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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

Dosing schedule of second generation sulfonylureas in the treatment of non-insulin dependent diabetes should be revised (A commentary) Darmansjah, Iwan
Medical Journal of Indonesia Vol 3, No 2 (1994): April-June
Publisher : Faculty of Medicine Universitas Indonesia

[no abstract available]

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

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

Comparison of the efficacy and safety of isepamicin plus metronidazole and amikacin plus metronidazole in intra-abdominal infections Philippi, Bernardus; Lalisang, Toar J.M.; Th-Akib, Husniah; Setiabudy, Rianto; Hudiono, Johannes; Darmansjah, Iwan
Medical Journal of Indonesia Vol 10, No 2 (2001): April-June
Publisher : Faculty of Medicine Universitas Indonesia

Intra-abdominal infections due to penetrating wound through the abdominal wall or rupture of the gastrointestinal tract are acuteÂ conditions requiring prompt surgical intervention and the use of appropriate antimicrobial agents. Isepamicin is an effectiveÂ aminoglycoside against various Gram-negative pathogens causing intra-abdominal infections. The objective of the present study is toÂ compare the efficacy and safety of isepamicin (15 mg/kgBW IV o.d.) with amikacin (7.5 mg/kgBB b.i.d.), in conjunction withÂ metronidazole for both drugs. An open, randomized, parallel design was applied in this trial. The subject allocation ratio forÂ isepamicin: amikacin is 2:1. Out of 50 patients enrolled in this study, 27 fuffilled the criteria for safety and efficacy population, and 46Â for intent-to-treat population. In the safety and efficacy population, the clinical success rare for isepamicin and amikacin group did notÂ differ significantly (i.e., 95% and 100%, respectively). In the intent-to-treat population, the clinical success rates for isepamicin andÂ amikacin group were also insignifficantly different (i.e., 97% and 100%, respectively). The rates of bacteriological elimination forÂ isepamicin and amikacin, were 95% and 100%, respectively in the efficacy and safety population, and 90% and 93%, respectively inÂ the intent-to-treat population. Streptococci and staphylococci were the most frequent (40%) pathogens isolated from pus, andÂ Acinetobacter anitratus (55%) was the most common one isolated from blood. In the efficacy and safety population, the mean (Â± SD)Â length of hospital stay in the isepamicin and amikacin groups was 10.7 Â±Â 3.9 and 11.1 Â±Â 3.8 days, respectively, while in the intent-to-treatÂ population, the mean (Â±Â SD) length of hospital stay in the isepamicin and amikacin groups was 10.1 Â±Â 3.4 and 10.5 Â±Â 3 days,Â respectively. In the present study, both aminoglycosides were well tolerated and there was no patient withdrawal associated with sideÂ effect. It is concluded that for intra-abdominal infections, intravenous isepamicin given once daily is as effective as intravenousÂ amikacin given twice daily in combination with metronidazole. (Med J Indones 2001; 10: 88-94)Keywords : Isepamicin, amikacin, inta-abdominal infections

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

Auditing drug therapy - special problems in less developed countries Darmansjah, Iwan
Medical Journal of Indonesia Vol 1, No 3/4 (1992): July-December
Publisher : Faculty of Medicine Universitas Indonesia

[no abstract available]

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