Publications (6)1.78 Total impact
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Article: Co-administration of Ritonavir and Primaquine Decreases Plasma Concentration of Primaquine: Single- and Multiple-dose Study in the Rats.
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ABSTRACT: Aim: to explore the effects of ritonavir and primaquine combination given as a single-dose or multiple-dose compared to ritonavir alone on ritonavir plasma concentration in the rats. Methods: in single-dose study, 30 male Spraque Dawley rats were randomly allocated to receive primaquine 12.5 mg/kgBW or primaquine 12.5 mg/kgBW + ritonavir 10 mg/kgBW or primaquine 12.5 mg/kgBW + ketokonazole 10 mg/kgBW. Ketokonazole was used as positive control for inhibitor of primaquine metabolism. In the multiple-dose study, thirty Spraque Dawley male rats were randomly allocated to receive primaquine 12.5 mg/kgBW/day or primaquine 12.5 mg/kgBW/day + ritonavir 10 mg/kgBW/day or primaquine 12.5 mg/kgBW/day + rifampicin 100 mg/kgBW/day. Rifampicin was used as a positive control for inducer of primaquine metabolism. Results: in the single-dose study, ketokonazole increases the area under the plasma concentration (AUC) of primaquine (h45.8%, p<0.000), while the ritonavir decreases the AUC of primaquine (i64.6%, p<0.000). Multiple-dose study shows that both rifampicin and ritonavir decreases the AUC of primaquine by 60.2% (p<0.000) and 67.7% (p<0.000), respectively. Conclusion: concomitant administration of primaquine and ritonavir decreases the AUC of ritonavir. This effect could result in the insufficient concentration of primaquine as anti-relapse therapy in malaria caused by Plasmodium vivax, which might lead to treatment failure with primaquine.Acta medica Indonesiana 10/2012; 44(4):273-9. -
Article: Current status of phase I clinical trials in Asia: an academic perspectives.
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ABSTRACT: Clinical trials increasingly occured in Asia during the past years as pharmaceutical industries embraced globalization in the clinical research fields. The trend is true with phase III clinical trials but not for early stage/phase I clinical trials in Asian countries is still under-represented. The conduct of phase I clinical trials is considered more sophisticated and difficult than the later stage clinical trials. There are continuing concerns from the pharmaceutical industries about the capacity of Asian countries in conducting this type of clinical trials. We highlighted several problems concerning the ethical and scientific issues, the implementation of ICH-GCP and local regulations, investigators and clinical trial subjects. The purpose of this paper is to give some perspectives addressing the problems in conducting phase I clinical trials. Improving collaboration and capacity building among the Asian countries is a solution that we proposed in order to increase the quality and quantity of phase I clinical trials in Asian countries.Acta medica Indonesiana 01/2012; 44(1):71-7. -
Article: Pharmacokinetic interaction between efavirenz and rifampicin in healthy volunteers.
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ABSTRACT: Rifampicin induces the metabolism of efavirenz in humans. This study evaluated efavirenz bioavailability after rifampicin administration to healthy volunteers. A 3-week, before-and-after trial was performed on 8 healthy volunteers. The pharmacokinetic parameters were: plasma drug concentration-time profile from 0 to 72 h (AUC0-72), plasma drug concentration-time profile from 0 h to infinity (AUC0-inf), maximal drug concentration (Cmax), time to reach maximal drug concentration (tmax), and time to reach half the initial drug concentration in elimination phase (t1/2). After an overnight fast, the volunteers ingested one efavirenz 600 mg tablet, then blood samples were drawn to evaluate plasma efavirenz levels at 0, 2, 3, 4, 5, 6, 24, 72, 120, and 168 h. The procedure was repeated after a 1-week induction period of 450 mg/day. Paired-t test and Wilcoxon matched-pairs test were used for differences between mean concentrations. Baseline mean AUC0-72 was 46.80 ± 9.27 µg/ml.h, AUC0-inf was 96.38 ± 38.10 µg/ml.h, Cmax 2.19 ± 0.68 µg/ml.h, tmax 4.50 ± 0.93 h, and t1/2 96.60 ± 42.38 h. Post-induction values were significantly increased: AUC0-72 9.53 ± 11.26 µg/ml.h (p < 0.05; CI95% = 0.112 - 18.940), AUC0-inf 37.24 ± 42.43 (p < 0.05; CI95% = 0.021 - 0.406) µg/ml.h, and tmax 1.13 ± 0.99 h (p < 0.05; CI95% = 0.296 - 1.953). No significant reduction occurred in post-rifampicin induction means of Cmax and t1/2. Co-administration of a single dose of efavirenz 600 mg/day with 1-week rifampicin 450 mg/day significantly reduced efavirenz bioavailability in healthy volunteers.International journal of clinical pharmacology and therapeutics 02/2011; 49(2):162-8. · 1.18 Impact Factor -
Article: A meta-analysis on treatment effects of thiazolidinediones for type 2 diabetes mellitus in Asian populations.
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ABSTRACT: to assess the effects of thiazolidinediones (pioglitazone and rosiglitazone) in the treatment of T2DM in Asian population. randomized controlled trials of T2DM patients in Asian population that compared pioglitazone or rosiglitazone with other treatments for more than 3 months and reported HbA1c data were included. Analyses for all outcomes were calculated using random effect model. the analyses included 37 studies in approximately 3,000 patients. Thiazolidinediones had beneficial effect on HbA1c (glycosylated hemoglobin/hemoglobin A1c) compared with control (weighted mean difference (WMD) -0.12%; 95% CI [confidence interval], -0.54 to -0.19% for pioglitazone and -0.47%; 95% CI, -0.89 to -0.40% for rosiglitazone). Overall, TZDs showed significant benefit on glycemic outcomes measured by HbA1c as main surrogate outcome compared with previous glycemic control but not with other anti-diabetics. thiazolidinediones treatment resulted in favorable effects on glycemic control in Asian patients with T2DM. Long-term efficacy and safety data of TZD could not yet be confirmed due to the lack of randomized studies with patient-oriented outcomes.Acta medica Indonesiana 01/2011; 43(1):39-52. -
Article: Open study on efficacy and safety of levofloxacin in treatment of uncomplicated typhoid fever.
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ABSTRACT: The main objective of this study was to determine the clinical efficacy and safety of levofloxacin in an open setting for typhoid fever cases. Patients with clinical signs and symptoms of typhoid fever without previous antimicrobial treatment admitted to affiliated hospitals of the Faculty of Medicine, University Indonesia were included in this study. Adults, 18 years or above, were screened for any serious underlying conditions, pregnancy or possible complications of typhoid fever before final enrollment. Fifty-three subjects were screened, 48 were enrolled. The final diagnosis of enteric fever was made by positive blood culture, polymerase chain reaction or serology, was obtained in 31 cases, in whom one had a concomitant sinus infection and had to be excluded. Thirty patients (11 males, 19 females) aged between 18-58 years (mean 31.7 years) with a history of fever between 1 and 10 days (mean 6.1 days) showed excellent clinical response, becoming afebrile at an average of 2.43 days (range 1-5 days). Adverse effects noted were nausea in 4 patients, vomiting in one and meteorism in another one, which were all difficult to distinguish from the enteric infection. A pruritic rash occurring in two patients may be related to levofloxacin, and insomnia in another patient may be related. Microbiological clearance was obtained both immediately after treatment and at one month. No carrier states were detected in the cases positive for Salmonella typhi or paratyphi. None of the treated typhoid fever cases experienced a clinical relapse. In this open study of levofloxacin 500 mg/day for one week in treatment of uncomplicated typhoid fever, a 100% clinical efficacy was obtained in 30 patients with minimal adverse reactions warranting more intensive studies for this new indication of an old but well known disease in the developing world.The Southeast Asian journal of tropical medicine and public health 02/2006; 37(1):126-30. · 0.60 Impact Factor -
Article: Survey on appropriateness of drug administration in elderly patients at The Internal Medicine Ward dr. Cipto Mangunkusumo Hospital.
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ABSTRACT: to evaluate the appropriateness of drug administration in elderly patients hospitalized at the Internal Medicine Ward dr. Cipto Mangunkusumo Hospital based on indication, dosage, duration of treatment, potential adverse events, contraindication, and potential drug interactions. a cross sectional observational study was performed in patients aged over >or= 60 years old staying at the Internal Medicine Ward. Appropriateness of drug administration was evaluated based on the support from literature. The supporting references being used were guidelines at the Internal Medicine Department, reference textbooks, and drug brochures for newly approved drugs but had not been listed in references nor guidelines. from 347 drug administrations in 43 patients, 228 of the drug administrations (67.71%) were considered appropriate for indication, 15.85% slightly inappropriate for indication, and 18.44% with inappropriate indication. From 228 drug administrations, 206 (90.35%) were administered with adequate dosage, 2.63% subtherapeutic dosage, 3.95% overdosage, and 3.07% undefined dosage. From 126 drug administration evaluated for duration of therapy, there were 77.78% administered with appropriate duration of therapy, 18.25% with inappropriate duration, and 3.97% undefined duration. Out of 347 drug administration there were 2 possibilities of adverse drug events, 5 drugs were actually contraindicated and 25 potential drug interaction. there were 67% of drugs appropriately administered for indication. From this number, 90% were using accurate dosage, of all drug administration there were 2 possibilities of adverse drug events, 5 drugs were contraindicated and 25 potentially interacted drugs. From 126 drugs evaluated for duration of therapy, 77.78% received the right duration of therapy.Acta medica Indonesiana 39(3):124-9.
