Dutasteride 500microgram capsules

Nowadays androgenetic alopecia (AGA) has become a common concern of affected subjects of both sexes. Finasteride is approved by the Food and Drug Administration for the treatment of male AGA. There is no clear evidence to support the use of dutasteride in male AGA. In female AGA, the effectiveness of dutasteride and finasteride is still under debate, and there is no clear evidence to use any of them in female AGA. A systematic review was conducted to compare dutasteride and finasteride in treating both male and female AGA and their efficacy, safety, and side effects with effective dosage. The review was done using several databases including: PubMed, Ovid Medline, Google Scholar, and Cochrane, using the following search terms/key words: "Dutasteride", "Finasteride", "Male pattern hair loss", "Female pattern hair loss", "Efficacy", "Tolerability", "Side effects", and "Comparison". Articles related to the efficacy, tolerability, and side effects of dutasteride and finasteride in the treatment of male and female AGA were specifically sought, considering the doses used for each medication. The review encompassed a total of nine studies. Four randomized controlled trials, one single-arm trial, two prospective cohorts, and two retrospective cohort studies. Seven studies exclusively enrolled male participants, while only two included female participants. All groups receiving various doses of dutasteride and finasteride exhibited a significant increase in hair count compared to the placebo group. Notably, dutasteride (0.5 mg) and dutasteride (2.5 mg) were significantly more effective than finasteride (1 mg) in increasing hair counts. Furthermore, no significant difference in adverse events was observed between finasteride and dutasteride. Dutasteride is more potent than finasteride in treating AGA in both males and females. All the adverse events between finasteride and dutasteride were comparable.

Abstract licence: CC BY-NC

BACKGROUND: Salivary duct carcinoma (SDC) is a rare and aggressive subtype of salivary gland cancer, frequently associated with incurable recurrences and distant metastases (R/M). Proliferation of SDC relies on androgen receptor (AR) signalling, prompting the use of combined androgen blockade (CAB, i.e., luteinizing hormone-releasing hormone agonist and/or AR antagonists) to R/M SDC patients. However, only a subset of patients benefits from such treatments. We have shown that response to CAB is associated with steroid 5α-reductase 1 (SRD5A1) mRNA expression. SRD5A1 catalyses the intracellular conversion of testosterone into the more potent AR-agonist dihydrotestosterone. This conversion can be inhibited by dutasteride, a potent SRD5A1-inhibitor, which is currently prescribed for benign prostatic hyperplasia. We hypothesize that repurposing dutasteride to target AR signalling in SDC could enhance therapeutic response and clinical outcome in SDC patients. METHODS: This prospective, open-label, randomized controlled phase II clinical trial, is designed to investigate whether dutasteride as an adjunct drug to CAB improves response rate and clinical outcome in patients with AR-positive R/M SDC. Patients are divided in two cohorts based on their prior systemic treatments. In cohort A, CAB-naïve patients (n = 74) will be randomly assigned to either a control arm (Arm 1) receiving CAB (goserelin 10.8 mg/3m and bicalutamide 50 mg/OD) or an experimental arm (Arm 2) where dutasteride (0.5 mg/OD) is added to the CAB regimen. In cohort B, patients with disease progression after adjuvant or first-line palliative CAB therapy (max. n = 24) will receive goserelin, bicalutamide, and dutasteride to assess whether the addition of dutasteride can overcome therapy resistance. The primary endpoints are the objective response rate and duration of response. Secondary endpoints are progression-free survival, overall survival, clinical benefit rate, quality of life, and safety. Translational research will be performed to explore molecular target expression differences and their correlation with clinical outcome. DISCUSSION: The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial's findings could be readily applied into clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05513365. Date of registration: August 24, 2022. PROTOCOL VERSION: Current protocol version 4.0, February 21, 2024.

Abstract licence: CC BY