Comparison of efficacy and safety of oral azithromycin and oral doxycycline in acne vulgaris

Background: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit with considerable psychosocial impact. Oral azithromycin or oral doxycycline can be used for the management of moderate and severe acne vulgaris. However, there is no consensus on which antibiotic is superior and the optimal dose for management.Methods: A prospective randomized interventional study was carried out among 120 patients of moderate to severe acne vulgaris. The patients were randomized into group A and B. While group A was prescribed oral azithromycin 500 mg three times a week, group B was given oral doxycycline 100 mg daily for 12 weeks. Topical clindamycin twice daily application was also given. Global Acne Grading Scale (GAGS) score was recorded at baseline and at 2nd, 4th, 8th and 12th weeks.Results: GAGS score at baseline in azithromycin (n = 53) and doxycycline (n = 55) group was 31.98±4.49 and 30.63±3.78 respectively (p value >0.05). 83.91±6.83% (p <0.001) and 81.87±6.75% (p <0.001) improvement was seen in azithromycin group and doxycycline group after 12 weeks of treatment. However, there was no difference in the GAGS score between the groups at any follow-up (p value >0.05). 15.09% patients in azithromycin group and 20% patients in doxycycline group reported adverse effects. The most commonly reported adverse effect was diarrhoea. All adverse effects were of ‘mild’ category and causality assessment was ‘possible’.Conclusions: Oral azithromycin is equally efficacious but safer alternative to oral doxycycline for the management of acne vulgaris.

Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: Interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

Efectividad y satisfacción del tratamiento con dosis diaria de Tadalafilo 5 mg para la disfunción eréctil / Effectiveness and satisfaction of the treatment with daily dose of Tadalafil 5 mg for erectile dysfunction

La base del tratamiento de la disfunción eréctil (DE) son los inhibidores de la fosfodiesterasa 5, disponibles mayoritariamente para dosificación a demanda. En 2008 la FDA aprobó el Tadalafilo 5 mg de uso diario. OBJETIVO: Evaluar la efectividad del Tadalafilo 5 mg de uso diario para el tratamiento de la DE y la satisfacción de los pacientes frente a su uso. PACIENTES Y METODOS: Se reclutaron pacientes con DE entre Junio de 2011 y Mayo de 2012. Se registraron datos sociodemográficos, clínicos y andrológicos. La DE se clasificó según el puntaje del cuestionario IIEF. Todos los pacientes iniciaron tratamiento diario con Tadalafilo 5 mg y fueron reevaluados luego de un mes. La satisfacción y calidad de vida se evaluó con cuestionarios validados (EDITS, SEAR y GAQ). Para el análisis estadístico se consideró significativo un P<0.05.RESULTADOS: Se reclutaron 49 pacientes con edad promedio de 59,9 +/- 8,8 años. Un 14,3 por ciento presentaba DE severa, 36,7 por ciento moderada, 36,7por ciento leve-moderada y 12,2 por ciento leve. Al mes de tratamiento, el puntaje IIEF aumentó significativamente (P<0.0005), encontrándose un 18,4 por ciento sin DE, 53,1 por ciento con DE leve, 28,6 por ciento con DE leve-moderada y ninguno con DE moderada o grave. El 87,7 por ciento de los pacientes refirió mejores erecciones y el 81,6 por ciento una mejor capacidad para mantener la relación sexual. La satisfacción global con el tratamiento fue de 64,1 por ciento. CONCLUSIÓN: El tratamiento diario con Tadalafilo 5 mg es efectivo para el manejo de la DE y se asocia a niveles adecuados de satisfacción y confianza al cabo de un mes de tratamiento.

The base of the treatment of erectile dysfunction (ED) are the phosphodiesterase-5 inhibitors, mostly available for “on demand” dosing. In 2008, the FDA approved Tadalafil 5mg for daily use. OBJECTIVE: To evaluate the effectiveness of Tadalafil 5 mg daily dose for the treatment of ED and the patient’s satisfaction with its use. PATIENTS AND METHODS: Patients with ED were enrolled between June 2011 and May 2012. Sociodemographic, clinical and andrologic data was recorded. The severity of ED was classified according to the score of the IIEF questionnaire. All patients started daily treatment with Tadalafil 5 mg and were reevaluated after one month. Satisfaction and quality of life was assessed using validated questionnaires (EDITS, SEAR and GAQ). A P<0.05 was considered significant in all statistical analysis. RESULTS: A total of 49 patients were enrolled, with mean age of 59.9 +/- 8.8 years. A 14.3 ´percent suffered severe ED, 36.7 percent moderate, 36.7 percent mild-moderate and 12.2 percent mild. After one month, the IIEF score significantly increased (P<0.0005), finding a 18.4 percent of patients without ED, 53.1 percent with mild ED, 28.6 percent with mild-moderate ED and no cases with moderate or severe ED. 87.7 percent of patients reported better erections and 81.6 percent stated a better capacity to maintain erections during. The global satisfaction rate with the treatment was of 64.1 percent. CONCLUSION: The treatment with daily dose of Tadalafil 5 mg is effective for the management of ED and is associated with adequate levels of satisfaction and confidence after one month of use.

Study of Efficacy and Safety in the Administration of 400 mg of Amikacin Sulfate Administered Once Daily to Elderly Patients / 医薬品情報学

<b>Objective: </b>In previously reported comparisons of aminoglycoside antimicrobials administered once daily versus multiple administration, toxicity was found to be equal or lower while efficiency remained high.  However, there are few reports on the clinical condition of targeted elderly persons.  The objective of this study was to evaluate the once-daily dosing regimen of 400 mg of AMK involving elderly pneumonia patients aged 75 years or older with regard to clinical evaluation including the efficacy and toxicity.<br><b>Methods: </b>A survey to clinically evaluate the efficacy and toxicity of 400 mg AMK administered once daily for 30 min at 24 h intervals was carried out.  One hundred twenty-seven patients with pneumonia and who were 75 years or older at Funabashi General Hospital were targeted, with the aim of an expected clinical effect of <i>C</i>_max/MIC≥ 8-10.  Serum concentration monitoring was carried out after administration began.<br><b>Results: </b>There were 121 patients (95.3%) of controlled AMK concentration with a trough serum concentration of <10 μg/mL, which is a safe concentration range.  There were 6 patients (4.7%) where trough serum concentration in the toxic range >10 μg/mL, with an average at 15.1±5.0 μg/mL, and the average administration days were 7.5 ± 3.3 days.  Moreover, before/after AMK administration, there were 3 patients (2.4%) where CRE values increased more than a 150% over the previous values, and were evaluated as renal dysfunction.  Average trough serum concentration at that time was 3.6 ± 1.1 μg/mL, and average number of days of administration were 13 ± 1.4 days.  Patients of trough serum concentration in the toxic range >10 μg/mL were not included.  The average peak serum concentration calculated by Winter’s pharmacokinetic parameter and the 1-compartment model was 35.3 ± 8.0 μg/mL, and the average <i>C</i>_max/MIC which correlates with the AMK effect was 9.9 ± 2.2.  The treatment was effective for 83 (65.4%) of the 127 patients.<br><b>Conclusion: </b>By once-daily administration of AMK 400 mg to aged persons 75 years or older, change in trough serum concentration into a safe range and <i>C</i>_max/MIC≥ 8-10, the level at which clinical effectivity can be expected, could be achieved.  This administration method is shown to be useful in maintaining AMK in the target serum concentration range for aged persons.

Once daily dosing of aminoglycoside in children / 소아과

Aminoglycosides are frequently used antibiotics in children. The multiple daily dosing (MDD) in infants and children is twice or three times daily depending on age. Recent studies in adults have shown that once daily dosing (ODD) maximizes the bactericidal activity and might minimize the toxicity of antibiotics. So, I reviewed many studies about efficacy, toxicity and cost effectiveness of ODD of aminoglycosides in children. Most studies suggest that ODD compared with MDD of aminoglycosides is theoretically more efficacious and has no higher toxicity in infants and children. But, the total number of patients included in the studies is not large. Multi-center, controlled prospective studies are required in larger numbers of infants and children to determine the efficacy and safety of the ODD regimen in children before ODD of aminoglycosides can be recommended for routine use.