Efficacy and safety of oral minocycline hydrochloride 40 mg extended-release capsules (DFD-29) versus doxycycline in rosacea: a systematic review and meta-analysis.

BACKGROUND

Rosacea is a chronic skin disorder characterized by facial erythema, telangiectasias, papules and pustules. Guidelines recommend subantimicrobial doses of drugs such as doxycycline 40 mg. In patients with persistent symptoms, evaluating the efficacy and safety of subantimicrobial doses of minocycline may expand treatment options.

OBJECTIVES

To evaluate minocycline hydrochloride 40 mg extended-release capsules (formerly known as and hereafter referred to as DFD-29) as a low-dose tetracycline alternative to treat rosacea.

METHODS

Our analysis included data from three randomized controlled trials sourced from the PubMed, Embase and Cochrane databases to compare Investigator Global Assessment treatment success (IGA-TS) scores, reduction in inflammatory lesion counts, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients using DFD-29 vs. modified-release doxycycline. Statistical analyses were conducted using RStudio.

RESULTS

In a pooled analysis of 643 patients, DFD-29 significantly increased the likelihood of achieving a successful IGA-TS score compared with doxycycline [odds ratio (OR) 2.51, 95% confidence interval (CI) 1.80-3.49; P < 0.001; I2 = 0%]. The DFD-29 40 mg group had significantly greater reductions in IGA-TS scores compared with the DFD-29 20 mg group (P = 0.02). The DFD-29 40 mg group also exhibited a significantly greater reduction in inflammatory lesion counts than the doxycycline group (mean difference -4.56, 95% CI -6.18 to -2.93; P < 0.001), whereas the DFD-29 20 mg group showed no significant reduction. There were no significant differences in TEAEs across groups (OR 0.96, 95% CI 0.55-1.66; P = 0.87; I2 = 0%), with just one SAE (atrial fibrillation) reported with DFD-29.

CONCLUSIONS

Our meta-analysis showed that DFD-29 at 40 mg daily is a superior, well-tolerated alternative to modified-release doxycycline for moderate-to-severe rosacea.