Armour Thyroid (desiccated thyroid extract) / AbbVie - LARVOL DELTA

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants (clinicaltrials.gov) - P2/3 | N=2800 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Jun 2028 ➔ Sep 2027

Trial primary completion date • Endocrine Disorders

Vital Signs Among Patients With Hypothyroidism Treated for up to 48 Weeks With Armour Thyroid or Synthetic Levothyroxine: ARCH Phase 2 Randomized Double-Blind Study (ATA 2024) - "Overall, the use of Armour Thyroid for up to 48 months was safe and well tolerated in the Phase 2 ARCH study. When examining SBP, DBP, and pulse rate as part of the safety evaluation, Armour Thyroid and LT4 treatment yielded clinically similar findings."

Clinical • P2 data • Endocrine Disorders

Evaluating the effectiveness of combined T4 and T3 therapy or desiccated thyroid versus T4 monotherapy in hypothyroidism: a systematic review and meta-analysis. (PubMed, BMC Endocr Disord) - "Our study revealed that combined therapy and DTE lead to higher T3 and lower T4 levels, compared to T4 monotherapy in hypothyroidism. However, no significant effects on heart rate, lipid profile, or quality of life were noted. Given the heterogeneity of results, personalized treatment approaches are recommended."

Clinical • Journal • Monotherapy • Retrospective data • Review • Endocrine Disorders

Evaluating the Effectiveness of Combined T4 and T3 Therapy or Desiccated Thyroid Versus T4 Monotherapy in Hypothyroidism: A Systematic Review and Meta-Analysis (ENDO 2024) - "We used the following keywords: "Armour Thyroid," OR "Thyroid Extract," OR "Natural Desiccated Thyroid," OR "Nature-Throid," "Desiccated Thyroid," OR "NP Thyroid," OR "Synthroid," OR "Levothyroxine," OR "Liothyronine," "Cytomel," OR "Thyroid USP," OR "Unithroid." AND "hypothyroidism. Our study revealed that combined therapy and DTE lead to higher T3 and lower T4 levels compared to T4 monotherapy in hypothyroidism. However, no significant effects on heart rate, lipid profile, or quality of life were noted. Given the heterogeneity of results, personalized treatment approaches are recommended.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation."

Monotherapy • Retrospective data • Review • CNS Disorders • Depression • Endocrine Disorders • Psychiatry

Evaluating the Effectiveness of Combined T4 and T3 Therapy or Desiccated Thyroid Versus T4 Monotherapy in Hypothyroidism: A Systematic Review and Meta-Analysis (ENDO 2024) - "We used the following keywords: "Armour Thyroid," OR "Thyroid Extract," OR "Natural Desiccated Thyroid," OR "Nature-Throid," "Desiccated Thyroid," OR "NP Thyroid," OR "Synthroid," OR "Levothyroxine," OR "Liothyronine," "Cytomel," OR "Thyroid USP," OR "Unithroid." AND "hypothyroidism. Our study revealed that combined therapy and DTE lead to higher T3 and lower T4 levels compared to T4 monotherapy in hypothyroidism. However, no significant effects on heart rate, lipid profile, or quality of life were noted. Given the heterogeneity of results, personalized treatment approaches are recommended.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation."

Monotherapy • Retrospective data • Review • CNS Disorders • Depression • Endocrine Disorders • Psychiatry

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants (clinicaltrials.gov) - P2/3 | N=2800 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants (clinicaltrials.gov) - P2/3 | N=2800 | Not yet recruiting | Sponsor: AbbVie

New P2/3 trial • Endocrine Disorders

"Consider Armour Thyroid. It provides a more direct form of hormone." (@DryHumorMe)

Drugs for hypothyroidism. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Endocrine Disorders

DOSE‐CONVERSION FROM LT4 TO ARMOUR THYROID (ATA 2022) - "For the LT4 participants, the slope of the regression line (the regression slope = 1.0008 [R2 = 0.8949]) was nearly identical to the slope of the identity line, indicating that most participants' pre-randomization dose matched their post-randomization dose (70.2%); 8.3% of participants required an up-titration and 20.7% of participants required a down-titration. For the ATH participants, the slope of the regression line (the regression slope = 0.0118 [R2 = 0.8249]) was greater than the slope of the identity line (y = 0.0100), indicating that many patients who were switched to ATH required titrations to a higher dose (48.6%) than that recommended by the USP; 1.8% of participants required a down-titration and 47.7% did not require titrations. Of the ATH participants not needing titrations, ∼78% had a pre-randomization dose of 88 mcg or lower."

THYPRO SYMPTOM OUTCOMES IN A SUBPOPULATION OF PATIENTS WITH HYPOTHYROIDISM FROM THE ARCH STUDY (ATA 2022) - "In a recent phase 2 study (ARCH), a post-hoc subpopulation analysis was performed in participants with baseline hypothyroid symptoms and low total T3 at baseline (ITT-T3 subpopulation) to explore changes in symptomology when switching to Armour Thyroid (ATH)... For the patients with hypothyroidism and residual symptoms (ITT-T3 subgroup), the study data support that symptomology may improve by transitioning to ATH treatment. Larger randomized controlled trials are warranted to further explore this subset of hypothyroid patients and should be adequately powered to demonstrate statistical difference in ThyPRO outcomes."

Clinical • Endocrine Disorders

PRIMARY RESULTS FROM A PHASE 2 STUDY OF ARMOUR THYROID IN PATIENTS WITH HYPOTHYROIDISM: THE ARCH STUDY (ATA 2022) - "While titrations of ATH led to improvements in TSH, the primary and secondary endpoint results for NI were not achieved. These results were highly impacted by the initial dosing of ATH using the dose-conversion chart based on the USP Drug Information 2000. ATH was safe and well tolerated; no new safety concerns were observed."

Clinical • P2 data • Endocrine Disorders

"@abbvie What's the data please on dose stability of Armour thyroid?" (@shimself)

[VIRTUAL] Porcine Desiccated Thyroid Extract Associated Dual Positive ANCA Vasculitis (KIDNEY WEEK 2021) - "We report the first case of drug-induced ANCA vasculitis presumed to be associated with porcine desiccated thyroid supplementation (Armour Thyroid)...She received pulse dose steroids with taper per the PEXIVAS trial protocol and Rituximab therapy per the RAVE trial protocol...However, this renal limited AAV case with desiccated thyroid supplementation suggests clinicians should also be aware of AAV as a possible adverse consequence of thyroid supplementation. Management should include discontinuation of the offending agent and consideration of immunosuppression with standard induction regimens based on disease severity."

Preclinical • Acute Kidney Injury • Atherosclerosis • Bipolar Disorder • Cardiovascular • CNS Disorders • Endocrine Disorders • Fatigue • Glomerulonephritis • Immunology • Inflammation • Lupus Nephritis • Nephrology • Psychiatry • Renal Disease • Vasculitis

Is there a role for Natural Desiccated Thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a Consecutive Case Series. (PubMed, Int J Clin Pract) - "Significant symptomatic benefit and improvement in QOL was experienced by people with a history of levothyroxine unresponsive hypothyroidism treated with NDT, suggesting the need for further evaluation of NDT in this context."

Clinical • Journal • Endocrine Disorders

ARCH: A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants (clinicaltrials.gov) - P2; N=284; Completed; Sponsor: Allergan; Trial completion date: Jan 2021 ➔ Jun 2021; Trial primary completion date: Jan 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Endocrine Disorders

ARCH: A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants (clinicaltrials.gov) - P2; N=284; Completed; Sponsor: Allergan; Active, not recruiting ➔ Completed; Trial completion date: Sep 2021 ➔ Jan 2021; Trial primary completion date: Sep 2021 ➔ Jan 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Endocrine Disorders

[VIRTUAL] A Curious Case of Anaphylaxis to Synthetic Thyroid Hormone (AACE 2021) - "Synthroid uses different additives than Armour thyroid formularies. In theory, patients should not have allergic reactions to both formularies."

Clinical • Allergy

[VIRTUAL] Refractory Postsurgical Hypothyroidism in Nephrotic Syndrome (ENDO 2021) - "Despite increasing her thyroxine dose multiple times and adding Armour thyroid based on increasing TSH and decreasing FT4 on outpatient labs, her edema continued to get worse...She was given a statin and ACE inhibitor as well as IV Lasix...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Alopecia • Complement-mediated Rare Disorders • Constipation • Dyslipidemia • Endocrine Cancer • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Thyroid Gland Carcinoma

[VIRTUAL] A Tale of Two Therapies- A Comparison of Armour Thyroid and Levothyroxine (ENDO 2021) - "For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Alopecia • Anorexia • Endocrine Cancer • Endocrine Disorders • Fatigue • Mood Disorders • Oncology • Psychiatry • Solid Tumor • Thyroid Gland Carcinoma

[VIRTUAL] Graves’ Disease Presenting After 25 Years of Stable Thyroid Hormone Replacement Therapy (ENDO 2021) - "After multiple dose changes in the first few years she was stabilized on 90 mg daily of Armour thyroid...Symptoms have been controlled over this time period with low dose (5-10 mg/day) methimazole. Hypothyroidism is very common in women, with Hashimoto's Thyroiditis as the usual etiology... Hypothyroidism is very common in women, with Hashimoto's Thyroiditis as the usual etiology. When patients on thyroid hormone replacement therapy (THRT) present with symptoms of hyperthyroidism they are usually managed with dose reduction. However, complete cessation of THRT is unusual, especially after more than 10-20 years of therapy."

Endocrine Disorders • Fatigue • Immunology

[VIRTUAL] Thyrotropin-Secreting Pituitary Adenoma Successfully Treated With Cabergoline. (ENDO 2021) - "Clinical case A 67-year-old female with a presumed history of hypothyroidism for the last 3 years managed with Armour thyroid was referred for fatigue associated with palpitations, intermittent diarrhea, insomnia, and anxiety. Her TSH was noted to be suppressed at that time, and her Amour thyroid was changed to Levothyroxine 25 mcg daily, which was eventually stopped as her symptoms persisted...Atenolol 25 mg daily was added temporarily for the management of her sympathetic symptoms...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

CNS Disorders • Endocrine Disorders • Fatigue • Insomnia • Pituitary Gland Carcinoma • Psychiatry • Sleep Disorder • IGF1 • MRI

ARCH: A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants (clinicaltrials.gov) - P2; N=220; Active, not recruiting; Sponsor: Allergan; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Endocrine Disorders

[VIRTUAL] Utilizing Patient Online Forums to Capture Experiences and Perceptions Associated with the Use of Desiccated Thyroid Extract (ENDO-I 2020) - "It is unclear why many patients prefer the use of DTE as a thyroid hormone replacement formulation over guideline-concordant therapies such as levothyroxine (LT4)...We searched the 10 most popular patient forums based on number of users (WebMD, Topix, Health questions, Patients like me, Drugs.com, Endocrine Web, Everyday Health, Talk Health Partnership, Spark People and Patients.info) using the key terms: desiccated thyroid extract, desiccated thyroid treatment, thyroid USP, commercial names of DTE (Armour Thyroid® or Natural Thyroid®), thyroid extract, AND hypothyroidism... Among patients with hypothyroidism, a subset may prefer DTE over guideline-concordant therapies for many reasons, including perceived effectiveness, despite the risks associated with DTE. Future work should incorporate patient-reported outcomes to better elucidate the mechanisms responsible for therapy preferences in this subset of patients."

Clinical • Endocrine Disorders

[VIRTUAL] Armour Thyroid and Liothyronine Combination Potentiated Thrombosis (ENDO-I 2020) - "Patient was started on daily oral levothyroxine and recovered eventually from neurological deficits. Also a number of case reports have shown association with hyperthyroidism and pro-thrombotic state. Although there are scarce publications associating liothyronine or Armour Thyroid and hypercoagulable thrombotic event, significant drug interactions may exist with patient who are more vulnerable with inherited condition or other risk factors."

Atrial Fibrillation • Cardiovascular • Endocrine Disorders • Hematological Disorders • Long-acting Reversible Contraceptives • Pain • Thrombosis • F2