Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study.

Context: Moderate to severe interstitial cystitis (also known as bladder pain syndrome) is a disabling disease with no effective treatment. Although pentosan polysulfate is an approved treatment for interstitial cystitis, some patients on this medication experience treatment failure after one year, and its long-term use has been linked to pigmentary maculopathy. The peptide Body Protective Compound 157 (BPC-157) is a possible treatment for interstitial cystitis but is currently not approved by the US Food and Drug Administration. Objective: To assess the safety and efficacy of BPC-157 manufactured by a 503A compounding pharmacy as a treatment for interstitial cystitis. Participants: Twelve women between the ages of 39 and 76 years with a mean age of 58.3 years participated in this trial at a private clinic. Of these, 10 were White, one was Asian, and one was Latina. None of the 12 women had responded to pentosan polysulfate. Methods: The women underwent cystoscopy and were treated with injections of the peptide BPC-157 (total of 10 mg) around the area of inflammation of the bladder during a single procedure. Global Response Assessment questionnaire was given to all the subjects to assess the efficacy of BPC-157. Results: Complete resolution of symptoms after one treatment was reported in 10 of 12 patients, who rated their success at 100%. The remaining 2 of 12 patients rated their success at 80%, with most symptoms resolved but about 20% of their symptoms lingering. No one dropped out of the study, and no adverse events were reported. This therapy was successful because all 12 patients scored a 5/5 on the Global Response Assessment. Conclusion: This is the first report of intravesical BPC-157 (10 mg) injection to help patients with moderate to severe interstitial cystitis who did not respond to pentosan polysulfate treatment.

Continuous mechanical aspiration thrombectomy performs equally well in main versus branch pulmonary emboli: A subgroup analysis of the EXTRACT-PE trial.

INTRODUCTION: The EXTRACT-PE trial evaluated the safety and performance of the Indigo Aspiration System (Penumbra Inc.) with an 8F continuous mechanical aspiration thrombectomy system for the treatment of pulmonary embolism (PE). This subgroup analysis evaluates performance outcomes of patients with main pulmonary artery (PA) emboli versus discrete unilateral or bilateral PA emboli without main PA involvement. METHODS: The EXTRACT-PE trial was a prospective, single-arm, multicenter trial that enrolled 119 patients with acute submassive PE. Emboli location was collected at the time of enrollment, CT obstruction was measured and assessed by a Core Lab, and patients were grouped on whether emboli involved the main PA (with or without branch vessels) or not (branch vessels alone). Procedural device time, changes in the right ventricle to left ventricle (RV/LV) ratio, and systolic PA pressure from pre-and posttreatment were compared between the two groups. RESULTS: Out of the 119 patients enrolled, 118 had core lab-assessed clot locations. Forty-five (38.1%) had emboli that involved the main PA and 73 (61.9%) had only branch emboli. No significant difference was observed between these groups for 30-day mortality, procedural device time, changes in RV/LV ratio, reduction in CT Obstruction Index, or for systolic PA pressure from pre-and posttreatment. The mean absolute reduction in clot burden was significant in both groups. CONCLUSION: Continuous mechanical aspiration thrombectomy with the 8F Indigo Aspiration System was effective at improving clinical outcomes for submassive PE patients regardless of emboli location, and clot burden was significantly reduced in both groups.