Systematic Appraisal of Lactose Intolerance as Cause of Increased Need for Oral Thyroxine

Cellini, Miriam; Santaguida, Maria Giulia; Gatto, Ilenia; Virili, Camilla; Duca, Susanna Carlotta Del; Brusca, Nunzia; Capriello, Silvia; Gargano, Lucilla; Centanni, Marco

doi:10.1210/jc.2014-1217

Cited by 64 publications

(64 citation statements)

References 20 publications

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“…Numerous published studies have demonstrated the difficulty of maintaining patients in the guideline-recommended therapeutic range for TSH using levothyroxine, with as many as 32-48% of patients being categorized as having either a "subadequate" or "excessive" response to therapy [3,[43][44][45][46]. Factors affecting levothyroxine efficacy include patient persistence and compliance, medication tolerability, Since levothyroxine is an NTI drug, small differences in dose or blood concentration may lead to therapeutic failures or adverse drug reactions [4][5][6][7][8][9]47]. It is not surprising that patients, pharmacists, and physicians have been concerned regarding the use of generic NTI drugs with varying levels of potency [48], particularly in diseases such as hypothyroidism.…”

Section: Discussionmentioning

confidence: 99%

“…Levothyroxine is classified as a narrow therapeutic index (NTI) medication, which indicates that small differences in absorption or bioavailability may lead to therapeutic failure or adverse drug reactions [4][5][6][7][8][9]. Currently, levothyroxine medications are available in various formulations, including compressed tablets (generic and branded) and soft gel caps.…”

Section: Introductionmentioning

confidence: 99%

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The Economic Impact of Changing Levothyroxine Formulations in Difficult-to-Treat Hypothyroid Patients: An Evidence-Based Model

Elmor¹,

Sandulli²,

Carter³

2017

Pharmacoeconomics

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Objective: To determine the budget impact of incorporating levothyroxine gel caps in the treatment plan of patients diagnosed with hypothyroidism who experience multiple levothyroxine dose or formulation changes annually due to inadequate efficacy or tolerability.Methods: Cost estimates of levothyroxine formulations were obtained. Estimated utilization patterns and costs of physician services, laboratory tests, ancillary healthcare services, and lost productivity were quantified based on published literature and government/public sources. The patient population was based on epidemiology reports and estimates from the American Association of Clinical Endocrinology and the American Thyroid Association. All calculations of economic outcomes were determined using a budget impact model constructed in a MS Excel platform.Results: The economic model demonstrated for a population of 500,000 persons, there are 23,000 (4.6%) people with hypothyroidism, of which 18,400 (80.0%) receive pharmacologic treatment, including 17,480 (95.0%) that receive levothyroxine. The proportion of patients requiring ≥ 1 dosage changes annually is 31.4%, producing 5,489 "hard-to-treat" patients. Similarly, the proportion of patients requiring ≥ 2 dosage changes annually is 8.0% or 1,398 "harder-to-treat" patients. Using evidence-based data of the tolerability and absorption characteristics of levothyroxine gel caps, changing 20.0% of the target cohort to the gel cap formulation produced annual net cost savings of $542,901 in direct medical costs and $564,650 in lost productivity for "hard-to-treat" patients and savings of $409,107 in direct medical costs and $441,926 in lost productivity for "harder-to-treat" patients. Conclusions:Consideration of switching levothyroxine product from a tablet to a gel cap formulation is justified on an economic and therapeutic basis for hypothyroid patients at risk of subadequate drug efficacy or tolerability as measured by the need for one or more annual levothyroxine dosage or formulation adjustments.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Economic Impact of Changing Levothyroxine Formulations in Difficult-to-Treat Hypothyroid Patients: An Evidence-Based Model

Elmor¹,

Sandulli²,

Carter³

2017

Pharmacoeconomics

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“…Exclusion criteria were: i) a history of hyperthyroidism or toxic nodular goitre as well as the presence of autonomously functioning areas in the thyroid scan; ii) the recent use (!6 months) of drugs known to interfere with thyroid homeostasis (20); iii) the presence of concomitant gastrointestinal disorders (gastritis related to Helicobacter pylori infection, atrophic gastritis, coeliac disease, lactose intolerance, etc.) known to increase L-T 4 requirement (21,22,23); iv) being pregnant.…”

Section: Methodsmentioning

confidence: 99%

“…All patients with NTMG were treated with an individually tailored dose of T 4 , as previously described (21,22,23,24) and in semi-suppressive mode (target serum TSHZ0.1-0.5 mU/l) (2). The individually tailored dose is the dose of T 4 which is administered following a standardized assumption procedure and titrated on the basis of patient's age, weight, BMI, the amount of residual thyroid tissue and the ability to absorb the hormone (12,14,15,21,22,23,24).…”

Section: Methodsmentioning

confidence: 99%

“…The individually tailored dose is the dose of T 4 which is administered following a standardized assumption procedure and titrated on the basis of patient's age, weight, BMI, the amount of residual thyroid tissue and the ability to absorb the hormone (12,14,15,21,22,23,24). All patients were treated with the same brand of oral and agreed to take T 4 under fasting conditions, abstaining from eating or drinking anything other than water for at least 1 h after treatment.…”

Section: Methodsmentioning

confidence: 99%

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Individually-tailored thyroxine requirement in the same patients before and after thyroidectomy: a longitudinal study

Duca

Santaguida

Brusca

et al. 2015

European Journal of Endocrinology

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Objective: Thyroxine (T 4 ) requirement after total thyroidectomy for differentiated thyroid carcinoma (DTC) is a debated issue. As most of the studies in the area have been retrospective and/or performed with heterogeneous therapeutic approaches, we designed our study to determine T 4 requirement in the same patients and treatment settings, before and after total thyroidectomy. Design, patients and methods: This was a longitudinal study including 23 goitrous patients treated with T 4 in an individually tailored fashion. All patients exhibited a stable TSH (median TSHZ0.28 mU/l) at a stable T 4 dose for at least 1 year before surgery (median T 4 doseZ1.50 mg/kg per day). The patients underwent total thyroidectomy based on cancer suspicion or compressive symptoms. Eventually diagnosed as having DTC (pT1b-pT2N0) and following surgical and radiometabolic treatment, they were treated with the same pre-surgical doses of T 4 . Results: Three months after surgery,using the same pre-surgical dose, median TSH increased up to 5.38 mU/l (P!0.0001) and so the T 4 dose had to be increased (median T 4 doseZ1.95 mg/kg per day; C30%; P!0.0001). Once divided by patients' age, we observed that, after thyroidectomy and maintaining the same pre-surgical dose, serum TSH significantly increased both in younger and in older patients (median TSHZ4.57 and 6.11 mU/l respectively). Serum TSH was restored to the pre-surgical level by increasing the dose up to 1.95 and 1.77 mg/kg per day (C25 and C21%) respectively. Conclusions: Following the same treatment regimen, a thyroidectomized patient requires one-third higher therapeutic T 4 dose than before surgery. Despite this increase, the dose of T 4 needed in our patients remains significantly lower than that previously described in athyreotic patients.

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Oral L‐thyroxine liquid versus tablet in patients submitted to total thyroidectomy for thyroid cancer (without malabsorption): A prospective study

Fallahi

Ferrari

Materazzi

et al. 2018

Laryngoscope Investig Oto

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ObjectiveNo consistent data are present in literature about the effectiveness of Levothyroxine (L‐T4) liquid formulation in patients without malabsorption after thyroidectomy. The aim of this study is to compare the effectiveness of L‐T4 liquid formulation, with L‐T4 tablets, in thyroid cancer patients after thyroidectomy (without malabsorption or drug interference).MethodsOne hundred five patients were recruited; 52 patients were treated with liquid L‐T4 formulation, while 53 with L‐T4 tablets, at the same dosage (1.5 mcg/kg/day). Patients started to assume the drug the day after surgery, 30 min before breakfast. In both groups circulating levels of thyrotropic hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3) were dosed at week 6 (first control), and then at week 12 (second control).ResultsWe obtained significantly lower TSH values in the liquid L‐T4 group patients, compared to the tablet L‐T4 group, at the first control (P < .05), and at the second control (P < .01), while FT4 and FT3 levels were not significantly different. Hypothyroid range (TSH > 3.6 mcU/mL) was significantly more prevalent in the patients treated with L‐T4 tablet.ConclusionsA better control of TSH was observed in thyroidectomized patients (without malabsorption, gastric disorders, or drug interference) with liquid L‐T4 regimen.Level of Evidence2c–Outcomes Research

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Systematic Appraisal of Lactose Intolerance as Cause of Increased Need for Oral Thyroxine

Abstract: These findings show that lactose intolerance significantly increased the need for oral T4 in hypothyroid patients.

Cited by 64 publications

References 20 publications

The Economic Impact of Changing Levothyroxine Formulations in Difficult-to-Treat Hypothyroid Patients: An Evidence-Based Model

The Economic Impact of Changing Levothyroxine Formulations in Difficult-to-Treat Hypothyroid Patients: An Evidence-Based Model

Individually-tailored thyroxine requirement in the same patients before and after thyroidectomy: a longitudinal study

Oral L‐thyroxine liquid versus tablet in patients submitted to total thyroidectomy for thyroid cancer (without malabsorption): A prospective study

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