Abstract
Objective Hypothyroid patients are treated by sodium levothyroxine (LT4). Tablet is the mostly used LT4 formulation, and the fasting regimen is required for the absorption of active principle. Also, gastrointestinal diseases and drugs may impair the LT4 bioavailability when tablet is used. Nonsolid LT4 formulations (i.e., liquid solution (LS) and soft gel (SG) capsule) were manufactured to overcome the limitations of LT4 tablet. This study was conceived to evaluate the performance of nonsolid LT4 formulations in a real-life scenario. Methods Two institutions participated in the study that was conducted in two phases (i.e., enrollment and re-evaluation). Adults with autoimmune or postsurgical hypothyroidism and on LT4 from a few months were selected. A nonparametric statistical analysis for paired or unpaired data was performed. Results 121 consecutive cases were included. At the enrollment phase, a 52% of patients took the therapy at least 30 min before breakfast with no difference between tablet and SG/LS users. TSH was 1.65 mIU/L (0.86–2.70) in patients on LT4 tablet and 1.70 mIU/L (1.10–2.17) in those on SG/LS (p=0.66). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group (p=0.66). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group (p=0.66). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group (p=0.66). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group (p=0.66). At the re-evaluation phase, among the patients using correct LT4 assumption, the TSH value was stable in the tablet group (Conclusion The performance of nonsolid LT4 formulations is not influenced by correct or incorrect use of therapy. On the contrary, LT4 tablet does not guarantee euthyroidism when it is ingested without waiting for at least 30 minutes before breakfast. These new data, obtained in a real-life scenario, suggest that LT4 SG/LS should be regarded as first-line therapy for treating adults with newly diagnosed hypothyroidism.
Highlights
Hypothyroid patients are electively treated by sodium levothyroxine (LT4) [1]
LT4 tablet is the most widely used formulation, which is taken per os and disintegrated and dissolved in the stomach [2]. ese events are essential preconditions for the effective drug absorption which takes place in the small intestine [3]. e fasting regimen is required to promote the absorption of LT4 tablet and its ingestion 30 minutes before breakfast is necessary [1]
Here, we conceived a study aiming to assess the performance of LT4 liquid solution (LS)/soft gel (SG) in a cohort of hypothyroid patients without causes of potential malabsorption of LT4 tablet and proving recent restored euthyroidism. is setting allowed us to evaluate LT4 performance in a real-life scenario, reducing or deleting the biases otherwise present in other papers. e outcomes of the present study were to (1) investigate how hypothyroid patients with proven restored euthyroidism really follow the initial instructions for the correct use of LT4 and (2) analyze the performance of LT4 LS/SG versus tablet in the different administration regimens of patients
Summary
Hypothyroid patients are electively treated by sodium levothyroxine (LT4) [1]. LT4 tablet is the most widely used formulation, which is taken per os and disintegrated and dissolved in the stomach [2]. ese events are essential preconditions for the effective drug absorption which takes place in the small intestine [3]. e fasting regimen is required to promote the absorption of LT4 tablet and its ingestion 30 minutes before breakfast is necessary [1]. Since the LS and SG commercialization, a growing number of studies reported their advantages [7,8,9,10,11,12,13] Most of these studies evaluated the changes of TSH attained by switching from tablet to LS or SG in selected patients consistently maintaining the prescribed LT4 regimen (i.e., such as 30 minutes before breakfast), introducing a performance bias [9, 11, 12]. E outcomes of the present study were to (1) investigate how hypothyroid patients with proven restored euthyroidism really follow the initial instructions for the correct use of LT4 and (2) analyze the performance of LT4 LS/SG versus tablet in the different administration regimens of patients Here, we conceived a study aiming to assess the performance of LT4 LS/SG in a cohort of hypothyroid patients without causes of potential malabsorption of LT4 tablet and proving recent restored euthyroidism. is setting allowed us to evaluate LT4 performance in a real-life scenario, reducing or deleting the biases otherwise present in other papers. e outcomes of the present study were to (1) investigate how hypothyroid patients with proven restored euthyroidism really follow the initial instructions for the correct use of LT4 and (2) analyze the performance of LT4 LS/SG versus tablet in the different administration regimens of patients
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