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All Journal Medical Journal of Indonesia Damianus Journal of Medicine Medicinus : Jurnal Kedokteran Cermin Dunia Kedokteran
Arini Setiawati
Departemen Farmakologi dan Terapi, Fakultas Kedokteran Universitas Indonesia
Health Professions Medicine & Pharmacology Public Health

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The importance of bioequivalence study: focus on clopidogrel Setiawati, Arini
Medical Journal of Indonesia Vol 20, No 2 (2011): May
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (50.636 KB) | DOI: 10.13181/mji.v20i2.445

Abstract

Bioequivalence (BE) study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown to be BE to the innovator product Plavix® and they contain API (active pharmaceutical ingredient) clopidogrel form 1 that complies with USP 30, 1997 requirements: the R-enantiomer content is not more than 1%. A proof that bioequivalence (BE) means therapeutic equivalence (TE) is also provided for cardiovascular drugs. Clopidogrel has 2 polymorphic forms, form 1 and form 2, which have the same indications. At least one pivotal study of clopidogrel, CAPRIE, used clopidogrel form 1. An atherothrombotic event may be associated with clopidogrel resistance, which occur in about 4 to 30% of patients treated with conventional doses of clopidogrel. (Med J Indones 2011; 20:149-53)Keywords: bioequivalent, clopidogrel
Venous thromboembolism in 13 Indonesian patients undergoing major orthopedic surgery Tambunan, Karmel L.; Hutagalung, Errol U.; Sukrisman, Lugyanti; Saleh, Ifran; Gunawan, S. B.; Sofyanuddin, Sofyanuddin; Setiawati, Arini
Medical Journal of Indonesia Vol 18, No 4 (2009): October-December
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (98.389 KB) | DOI: 10.13181/mji.v18i4.373

Abstract

Aim: To estimate the incidence of VTE in Indonesian patients undergoing major orthopedic surgery and not receiving thromboprophylaxis.Methods: This was an open clinical study of consecutive Indonesian patients undergoing major orthopedic surgery, conducted in 3 centers in Jakarta. Bilateral venography was performed between days 5 and 8 after surgery to detect the asymptomatic and to confi rm the symptomatic VTE. These patients were followed up to one month after surgery.Results: A total of 17 eligible patients were studied, which a median age of 69 years and 76.5% were females. Sixteen out of the 17 patients (94.1%) underwent hip fracture surgery (HFS). The median time from injury to surgery was 23 days (range 2 to 197 days), the median duration of surgery was 90 minutes (range 60 to 255 minutes), and the median duration of immobilization was 3 days (range 1 to 44 days). Thirteen out of the 17 patients were willing to undergo contrast venography. A symptomatic VTE was found in 9 patients (69.2%) at hospital discharge. Symptomatic VTE was found in 3 patients (23.1%), all corresponding to clinical signs of DVT and none with clinical sign of PE. These patients were treated initially with a low molecular weight heparin, followed by warfarin. Sudden death did not occur up to hospital discharge. From hospital discharge until 1-month follow-up, there were no additional cases of symptomatic VTE. No sudden death, bleeding complication, nor re-hospitalization was found in the present study.Conclusion: The incidence of asymptomatic (69.2%) and symptomatic (23.1%) VTE after major orthopedic surgery without thromboprophylaxis in Indonesian patients (SMART and AIDA), and still higher than the results of the Western studies. A larger study is required to establish the true incidence, and more importantly, that the use of thromboprophylaxis in these patients is warranted. (Med J Indones 2009; 18: 249-56)Keywords: venous thromboembolism (VTE), orthopedic surgery, Indonesia
Dissolution test of various low-dose acetylsalicylic acid preparations marketed in Indonesia Sumirtapura, Yeyet C.; Setiawati, Arini; Pamudji, Jessie S.; Rachmawati, Heni
Medical Journal of Indonesia Vol 18, No 3 (2009): July-September
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (389.626 KB) | DOI: 10.13181/mji.v18i3.355

Abstract

Aim To compare the dissolution profi les of various enteric-coated low-dose acetylsalicylic acid (ASA) tablets marketed in Indonesia.Methods The dissolution study was carried out according to US Pharmacocopoeiae (USP) /European Pharmacopoeiae, method A, using USP apparatus 1 (basket) 100 rpm, with 2 media: 0.1 N HCl, 120 minutes for acid stage, and phosphate buffer pH 6.8, 90 minutes for buffer stage. The sampling points were 120 minutes for the acid stage, and every 10 minutes until 90 minutes for the buffer stage. The acetylsalicylic acid was assayed using spectrophotometry at 280 nm for the acid stage, and at 265 nm for the buffer stage. The free salicylic acid was determined only at the end of the buffer stage with HPLC method. There were 6 test products (Cardio Aspirin® 100 mg, Aptor® 100 mg, Ascardia® 80 mg, Thrombo Aspilet® 80 mg, Astika® 100 mg and Farmasal® 100 mg), 3 batches for each product, and 6 units for each batch.Results The amount of ASA released from each ASA product tested at the end of acid stage (120 minutes) ranged from 1.79% for Cardio Aspirin® to 6.92% for Thrombo Aspilet®, all conformed to the compendial requirement for enteric-coated product (< 10%). The amount of salicylic acid observed at the end of the dissolution test ranged from 3.47% for Cardio Aspirin® to 10.90% for Astika® and 11.90 % for Thrombo Aspilet®. Thrombo Aspilet® showed sustained-release properties, causing high variability in ASA release, such that one of the 3 batches tested did not fulfill the compendial requirement of more than 75% (the release was only 55.11%). High variability in ASA release between batches was also found with Farmasal® at 10, 20, and 30 minutes in buffer medium. The lowest effective dose of ASA as an antiplatelet drug for longterm use is 75 mg of plain ASA, and this is equivalent to 100 mg of enteric-coated ASA.Conclusions All of the low-dose ASA preparations marketed in Indonesia are enteric-coated products, while Thrombo Aspilet® is not only an enteric-coated but also a sustained-release product. Cardio Aspirin®, followed by Aptor®, has the right dose for low-dose enteric-coated preparation (100 mg), produces consistent ASA release between batches,and the most stable towards deacetylation (antiplatelet inactivation). (Med J Indones 2009;18:159-64)Key words: Dissolution profile, enteric coated, deacetylation
Profil Respons Glukosa Darah dan Tingkat Rasa Kenyang setelah Pemberian Diabetasol® Dibandingkan Makanan Padat Gizi Terkontrol pada Pasien Diabetes Melitus tipe 2 Eliana, Fatimah; Handoko, Iwan Surjadi; Diah Ambarwati, Fransisca; Setiawati, Arini
Cermin Dunia Kedokteran Vol 45, No 7 (2018): Onkologi
Publisher : PT. Kalbe Farma Tbk.

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (637.545 KB) | DOI: 10.55175/cdk.v45i7.640

Abstract

Tujuan penelitian ini adalah untuk menentukan stabilitas kadar glukosa darah harian, tingkat kenyang, dan keamanan setelah menggunakan Diabetasol® dibandingkan dengan makanan padat dengan gizi terkontrol. Diabetasol® adalah makanan indeks glikemik rendah mengandung isomaltulosa, resisten dekstrin, dan inulin. Penelitian ini merupakan studi awal, prospektif, acak, terbuka, dan melibatkan 30 subjek DM tipe 2 pria dan wanita. Pengukuran glukosa darah dengan continuous glucose monitoring selama 48 jam di setiap kunjungan. Tingkat rasa kenyang diukur dengan kuesioner satiety quotient dengan visual analog scale (VAS) pada interval 0, 15, 30, 60, dan 120 menit. Evaluasi efek samping didasarkan pada terjadinya hipoglikemia dan masalah pencernaan selama masa pengobatan. Hasil penelitian menunjukkan respons glikemik Diabetasol® lebih rendah dibandingkan makanan padat gizi terkontrol kendati tidak bermakna, di lain pihak Diabetasol® memberikan rasa kenyang lebih lama tanpa efek samping serius.The purpose of this study was to determine the stability of daily blood glucose level, satiety level, and safety after using Diabetasol® in comparison with controlled nutrition solid food. Diabetasol® is low glycemic index foods contained of isomaltulose, resistant dextrin, and inulin. This study is a preliminary, prospective, randomized, open-ended study, and involving 30 male and female type 2 DM subjects. Blood glucose was measured with continuous glucose monitoring within 48 hours after every visit. The satiety level was measured with satiety quotient questionnaire with visual analog scale (VAS) at interval of 0, 15, 30, 60, and 120 minutes. The evaluation of side effects was based on the occurrence of hypoglycemia and digestive problems during the treatment period. Eventhough not stastistically significant, Diabetasol® leads to decreased glycemic response and longer satiety compared to controlled nutrition solid foods, with no serious side effects.
KADAR 2,3-DINOR-6-KETO-PROSTAGLANDIN-F1 DALAM URIN WANITA PASCAMENOPAUSE ALAMI DAN PRAMENOPAUSE YANG MINUM ASPIRIN 100 MG Arieselia, Zita; Setiawati, Arini; Setiabudy, Rianto; Baziad, Ali
Bahasa Indonesia Vol 10 No 2 (2011): Damianus Journal of Medicine
Publisher : Atma Jaya Catholic University of Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

Background: The prevalence of cardiovascular diseases in women increases sharply after menopause. In postmenopausal women, thromboxane production increases while prostacyclin production decreases. Low dose aspirin (75- 150 mg) has long been known as an antiplatelet aggregator. Aspirin reduces the production of both thromboxane (potent thrombocyte aggregator and vasoconstrictor) and prostacyclin (anti thrombocyte aggregator and potent vasodilator).Methods: The present study was an open-label clinical trial with 2 parallel groups. One group consisted of 15 premenopausal women (age > 40 years) while the other group 15 postmenopausal women (for 3 - 5 years). Twenty-four hours urine was collected from each subject before and after aspirin 100 mg daily for 7 days. The concentration of prostacyclin was measured as its metabolite (2,3-dinor-6-keto-prostaglandin-F1) in urine using EIA (Enzyme Immunoassay). Thromboxane as its urinary metabolites (11-dehidrotromboksan-B2) was also measured in these same urine samples in the previous study.Results: Previous study showed that aspirin significantly reduced thromboxane in both groups, with significantly larger percentage reduction in postmenopausal women compared to premenopausal women. Results of the present study showed that aspirin reduced prostacyclin significantly in both premenopausal women (mean difference = 78.44 ng/g creatinine; p = 0.001) and postmenopausal women (mean difference = 35.71 ng/g creatinine; p <0.001), but the percentage reduction between the groups was not significantly different (46,26% vs. 40,94%; p = 0,574). The decrease in thromboxane and prostacyclin should be compared (as the decrease in the ratio of 11-dehidrotromboksan-B2 / 2,3-dinor-6-keto-prostaglandin-F1) to assess aspirin efficacy as an antithrombotic. Calculation of the ratio of 11-dehidro-tromboksanB2 / 2,3-dinor-6-keto-prostaglandin-F1 before aspirin consumption was much higher in postmenopausal women compared to that in premenopausal women (4.09 vs. 1.13; p = 0.001). The decrease in 11-dehidro-tromboksan-B2 / 2,3- dinor-6-keto-prostaglandin-F1? ratio by aspirin was found much larger in postmenopausal women compared to that in premenopausal women (1.91 vs.0.17; p = 0.022).Conclusions: It was concluded that aspirin reduced prostacyclin significantly in each group with nonsignificant percentage reduction between groups, but reduced the 11-dehidro-tromboksan-B2/2,3-dinor-6-keto-prostaglandin-F1? ratio much larger in post-menopausal women compared to that in premenopausal women.
Randomized Trial Comparing Adjuvant Intravitreal Triamcinolone Acetonide 2mg and Bevacizumab 12,5mg for Diabetic Macular Edema Larasati, maria; Setiawati, Arini; Djatikusumo, Ari
Medicinus Vol. 7 No. 2 (2018): February 2018 - May 2018
Publisher : Fakultas Kedokteran Universitas Pelita Harapan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.19166/med.v7i2.1792

Abstract

ObjectivesTo evaluate the efficacy and safety of Intravitreal Triamcinolone Acetonide (IVTA) 2 mg and Bevacizumab (IVB) 12,5 mg for adjuvant therapy of Diabetic Macular Edema (DME)DesignThis was a prospective, randomized clinical trial. Each participants with DME was randomized to received single intravitreal injection of IVTA or IVB  and then being followed until fourth week after injection. The efficacy parameters were the improvement in Best Corrected Visual Acuity (BCVA) in logMAR and Standardized Central Macular Thickness (SCMT) by Optical Coherence Tomography. The safety parameters were the Intra Ocular Pressure (IOP) and Posterior Capsular cataract progression using LOCSIII criteria.ResultsTwenty five eyes of 20 participants were randomly assigned to receive IVTA 2 mg (n=12) and IVB (n=13). At 4 weeks, mean BCVA was better in IVTA group than in IVB group -0,39 logMAR (p<0,05). CMT reduction were significant in all visits of both groups. The SCMT showed 78,37%  at final follow-up for IVTA group. There were no statistic significant difference in the mean IOP and posterior capsular cataract changes among two groups. (p>0,05)ConclusionAdjuvant IVTA injections were more effective than IVB injections in patients with DME. However, it was associated with higher increment in IOP, despite not reaching statistical significance.
Co-Authors Ali Baziad Andhika Rachman Arif Abdillah Diah Ambarwati, Fransisca Dian Saraswati Djatikusumo, Ari Dwi R. Parwati Elise Kasakeyan Errol U. Hutagalung Faiz Faiz Fatimah Eliana, Fatimah Fitriyadi Kusuma Franciscus D. Suyatna Frans D. Suyatna Hadiarto Mangunnegoro Handoko, Iwan Surjadi Harmani Kalim HENI RACHMAWATI Ifran Saleh Ikhwan Rinaldi Iwan Darmansjah Iwin Sumarman Jan Susilo Jessie S. Pamudji Juan T. Sion Junita Indarti Karmel L Tambunan, Karmel L Karmel L. Tambunan Kris Pranarka Lugyanti Sukrisman Lukman H. Makmun Maria Marietta Bali Larasati Marina Hamadian Melva Louisa Metta S.S. Wiria Mulyarjo Mulyarjo Nafrialdi Nafrialdi Nina Irawati Nur A. Aroeman Rianto Setiabudy Robby Zulkarnain Roestiniadi D. Soemantri S. B. Gunawan Samsirun Halim Shufrie Effendi, Shufrie Sidartawan Soegondo Sofyanuddin Sofyanuddin Sri W.A. Jusman T. Djumhana Atmakusuma, T. Djumhana Tety H. Rahim Theresia G Kurniawan, Theresia G Wiguno Prodjosudjadi Yeyet C. Sumirtapura Zita Arieselia Zulkifli Alkaf