Retroperitoneal fibrosis and ß-blocking agents: Is there an association?

AIMS: Retroperitoneal fibrosis (RPF) is a rare chronic fibro-inflammatory disorder that may be secondary to certain drugs, including ß-blocking agents (BBAs). However, their causative role is unclear. We aimed to investigate this association. METHODS: Disproportionality analysis was carried out on cases from 1985 to 4 October 2020 in VigiBase, the World Health Organization pharmacovigilance database. The Bayesian-based IC025 metric and reporting odds ratio were used in order to assess the adverse event signal. We also analysed all published case reports from the literature regarding BBA-associated RPF to assess the value of suggested supportive clinical evidence. RESULTS: In total, 1599 individual case safety reports of RPF were reported to VigiBase, of which 132 (32%) concerned 16 different single BBA. For 12 of these agents (75%), reporting of RPF was disproportionate, indicating a potential safety signal. Line listing analysis of individual case safety reports showed no consistent time interval from start of BBA to RPF diagnosis (range 0.7-264 mo). Dechallenge was negative or unknown in the majority of cases (74%). In 18 published cases from the literature, time from start of BBA to RPF diagnosis varied widely (range 3-156 mo). BBA were discontinued 6 months before (n = 1) or at the time of RPF diagnosis (n = 17). Most patients (84%) also received RPF specific treatment. Follow-up duration was short (median 5 mo [range 1-24 mo]) and in most cases (83%) relevant follow-up data were lacking. CONCLUSION: Although disproportionality analysis indicated a potential safety signal for RPF associated with BBAs, clinical evidence did not support a cause-and-effect relationship.

Prognostic impact of low muscle mass and low muscle density in patients with diffuse large B-cell lymphoma.

Low muscle mass (LMM) and low muscle density (LMD) are increasingly recognized as prognostic factors for survival in different malignancies. This study determined the association of LMM and LMD with survival in DLBCL (diffuse large B-cell lymphoma) patients. CT-based measurement of muscle was performed in 164 DLBCL patients prior to chemo-immunotherapy. Z-scores adjusted for gender, age, and body mass index were derived from a healthy reference population. LMM or LMD were defined as a Z-score below -1 and were related to OS and PFS. The co-existence of both LMM and LMD was observed in 13% of the DLBCL patients and was significantly associated with shorter OS and PFS. Also, these patients more often did not complete the planned treatment. The combination of LMM and LMD is an independent prognostic factor for survival in DLBCL patients. This may guide clinical decision-making in patients with suspected insufficient performance to benefit from chemo-immunotherapy in standard doses.Key pointsPatients with DLBCL have low muscle mass (LMM) and low muscle density (LMD) compared to healthy counterparts.The combination of LMM and LMD is a negative prognostic factor for survival, independent of comorbidities and unfavorable lymphoma characteristics.