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      Comorbidities, Concomitant Medications, and Diet as Factors Affecting Levothyroxine Therapy: Results of the CONTROL Surveillance Project

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          Abstract

          Background

          The CONTROL Surveillance Project was a comprehensive patient-based survey conducted among hypothyroid patients undergoing treatment. The primary objective of the study was to specifically quantify the prevalence of factors adversely affecting levothyroxine therapy.

          Methods

          Participants were selected from a large proprietary database. Those eligible for the study completed a 21-question survey.

          Results

          Of the eligible hypothyroid patients, 925 (92.5 %) were being treated with levothyroxine monotherapy. The mean age was 60.4 years; 755 (81.6 %) were female and 168 (18.2 %) were male. Almost half of those receiving levothyroxine (435, 47.0 %) had at least one comorbid condition that could adversely affect its absorption: gastroesophageal reflux disease (33.8 % of patients), irritable bowel syndrome (9.7 %), lactose intolerance (7.8 %), or a history of gastric bypass surgery or bowel resection (3.0 %). Other factors reported by many patients that could adversely affect levothyroxine absorption included use of prescription medications (20.6 %) and over-the-counter medications (34.3 %) used to treat comorbid gastrointestinal (GI) conditions; use of dietary supplements (51.8 %, primarily calcium and iron); and intake of foods/beverages high in fiber, iodine, or soy (68.0 %). Of the 13.4 % who reported difficulty controlling their hypothyroid symptoms, significantly more patients with comorbid GI conditions reported such difficulty (7.8 versus 5.6 %, P < 0.01). Frequent changes in levothyroxine dosing (two or more dose changes in the past year) were reported by 8.0 % of survey participants. Those with GI comorbidities were nearly twice as likely to have such changes (5.0 versus 3.0 %, P < 0.01).

          Conclusion

          Better initial workup of patients, including identification of relevant GI comorbidities and allergies, may help in the early detection of factors that may affect the performance of levothyroxine.

          Related collections

          Most cited references43

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          • Article: not found

          Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

          Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.
            • Record: found
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            • Article: not found

            The Colorado thyroid disease prevalence study.

            The prevalence of abnormal thyroid function in the United States and the significance of thyroid dysfunction remain controversial. Systemic effects of abnormal thyroid function have not been fully delineated, particularly in cases of mild thyroid failure. Also, the relationship between traditional hypothyroid symptoms and biochemical thyroid function is unclear. To determine the prevalence of abnormal thyroid function and the relationship between (1) abnormal thyroid function and lipid levels and (2) abnormal thyroid function and symptoms using modern and sensitive thyroid tests. Cross-sectional study. Participants in a statewide health fair in Colorado, 1995 (N = 25 862). Serum thyrotropin (thyroid-stimulating hormone [TSH]) and total thyroxine (T4) concentrations, serum lipid levels, and responses to a hypothyroid symptoms questionnaire. The prevalence of elevated TSH levels (normal range, 0.3-5.1 mIU/L) in this population was 9.5%, and the prevalence of decreased TSH levels was 2.2%. Forty percent of patients taking thyroid medications had abnormal TSH levels. Lipid levels increased in a graded fashion as thyroid function declined. Also, the mean total cholesterol and low-density lipoprotein cholesterol levels of subjects with TSH values between 5.1 and 10 mIU/L were significantly greater than the corresponding mean lipid levels in euthyroid subjects. Symptoms were reported more often in hypothyroid vs euthyroid individuals, but individual symptom sensitivities were low. The prevalence of abnormal biochemical thyroid function reported here is substantial and confirms previous reports in smaller populations. Among patients taking thyroid medication, only 60% were within the normal range of TSH. Modest elevations of TSH corresponded to changes in lipid levels that may affect cardiovascular health. Individual symptoms were not very sensitive, but patients who report multiple thyroid symptoms warrant serum thyroid testing. These results confirm that thyroid dysfunction is common, may often go undetected, and may be associated with adverse health outcomes that can be avoided by serum TSH measurement.
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              • Abstract: not found
              • Article: not found

              The spectrum of thyroid disease in a community: the Whickham survey.

                Author and article information

                Contributors
                +1-901-5699487 , aci@wrte4u.com , margiesmc@aol.com
                Journal
                Drugs R D
                Drugs R D
                Drugs in R&D
                Springer International Publishing (Cham )
                1174-5886
                1179-6901
                21 December 2015
                21 December 2015
                March 2016
                : 16
                : 1
                : 53-68
                Affiliations
                [ ]McMillan Survey Research and Statistical Consulting, 8428 Arendal Cove, Memphis, TN USA
                [ ]Akrimax Pharmaceuticals, LLC, Cranford, NJ USA
                [ ]Morristown, NJ USA
                [ ]LT Associates Ltd, Paris, France
                [ ]Department of Neuroscience, University of Oxford, Oxford, UK
                [ ]Medical/Marketing Decisions, LLC, Bridgewater, NJ USA
                [ ]Quantum Change Group, LLC, Gaithersburg, MD USA
                Article
                116
                10.1007/s40268-015-0116-6
                4767717
                26689565
                4a5f3d76-25fc-43a8-a91e-bafead06ae9d
                © The Author(s) 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Funding
                Funded by: Akrimax Pharmaceuticals, LLC
                Categories
                Original Research Article
                Custom metadata
                © Springer International Publishing Switzerland 2016

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