Multicenter Real-World Observational Study of Pargeverine/Lysine Clonixinate in Acute Visceral Colicky Pain

Background and objectives: Acute colicky abdominal pain, involving visceral spasms and inflammatory mechanisms, is a common complaint in everyday medical practice. Despite its widespread use, clinical evidence on the fixed-dose combination of pargeverine 10 mg plus lysine clonixinate 125 mg remains limited. The objective of this study was to describe real-world clinical outcomes, safety, and patient-reported experience associated with this combination in routine practice. Materials and methods: This multicenter, observational, non-comparative, real-world study included adult patients with acute colicky abdominal pain of gastrointestinal, urological, or gynecological origin. Pain intensity was assessed using a visual analog scale (VAS) at baseline and at 5 ± 3 days. Secondary outcomes included time to pain relief, satisfaction with treatment, and safety. Associations between pain reduction and patient-reported outcomes were explored. Results: A total of 202 patients were analyzed. Significant pain reduction was observed across all etiologies (p < 0.001), with median VAS reductions ranging from 6 to 9 points (approximately 70% to 90% from baseline). More than 95% of patients reported early improvement, and sustained relief was maintained in more than 96% throughout the study period, regardless of the pain’s origin. Adverse events were infrequent (3%), mild in intensity (primarily transient gastrointestinal symptoms), and did not lead to treatment discontinuation. Conclusions: In real-world clinical practice, the fixed-dose combination of pargeverine and lysine clonixinate was associated with early and sustained, clinically meaningful pain reduction across multiple forms of acute visceral colicky pain, with a favorable safety and tolerability profile, supporting its relevance as a short-term therapeutic option in mild to severe acute pain.