Background: Facial angiofibroma is the most predominant cutaneous manifestation of tuberous scler... more Background: Facial angiofibroma is the most predominant cutaneous manifestation of tuberous sclerosis complex (TSC), a rare autosomal dominant genetic disorder impacting the mechanistic target of rapamycin (mTOR). Facial angiofibroma can bleed spontaneously, impair eyesight, and cause aesthetic disfiguration causing psychological and social stress. To date, there is little or no evidence on the demographics, and other TSC features associated with facial angiofibroma or the use of mTOR inhibitor for the management of facial angiofibroma. This is a retrospective study of TSC Alliance’s Natural History Database aimed to characterize facial angiofibroma and to evaluate features associated with a higher risk of facial angiofibroma or the use of topical mTOR inhibitors for management of facial angiofibroma. Data in the NHD was obtained from 18 clinical sites in the US since 2006.Results: Of the 2240 patients, 2088 patients were enrolled in the US and data from 2057 patients were included ...
Purpose The budgetary impact of adding ceftaroline fosamil to a hospital formulary for the treatm... more Purpose The budgetary impact of adding ceftaroline fosamil to a hospital formulary for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) was evaluated. Methods A three-year hospital budget impact model was constructed with three initial treatment options for ABSSSIs: ceftaroline fosamil, vancomycin plus aztreonam, and other vancomycin-containing regimens. The target population was hospitalized adult patients with an ABSSSI. Clinical cure rates with initial treatment were assumed to be similar to those from ceftaroline fosamil clinical trials. Patients who did not respond to initial treatment were assumed to be treated successfully with second-line antimicrobial therapy. Length of stay and cost per hospital day (by success or failure with initial treatment) were estimated based on a large database from more than 100 U.S. hospitals. Other model inputs included the annual number of ABSSSI admissions, projected annual case growth rate, proportion of ABSSSI ta...
Background: In addition to traditional endpoints for CAP clinical trials at Test of Cure, earlier... more Background: In addition to traditional endpoints for CAP clinical trials at Test of Cure, earlier clinical endpoints to evaluate efficacy of antimicrobial treatment has become an important assessment. Ceftaroline fosamil (CPT-F), the prodrug of CPT, is the first antimicrobial approved in the US with FDA-defined clinical response at Day 4 (based on clinical stability and symptom improvement). In the FDA-defined exploratory analysis, there was a 12% treatment difference in clinical response at Day 4 between CPT-F and ceftriaxone (CRO) patients, 70.2% vs 58% respectively. The present analyses described hospital LOS among patients achieving or not achieving clinical response at Day 4. Methods: In 2 CPT-F phase 3 clinical trials (FOCUS 1 and FOCUS 2, NCT00621504 and NCT00509106) with hospitalized adult patients due to CAP, data on hospital admission and discharge dates, discharge status, and time in various inpatient units (including intensive care unit, step-down unit, General medical/s...
Introduction. Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for the... more Introduction. Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for their efficacy and safety in various clinical trials in men with erectile dysfunction (ED) with or without associated comorbidities.Aim. This is the first prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a PDE-5 inhibitor (i.e., vardenafil) in an exclusive population of men with ED and dyslipidemia.Main Outcome Measures. Three coprimary efficacy measurements (Sexual Encounter Performance [SEP]2, SEP3, International Index of Erectile Function-Erectile Function [IIEF-EF] domain scores) were used to assess the differential effect of vardenafil vs. placebo in this patient population. Adverse events (AEs) safety data were obtained to compare safety outcomes.Methods. This 12-week of randomized, double-blind, placebo-controlled study was conducted in 59 U.S. centers. Patients received either on-demand, flexible-dose vardenafil 10 mg (titrated to 5 mg or 20 mg based upon efficacy and safety) or placebo.Results. Of the 712 patients screened and entered into the study, 395 were randomized. Baseline demographics for the intent-to-treat population included: mean age, 54.4 years (±7.5 standard deviation [SD]); 76% Caucasian; mean body mass index (BMI), 31.7 kg/m2 (±12.7 SD); 47% past/present smoker; and 42% severe ED. Aside from dyslipidemia, other comorbidities included hypertension, 61%; obesity (i.e., BMI ≥ 30), 51%; and type 1 or 2 diabetes, 40%. During the 12-week treatment period, the least squares (LS) adjusted mean success rates in patients on vardenafil vs. placebo were: SEP2, 79.09% vs. 51.92%; and SEP3, 66.69% vs. 33.83% (P < 0.001). The LS adjusted mean IIEF-EF domain score for week 12 using LOCF was 21.99 in patients on vardenafil therapy vs. 14.83 in those on placebo (P < 0.001). The most commonly encountered AEs were headache and nasal congestion.Conclusions. Vardenafil was demonstrated to be safe and effective for managing ED in men with ED and associated dyslipidemia. The results of this study support the role of expanded research on outcomes related to effective ED treatment and aggressive lipid control. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M, Beresford E, and Barnes A. Vardenafil in men with stable statin therapy and dyslipidemia. J Sex Med 2008;5:1455–1467.
The objective of this phase 1, open-label, parallel, randomized study was to determine the effect... more The objective of this phase 1, open-label, parallel, randomized study was to determine the effect of posaconazole on the pharmacokinetics of caspofungin and micafungin in 67 healthy subjects. Caspofungin (70 mg on day 1, 50 mg on days 2–14 once daily; 1-hour intravenous infusion) (cohort 1) or micafungin (150 mg once daily days 1–7; 1-hour IV infusion) (cohort 2) was administered alone or with posaconazole oral suspension 400 mg twice daily, on days 1 to 14 (cohort 1) or days 1 to 7 (cohort 2). Pharmacokinetic parameters, maximum plasma concentration (Cmax), steady-state area under the plasma concentration—time curve over the dosing interval (AUC[τ]), and time to Cmax (Tmax) were assessed. Safety assessments included adverse events, clinical laboratory tests, vital signs, and electrocardiograms. Repeated posaconazole dosing did not affect caspofungin or micafungin pharmacokinetics. Log-transformed ratio estimates of caspofungin with posaconazole Cmax and AUC(τ) were 90% and 98%, respectively, of those with caspofungin alone at day 14; ratio estimates of micafungin with posaconazole Cmax and AUC(τ) were 104% and 109%, respectively, of those with micafungin alone at day 7. Median Tmax (1 hour) did not change. Coadministration of posaconazole with caspofungin or micafungin was generally well tolerated and did not affect the pharmacokinetics of either echinocandin.
Background: Facial angiofibroma is the most predominant cutaneous manifestation of tuberous scler... more Background: Facial angiofibroma is the most predominant cutaneous manifestation of tuberous sclerosis complex (TSC), a rare autosomal dominant genetic disorder impacting the mechanistic target of rapamycin (mTOR). Facial angiofibroma can bleed spontaneously, impair eyesight, and cause aesthetic disfiguration causing psychological and social stress. To date, there is little or no evidence on the demographics, and other TSC features associated with facial angiofibroma or the use of mTOR inhibitor for the management of facial angiofibroma. This is a retrospective study of TSC Alliance’s Natural History Database aimed to characterize facial angiofibroma and to evaluate features associated with a higher risk of facial angiofibroma or the use of topical mTOR inhibitors for management of facial angiofibroma. Data in the NHD was obtained from 18 clinical sites in the US since 2006.Results: Of the 2240 patients, 2088 patients were enrolled in the US and data from 2057 patients were included ...
Purpose The budgetary impact of adding ceftaroline fosamil to a hospital formulary for the treatm... more Purpose The budgetary impact of adding ceftaroline fosamil to a hospital formulary for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) was evaluated. Methods A three-year hospital budget impact model was constructed with three initial treatment options for ABSSSIs: ceftaroline fosamil, vancomycin plus aztreonam, and other vancomycin-containing regimens. The target population was hospitalized adult patients with an ABSSSI. Clinical cure rates with initial treatment were assumed to be similar to those from ceftaroline fosamil clinical trials. Patients who did not respond to initial treatment were assumed to be treated successfully with second-line antimicrobial therapy. Length of stay and cost per hospital day (by success or failure with initial treatment) were estimated based on a large database from more than 100 U.S. hospitals. Other model inputs included the annual number of ABSSSI admissions, projected annual case growth rate, proportion of ABSSSI ta...
Background: In addition to traditional endpoints for CAP clinical trials at Test of Cure, earlier... more Background: In addition to traditional endpoints for CAP clinical trials at Test of Cure, earlier clinical endpoints to evaluate efficacy of antimicrobial treatment has become an important assessment. Ceftaroline fosamil (CPT-F), the prodrug of CPT, is the first antimicrobial approved in the US with FDA-defined clinical response at Day 4 (based on clinical stability and symptom improvement). In the FDA-defined exploratory analysis, there was a 12% treatment difference in clinical response at Day 4 between CPT-F and ceftriaxone (CRO) patients, 70.2% vs 58% respectively. The present analyses described hospital LOS among patients achieving or not achieving clinical response at Day 4. Methods: In 2 CPT-F phase 3 clinical trials (FOCUS 1 and FOCUS 2, NCT00621504 and NCT00509106) with hospitalized adult patients due to CAP, data on hospital admission and discharge dates, discharge status, and time in various inpatient units (including intensive care unit, step-down unit, General medical/s...
Introduction. Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for the... more Introduction. Phosphodiesterase type-5 (PDE-5) inhibitors have previously been evaluated for their efficacy and safety in various clinical trials in men with erectile dysfunction (ED) with or without associated comorbidities.Aim. This is the first prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a PDE-5 inhibitor (i.e., vardenafil) in an exclusive population of men with ED and dyslipidemia.Main Outcome Measures. Three coprimary efficacy measurements (Sexual Encounter Performance [SEP]2, SEP3, International Index of Erectile Function-Erectile Function [IIEF-EF] domain scores) were used to assess the differential effect of vardenafil vs. placebo in this patient population. Adverse events (AEs) safety data were obtained to compare safety outcomes.Methods. This 12-week of randomized, double-blind, placebo-controlled study was conducted in 59 U.S. centers. Patients received either on-demand, flexible-dose vardenafil 10 mg (titrated to 5 mg or 20 mg based upon efficacy and safety) or placebo.Results. Of the 712 patients screened and entered into the study, 395 were randomized. Baseline demographics for the intent-to-treat population included: mean age, 54.4 years (±7.5 standard deviation [SD]); 76% Caucasian; mean body mass index (BMI), 31.7 kg/m2 (±12.7 SD); 47% past/present smoker; and 42% severe ED. Aside from dyslipidemia, other comorbidities included hypertension, 61%; obesity (i.e., BMI ≥ 30), 51%; and type 1 or 2 diabetes, 40%. During the 12-week treatment period, the least squares (LS) adjusted mean success rates in patients on vardenafil vs. placebo were: SEP2, 79.09% vs. 51.92%; and SEP3, 66.69% vs. 33.83% (P < 0.001). The LS adjusted mean IIEF-EF domain score for week 12 using LOCF was 21.99 in patients on vardenafil therapy vs. 14.83 in those on placebo (P < 0.001). The most commonly encountered AEs were headache and nasal congestion.Conclusions. Vardenafil was demonstrated to be safe and effective for managing ED in men with ED and associated dyslipidemia. The results of this study support the role of expanded research on outcomes related to effective ED treatment and aggressive lipid control. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M, Beresford E, and Barnes A. Vardenafil in men with stable statin therapy and dyslipidemia. J Sex Med 2008;5:1455–1467.
The objective of this phase 1, open-label, parallel, randomized study was to determine the effect... more The objective of this phase 1, open-label, parallel, randomized study was to determine the effect of posaconazole on the pharmacokinetics of caspofungin and micafungin in 67 healthy subjects. Caspofungin (70 mg on day 1, 50 mg on days 2–14 once daily; 1-hour intravenous infusion) (cohort 1) or micafungin (150 mg once daily days 1–7; 1-hour IV infusion) (cohort 2) was administered alone or with posaconazole oral suspension 400 mg twice daily, on days 1 to 14 (cohort 1) or days 1 to 7 (cohort 2). Pharmacokinetic parameters, maximum plasma concentration (Cmax), steady-state area under the plasma concentration—time curve over the dosing interval (AUC[τ]), and time to Cmax (Tmax) were assessed. Safety assessments included adverse events, clinical laboratory tests, vital signs, and electrocardiograms. Repeated posaconazole dosing did not affect caspofungin or micafungin pharmacokinetics. Log-transformed ratio estimates of caspofungin with posaconazole Cmax and AUC(τ) were 90% and 98%, respectively, of those with caspofungin alone at day 14; ratio estimates of micafungin with posaconazole Cmax and AUC(τ) were 104% and 109%, respectively, of those with micafungin alone at day 7. Median Tmax (1 hour) did not change. Coadministration of posaconazole with caspofungin or micafungin was generally well tolerated and did not affect the pharmacokinetics of either echinocandin.
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