Viewing Study NCT06408909



Ignite Creation Date: 2024-05-11 @ 8:30 AM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06408909
Status: COMPLETED
Last Update Posted: 2024-05-13
First Post: 2024-05-07

Brief Title: Pharmacist Role in Thyroid Disorders
Sponsor: Istanbul University - Cerrahpasa IUC
Organization: Istanbul University - Cerrahpasa IUC

Study Overview

Official Title: Evaluation of the Clinical Pharmacists Effect in Achieving Treatment Goals in Hypothyroid Patients
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Hypothyroidism HoT treatment involves lifelong thyroxine replacement therapy and regular monitoring The objective of this study was to assess the impact of clinical pharmacist CP intervention in managing drug-related problems DRPs on outcomes among hypothyroid patients receiving levothyroxine LT4 therapy
Detailed Description: The first choice in the treatment of hypothyroidism HoT is replacement therapy with levothyroxine LT4 Factors other than the use of the drug are as crucial as the use of LT4 at the right time and in the right way Drugs used by patients other than LT4 comorbidities diet age and weight of the patient also affect the benefit seen from LT4 treatment

LT4 which has a narrow therapeutic index may cause drug-related problems DRP such as non-adherence to treatment the timing of drug use inappropriate use of the drug inadequate therapeutic dose duration of treatment inadequate monitoring of treatment and potential drug-drug interactions pDDI In a study conducted in a hospital in India DRP encountered during treatment with narrow therapeutic index drugs were compared with DRP encountered with other drugs It was reported that DRPs were associated with pDDIs adverse effects dose overdose dose underdose untreated indications inappropriate drug use unnecessary drug use and patient-related factors In the study in which LT4 was also included the rate of DRPs to narrow therapeutic index was 22 and the rate of DRPs to other drugs was reported to be 8 In a study documenting the interventions of pharmacists in hospitals in Germany the interventions made between 2009 and 2012 were analyzed LT4 was one of the ten drugs with the highest number of problems and half of these problems were drug interactions and the inadequate therapeutic dose in patients with organ failure

Aluminum hydroxide bile acid secretagogues calcium polystyrene sulphonate sodium polystyrene sulphonate calcium salts iron preparations multivitamin supplements containing iron lanthanum carbonate sevelamer magnesium salts orlistat and raloxifene cause D-level drug interactions with LT4 In the concomitant use of calcium salts with LT4 it is observed that LT4 absorption and consequently therapeutic effect decreases 89 In a systematic review of the concomitant use of LT4 and proton pump inhibitors PPI in hypothyroid patients with dyspepsia gastroesophageal reflux or peptic ulcer a statistically significant increase in thyroid-stimulating hormone TSH levels was observed

Since the therapeutic index of the LT4 drug is narrow it emphasizes the importance of adherence to the drug in reaching ideal TSH levels Medication adherence is a dynamic process closely linked to treatment outcomes in patients with chronic diseases Very few studies exist on LT4 treatment and patient adherence to treatment In their study Yavuz et al emphasized that almost half of HoT patients had serum TSH values outside the reference range despite receiving LT4 treatment and that adherence with LT4 treatment was one of the most critical determinants in reaching target TSH levels

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None