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All Journal Medical Journal of Indonesia Cermin Dunia Kedokteran

Arini Setiawati

Departemen Farmakologi dan Terapi, Fakultas Kedokteran Universitas Indonesia

Author-ID : 377210

Health Professions Medicine & Pharmacology Public Health

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Safety and tolerability of moxifloxacin in the treatment of respiratory tract infections: a post-marketing surveillance conducted in Indonesia Setiawati, Arini; Darmansjah, Iwan; Mangunnegoro, Hadiarto
Medical Journal of Indonesia Vol 14, No 1 (2005): January-March
Publisher : Faculty of Medicine Universitas Indonesia

Moxifloxacin 400 mg tablet has been marketed in Indonesia for several indications, i.e. acute exacerbation of chronic bronchitis (AECB), community-acquired pneumonia (CAP), and acute bacterial sinusitis (ABS). To assess the safety and tolerability of moxifloxacin, a post-marketing surveillance study was conducted in the year 2001 involving 589 physicians. Clinical efficacy was also evaluated, both by physicians and patients, using a 6-symptom total score, which was scaled 0-12. A total of 1715 patients with acute sinusitis, CAP, AECB, and other infections were treated with oral moxifloxacin 400 mg once daily. There were 151 (8.8%) patients with adverse events (AEs) and 5 (0.29%) patients with serious adverse events (SAEs) that were considered related to moxifloxacin treatment. The most common adverse reactions were nausea (4.96%), dizziness (1.52%), vomiting (0.64%), headache (0.47%), and weakness (0.47%). Twenty three (1.34%) patients discontinued treatment due to adverse events. Tolerance to treatment was rated very good and good by 647 (37.7%) and 919 (53.6%) of patients, respectively. Based on physiciansâ clinical assessment, 57.7% of patients were cured and 39.9% were improved at the end of treatment. Mean total symptom score, as assessed by the patients, decreased from 6.43 on day-1 to 2.76 on day-3. Totally, 95.3% of patients felt better after receiving moxifloxacin and 97.6% of patients had good impression on moxifloxacin treatment. In conclusion, treatment of respiratory tract infections, mainly AECB, CAP and ABS, with moxifloxacin 400 mg once daily in this post-marketing surveillance was shown to be safe and well tolerated. Moxifloxacin was also shown to be highly effective in the treatment of these infections with rapid improvement of symptoms. (Med J Indones 2005; 14: 11-19)Keywords : post-marketing survtillance, PMS, moxifloxacin, respiratory tract infections

Interaction of erythromycin and clarithromycin with orange juice Setiawati, Arini; Wiria, Metta S.S.; Suyatna, Franciscus D.; Sion, Juan T.; Hamadian, Marina
Medical Journal of Indonesia Vol 14, No 2 (2005): April-June
Publisher : Faculty of Medicine Universitas Indonesia

Concomitant administration of orange juice with fexofenadine has been found to decrease the bioavailability of fenofenadine to less than 30% via inhibition of organic-anion transporting polypeptide (OATP), a drug uptake transporter expressed in organs such as liver, kidney and intestine. Erythromycin and clarithromycin are substrates and inhibitors of CYP3A4, a drug metabolizing enzyme in the liver and enterocytes, and P-glycoprotein (P-gp), a drug efflux transporter expressed in the same organs as OATP. Since an extensive overlap exists between substrates and inhibitors of CYP3A4, P-gp and OATP transporters, we want to study the effect of coadministration of our local orange (Siam orange) juice on the bioavailability of the above antibacterials. We conducted two 2-way cross-over randomized studies, one study for each antibacterial (500 mg), crossed between administration with orange juice (200 ml) and with water, in 12-13 healthy subjects per study. The serum concentrations of the antibacterials were assayed by microbiological method. The mean (range) ratio of AUC0-t with orange juice/with water were as follows : erythromycin : total (n=13) 81.7 (9.7-193.8)%, unchanged (n=4) 96.4 (80.5-107.9)%, decreased (n=6) 31.9 (9.7-49.0)%, increased (n=3) 161.8 (134.6-193.8)%; clarithromycin : total (n=12) 91.4 (20.6-158.3)%, unchanged (n=5) 103.1 (80.9-123.0)%, decreased (n=4) 34.8 (20.6-64.3)%, increased (n=3) 147.2 (132.9-158.3)%. It was concluded that coadministration of Siam orange juice with erythromycin or clarithromycin produced unpredictable effects on the bioavailability of these antibacterials in individual subjects, with marked decreases in almost half of the subjects, although in totals the effects were not statistically significant. (Med J Indones 2005; 14: 78-86)Keywords: interaction, erythromycin, clarithromycin, orange juice.

Clinical efficacy and tolerability of mometasone furoate nasal spray in perennial allergic rhinitis patients : an open multicentre study Darmansjah, Iwan; Setiawati, Arini; Sumarman, Iwin; Mulyarjo, Mulyarjo; Kasakeyan, Elise; Aroeman, Nur A.; Soemantri, Roestiniadi D.; Irawati, Nina; Rahim, Tety H.
Medical Journal of Indonesia Vol 11, No 2 (2002): April-June
Publisher : Faculty of Medicine Universitas Indonesia

Mometasone furoate (MF) aqueous nasal spray has been shown to be effective and well-tolerated in the treatment of perennial allergicÂ rhinitis (PAR). All of the sudies, however, have been conducted in Canada, UK, and Europe. Therefore, a bridging study is warranted inÂ view of the different climatic conditions in tropical countries. To evaluate the clinical efficacy and tolerability of MF aqueous nasal spray inÂ the treatment of PAR in a tropical country. This study was an open, non comparative, 4-week 3-centre trial in outpatients of 12 to 60 yearsÂ with moderate to severe PAR of at least 2 years duration. Patients were allergic to at least one major PAR allergen, confirmed by skin prickÂ test. They had total nasal symptom score (TNSS) of â¥Â 6 and nasal congestion score (NCS) of â¥Â 2 on â¥Â 3 diary time points prior to baselineÂ visit and at both screening and baseline visits. Eligible patients received MF aqueous nasal spray at baseline visit, and administered 200 ÂµgÂ mometasone every morning for 4 weeks. The primary clinical efficacy parameter was the mean percentage reduction of TNSS fromÂ baseline. Of 100 eligible patients, all completed this 4-week trial. The patient-evaluated TNSS (sum of the Last 3 mornings) decreasedÂ signiftcantly from baseline with a mean reduction of 60.9 % (p < 0.0001,) at week-2 and 73.6 % (p < 0.0001) at week-4. The meanÂ reductions in physician-rated TNSS (61.7 % at week-2 and 77.8 % at week-4) were higher than those in the previous studies (43 % and 51Â % at week-2, 52 % and 54 % at week-4). Similar trends were observed for nasal congestion score (NCS), other individual symptoms, totalÂ symptoms, and clinical efficacy rates. Evening symptoms were reduced similarly as morning symptoms There was no withdrawal due toÂ adverse event. MF aqueous nasal spray, at a dose of 200 Âµg once daily in the morning for the treatment of moderate to severe PAR in aÂ tropical country, was clinically effective with 24-hour control of PAR symptoms, and was well tolerated. (Med J Indones 2002; 11: 69-80)Keywords : mometasone furoate, nasal spray, perennial allergic rhinitis.

Safety and tolerability of fluvastatin XL in the treatment of hyper-cholesterolemia : a postmarketing surveillance conducted in Indonesia Setiawati, Arini; Darmansjah, Iwan
Medical Journal of Indonesia Vol 17, No 2 (2008): April-June
Publisher : Faculty of Medicine Universitas Indonesia

Fluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%), nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physicianâs global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG > 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of > 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice. (Med J Indones 2008; 17:88-95)Keywords: post-marketing surveillance (PMS), fluvastatin XL, hypercholesterolemia

Prevalence and risk factors for microalbuminuria in a cross-sectional study of type-2 diabetic patients in Indonesia : a subset of DEMAND study Soegondo, Sidartawan; Prodjosudjadi, Wiguno; Setiawati, Arini
Medical Journal of Indonesia Vol 18, No 2 (2009): April-June
Publisher : Faculty of Medicine Universitas Indonesia

Aims Microalbuminuria (MA) is a strong predictor of diabetic nephropathy and cardiovascular morbidity and mortality in patients with type-2 DM. The present study aimed to gather information on the prevalence and risk factors for MA in Indonesian patients with type-2 DM.Methods The DEMAND study was an international open cross-sectional 1-day survey on microalbuminuria prevalence and its risk factors in type-2 diabetic patients. This study reports the results of the Indonesian survey which was performed in primary care practice in Indonesia from June to December 2003. Normotensive or hypertensive adult patients of both genders with type-2 DM without known proteinuria and/or kidney disease were recruited into the study. Patients with known pregnancy, having menstruation or acute fever were excluded. A single urinary albumin/creatinine test was carried out in all patients.Results A total of 770 patients were eligible for analysis. Approximately 80% of the patients had micro-/ macroalbuminuria, while renal insufficiency was detected in about 36% of the 433 patients with available data. Target HbA1c (< 7%) was reached by only 40% of the 118 patients who had HbA1c values. Most antidiabetic treatment prescribed was oral (82%), while insulin was used by only 14% of patients. Goal BP (< 130/80 mm Hg) was achieved in only 9% of patients. The frequency of patients receiving antihypertensives was 52%, statins 18%, and aspirin 26%. The most frequently used antihypertensives were RAS blockers (45%), while diuretics were used in 7 % of the patients. The family history of DM was found in 43% of patients, the history of retinopathy in 16%, diabetic foot 9%, and history of smoking in 20% of patients.Conclusion These data reveal that Indonesia has one of the highest frequencies of silent diabetic kidney disease seen in any national group in the global DEMAND Study. Early detection, monitoring of vascular complications, and more aggressive multifactorial treatment aiming at renal and vascular protection are urgently needed for Indonesian patients with type-2 diabetes. (Med J Indones 2009; 18: 124-30)Key words: microalbuminuria, type-2 DM, Indonesia, DEMAND study

Effect of a combination of Phaseolus vulgaris L. extract and acarbose on postprandial glucose level after cooked rice intake in healthy volunteers Zulkarnain, Robby; Setiawati, Arini; Setiabudy, Rianto
Medical Journal of Indonesia Vol 18, No 1 (2009): January-March
Publisher : Faculty of Medicine Universitas Indonesia

Aim This study was aimed to measure the effects of combination Phaseolus vulgaris extract and acarbose compared to acarbose alone on postprandial glucose concentration in healthy volunteers after cooked rice intake.Methods Blood sample were obtained at several time points up to three hours after cooked rice intake. The parameter for postprandial glucose concentration is the area under the curve (AUC) of glucose concentration vs.time for three hours after cooked rice intake.Results After taking this combination, postprandial glucose concentration was reduced by 21.6%, while the reduction by acarbose alone was 22.9%.Conclusions The reduction of postprandial glucose concentration after administration of this combination was not significantly different compared to that after administration of acarbose alone. (Med J Indones 2009; 18: 25-30)Keywords: Phaseolus vulgaris extract, acarbose, postprandial glucose concentration

The efficacy of RhinosÂ® SR on nasal resistance and nasal symptoms in patients with perennial allergic rhinitis : a randomized, double-blind, placebo-controlled study Setiawati, Arini; Darmansjah, Iwan; Mulyarjo, Mulyarjo; Parwati, Dwi R.; Faiz, Faiz; Soemantri, Roestiniadi D.
Medical Journal of Indonesia Vol 17, No 2 (2008): April-June
Publisher : Faculty of Medicine Universitas Indonesia

RhinosÂ® SR is a fixed combination of 5 mg loratadine and 60 mg pseudoephedrine immediate release and 60 mg pseudoephedrine sustained release. The present study was aimed to assess the efficacy of RhinosÂ® SR on nasal airway resistance (NAR) objectively using rhinomanometer and on nasal symptoms in patients with perennial allergic rhinitis (PAR) in a tropical country. This was a randomized, double-blind, parallel group study in 59 PAR patients who visited the ENT clinic at Dr. Soetomo General Hospital, Surabaya. Outpatients of both gender, having moderate to severe PAR for a minimal of 2 years, aged 12 years or older, with a total nasal symptom score (TNSS) > 6 and a nasal congestion score > 2, received RhinosÂ® SR or placebo twice daily for 7 days. The primary efficacy parameter was the decrease in the NAR values (measured by rhinomanometer on Day 1) of RhinosÂ® SR from those of placebo. The NAR values were calculated as the area under the curve (AUC) of NAR versus time. The secondary efficacy parameters were the percentage reduction of the clinical symptoms (nasal and nonnasal) evaluated by both the patient and the physician after 1 week use of RhinosÂ® SR or placebo. From 59 eligible patients, all completed this 1-week trial. For NAR values, after the baseline were considered as 100%, the AUC0-10 h were not significantly different between RhinosÂ® SR and placebo. However, as the pseudoephedrine reached its peak concentration, i.e. 2 hrs for the immediate release and 6 hrs for the sustained release, then AUC0-2 h and AUC0-6 h of RhinosÂ® SR were significantly lower compared to those of placebo. Total nasal symptom score (TNSS) evaluated by the patient (sum of the last 3 mornings) for RhinosÂ® SR decreased 33.0% from baseline (p < 0.001), for placebo decreased 21.9% from baseline (p = 0.002), but the decrease by RhinosÂ® SR was not significantly different from the decrease by placebo. TNSS evaluated by the physician, nasal congestion score (NCS) and total symptom score (TSS, total nasal and nonnasal), and even the individual symptom scores, evaluated by the patient and the physician, showed similar pattern, i.e. both RhinosÂ® SR and placebo decreased the symptoms significantly from baseline, and the decreases by RhinosÂ® SR were larger than the decreases by placebo, but the decreases by RhinosÂ® SR and placebo were not statistically different. No adverse event was found in this study. From the present study it was concluded that in patients with moderate to severe PAR in a tropical country, RhinosÂ® SR was effective in relieving nasal congestion by objective measurements of NAR. RhinosÂ® SR twice a day for 7 days was also effective in reducing the clinical symptoms of PAR although the reductions did not reach statistical significance compared to those by placebo, and was well tolerated. (Med J Indones 2008; 17: 114-26)Keywords: loratadine, pseudoephedrine, rhinomanometry, perennial allergic rhinitis

Low-dose ketoconazole-fluconazole combination versus fluconazole in single doses for the treatment of vaginal candidiasis Susilo, Jan; Setiawati, Arini; Darmansjah, Iwan; Indarti, Junita; Kusuma, Fitriyadi
Medical Journal of Indonesia Vol 20, No 3 (2011): August
Publisher : Faculty of Medicine Universitas Indonesia

Background: Vaginal candidiasis (VC) is one of the most common fungal diseases. Candida albicans is the most commonÂ causative fungus and has been isolated from more than 80% of specimens obtained from women with VC. KetoconazoleÂ is the first orally active antifungal, the dosage for VC is 200 mg twice daily for 5 days. Fluconazole is the newer oralÂ antifungal, its dosage for VC is a single oral dose of 150 mg. Since fluconazole 150 mg is considerably expensive, aÂ single dose of 100 mg ketoconazole and 40 mg fluconazole in combination has been tested for the treatment of VC. TheÂ results showed that from 11 women with confirmed VC, 1-2 weeks after drug administration, the mycological cultureÂ was negative in 8 women, positive in 1 woman, and 2 woman lost to follow-up. This promising result led to the presentÂ study with the objective to confirm the efficacy and safety of the above combination in a formal clinical trial.Methods: A total of 165 female patients, aged 18 years or older, with the diagnosis of VC from clinical symptomsÂ (pruritus or burning or excessive discharge) and positive microscopic smear (pseudohyphae and/or yeast cells) wereÂ randomized to receive a single dose of either keto-fluco combination (n = 85) or fluconazole (n = 80), and returnedfor follow-up visit on day 8.Results: Among these patients, 39 patients had negative baseline culture, leaving 126 patients eligible for efficacyÂ evaluation. The mycological eradication in the keto-fluco group was 74.5% (41 patients from a total of 55 patientsÂ with available mycological culture), while that in the fluconazole group was 70.2% (40 patients from 57 patientsÂ with available culture) and this difference was not significant. The clinical favorable response (clinical cure andÂ clinical improvement) in the keto-fluco arm (n = 60) was 98.3%, while that in the fluconazole group (n = 66) wasÂ 100%. Adverse events were found in 5 patients, 3 patients in the keto-fluco group (3/85 = 3.5%) and 2 patients in theÂ fluconazole group (2/80 = 2.5%).Conclusion: The present study showed that the efficacy and safety of ketoconazole 100 mg and fluconazole 40 mgÂ combination was not inferior compared to fluconazole 150 mg in single doses for the treatment of vaginal candidiasis.Â (Med J Indones 2011; 20:205-11)Keywords: fluconazole, low-dose ketoconazole-fluconazole combination, single dose, vaginal candidiasis

Glimepiride monotherapy in achieving good blood glucose control in type-2 diabetes mellitus: a prospective observational study Pranarka, Kris; Setiawati, Arini; Halim, Samsirun; Saraswati, Dian; Alkaf, Zulkifli
Medical Journal of Indonesia Vol 18, No 3 (2009): July-September
Publisher : Faculty of Medicine Universitas Indonesia

Aims Glimepiride is a sulphonylurea antihyperglycemic agent for oral therapy of type-2 diabetes mellitus. This studyÂ was carried out to evaluate glimepiride monotherapy in controlling blood glucose (HbA1c) in type-2 DM patients, itsÂ dosage, and safety profile.Methods This was a prospective observational study carried out at 4 private clinics in Semarang, Jambi, Mojokerto and MedanÂ between October 2006 and September 2007 in outpatients of both gender, aged > 20 years, with type-2 DM, HbA1c > 7%, andÂ received no oral antidiabetic treatment for at least 3 months. Glimepiride tablet was given once daily for 3 months.Results From 74 eligible patients, 18 patients were lost to follow-up and 56 patients completed this 3 months study,Â consisting of 26 treatment-naive patients and 30 previously treated patients. The initial and final doses of glimepirideÂ were similar in both treatment-naive patients and previously treated patients (initial 2.0 mg, final 2.3 mg). The meanreduction of HbA1c levels was 1.8% (absolute) for all patients, higher in naive patients (2.3%) compared to previouslyÂ treated patients (1.3%). Based on BMI, the mean reduction of HBA1c in 20 normal weight patients was 1.3%, and moreÂ marked in 20 obese patients (2.4%). The mean reduction of FBG levels in all patients was 54 mg/dL, more pronouncedin naive patients ( 83 mg/dL) compared to previously treated patients (30 mg/dL), but not affected by body weight.Â Bodyweight was increased during the study by a mean of 0.9 kg. No adverse event was encountered in any patientÂ during 3 months monotherapy with glimepiride in the present study.Conclusion Glimepiride monotherapy in the present observational study in daily practice for 3 months was shown toÂ be effective in reducing HbA1c and FBG levels, especially in treatment naive patients. Glimepiride in the present studyÂ was associated with weight gain, although not statistically signifi cant. No adverse event was reported in the present study.Â (Med J Indones 2009;18:170-8)Key words: glimepiride monotherapy, observational study, type-2 diabetes mellitus.

The effect of lycopene on the total cytochrome P450, CYP1A2 and CYP2E1 Louisa, Melva; Suyatna, Frans D.; Setiawati, Arini; Jusman, Sri W.A.
Medical Journal of Indonesia Vol 18, No 4 (2009): October-December
Publisher : Faculty of Medicine Universitas Indonesia

Aim: Some carotenoids such as canthaxantin, astaxanthin and beta apo-8â-carotenal were reported to have modulatoryeffect on the cytochrome P450. The present study was conducted to investigate the effects of lycopene, a nonprovitamin A carotenoid, on microsomal cytochrome P450, CYP1A2 and CYP2E1.Methods: Total cytochrome P450 levels, CYP1A2 and CYP2E1-catalyzed reactions (acetanilide 4-hydroxylation and p-nitrophenol hydroxylation) were studied in the liver microsomes of male Sprague Dawley rats. Microsomes were prepared using differential centrifugation combined with calcium aggregation method. Lycopene was orally administered in the dosages of 0, 25, 50 or 100 mg/kgBW/day for 14 days in a repeated fashion. Data were analyzed using ANOVA test.Results: Total cytochrome P450 level and acetanilide 4-hydroxylase activity were unaffected by any of the treatments. The CYP2E1 probe enzyme (p-nitrophenol hydroxylase) was significantly reduced by repeated administration of 100mg/ kgBW/day lycopene (7.88 + 2.04 vs 12.26 + 2.77 n mol/min/mg prot).Conclusion: The present results suggest that lycopene does not affect the total cytochrome P450 or CYP1A2 activity but it inhibits the activity of CYP2E1 (p-nitrophenol hydroxylase) in the rat. (Med J Indones 2009; 18: 233-8)Keywords: lycopene, cytochrome P450, CYP1A2, CYP2E1

Co-Authors Andhika Rachman Arif Abdillah Diah Ambarwati, Fransisca Dian Saraswati 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 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 Zulkifli Alkaf

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