First-line FOLFIRI and bevacizumab in patients with advanced colorectal cancer prospectively stratified according to serum LDH: Final results of the GISCAD (Italian Group for the Study of Digestive Tract Cancers) CENTRAL (ColorEctalavastiNTRiAlLdh) trial

Background:Previous findings suggested that bevacizumab might be able to improve response rate (RR) in colorectal cancer patients with high lactic dehydrogenase (LDH) basal levels.Methods:We conducted a phase II trial to prospectively ascertain whether bevacizumab in combination with FOLFIRI could have an improved clinical activity in patients with high LDH serum levels. Primary end point of the study was RR; secondary end points were median overall survival and median progression-free survival (mPFS).Results:A total of 81 patients were enrolled. No difference in terms of ORR (39% vs 31% for low vs high LDH level stratum, P=0.78) and mPFS (14.16 vs 10.29 months, HR: 1.07, 95% CI: 0.51-2.24, P=0.83) between the strata was observed, whereas overall survival (OS) was significantly longer for patients with low LDH (24.85 vs 15.14 months, HR: 4.08, 95% CI: 1.14-14.61, P=0.0004). In a not-pre-planned exploratory analysis using different cut-off ranges for LDH, we observed RR up to 70%, with no improvement in progression-free survival or OS.Conclusions:The CENTRAL trial failed to demonstrate that high LDH levels were related to a significantly improved RR in patients receiving first-line FOLFIRI and bevacizumab. The LDH serum levels should then no further be investigated as a predictive factor in this setting

Association of kidney disease measures with risk of renal function worsening in patients with type 1 diabetes

Background: Albuminuria has been classically considered a marker of kidney damage progression in diabetic patients and it is routinely assessed to monitor kidney function. However, the role of a mild GFR reduction on the development of stage 653 CKD has been less explored in type 1 diabetes mellitus (T1DM) patients. Aim of the present study was to evaluate the prognostic role of kidney disease measures, namely albuminuria and reduced GFR, on the development of stage 653 CKD in a large cohort of patients affected by T1DM. Methods: A total of 4284 patients affected by T1DM followed-up at 76 diabetes centers participating to the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD) initiative constitutes the study population. Urinary albumin excretion (ACR) and estimated GFR (eGFR) were retrieved and analyzed. The incidence of stage 653 CKD (eGFR < 60 mL/min/1.73 m2) or eGFR reduction > 30% from baseline was evaluated. Results: The mean estimated GFR was 98 \ub1 17 mL/min/1.73m2 and the proportion of patients with albuminuria was 15.3% (n = 654) at baseline. About 8% (n = 337) of patients developed one of the two renal endpoints during the 4-year follow-up period. Age, albuminuria (micro or macro) and baseline eGFR < 90 ml/min/m2 were independent risk factors for stage 653 CKD and renal function worsening. When compared to patients with eGFR > 90 ml/min/1.73m2 and normoalbuminuria, those with albuminuria at baseline had a 1.69 greater risk of reaching stage 3 CKD, while patients with mild eGFR reduction (i.e. eGFR between 90 and 60 mL/min/1.73 m2) show a 3.81 greater risk that rose to 8.24 for those patients with albuminuria and mild eGFR reduction at baseline. Conclusions: Albuminuria and eGFR reduction represent independent risk factors for incident stage 653 CKD in T1DM patients. The simultaneous occurrence of reduced eGFR and albuminuria have a synergistic effect on renal function worsening

KEJADIAN EFEK SAMPING PEMBERIAN PRAZIQUANTEL DALAM PROGRAM POPM SCHISTOSOMIASIS PADA MASYARAKAT DESA DODOLO LEMBAH NAPU SULAWESI TENGAH

KEJADIAN EFEK SAMPING PEMBERIAN PRAZIQUANTEL DALAM PROGRAM POPM SCHISTOSOMIASIS PADA MASYARAKAT DESA DODOLO LEMBAH NAPU SULAWESI TENGAH Rahmawati R. Daris*, Ayu Sekarani Damana Putri**, Rabiatul Adawiyah*** *Mahasiswa Kedokteran, Fakultas Kedokteran Universitas Tadulako **Departement Parasitologi Program Studi Kedokteran, Fakultas Kedokteran Universitas Tadulako ***Departement Biokimia Program Studi Kedokteran, Fakultas Kedokteran Universitas Tadulako ABSTRAK Latar Belakang: Schistosomiasis adalah penyakit yang disebabkan karena infeksi cacing dalam genus schistosoma. Pada tahun 1935 pertama kali diidentifikasi schistosomiasis pada manusia di Indonesia. Upaya penanggulangan dilakukan oleh pemerintah sejak tahun 1974 melalui pemberian obat massal praziquantel kepada penderita dan keluarga oleh Departemen Kesehatan Sulawesi Tengah. Prevalensi schistosomiasis pada manusia di Lembah Napu mengalami fluktuasi dalam lima tahun terakhir (2013-2017). Namun, hingga saat ini schistosomiasis belum mampu dieradikasi sehingga tahun 2018 pemerintah Indonesia menerapkan pendekatan pengobatan baru, yakni dengan memberikan pengobatan praziquantel secara massal bagi seluruh warga yang berusia >5 tahun di wilayah desa Dodolo Lembah Napu Sulawesi Tengah. Program POPM saat ini dilakukan pemerintah diduga dapat menimbulkan kejadian efek samping pasca pemberian praziquantel, sehingga melatarbelakangi penulis untuk melakukan penelitian tentang kejadian efek samping pemberian praziquantel dalam program POPM schistosomiasis pada masyarakat desa Dodolo Lembah Napu Sulawesi Tengah. Tujuan: Mengetahui gambaran efek samping pemberian praziquantel dalam program POPM schistosomiasis pada masyarakat desa Dodolo Lembah Napu Sulawesi Tengah. Metode: Jenis penelitian ini adalah deskriptif dengan mengetahui gambaran kejadian efek samping pemberian praziquantel dalam program POPM schistosomiasis. Hasil: Efek samping pasca mengkonsumsi praziquantel menunjukan efek samping mual adalah efek samping tertinggi dirasakan oleh 69 responden (87,34%) diikuti dengan efek samping muntah dirasakan oleh 57 responden (72,15%) dan efek samping penglihatan kabur adalah efek samping terendah dirasakan oleh 9 responden (11,39%). Kesimpulan: Kejadian efek samping pemberian praziquantel dalam program POPM schistosomiasis di desa Dodolo Lembah Napu Sulawesi Tengah tertinggi adalah mual yang dirasakan oleh 69 responden. Kata Kunci: efek samping, praziquantel, POPM, schistosomiasis ADVERSE DRUG REACTION FOLLOWING PRAZIQUANTEL CONSUMPTION IN SCHISTOSOMIASIS MASS DRUGS ADMINISTRATION IN DODOLO VILLAGE, NAPU VALLEY CENTRAL SULAWESI Rahmawati R. Daris*, Ayu Sekarani Damana Putri**, Rabiatul Adawiyah*** *Medical students, Faculty of Medicine, Tadulako University **Department of Parasitology Medical Study Program, Medical Faculty of Tadulako University ***Department of Biochemistry Medical Study Program, Medical Faculty of Tadulako University ABSTRACT Background: Schistosomiasis is disease caused by worm infection in genus schistosoma. Schistosomiasis said to be zoonic disease because it can infect not only humans, but also other animals beloging to mammals. In 1935 schistosomiasis was first identified in humans in Indonesia. Prevention efforts have been initiated since 1940, after the discovery of schistosomiasis. Countermeasures have been carried out by the goverment since 1974 through mass admission of praziquantel to sufferers and their families by the ministry of Health Central Sulawesi. The prevalence of schistosomiasis humans in Napu Valley experienced fluctuation in the last five years (2013-2017). Howefer, until now schistosomiasis han’t been able to be eradicated so that in 2018 the government of Indonesia implement a new treatment approach by providing mass praziquantel treatment for all people aged >5 years of age living in schistosomiasis endemic areas, one of them is Dodolo Valley Napu, Central Sulawesi. The POPM program currently being carried out by the government is suspected to cause side effect after the administration of praziquantel, so it raises author’s interest to conduct a study of the occurrence of praziquantel side effect in schistosomiasis POPM program in Dodolo Valley communities, Napu Valley, Central Sulawesi. Objective: To describe the side effects of praziquantel consumption in schistosomiasis POPM programs in Dodolo Valley communities in Napu Valley, Central Sulawesi. Method: This is a descriptive research by describing the incidence of praziquantel side effect experienced by 69 respondents (87,34%) followed by vomiting experienced by 57 respondents (72,15%). Results: Distribution of side effects after consuming praziquantel shows nausea is the highest side effect experienced by 69 respondents (87,34%) and vomiting side effect felt by 57 respondents (72,15%). Conclusion: Highest side effects after administration of praziquantel in the schistosomiasis POPM in DodoloValley Napu village in Central Sulawesi is nauseous, experienced by 69 respondents. Keywords: side effects, praziquantel, POPM, schistosomiasi