A Retrospective Nationwide Non-Interventional Study of an Aqueous Sublingual Immunotherapy Formulation Administered with a 200-µL Dosing Pump.

BACKGROUND: Convenient dosing is a key component of treatment adherence and thus efficacy and safety. Aqueous sublingual immunotherapy (SLIT) formulations can be administered with a dosing pump that delivers 200 µL of volume per actuation. OBJECTIVE: The objective of this study was to describe the use of Staloral® 300 Rapid in its new dosing pump presentation and to evaluate the safety and satisfaction from both the patient and doctor. PATIENTS AND METHODS: We performed a retrospective non-interventional study in a population (aged 5 years or over) of individuals with allergic rhinitis or allergic asthma who were being treated with aqueous 300 index of reactivity SLIT formulations of various allergens (grass pollen, tree pollen, house dust mites). Based on a detailed, SLIT-specific, patient self-questionnaire (Quartis®) and the inspection of medical records, we assessed the characteristics of the SLIT, safety, patient satisfaction and willingness to continue SLIT. The physician's satisfaction with the treatment was measured on a 0-100 visual analogue scale. Adverse events were coded with the Medical Dictionary for Regulatory Activities. RESULTS: A total of 801 valid patients were included (52.4% male; mean ± standard deviation age: 25.9 ± 17.2 years; mean time since diagnosis: 4.56 ± 4.68 years; mean time using the previous dosing pump: 19.2 ± 13.0 months; time using the 200-µL dosing pump: 14.95 ± 3.80 months). Among the study population, 317 subjects comprised the paediatric subgroup (57%: male; mean age: 9.8 ± 2.5 years). Overall, 54 patients (6.7%) reported a total of 68 adverse events (including 51 gastrointestinal adverse events). The large majority of adverse events were mild, local and transient and did not require treatment. There were no severe adverse events. The level of patient satisfaction with the ease of SLIT administration was high (84.3% overall, and 82.6% in the paediatric subgroup). The mean ± standard deviation visual analogue scale score for physician satisfaction with the treatment was 70.6 ± 25.1 out of 100. CONCLUSIONS: Administration of 300 index of reactivity SLIT with a 200-µL dosing pump is safe, well tolerated and associated with good levels of patient satisfaction.

Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. Satisfaction and expectancies.

BACKGROUND: One of the factors affecting compliance is the pharmaceutical formulation used. Many patients find it difficult to swallow tablets or capsules. The fast dissolving tablet (FDT) formulation could help to enhance patient compliance, because of its ease of administration and because no liquid is required to help intake. MATERIAL AND METHODS: A survey was conducted in patients diagnosed with allergic rhinitis or dermatitis (positive skin tests and/or specific IgE) and urticaria to asses the degree of acceptance of and preference for an FDT formulation. RESULTS: Of the 7,686 patients who participated in the survey, 90 % considered the initial flavor and 83 % considered the aftertaste to be very or quite satisfactory, 95 % were very satisfied with the disintegration time, 79 % were very satisfied with the form, 82 % with the size, 72 % with the packaging and 78 % with the instructions for use. Ninety-three percent considered that being able to take the drug at any time or place was very important or fairly important. Ninety-four percent considered the ease of use to be much better or better. If given the choice, 93 % would choose an FDT formulation. Eighty-eight percent of the patients would like to change their current antihistaminic drug for a new allergy drug in an FDT formulation. CONCLUSIONS: Most of the patients were highly satisfied with the characteristics of the FDT formulation and would choose it for the treatment of their allergies.

Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. Satisfaction and expectancies

Background: One of the factors affecting compliance is the pharmaceutical formulation used. Many patients find it difficult to swallow tablets or capsules. The fast dissolving tablet (FDT) formulation could help to enhance patient compliance, because of its ease of administration and because no liquid is required to help intake. Material and methods: A survey was conducted in patients diagnosed with allergic rhinitis or dermatitis (positive skin tests and/or specific IgE) and urticaria to asses the degree of acceptance of and preference for an FDT formulation. Results: Of the 7,686 patients who participated in the survey, 90 % considered the initial flavor and 83 % considered the aftertaste to be very or quite satisfactory, 95 % were very satisfied with the disintegration time, 79 % were very satisfied with the form, 82 % with the size, 72 % with the packaging and 78 % with the instructions for use. Ninety-three percent considered that being able to take the drug at any time or place was very important or fairly important. Ninety-four percent considered the ease of use to be much better or better. If given the choice, 93 % would choose an FDT formulation. Eighty-eight percent of the patients would like to change their current antihistaminic drug for a new allergy drug in an FDT formulation. Conclusions: Most of the patients were highly satisfied with the characteristics of the FDT formulation and would choose it for the treatment of their allergies

Introducción: Uno de los factores que afecta al cumplimiento es la forma farmacéutica oral utilizada. Muchos pacientes encuentran difícil poder tragar comprimidos o cápsulas. La forma farmacéutica en liofilizado oral (Flas) podría contribuir a un mayor cumplimiento del tratamiento por parte del paciente, dada su facilidad de administración y por no precisar la ayuda de ningún líquido para su ingesta. Material y Método: Se realizó una encuesta a pacientes diagnosticados de rinitis o dermatitis alérgica (pruebas cutáneas y/o IgE específica positiva) y urticaria, para evaluar el grado de aceptación y la preferencia por una formulación en liofilizado oral (Flas). Resultados: De los 7686 pacientes que respondieron a la encuesta, el 90% consideraron que el sabor inicial y el 83% que el sabor final era muy o bastante satisfactorio, el 95% estaban muy o bastante satisfechos con el tiempo de disgregación; el 79% estaban muy satisfechos con la forma, el 82% con el tamaño, el 72% con el envasado y el 78% con las instrucciones de uso. El 93% opinaron que era muy o bastante importante que el medicamento pueda tomarse en cualquier momento y lugar. El 94% opinaron que su comodidad de uso era mucho mejor o mejor. Si pudieran elegir el 93% elegirían una formulación Flas. Un 88% de los pacientes desea cambiar su antihistamínico actual por un nuevo medicamento para la alergia en forma de liofilizado oral (Flas). Conclusiones: La mayoría de los pacientes se muestran muy satisfechos con las características de la formulación liofilizada oral Flas y elegirían ésta para el tratamiento de su alergia