Hypothyroidism is an important endocrine disorder which is related to the low production of the thyroid hormone. It is thought to occur in around 0.3% of the population, but could be present in subclinical levels at around 8.5% (DiMasi et al., 2003). Schmidt et al. (2013) conducted a randomized controlled trial to investigate whether a combination of levothyroxine and levotriiodothyronine is more beneficial to monotherapy with levothyroxine in terms of quality of life. This study used a total of 26 participants with hypothyroidism, and used a double-blind randomized crossover method. It was thought that the brain may register the increased availability of levotriiodothyronine during combination therapy and that the peripheral tissue might be more stimulated during combination therapy than in monotherapy. This summary aims to give an overview of the methods and results of this evidence.
The 26 participants were sorted into two main groups using block randomization. The first 12 weeks of the study involved 50 μg of the usual T4 dose was replaced with either 20 μg T3 or 50 μg T4 (tablets were identical), followed by a crossover for another 12 weeks (Schmidt et al., 2013). All of the patients had overt and spontaneous forms of hypothyroidism, which meant that for inclusion the participants had to have serum TSH levels >20 mU/l, serum T4<60 nmol/l, and positive thyroid peroxidase antibodies (>60 U/ml) at the time of diagnosis (Schmidt et al., 2013). The levels of SHBG was measured using a standard ELISA assay, whilst NT-proBNP levels. Thyroid function was measured using standard enzyme immunoassays, whilst the levels of free T4 and T3 were measured by simple calculations that have previously been evaluated for reliability. The statistical analyzed were conducted using repeated measures ANOVA to ensure that any differences in results were significant enough to be valid.
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The results showed that levels of TSH did not change between groups, which means that both therapies are equally effective. It should also be noted that combination therapy is cheaper than monotherapy with levothyroxine, which makes this finding into a more viable option financially (Biondi & Wartofsky, 2012). Additionally, it was found that the SHBG levels increased in the combination therapy group when compared with the monotherapy group, suggesting an improved level of thyroid hormones overall. PINP levels were also higher in the combination group. Taking this information and combining it with the fact that combination therapies are cheaper to produce, this suggests that combination therapy is better on the three measures of cost, efficacy and quality that make a good drug. The results also suggest that it may be more beneficial to hypothyroid patients overall, without causing any problems with reduced TSH and NT-proBNP which have been associated with past treatments (Schmidt et al., 2013).
The overall conclusions of the study was that the combination therapy was much more beneficial in terms of peripheral tissues, which registered a different level of T3 availability when the participant was on the combination drug. It was also found that hepatic function and collagen production was increased, suggesting that the combination therapy might be better overall for quality of life (Schmidt et al., 2013). Schmidt et al. (2013) suggest that future research needs to focus on the formulation of prolonged T3 and testing these further in the clinical settings. Overall, the results show that hypothyroidism can be managed in the long-term by combinations of T3 and T4 therapy, and this study adds to previous data that has suggested this to be a possibility. Schmidt et al. (2013) note that the benefits of the findings of this study are overall unclear, but it does suggest future research directions and potential positives for hypothyroid patients.
The majority of endocrine diseases are chronic, which means that cost and efficacy are important considerations to make. If a patient needs to take the drug over an extended period of time, ensuring that the drug is low cost can help to increase adherence to medication schedules (DiMasi, Hansen & Grabowski, 2003). The drug also needs to be efficient, as this can help to lower costs by requiring lower doses at less frequent intervals. In the case of type 1 diabetes, for example, insulin needs to be taken regularly throughout the lifetime of the diabetic. If insulin was priced high, then a number of diabetics could not access the drug and therefore could be themselves in extreme danger. Current research is consistently trying to improve the cost and efficacy of type 1 diabetes medications because of this consideration (DiMasi et al., 2003).
Quality is important in any type of medication. When making decisions about the endocrine system, however, quality becomes related to the length of time that the individual is likely to require treatment (DiMasi et al., 2003). In many cases this is for life, which means that the quality needs to be high enough to prevent problems. Low quality drugs have more side-effects, which become dangerous the longer that the patient is taking the drug. To return to the example of type 1 diabetes, this could be taking insulin for life. If the insulin is of lower quality or has a low quality delivery system, this could put the patient’s health in danger. Healthcare professionals need to be aware of the quality of drugs when they are prescribing them to help prevent the problems associated with long-term adherence to lower quality medications, which is as true of endocrine system medications as other system medications (DiMasi et al., 2003).
