine over three years, suggesting similar safety profiles in terms of maintaining TSH levels. However, specific safety concerns or adverse events related to NDT were not detailed in the provided studies.678910
What data supports the idea that Armour Thyroid vs Synthetic T4 for Hypothyroidism is an effective treatment?The available research shows that some people with hypothyroidism who do not respond well to synthetic T4, like levothyroxine, may experience improved quality of life and reduced thyroid symptoms when switching to Armour Thyroid, which is a natural desiccated thyroid (NDT). Additionally, some studies indicate that patients may prefer a combination of T4 and T3, which is found in Armour Thyroid, over synthetic T4 alone. However, it's important to note that this preference does not necessarily mean it is more effective for everyone, as the evidence is mixed and some studies consider it experimental.1451012
Eligibility Criteria
This trial is for adults with primary hypothyroidism who have been stable on synthetic T4 therapy for at least a year. Participants must have had their thyroid condition diagnosed over 12 months ago and show consistent in-range thyroid-stimulating hormone (TSH) levels.Inclusion Criteria
I am taking a stable dose of synthetic thyroid hormone (T4) of at least 25 mcg daily.
Exclusion Criteria
I am allergic to Armour Thyroid or its ingredients, synthetic T4, other thyroid meds, or pork.
Treatment Details
The study compares Armour Thyroid, a natural desiccated thyroid medication, to synthetic T4 (Levothyroxine) in treating hypothyroidism. It will assess the safety and effectiveness of switching from synthetic T4 to Armour Thyroid.
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment2 Interventions
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Group II: Group 1Experimental Treatment1 Intervention
Participants will receive Armour Thyroid for up to 81 weeks.
Armour Thyroid is already approved in United States for the following indications:
🇺🇸 Approved in United States as Armour Thyroid for:
- Hypothyroidism
- Thyroid nodules and goiters
- Thyroid cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Endocrine Research Solutions /ID# 256784Roswell, GA
East Coast Research - Jacksonville /ID# 256971Jacksonville, FL
Palm Research Center /ID# 256131Las Vegas, NV
West Broadway Clinic /ID# 256756Council Bluffs, IA
More Trial Locations
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Who is running the clinical trial?
AbbVieLead Sponsor
References
[The use of immunoregulator preparations in the combined treatment of idiopathic hypothyroidism]. [2006]A comparative analysis of idiopathic hypothyroidism (IHT) outcomes in different therapeutic regimens which incorporated or did not incorporate splenin and sodium nucleinate showed more frequent disease exacerbations in patients who received no immunoactive drugs. Combined therapy reduced the number of patients with decompensation 3.7-fold. Stable IHT compensation was achieved in those patients who had received adjuvant splenin in 80.8% of cases, sodium nucleinate in 86.2% against a 40.9% response rate under conventional replacement therapy with thyreoidin.
[Randomized, double-blind crossover study of bioavailability of levothyroxine]. [2019]The synthetic thyroid hormone levothyroxine-sodium (LT4) is still the treatment of choice to replace thyroid hormone deficiency in hypothyroidism, and for adjuvant treatment of euthyroid goiter. A change of LT4 preparations during treatment may lead to major changes of thyroid hormone levels. In this study, we compared the bioavailability of two LT4 preparations, L-Thyroxin Henning 100 and Eferox 100.
Atypical celiac disease as cause of increased need for thyroxine: a systematic study. [2022]Replacement T4 dose in hypothyroid patients bearing both chronic autoimmune thyroiditis and atypical celiac disease (CD) has been analyzed.
Treating Hypothyroidism with Thyroxine/Triiodothyronine Combination Therapy in Denmark: Following Guidelines or Following Trends? [2022]Five to ten percent of patients with hypothyroidism describe persistent symptoms despite being biochemically well regulated on levothyroxine (L-T4). Thyroxine (T4)/triiodothyronine (T3) combination therapy [L-T4/liothyronine (L-T3) or desiccated thyroid] are still regarded as experimental with no evidence of superior effect on persistent symptoms according to meta-analyses. However, some randomized controlled trials have demonstrated patients' preference for T4/T3 combination therapy as compared to L-T4 monotherapy. In 2013, attention to combination therapy increased in Denmark after a patient published a book describing her experiences with hypothyroidism and treatment.
Hypothyroid Patients Encoding Combined MCT10 and DIO2 Gene Polymorphisms May Prefer L-T3 + L-T4 Combination Treatment - Data Using a Blind, Randomized, Clinical Study. [2022]In previous studies, around half of all hypothyroid patients preferred levo-thyroxine (L-T4) + levo-triiodothyronine (L-T3) combination therapy, 25% preferred T4, and 25% had no preference. The reason for this is yet to be explored.
Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution. [2023]Oral levothyroxine (LT4) is the standard therapy for patients with hypothyroidism. Oral LT4 is available in several formulations, including tablets, soft gel capsules and oral solution. Multiple brand-name and generic LT4 tablets are available. In the US, the Food and Drug Administration (FDA) has developed a protocol for establishing bioequivalence of LT4 formulations based on serum thyroxine (T4) levels after a single oral dose administered to healthy volunteers. This protocol has been criticized by professional endocrinology associations for using healthy individuals and ignoring serum thyroid-stimulating hormone (TSH) levels. In addition, the protocol did not initially correct for baseline T4 levels, although this was changed in a later version. There are concerns that the FDA's protocol could allow products with clinically significant differences in bioavailability to be declared therapeutically equivalent and interchangeable. Once a generic LT4 has been shown to be bioequivalent to a brand-name LT4, it may be substituted for that brand-name LT4 with no need for dose adjustment or follow-up therapeutic monitoring. Often, the substitution is made by the pharmacy without the physician's knowledge. Even small differences between LT4 formulations can cause significant changes in TSH levels. This may be a particular concern in vulnerable populations, including elderly, pregnant, and pediatric patients. Problems that can be encountered when switching between formulations or when original products are reformulated are discussed in this review. These problems include altered efficacy and adverse events, some of which can be caused by excipients. Patients should be maintained on the same LT4 preparation if possible. If the LT4 preparation is changed, TSH levels should be evaluated and, if necessary, the dose of LT4 adjusted.Funding: Merck.Plain Language Summary: Plain language summary available for this article.
Impact of a Forced Dose-Equivalent Levothyroxine Brand Switch on Plasma Thyrotropin: A Cohort Study. [2021]Background: Patients with primary hypothyroidism are treated with levothyroxine (LT4) to normalize their serum thyrotropin (TSH). Finding the optimal dosage is a long-lasting process, and a small change can have major impact. Currently, limited data are available on the impact of dose-equivalent substitution between brands. This study aimed to determine the effect of the shortage of the LT4 brand Thyrax® in the Netherlands and the resulting dose-equivalent switch to another brand on plasma TSH concentrations in a large cohort of patients. Methods: Observational cohort study. Two registries representative for the Dutch population containing prescription and laboratory test data: the Nivel Primary Care Database and the PHARMO Database Network. Patients using at least 25 μg Thyrax daily for one year or longer were included. Two cohorts were formed: a switch cohort consisting of patients who switched from Thyrax to an alternative brand, and a Thyrax cohort including patients who continued to use Thyrax. Patients in the switch cohort did switch from Thyrax to a different brand of LT4 in 2016 and had two consecutive TSH measurements on the same dose of LT4, one before and one 6 weeks after the switch. Patients in the Thyrax cohort had two consecutive TSH measurements on the same dose of Thyrax that were 6 weeks apart. Results: In the Thyrax cohort, 19% of euthyroid patients using ≤100 μg had a TSH level outside the reference range at the subsequent measurement compared with 24% in the switch cohort (p < 0.0001). For patients using >100 μg Thyrax, these figures were 24% and 63%, respectively (p < 0.0001). Furthermore, patients using >50 μg Thyrax were four to five times more likely to become hyperthyroid after a dose-equivalent switch to a different brand compared with patients who stayed on Thyrax. Conclusions: In euthyroid patients continuing the LT4 product Thyrax at the same dose, TSH was out of range in 19-24% at least 6 weeks later. A dose-equivalent switch from Thyrax to other LT4 brands induced biochemical signs of overdosing in an even larger proportion (24-63%) of patients. The results indicate that a dose-equivalent LT4 brand switch may necessitate a dose adjustment in a large number of patients.
Thyroid Stimulating Hormone Stability in Patients Prescribed Synthetic or Desiccated Thyroid Products: A Retrospective Study. [2021]The purpose of this retrospective matched-cohort study was to evaluate the stability of thyroid stimulating hormone (TSH) in patients using synthetic compared with desiccated thyroid products. Patients using a thyroid product for the treatment of hypothyroidism were matched 1:1 on age, sex, race/ethnicity, and had a follow-up period of 3 years after the index date. The primary outcome was percent of in-range TSH values. Over 3 years, TSH values in both groups were in-range 79% of the time (P = 0.905). Our results showed no difference in longitudinal TSH stability between desiccated thyroid products and synthetic levothyroxine.
The Stability of TSH, and Thyroid Hormones, in Patients Treated With Tablet, or Liquid Levo-Thyroxine. [2021]Approximately, 5% of the population is affected by hypothyroidism, mainly women and persons aged more than 60 years. After the diagnosis of hypothyroidism the usual therapy is tablet levothyroxine (L-T4), with a monitoring of the thyroid-stimulating hormone (TSH) level in primary hypothyroidism every 6-8 weeks and L-T4 is adjusted as necessary to reach an euthyroid state. Once TSH is stabilized in the normal range, it is recommended to conduct annual testing in the treated subjects to warrant suitable replacement. More recently advances regarding L-T4 treatment are the introduction of new oral formulations: the liquid solution, and soft gel capsule. The soft gel capsule permits a quick dissolution in the acid gastric pH. The liquid preparation does not require an acid gastric environment. Many pharmacokinetic studies demonstrated a more rapid absorption for the liquid L-T4, or capsule, than with tablet. Many studies have shown that the liquid, or capsule, formulations can overcome the interaction with foods, drugs or malabsorptive conditions, that are able to impair the tablet L-T4 absorption. Lately studies have suggested that liquid L-T4 can permit to maintain more efficiently normal TSH levels in hypothyroid patients in the long-term follow-up, than tablet L-T4, both in patients with malabsorptive states, and in those without malabsorption. Further large, prospective, longitudinal studies are needed to evaluate the stability of TSH, in hypothyroid patients treated with different L-T4 formulations.
Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Some levothyroxine unresponsive individuals with hypothyroidism are prescribed a natural desiccated thyroid (NDT) preparation such as Armour Thyroid® or ERFA Thyroid® . These contain a mixture of levothyroxine and liothyronine in a fixed ratio. We evaluated the response to NDT in individuals at a single endocrine centre in terms of how the change from levothyroxine to NDT impacted on their lives in relation to quality of life (QOL) and thyroid symptoms.
Precision Medicine in Autoimmune Thyroiditis and Hypothyroidism. [2021]Autoimmune thyroid diseases (AITD) are T-cell-mediated organ specific autoimmune disorders, deriving from an altered response of the immune system that leads to the immune attack to the thyroid. Hashimoto's thyroiditis (HT) and Graves' disease (GD) are the two principal AITD clinical presentations. Hypothyroidism and thyrotoxicosis are, respectively, the clinical hallmarks of HT and GD. Patients with autoimmune thyroiditis are treated daily with synthetic L-thyroxine (L-T4) at the dose of 1.5-1.7 μg/kg. Various L-T4 formulations are commercially available (tablet, liquid solution, or soft gel capsule). L-T4 in tablets is generally prescribed to treat hypothyroidism, whereas the liquid formulation, or soft gel capsules, can be administered in hypothyroid patients in case of malabsorption or in patients in therapy with drugs interfering with L-T4 absorption. Furthermore, myoinositol has a crucial role in thyroid autoimmunity and function. Clinical studies reported a significant decline in TSH and antithyroid autoantibodies levels after treatment with myoinositol + selenium in patients with subclinical hypothyroidism and autoimmune thyroiditis. Moreover, thyroidectomy can be rarely recommended in patients with autoimmune thyroiditis, with cosmetic reasons for a goiter, or with important signs or symptoms of local compression, or nodular disease with a "suspicious" cytology for malignancy. Furthermore, a recent randomized trial suggested that total thyroidectomy can improve quality of life and fatigue, while medical therapy did not. In this review, we overview currently available evidence in personalized medicine in patients with autoimmune thyroiditis and hypothyroidism. Further research is needed in larger population to investigate the effect of these new treatments on quality of life.
Levothyroxine Treatment Adequacy and Formulation Changes in Patients with Hypothyroidism: A Retrospective Study of Real-World Data from the United States. [2023]Background: The prevalence of hypothyroidism (HT) has increased over time. To assess the effectiveness of treatment, we (1) studied thyrotropin (TSH) levels among patients receiving levothyroxine (LT4) and (2) determined the percentages of patients switching among LT4 formulations. Methods: Data on patients with HT receiving LT4 from the Optum™ Clinical and Claims Database were analyzed from March 2013 through February 2020. Eligible adult patients had ≥1 medical claim with an HT diagnosis and all patients were observed for ≥12 months. Patients included in Objective 1 were indexed on a randomly selected TSH result and had ≥2 results for TSH 1-15 months apart. Patients included in Objective 2 were indexed on a randomly selected LT4 pharmacy claim and had ≥2 LT4 claims ≥1 month apart and ≥1 claim during follow-up. Outcomes were the proportion of patients with low, normal, or high (<0.45, 0.45-4.5, or >4.5 mIU/L, respectively) TSH levels and the proportion of patients switching LT4 formulations, respectively. Data were stratified by age group, sex, and insurance type. All data reported were analyzed using descriptive statistics. Results: Of patients who were in the indexed TSH group, 81.1% [confidence intervals: 80.4-81.8; n/N = 9130/11,259] achieved normal TSH values. When stratified by age group, sex, and insurance type, ≥70% of patients in each of these subgroups exhibited normal mean TSH values at follow-up. For Objective 2 (N = 25,076), 24.9% (N = 6238) of the LT4-indexed group had ≥1 formulation switch in 12 months, of which 67.3% only switched once, and 41.4% (N = 10,370) had ≥1 formulation switch in up to 24 months. A significantly higher proportion of Medicare vs. commercially insured patients had switched formulations (26.2% vs. 23.1%, p < 0.001). Conclusions: Most LT4-treated patients maintain normal TSH levels, which is an improvement vs. previous reports. Continued physician engagement and patient education are advised to further reduce the number of patients who maintain off-target TSH levels. Contrary to clinical recommendations, about 25% of patients receiving LT4 switched formulations within 1 year, with >40% switching within 2 years; among patients who switched, most only switched once.