CO 022: EFFICACY AND SAFETY OF RECOMBINANT STREPTOKINASE VERSUS HYDROCORTISONE ACETATEBASED SUPPOSITORIES IN THE TREATMENT OF HEMORRHOIDAL DISEASE. RANDOMIZED, CONTROLLED TRIAL (THERESA-4 STUDY)

J Pharm Pharmacogn Res 2(Suppl. 1): S11, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 022: EFFICACY AND SAFETY OF RECOMBINANT STREPTOKINASE VERSUS HYDROCORTISONE ACETATEBASED SUPPOSITORIES IN THE TREATMENT OF HEMORRHOIDAL DISEASE. RANDOMIZED, CONTROLLED TRIAL (THERESA-4 STUDY)

Hernández-Bernal F1, Castellanos-Sierra G2, Valenzuela-Silva CM1, Catasús-Álvarez KM1, Martínez-Serrano O3, Lazo-Diago OC1, CausaGarcía JR4, Domínguez-Suárez JE5 and López-Saura PA1 for the THERESA-4 (Treatment of HEmorrhoids with REcombinant Streptokinase Application) Group of Investigators.

1Center for Genetic Engineering and Biotechnology, La Habana, Cuba.
2“Juan B. Zayas” Hospital, Santiago de Cuba.
3“Ernesto Guevara” Hospital, Las Tunas, Cuba.
4“Celia Sánchez” Hospital, Manzanillo, Granma, Cuba. , Cuba 5“Gustavo Aldereguía” Hospital, Cienfuegos, Cuba.
Abstract

Introduction: The aim of this study was compare the efficacy and safety of two schedules of recombinant streptokinase (rSK) suppositories and a hydrocortisone acetate-based suppository (Anusol-HC®), for the treatment of acute hemorrhoidal disease.

Material and methods: A multicenter (11 sites), randomized (1:1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK (200000 IU, schedules A or B) or Anusol-HC® (25 mg hydrocortisone acetate) suppositories, which had different organoleptic characteristics. rSK was administered by the rectal route, three units, one every 8 hours, and then five units, one every 12 hours (schedule A) or six units, one every 8 hours (schedule B). Anusol-HC® suppositories were given every 8 hours up to a maximum of 24 administrations according to the product label. Evaluations were performed at 3, 5 and 10 days postinclusion. The main end-point was the 5th-day response (disappearance of pain and bleeding, and ≥70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too.

Results: Response rates were 156/170 (91.8%) and 155/170 (91.2%) with rSK schedules A and B, respectively, which were significantly larger (p<0.001) than with Anusol-HC® suppositories (46/170; 27.1%). Time for response were significantly shorter (p<0.001; log-rank test) in the rSK groups (median: 3 days) with respect to the active control (median: 10 days). Thrombectomy was necessary in 2/122 and 2/129 with baseline thrombosis in the rSK schedules A and B, respectively vs. 14/133 in the Anusol-HC® group (p=0.001). There were no adverse events attributable to the experimental treatment.

Conclusion: rSK suppositories showed a significant advantage over the widely used over-the-counter Anusol-HC® for the treatment of acute hemorrhoidal illness, with an adequate safety profile.