Efficacy and safety of a new medicated nail hydrolacquer in the treatment of adults with toenail onychomycosis: A randomised clinical trial.

BACKGROUND: A new water-soluble formulation with ciclopirox has shown a higher penetration than other ciclopirox nail lacquers currently marketed, thus providing a higher concentration of ciclopirox into the nail. OBJECTIVE: To evaluate the efficacy and safety of a new ciclopirox nail hydrolacquer compared with its vehicle and an active comparator (hydroxypropyl chitosan-based 80 mg/g ciclopirox nail lacquer) for the treatment of toenail fungal infection. METHODS: Phase III, multicenter, randomised, double-blind, clinical trial in patients with distal mild to moderate toenail onychomycosis due to dermatophyte fungi. Patients were randomised to apply topically a ciclopirox nail hydrolacquer, its vehicle or a reference product once daily for 48 weeks with a follow-up period of 4 weeks up to week 52. RESULTS: A total of 381 patients were included. No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure. At week 52, a higher percentage of patients in the ciclopirox nail hydrolacquer group achieved a mycological cure (negative for culture and DTS/KOH test, with results: 32.0% ciclopirox nail hydrolacquer, 23.2% vehicle and 27% reference product, respectively), and similar results were found for improvement (mycological cure and reduction of diseased nail ≥20%, with results: 27.2% ciclopirox nail hydrolacquer, 21.6% vehicle and 20.6% reference product, respectively). Regarding mycological results, only ciclopirox nail hydrolacquer demonstrated significant statistical superiority versus vehicle negativizing dermatophyte culture (p = .039) with no recurrences, relapses or re-infections in a four-week follow-up patients with complete cure. The safety profile was comparable to the vehicle and reference product and consistent with the previously reported. CONCLUSIONS: A new water-soluble formulation for a ciclopirox nail lacquer showed similar efficacy to the reference product to eradicate toenail onychomycosis and superiority in the mycological cure defined by negative culture, thus preventing reinfections and recurrences. Efficacy and safety data demonstrate the positive benefit-risk profile of this new topical antifungal preparation. [Correction added on 13 April 2023, after first online publication: The results and conclusions in the Abstract contained incorrect information and were revised in this version.].

Estudio observacional: seguridad de Nife-Par(R) en amenaza de parto pretérmino / Observational study: Safety of Nife-Par(R) in the threatened preterm labour

Objetivo: analizar en un estudio de forma preliminar el perfil de seguridad de nifedipino solución oral (Nife-Par(R)) en el tratamiento de la amenaza de parto prematuro. Material y métodos: análisis preliminar del estudio prospectivo y observacional de un solo brazo en mujeres con amenaza de parto pretérmino a quienes se les haya prescrito Nife-Par(R) según las indicaciones de ficha técnica. Los resultados serán contrastados con los datos de seguridad publicados sobre el uso de nifedipino en cápsulas en el trabajo de Roel de Heus y cols. Adverse drug reactions to tocolytic treatment for preterm labour: Prospective cohort study. BMJ 2009;338:b744. DOI:10.1136/bmj.b744. Resultados: en el análisis preliminar, de los 125 casos del estudio observacional con Nife-Par(R) no se ha reportado ninguna reacción adversa grave ni severa. En 6 pacientes (5%) se reportaron episodios de reacciones adversas moderadas, y en el 2,4% de las pacientes (3 casos), estas reacciones adversas provocaron la interrupción del tratamiento. Estos datos se comparan favorablemente con la literatura en la que se refieren reacciones adversas graves en 5 pacientes (1%) de 542 con el uso de nifedipino cápsulas, y un 3,1% de interrupciones de tratamiento. Conclusión: los resultados obtenidos en este estudio preliminar muestran la ausencia de reacciones adversas graves y la reducción de la intensidad, gravedad de las reacciones adversas y una reducción del 22,6% en las interrupciones de tratamiento con el uso de Nife-Par(R) respecto a lo reportado en la literatura con nifedipino cápsulas

Objective: To analyze the safety profile of nifedipine oral solution (Nife-Par(R)) compared in the treatment of threaten preterm labor. Material and methods: Preliminary analysis of the prospective, single-arm, observational study, in womensingle- arm observational study in women who have been treated with Nife-Par(R) according to the specifications of the technical data sheet. Results will be compared with published safety data on the use of nifedipine in capsules in the study by Roel de Heus et al. Adverse drug reactions to tocolytic treatment for preterm labor: prospective cohort study. BMJ 2009;338:b744. DOI:10.1136/bmj.b744. Results: In the preliminary analysis of the 125 cases of the observational study with Nife-Par(R), no severe adverse reaction or severe intensity was reported. In 6 patients (5%) episodes of adverse reactions of moderate intensity were reported, and in 2.4% of the patients (3 cases), these adverse reactions caused the discontinuation of the treatment. These data compare favorably with the literature where serious adverse reactions are reported in 5 patients (1%) of 542 with the use of nifedipine capsulesand a 3.1% of treatment discontinuation 1,2. Conclusion: The results in the present preliminary analysis show the absence of severe adverse events together with reduction of the intensity and severity of the adverse events and a 22.6% reduction on treatment discontinuation compared with that reported in the literature with nifedipine capsules

Alternativas terapéuticas para la tocólisis en el manejo de la amenaza de parto pretérmino / Therapeutic alternatives for the tocolysis in the management of the threatened preterm labour

La amenaza de parto pretérmino (APP) es una urgencia obstétrica que, en ausencia de intervención, desemboca en un parto prematuro. Detener la APP y prolongar la gestación todo lo posible permite trasladar a la gestante a un centro apropiado, administrar los cuidados necesarios y conceder un mayor periodo de maduración al feto, esencial para reducir la morbimortalidad asociada al parto prematuro. El empleo de tocolíticos al inicio de este proceso es esencial. En este artículo se revisa el escenario clínico y la información sobre los tocolíticos actualmente autorizados en España, dos de ellos por vía intravenosa (ritodrina y atosibán) y otro por vía oral (nifedipino solución oral) (AU)

Threatened preterm labour is an urgent obstetric condition leading to a preterm birth in the absence of medical intervention. Intervention must focus on stopping birth progression in order for the patient and the fetus be administered an adequate medical care, providing a temporal window for fetus´ maturation. This medical management is aimed to reduce the morbimortality associated to preterm birth. This manuscript consists of a review of the toclytics of more extended use in our context. Currently, three drugs are authorised as tocolytics in Spain: ritodrine and atosiban (intravenous) and nifedipine (oral solution) (AU)

Estudio observacional, transversal, de una muestra representativa de las mujeres españolas en edad fértil, sobre los cuidados, hábitos y promoción de la salud previamente y durante el embarazo: Estudio GESTMUJER / Cross-sectional study of vitamin and folic acid supplementation in a representative sample of Spanish women of fertile age before and during pregnancy: The GESTMUJER study

Objetivo. Conocer los hábitos de las mujeres españolas en edad fértil, respecto al uso de suplementos vitamínicos y ácido fólico antes y durante el embarazo. Material y método. Encuesta telefónica realizada a una muestra representativa de 1.020 mujeres residentes en España de 15 a 49 años de edad, durante el mes de marzo del 2013. Resultados. Una de cada 4 mujeres españolas planifica su embarazo. Como consecuencia de esta falta de planificación, solo el 28,6% de las mujeres había tomado un suplemento de ácido fólico con anterioridad al momento de quedar embarazada. Conclusiones. Sigue existiendo la necesidad de informar y aconsejar a las mujeres en edad fértil sobre la conveniencia de utilizar ácido fólico previamente a un embarazo. Parecen necesarias campañas institucionales que promuevan tanto la planificación de un futuro embarazo, como el uso de suplementos vitamínicos antes y durante el mismo (AU)

Objective. To identify the use of folic acid and other vitamins in Spanish women of fertile age before and during pregnancy. Material and method. A representative survey of 1020 Spanish women aged 15 to 49 years was carried out in March 2013. Results. Only one quarter of Spanish women planned their pregnancies and,as a result, only 28.6% of women took folic acid before becoming pregnant. Conclusions. There is a lack of information about the role and importance of folic acid to prevent neural tube defects. Institutional campaigns are needed to promote both pregnancy planningand the use of vitamin supplements before and during pregnancy (AU)

Trends in contraception use in Spanish adolescents and young adults (15 to 24 years) between 2002 and 2008.

OBJECTIVE: To assess changes in the use of contraceptive methods, and induced abortion rates, in Spanish adolescents and young adults aged 15 to 24 years, between 2002 and 2008. STUDY DESIGN: Representative samples of Spanish men and women aged 15 to 24 years were surveyed in 2002 (N = 1826) and 2008 (N = 2000). RESULTS: The rate of use of contraceptive methods increased from 61% in men and 60% in women in 2002 to 80% and 75%, respectively, in 2008. The most commonly used method was the condom (51% in 2002 and 71% in 2008), followed by the contraceptive pill (18% in 2002 and 18% in 2008). None of the adolescents and young adults surveyed used natural methods or the diaphragm, or had undergone sterilisation. The induced abortion rate increased from 9.28 to 13.48 per 1000 women in the group aged between 15 and 19 years, and from 14.37 to 21.05 per 1000 women in the group aged 20 to 24 years. CONCLUSION: Despite an increase in the use of effective birth control methods, the rates of abortion rose during the study period, which may indicate that compliance with the use of condoms is inadequate. There is an urgent need to develop educational campaigns or to design specific policies addressing contraception-related issues for young people.

Contraceptive practices of women requesting induced abortion in Spain: a cross-sectional multicentre study.

OBJECTIVES: To collect information on (i) contraceptive methods used immediately before unwanted pregnancy, and (ii) planned contraception following induced abortion among Spanish residents. METHODS: Eight centres officially accredited to perform abortions participated in a cross-sectional study. The study population included 2475 women requesting induced abortion between 1 January and 31 March 2007. RESULTS: Contraceptive methods used before unwanted pregnancy were condoms in 40% of the cases, combined hormonal contraception in 14%, and other methods (mainly natural methods and withdrawal) in 10%. Thirty-six percent of women did not use any contraceptive method. Failure of the method due to incorrect use was reported by 77% of those using condoms and by 84% of those using hormonal contraception. Only 23% of women planned to use a contraceptive method after abortion. Almost half of the women were immigrants. CONCLUSION: Despite the use of effective contraceptive methods, the majority of women requesting induced abortion in Spain became pregnant during the use of these methods. These data reflect a lack of compliance. More education programmes are needed to improve compliance rates. The long-acting reversible contraceptive methods could constitute an appropriate approach.

Development and validation of the SEC-QOL questionnaire in women using contraceptive methods.

OBJECTIVES: Develop and validate a Spanish society of contraception quality-of-life (SEC-QOL) questionnaire to assess the impact of contraceptive methods on the health-related quality of life (HRQOL) of women. METHODS: SEC-QOL was developed following a standardized procedure including review of the literature, interviews with contraception users, and the administration of a pilot questionnaire to 187 women. SEC-QOL consists of 19 items and includes five dimensions. To validate the questionnaire, a multicenter, observational, prospective study was conducted in Spain. The following three study groups were defined: group A (n = 129) comprised women using effective contraceptive methods; group B (n = 251), comprised women about to start using an effective method; and group C (n = 73) comprised women using no or poorly effective contraception. All women attended baseline and final visits (4 ± 1 months). Participants completed the SEC-QOL, psychological well-being index, EuroQol five-dimensional questionnaire, and perceived health state questionnaires. RESULTS: At baseline, women from group A had a better HRQOL in all SEC-QOL dimensions, except for breast symptoms. Heavier menstrual bleeding, more androgenic and breast symptoms, menstrual pain, and not using hormonal contraceptive methods were associated with lower HRQOL. SEC-QOL scores showed moderate correlations to psychological well-being index and slightly lower correlation to EuroQol five-dimensional questionnaire scores. At follow-up, HRQOL had improved in all groups; most markedly in group B, which obtained an average effect size of 0.59. The minimum important difference was established as a 3.4-point change in the global SEC-QOL score. SEC-QOL obtained a Cronbach's α of 0.88 and an intraclass correlation coefficient of 0.82. CONCLUSIONS: SEC-QOL is a valid, reliable, and sensitive to change questionnaire for use in daily clinical practice and future research projects on contraception.

Prevalence of premenstrual syndrome and premenstrual dysphoric disorder in a representative cohort of Spanish women of fertile age.

OBJECTIVE: To assess the prevalence of premenstrual symptoms, premenstrual syndrome and premenstrual dysphoric disorder in a cohort of women of fertile age representative of the general Spanish population. STUDY DESIGN: During the period between November 27th and December 22nd, 2008, a cross-sectional nationwide survey was conducted among a cohort of Spanish women aged between 15 and 49 years. Participants were personally interviewed at home and completed the premenstrual symptoms screening tool. RESULTS: Of the 2108 participants, 1554 women (73.7%) complained of some of the premenstrual symptoms during the last 12 menstrual cycles. A total of 1415 (91%) women presented isolated symptoms and 139 (8.9%) a moderate/severe premenstrual syndrome. Twenty-four (1.1%) women fulfilled criteria for a diagnosis of premenstrual dysphoric disorder. CONCLUSION: The prevalence of premenstrual symptoms (73.7%) and premenstrual dysphoric disorder (1.1%) in Spanish women aged between 15 and 49 years is similar to that reported in other Western countries. Only women with moderate or severe premenstrual syndrome or premenstrual dysphoric disorder, however, had daily life activities significantly impaired by premenstrual symptoms.

Trends in the use of contraceptive methods and voluntary interruption of pregnancy in the Spanish population during 1997-2007.

BACKGROUND: This study was designed to acquire information about the use of contraceptive methods in order to reduce the number of elective abortions. STUDY DESIGN: Since 1997, representative samples of Spanish women of childbearing potential (15-49 years) have been surveyed by the Daphne Team every 2 years to gather data of contraceptive methods used. RESULTS: During the study period, 1997 to 2007, the overall use of contraceptive methods increased from 49.1% to 79.9%. The most commonly used method was the condom (an increase from 21% to 38.8%), followed by the pill (an increase from 14.2% to 20.3%). Female sterilization and IUDs decreased slightly and were used by less than 5% of women in 2007. The elective abortion rate increased from 5.52 to 11.49 per 1000 women. CONCLUSIONS: The factors responsible for the increased rate of elective abortion need further investigation.

La juventud española y el doble método: un análisis de la situación actual. Resultados de un estudio transversal de una muestra amplia / Spanish 15-24-year-olds and the «double method»: Analysis of the current situation. Results of a cross-sectional study in a broad sample

Objetivos: Conocer el porcentaje de jóvenes españoles de ambos sexos, con edades comprendidas entre los 15 y los 24 años, que utilizan o conocen el doble método. Material y métodos: Estudio descriptivo, transversal, realizado en el mes de marzo de 2005 mediante una encuesta nacional entre una muestra de 2.015 jóvenes españoles con edades comprendidas entre los 15 y los 24 años. Los datos fueron recogidos en una base de datos diseñada para el estudio y su tratamiento estadístico se realizó mediante el paquete SPSS. Resultados: El 70% de los jóvenes es sexualmente activo. El método anticonceptivo más utilizado es el preservativo. Sólo el 3,4% de los jóvenes varones españoles y el 7,3% de las mujeres han utilizado, en alguna ocasión, un doble método, y este porcentaje desciende hasta el 0,2 y el 2,9%, respectivamente, cuando se refiere a la última relación sexual mantenida. El 31% de los varones y el 36,8% de las mujeres conocen el doble método. Conclusiones: El uso y el conocimiento del doble método entre la población joven española son bajos

Objectives: To determine the percentage ofSpanish 15-24-year-olds of both sexes that use orknow about the double method.Material and methods: We performed a crosssectionalstudy in March 2005 through a national survey of a sample of 2015 Spanish 15-24-yearolds.The data were collected in a databasespecifically designed for the study and wereanalyzed using the SPSS statistical system.Results: Seventy percent of the 15-24-year-oldswere sexually active. The most widely usedcontraceptive method was the condom. Only 3.4%of males and 7.3% of females had ever used thedouble method and this percentage decreased to0.2% and 2.9%, respectively, in the last sexualrelationship. Thirty-one percent of males and 36.8%of females were aware of the double method.Conclusions: Use and knowledge of the double method are low among young Spaniards (AU)