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1.
J Am Acad Dermatol ; 75(2): 297-305, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27189825

RESUMO

BACKGROUND: Peripheral leukocytes in patients with atopic dermatitis (AD) have elevated phosphodiesterase-4 activity, which is associated with production of proinflammatory mediators. OPA-15406 is a phosphodiesterase-4 inhibitor with high selectivity for phosphodiesterase-4-B. OBJECTIVES: We sought to assess effectiveness and tolerability of topical OPA-15406 in patients with AD. METHODS: This was a randomized, double-blind, vehicle-controlled, phase-II study. Patients 10 to 70 years of age with mild or moderate AD received topical OPA-15406 0.3% (n = 41), OPA-15406 1% (n = 43), or vehicle (n = 37) twice daily for 8 weeks. RESULTS: The primary end point, Investigator Global Assessment of Disease Severity score of 0 or 1 with greater than or equal to 2-grade reduction, was met at week 4 in the OPA-15406 1% group (P = .0165 vs vehicle). Mean percentage improvement from baseline Eczema Area and Severity Index score for OPA-15406 1% was notable in week 1 (31.4% vs 6.0% for vehicle; P = .0005), even larger in week 2 (39.0% vs 3.0%; P = .0001), and persisted for 8 weeks. Visual analog scale pruritus scores improved from moderate to mild within the first week in the OPA-15406 1% group (36.4% mean change; P = .0011). OPA-15406 levels in blood were negligible. Incidence of adverse events was low, with most events mild in intensity. LIMITATIONS: Further confirmatory phase-III studies are required. CONCLUSION: OPA-15406 ointment may provide an effective therapeutic modality for patients with mild to moderate AD.


Assuntos
Anisóis/uso terapêutico , Dermatite Atópica/tratamento farmacológico , Nitrilas/uso terapêutico , Inibidores da Fosfodiesterase 4/uso terapêutico , Administração Cutânea , Adolescente , Adulto , Anisóis/efeitos adversos , Anisóis/sangue , Criança , Dermatite Atópica/complicações , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nitrilas/efeitos adversos , Nitrilas/sangue , Inibidores da Fosfodiesterase 4/efeitos adversos , Inibidores da Fosfodiesterase 4/sangue , Prurido/tratamento farmacológico , Prurido/etiologia , Índice de Gravidade de Doença , Adulto Jovem
2.
Pancreas ; 40(3): 376-82, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21343835

RESUMO

OBJECTIVES: EUR-1008 (ZENPEP® [pancrelipase] Delayed-Release Capsules) delayed-release capsules is a novel, enteric-coated, porcine-derived pancreatic enzyme product. This study evaluated the efficacy and safety of 2 doses of ZENPEP in patients with chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI). METHODS: The effect of ZENPEP on the coefficient of fat absorption (CFA) was investigated in a randomized, double-blind, dose-response, crossover study with placebo run-in (7-9 days) and 2 treatment periods (9-11 days) composed of a high dose (7 × 20,000 lipase units per day) and a low dose (7 × 5000 lipase units per day). RESULTS: Mean CFA was significantly higher with low- (88.9%) and high-dose (89.9%) ZENPEP versus placebo run-in (82%; P < 0.001; n = 72) with no difference between doses (P = 0.228, primary end point). In patients with baseline CFA less than 90% (n = 33), the high dose was significantly more effective (CFA: 84.1%) than the low dose (CFA: 81.1%; P < 0.001). Post hoc analysis revealed an increase in treatment effect with more severe EPI. Coefficient of nitrogen absorption (P < 0.001), body weight (P ≤ 0.021), and body mass index (P ≤ 0.020) also increased significantly with both doses compared with baseline. Percentage of days with EPI symptoms decreased with both doses. CONCLUSIONS: Our findings suggest that CP patients with EPI benefit from a low dose of ZENPEP, whereas the high dose might be needed for patients with more severe EPI.


Assuntos
Insuficiência Pancreática Exócrina/tratamento farmacológico , Pancreatite Crônica/tratamento farmacológico , Pancrelipase/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Cross-Over , Gorduras na Dieta/análise , Gorduras na Dieta/farmacocinética , Relação Dose-Resposta a Droga , Método Duplo-Cego , Insuficiência Pancreática Exócrina/etiologia , Insuficiência Pancreática Exócrina/fisiopatologia , Fezes/química , Feminino , Humanos , Absorção Intestinal/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Pancreatite Crônica/complicações , Pancreatite Crônica/fisiopatologia , Pancrelipase/administração & dosagem , Pancrelipase/efeitos adversos , Resultado do Tratamento , Adulto Jovem
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