Barnidipine as a potential alternative treatment for Raynaud's phenomenon secondary to systemic sclerosis: a retrospective pilot study.

OBJECTIVES

To assess short-term barnidipine efficacy and tolerability on Systemic Sclerosis (SSc)-Raynaud's phenomenon (RP).

METHODS

We retrospectively evaluated patients with SSc starting barnidipine 10 mg/day. Raynaud's Condition Score (RCS) and mean blood pressure (MBP) were assessed at baseline and 6-month follow-up. Discontinuation rates and adverse events (AEs) were compared with retrospectively evaluated patients who started MR-nifedipine 20 mg/day at our centre.

RESULTS

Sixty-four patients (29 barnidipine, 35 MR-nifedipine) were evaluated. Most patients starting barnidipine had a previous CCB exposure (69%; 57.9% of these were withdrawn for AEs). During follow-up, RCS decreased significantly (6.6 ± 1.8 vs 4.4 ± 1.8, p < 0.001), while the MBP did not change significantly (86.4 ± 8.4 vs 85 ± 7.3 mmHg; p = 0.36). Nine patients (31%) discontinued barnidipine during the follow-up (AEs 6/9, inefficacy 3/9). Previous CCB failure did not predict barnidipine withdrawal (OR = 0.188 95%CI [0.02-1.8]; p = 0.147). No predictors of barnidipine withdrawal were found, and no clinical or demographic differences were found between patients withdrawing and continuing barnidipine. The 6-month retention rates of barnidipine and MR-nifedipine did not differ significantly (69 vs 80%; log-rank p = 0.23), and the two groups had a similar incidence of AEs leading to discontinuation (20.1 vs 17%; p = 0.48).

CONCLUSIONS

Barnidipine could be an effective and well-tolerated therapeutic option to treat SSc-RP, even in patients previously failing other CCBs. Key Points • Calcium channel blockers (CCBs) currently represent the first-line treatment for Raynaud's phenomenon secondary to Systemic Sclerosis (SSc-RP). However, little data exists about using novel CCBs, such as barnidipine, in this condition. • This study retrospectively evaluated patients with SSc-RP treated with barnidipine to assess its short-term efficacy. To serve as a control group for tolerability, we retrospectively compared these patients with others starting modified release-nifedipine (MR-nifedipine). • In patients treated with barnidipine, we observed a significant decrease in Raynaud's condition score at the 6-month follow-up without substantial changes in mean blood pressure. • The proportion of adverse events and drug withdrawal rate between patients starting barnidipine and MR-nifedipine did not differ significantly, even in patients starting barnidipine after previously failing other CCBs.