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OCTUBRE 2.003
OCTOBER 2.003
YASMIN, NIMESULIDE,
CELEBREX, DUTASTERIDE, ANTIRETROVIRAL
1.)
Yasmin®, la píldora que no aumenta de peso, representa la nueva generación de
anticonceptivos.
2.)
[Venous thromboembolism and
combined oral contraceptives. Reported adverse reactions indicate at least
similar risk with the most recent contraceptive pills].
3.) Yasmin advert withdrawn--why and
how.
4.)
A randomized study over 13 cycles to assess the influence of oral contraceptives
containing ethinylestradiol combined with drospirenone or desogestrel on
carbohydrate metabolism.
5.) Nimesulide-induced fulminant hepatitis (AULIN).
6.) Nimesulide, a Cyclooxygenase-2
Preferential Inhibitor, Impairs Renal Function in the Newborn Rabbit.
7.) Cardiovascular thrombotic events in arthritis
trials of the cyclooxygenase-2 inhibitor celecoxib (CELEBREX).
8.) Dutasteride: a new 5-alpha reductase inhibitor
for men with lower urinary tract symptoms secondary to benign prostatic
hyperplasia.
9.) La Organización Mundial de la Salud (OMS) presentó hoy tres nuevos medicamentos
anti retrovíricos, que serán utilizados para tratar a tres millones de enfermos
con el Síndrome de Inmunodeficiencia Adquirida (Sida) en el 2005.
10.) Thromboembolism associated with the new contraceptive Yasmin.
11.) Dutasteride.
12.) Effect of an oral contraceptive containing ethinyl estradiol
and drospirenone on premenstrual symptomatology and health-related quality of
life.
1.) Yasmin®, la píldora que no aumenta de peso,
representa la nueva generación de anticonceptivos
Yasmin®, la píldora que no aumenta de peso, representa la nueva generación de
anticonceptivos
Source: http://www.analitica.com
Viernes, 24 de octubre de 2003
Caracas. octubre de 2003.- La revolución de la anticoncepción femenina da un
paso adelante con la llegada de Yasmin® (drospirenona/estradiol), la primera
píldora que combina la mayor eficacia anticonceptiva con el cuidado de la
belleza personal y el bienestar íntimo de la mujer. Yasmin® ha sido muy bien
recibida por ginecólogos y mujeres en Europa, donde ya es usada por más de un
millón de mujeres, y en Estados Unidos es conocida como la píldora que no
aumenta de peso, dando respuesta a una de las principales inquietudes que las
mujeres han tenido respecto a la anticoncepción hormonal oral.
Yasmin® no produce retención de agua, manteniendo el peso estable, alivia
también las molestias características de la menstruación, como tensión mamaria o
sensación de hinchazón, a la vez que aumenta la calidad del pelo y la tersura de
la piel”, afirma la doctora Marianella Escobar, médico ginecóloga infanto-juvenil.
Adicionalmente, cabe señalar que esta nueva píldora mantiene las características
de todos los anticonceptivos modernos de baja dosis en términos de eficacia,
confiabilidad, seguridad y control del ciclo menstrual de la mujer.
El secreto de Yasmin® reside en su innovadora composición formada por 30
microgramos del estrógeno etinilestradiol y tres miligramos de drospirenona, un
progestágeno de perfil similar al natural generado por el organismo de la mujer,
desarrollado por los investigadores del laboratorio Schering AG, distinguido por
su capacidad de renovar la anticoncepción femenina en los últimos cuarenta años.
La drospirenona interviene en la regulación del agua y en el equilibrio
electrolítico corporal, por lo cual tiene un efecto positivo en el control del
peso y en la mejora de la belleza de la mujer.
En los diferentes estudios clínicos previos al lanzamiento de Yasmin®, que
involucraron a 2 mil 263 mujeres y 29 mil 735 ciclos, se constató la eficacia
anticonceptiva cercana al 100 por ciento, junto a un excelente control del ciclo
menstrual y una muy baja aparición de irregularidades durante el mismo. Esto
significa que esta nueva píldora también reduce la duración e intensidad del
sangrado y disminuye la aparición de manchado y de amenorrea (ausencia de
menstruación).
Esta píldora está especialmente indicada para mujeres que sean nuevas usuarias y
que le den importancia a su estado físico y su estabilidad emocional. Las
características de Yasmin® son ideales para las mujeres preocupadas por mantener
una buena línea y por su belleza física, pero también deseosas de mejorar su
calidad de vida de una manera integral.
Control del peso, más belleza
La sensación de aumento de peso es una de las principales quejas de las mujeres
con respecto a los anticonceptivos hormonales orales. Distintos estudios afirman
que el 46 por ciento de las mujeres dicen abandonar el método a los seis meses
por efectos adversos. Una encuesta reciente señaló que el 27 por ciento de las
mujeres que habían usado un anticonceptivo oral experimentó un aumento de peso
que atribuyó a la utilización de la píldora.
Los diferentes estudios desarrollados con Yasmin® demostraron que la
drospirenona posee un efecto beneficioso sobre el peso corporal de la mujer. La
conclusión es que esta píldora es capaz, no sólo de no aumentar de peso, sino
también de disminuir ligeramente el peso corporal de algunas mujeres. En uno de
los estudios se observó que durante los tres primeros ciclos el peso de las
usuarias de Yasmin® disminuyó uniformemente durante los tres primeros ciclos. En
otro estudio de 13 ciclos, se corroboró que las mujeres que usaban Yasmin®
tienen menos probabilidad de aumentar de peso que las que utilizan los
anticonceptivos convencionales. “Estos datos sugieren que la drospirenona de
Yasmin® conduce a que no exista un aumento de peso en la mayoría de las mujeres,
fruto de la reducción en la retención de agua pero no es un indicador de pérdida
de grasa corporal”, afirma la doctora Sandra Maucó, médico gineco-obstetra
coordinadora regional del Centro Latinoamericano Salud y Mujer (Celsam).
Otros estudios han demostrado que Yasmin® , a través de la drospirenona, cuenta
con un efecto beneficioso en las jóvenes con acné de leve a moderado debido a su
actividad contra los efectos masculinizantes, que se extienden también a la
seborrea. Estos estudios analizaron el impacto positivo sobre lesiones faciales
como comedones, pápulas, pústulas y nódulos, así como la producción sebácea.
Asimismo, Yasmin® ha demostrado su eficacia en el tratamiento del síndrome
premenstrual, que afecta a más del 25 por ciento de las mujeres. Esto se observó
en un amplio espectro de síntomas relacionados a la retención de líquido
(tensión mamaria y abdominal, las manchas en la piel y el aumento de peso) y a
los de manifestación del afecto (sensación de soledad, tristeza, tendencia al
llanto, cambios de humor, irritabilidad e inquietud).
Calidad de vida
Las mejoras que representa Yasmin® afectan significativamente la calidad de vida
de las mujeres. Para comprobar la reacción de las usuarias, se llevó a cabo una
encuesta en varios países europeos con preguntas formuladas durante y después de
la toma de esta píldora, preguntándole a las mujeres cómo se sentían. Las
participantes indicaron que tras la toma de Yasmin® se mostraban satisfechas con
su peso corporal, su estado de ánimo y la mejora en aspectos ligados a la
belleza como el cabello y la piel. “Esta alta satisfacción de las mujeres con el
método anticonceptivo hormonal oral mejora el cumplimiento y reduce el número de
abandonos del método y un mejor control de los embarazos no deseados”, afirmó
Maucó.
Acerca de Schering
El laboratorio Schering AG, líder en control de fertilidad, desarrollo Yasmin®.
En los últimos 40 años sus esfuerzos de investigación han permitido el avance de
la anticoncepción con adelantos como el uso del etinilestradiol, las píldoras
microdosificadas, las trifásicas y las denominadas de tercera generación.
Schering está especializada en salud de la mujer, dedicando un 18 por ciento de
sus ventas a investigación y desarrollo de nuevas soluciones, una de las cifras
más altas del sector farmacéutico. También está presente en oncología,
esclerosis múltiple, dermatología y diagnóstico, con productos de primera
calidad. En América Latina, la compañía inició sus actividades en 1923,
consiguiendo una presencia homogénea en todos los países y demostrando, al cabo
de estos años, su compromiso con la sociedad y con la ciencia en la región.
2.) [Venous thromboembolism and combined oral contraceptives.
Reported adverse reactions indicate at least similar risk with the most recent
contraceptive pills]
Lakartidningen. 2003 Sep 25;100(39):3050-2.
[Article in Swedish]
Kieler H, Persson I, Odlind V.
Lakemedelsverket, Uppsala. [email protected]
Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such
as venous thromboembolism (VTE), are seldom disclosed until a COC has been on
the market for some time. Two new COCs, Yasmin and Cilest have recently been
launched in several European countries with expectations of being safer than
older COCs. Utilising data from spontaneous reporting of ADRs to the Medical
Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest
was estimated and compared with VTE incidence for a second (Follimin) and a
third generation (Desolett) COC. The reported VTE incidence for Yasmin and
Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the
corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000
users per year, respectively. The differences were, however, not statistically
significant. We conclude that the risk of VTE associated with the most recent
COCs is at least similar to that of older COCs.
3.) Yasmin advert withdrawn--why and how.
Drug Ther Bull. 2003 Mar;41(3):17-8.
[No authors listed]
In April 2002, Schering Health Care launched its combined oral contraceptive (COC)
pill Yasmin in the UK with an advertising campaign that centred on claimed 'lifestyle'
advantages of the product. In our August 2002 article 'Is Yasmin a "truly
different" pill?', we concluded that the company's claim that Yasmin is "the
pill for wellbeing" was unjustified and misleading and should be withdrawn. We
also argued that there was no compelling published evidence that Yasmin offered
any advantages over other, longer-established, COCs with regards to weight gain,
skin condition or premenstrual symptoms. In September, we received a letter from
Schering's solicitors threatening to sue us for defamation on the grounds that "the
article has damaged the reputation of Yasmin and the Company". In December, we
learned that the company had withdrawn the advertising. Here, we summarise the
events that led to the withdrawal. We also consider the weaknesses this episode
reveals about current procedures for controlling medicines promotion in the UK.
4.) A randomized study over 13 cycles to
assess the influence of oral contraceptives containing ethinylestradiol combined
with drospirenone or desogestrel on carbohydrate metabolism.
Contraception. 2003 Jun;67(6):423-9.
Gaspard U, Scheen A, Endrikat J, Buicu C, Lefebvre P, Gerlinger C, Heithecker R.
Department of Gynecology, University of Liege, Sart Tilman University Hospital,
Liege, Belgium. [email protected]
In this open-label, randomized study we compared the influence of a new oral
contraceptive containing 30 microg ethinylestradiol and 3 mg drospirenone (Yasmin)
with a reference preparation containing 30 microg ethinylestradiol and 150
microg desogestrel (Marvelon) on variables of carbohydrate metabolism by means
of oral glucose tolerance tests at baseline and in the 6th and 13th treatment
cycle. The mean levels of fasting glucose and insulin were similar at baseline
and after 13 treatment cycles, whereas C-peptide and free fatty acid levels
decreased slightly in both groups. All blood glucose and insulin values measured
in the oral glucose tolerance tests were within normal ranges, despite a slight
increase in the mean areas under the curves of 0-3 h [AUCs (0-3 h)] of both
variables from baseline to treatment cycle 13. Differences between both
treatments were not statistically significant. The mean AUCs (0-3 h) for C-peptide
were not markedly changed in any treatment group. Free fatty acid levels
decreased by 42% in the drospirenone group and increased by 48.9% in the
desogestrel group, in terms of means of individual changes. Both preparations
were well tolerated and equally efficacious regarding contraception and cycle
control. The mean body weight was slightly decreased in most cycles during
treatment with the drospirenone combination, as compared to baseline, while it
was slightly increased versus baseline in all cycles during treatment with the
desogestrel combination. The combination with drospirenone had less impact on
blood pressure than the combination with desogestrel. In conclusion, Yasmin, a
combined low-dose oral contraceptive with 30 microg ethinylestradiol and 3 mg of
the novel progestogen drospirenone, as well as the reference Marvelon,
containing 30 microg ethinylestradiol and 150 microg desogestrel had little
impact on carbohydrate metabolism when used for 1 year. The observed changes
were small and not suggestive of a clinically relevant deterioration of
carbohydrate metabolism.
5.) Nimesulide-induced fulminant hepatitis. (AULIN)
Turk J Gastroenterol. 2003 Sep;14(3):208-210.
Ozgur O, Hacihasanoglu A, Karti SS, Ovali E.
Division of Gastroenterology, School of Medicine, Karadeniz Technical University,
Trabzon, Turkey. [email protected]
An 18-year-old boy was brought to the hospital with jaundice, confusion,
abdominal discomfort and distension. He had a history of oral intake of
nimesulide for three days. Clinical and laboratory findings were compatible with
fulminant hepatitis. Exclusion of other causes of liver injury strongly favored
drug-induced toxicity. All of the signs, symptoms and laboratory abnormalities
returned to normal after cessation of the nimesulide and supportive treatment,
and he was discharged on the 15th day after admission. This case differs from
the other cases in the literature regarding the time of onset, and indicates
that nimesulide may induce fulminant hepatitis in the first few days of
administration. Therefore, patients receiving nimesulide should be frequently
monitored with serial serum transaminases, beginning from the first week of
intake.
6.) Nimesulide, a Cyclooxygenase-2 Preferential Inhibitor,
Impairs Renal Function in the Newborn Rabbit
Nimesulide, a
Cyclooxygenase-2 Preferential Inhibitor, Impairs Renal Function in the Newborn
Rabbit.
Pediatr Res. 2003 Nov 6 [Epub ahead of print].
Prevot A, Mosig D, Martini S, Guignard JP.
Nephrology Unit, Department of Pediatrics, Lausanne University Medical Center,
CH 1011 Lausanne, Switzerland.
Tocolysis with nonsteroidal anti-inflammatory drugs (NSAIDs) has been widely
accepted for several years. Recently, the use of the cyclooxygenase-2 (COX2)
preferential NSAID nimesulide has been proposed. However, data reporting
neonatal acute renal failure or irreversible end-stage renal failure after
maternal ingestion of nimesulide question the safety of this drug for the fetus
and the neonate. Therefore, this study was designed to define the renal effects
of nimesulide in newborn rabbits. Experiments were performed in 28 newborn
rabbits. Renal function and hemodynamic parameters were measured using inulin
and para-aminohippuric acid clearances as markers of GFR and renal blood flow,
respectively. After a control period, nimesulide 2, 20, or 200 micro g/kg was
given as an i.v. bolus, followed by a 0.05-, 0.5-, or 5- micro g. kg(-1). min(-1)
infusion. Nimesulide administration induced a significant dose-dependent
increase in renal vascular resistance (30, 36, and 92%, respectively), with a
concomitant decrease in diuresis (-5, -23, and -44%), GFR (-12, -23, and -44%),
and renal blood flow (-23, -23, and -48%). These results are in contrast with
recent reports claiming that selective COX2 inhibition could be safer for the
kidney than nonselective NSAIDs. These experiments confirm that prostaglandins,
by maintaining renal vasodilation, play a key role in the delicate balance
regulating neonatal GFR. We conclude that COX2-selective/preferential inhibitors
thus should be prescribed with the same caution as nonselective NSAIDs during
pregnancy and in the neonatal period.
7.) Cardiovascular thrombotic events in arthritis trials of
the cyclooxygenase-2 inhibitor celecoxib. (CELEBREX)
Am J Cardiol. 2003 Aug 15;92(4):411-8.
White WB, Faich G, Borer JS, Makuch RW.
Division of Hypertension and Clinical Pharmacology, Department of Medicine,
University of Connecticut School of Medicine, Farmington, Connecticut
06030-3940, USA. [email protected]
To determine whether the cyclooxygenase-2 (COX-2) inhibitor celecoxib affects
cardiovascular thrombotic risk, we analyzed the incidence of cardiovascular
events for celecoxib, placebo, and nonsteroidal anti-inflammatory drugs (NSAIDs)
in the entire controlled, arthritis clinical trial database for celecoxib. The
primary analysis used the Antiplatelet Trialists' Collaboration end points,
which include: (1) cardiovascular, hemorrhagic, and unknown deaths, (2) nonfatal
myocardial infarction, and (3) nonfatal stroke. Other secondary thrombotic
events were also examined. Separate analyses were performed for all patients and
for those not taking aspirin. Data from all controlled, completed arthritis
trials of > or =4 weeks duration, including 13 new drug application studies and
2 large post-marketing trials (CLASS and SUCCESS) were included for analyses.
Patients were randomized to celecoxib at doses from 100 to 400 mg twice daily
(18,942 patients; 5,668.2 patient-years of exposure), diclofenac 50 to 75 mg
twice daily, ibuprofen 800 mg thrice daily, naproxen 500 mg twice daily (combined
NSAID exposure of 11,143 patients; 3,612.2 patient-years), or placebo (1,794
subjects; 199.9 subject-years). Data from a long-term uncontrolled trial with
5,209 patients (6,950 patients-years) treated with celecoxib were included in a
supplemental analysis. The entire 15-trial database was searched for possible
serious thrombotic events as well as to identify all deaths. For these patients,
detailed clinical data were obtained and reviewed by 2 of the investigators (WBW
and JSB), who were independently and blinded to exposure, to classify the event
as primary, secondary, or neither. All analyses were done using the intent-to-treat
population, and time-to-event analyses were performed using per-patient data. To
examine heterogeneity of results among studies, tests of interaction were
performed using the Cox model. Incidences of the primary and secondary events
were not significantly different between the celecoxib and placebo groups, nor
for the celecoxib group compared with the NSAIDs group, regardless of aspirin
use and NSAID type. The relative risks comparing celecoxib with the NSAIDs for
the primary events were 1.06 (95% confidence interval 0.70 to 1.61, p = 0.79)
for all patients, and 0.86 (95% confidence interval 0.48 to 1.56, p = 0.62) for
the subgroup not taking aspirin. Similarly, for secondary cardiovascular end
points, all relative risks were < or =1 for celecoxib compared with either
placebo or NSAIDs. These comparative analyses demonstrate no evidence of
increased risk of cardiovascular thrombotic events associated with celecoxib
compared with either conventional NSAIDs or placebo.
8.) Dutasteride: a new 5-alpha reductase inhibitor for men with
lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Int J Clin Pract. 2003 Oct;57(8):705-9.
Brown CT, Nuttall MC.
Clinical Effectiveness Unit, Royal College of Surgeons of England, London, UK.
Dutasteride is a new 5-alpha reductase inhibitor for the treatment of men with
moderate to severe lower urinary tract symptoms secondary to benign prostatic
hyperplasia. It has been available in the UK since March 2003. It is a
competitive inhibitor of both type I and type II isoforms of the 5-alpha
reductase enzyme that converts testosterone to the more potent androgen,
dihydrotestosterone. Randomised controlled studies have shown dutasteride to be
statistically more effective than placebo in reducing lower urinary tract
symptoms and increasing maximum urinary flow rates. This is a consequence of a
reduction in serum dihydrotestosterone and hormone dependent prostate volume.
Dutasteride has also been shown to decrease the absolute risk of urinary
retention and the need for prostate-related surgery when compared to placebo
taken over a 24-month period. In this review article we discuss the pharmacology
and clinical effects of dutasteride, a new dual-acting 5-alpha reductase
inhibitor.
9.)
La Organización Mundial de la Salud (OMS) presentó hoy
tres nuevos medicamentos anti retrovíricos, que serán utilizados para tratar a
tres millones de enfermos con el Síndrome de Inmunodeficiencia Adquirida (Sida)
en el 2005.
Presentan nuevos fármacos contra el Sida
Source: http://www.tabascohoy.com.mx
Por Redacción
Tabasco HOY / Notimex
París, Francia 12:06 horas
Lunes 01 de Diciembre del 2003
La Organización Mundial de la Salud (OMS) presentó hoy tres nuevos medicamentos
anti retrovíricos, que serán utilizados para tratar a tres millones de enfermos
con el Síndrome de Inmunodeficiencia Adquirida (Sida) en el 2005.
Los fármacos fueron presentados en el marco del Día Mundial del Sida, que se
celebra este lunes en todo el mundo para intensificar el combate contra esa
enfermedad así como fomentar las medidas de prevención y detener su propagación.
Las tres nuevas píldoras son una combinación de tres de los principales
retrovirales (ARV): lamivudin, stavudin y nevirapin, fueron aprobados la semana
pasada por expertos de las Naciones Unidas (ONU), tras el visto bueno de la OMS.
Los nuevos medicamento se suman a los 48 que ya son comercializados a nivel
mundial y que cumplen con todas las normas de calidad, inocuidad y eficacia,
establecidas por la OMS y el Programa de las Naciones Unidas sobre el Sida (ONUSIDA).
Los anti retrovirales serán empleados en un nuevo plan de ambos organismos para
tratar a más de tres millones de cero positivos en países en vías de desarrollo
de manera gratuita a partir del 2005, con un costo aproximado de dos mil 700
millones de dólares.
El director general de la OMS, Lee Jong-Wook, dijo este lunes que el proyecto
representa un paso vital para proporcionar un tratamiento eficaz para mejorar
las condiciones de vida de los enfermos de Sida más necesitados de todo el
mundo.
"Prevenir y atender el Sida es quizás la tarea más ardua en materia sanitaria de
todas las que se ha enfrentado el mundo pero es también la más urgente", indicó
Lee en una conferencia de prensa en Ginebra para presentar los medicamentos.
Destacó que la vida de millones de personas está en juego, por lo que se
requiere una estrategia masiva y no convencional para asegurar que sigan vivos y
en buenas condiciones de salud, ante el incesante crecimiento de infectados con
la enfermedad.
De acuerdo con el más reciente reporte de la OMS y el ONUSIDA existen en el
mundo más de 40 millones de enfermos con el VIH en el mundo, de los cuales cinco
millones se infectaron tan sólo en el 2003, lo que representa que cada minuto se
presentan 10 nuevos casos.
En su reporte titulado "Situación de la epidemia de SIDA en el 2003", difundido
la semana pasada, la OMS advirtió que al menos seis millones de personas
necesitan de manera urgente un tratamiento contra el Sida, principalmente en
Africa, el este de Europa y Asia.
La región de Asia-Pacífico es en la actualidad la más susceptible a la
propagación de mal, debido a la cultura y religión de país como India y China,
donde no existen acciones efectivas para combatir la enfermedad, ni campañas
sobre el uso del condón.
En las celebraciones de este lunes del Día Mundial del Sida, China reconoció que
ese país afronta uno de los momentos más cruciales en el combate de la epidemia,
ya que existen más de 800 mil casos y el ritmo de crecimiento es sumamente
acelerado.
En un hecho sin precedentes, el primer ministro chino, Wen Jiabao asistió esta
mañana a un hospital de Beijing para estrechar la mano de pacientes terminales
por el Sida y explicarles las medidas que realiza el gobierno para combatir el
mal.
Con el emblemático listón rojo de la lucha mundial contra el Sida en el pecho,
Jiabao dijo que el mal puede ser prevenido, por lo que exhortó a la población a
fomentar entre sus hijos una educación sexual sana.
En la India, donde existen más de 4.5 millones de personas infectada con el VIH,
las autoridades organizaron varios actos públicos sobre el mal, en un intento
por acabar con la discriminación que sufren a diario los enfermos de Sida.
Singapur y Tailandia celebraron con desfiles y oraciones el Día Mundial del
Sida, mientras que en Nueva Zelandia, autoridades sanitarias y voluntarios
salieron a las calles a repartir gratuitamente preservativos.
En países africanos como Sudáfrica, la República Democrática del Congo (RDC, ex
Zaire) y Kenya se llevaron a cabo varias ceremonias simbólicas en honor de los
millones de fallecidos por el mal y se emprendieron nuevas campañas de
prevención.
En Rusia y Reino Unido, dos de las naciones europeas con mayor índice de
crecimiento de infectados con VIH, los gobiernos instaron a la población a
mantener una cultura de prevención contra la enfermedad.
10.) Thromboembolism associated with the new contraceptive
Yasmin.
Kees van Grootheest, Tom Vrieling
Source: BMJ. 2003 February 1; 326 (7383): 257
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch,
Netherlands
Correspondence to: K van Grootheest [email protected]
Our centre, the Dutch spontaneous reporting system for adverse drug reactions,
recently received five reports of thromboembolism as a suspected adverse drug
reaction to the new oral contraceptive Yasmin (ethinylestradiol and drospirenone).
A 17 year old woman suddenly collapsed and died after taking the contraceptive
for six months. Autopsy showed that she had had a massive pulmonary embolism. No
obvious risk factors for thromboembolism, such as smoking, a period of long
immobilisation, air flights, or concomitant medication, were evident.1 Because
she died suddenly no blood sample was taken. Blood taken from her parents did
not test positive for any of the known risk factors: concentrations of protein C
and antithrombin III were normal. The activated partial thromboplastin time and
partial thromboplastin time were normal, and the existence of factor V Leiden
mutation was excluded.
A 28 year old woman changed her oral contraceptive from ethinylestradiol with
desogestrel (Marvelon) to ethinylestradiol with drospirenone. Four months later
she had thrombosis in one leg and was treated with acenocoumarol. Risk factors
or concomitant drugs were unknown.
Another patient, a 45 year old woman, had deep vein thrombosis in one leg after
taking ethinylestradiol with drospirenone for two months, as did a 50 year old
woman who took the contraceptive for three months. A 35 year old woman had
pulmonary thrombosis 17 days after she started taking the contraceptive. She had
given birth four months earlier.
Ethinylestradiol with drospirenone has been approved as an oral contraceptive in
all European Union countries since 2000 and has recently been launched in the
United Kingdom.2 The public assessment report of the contraceptive gives only
one suspected case of pulmonary embolism but also says that the number of cases
in the preregistration studies are too low for a reliable conclusion on this
matter.3
The risk of thromboembolism for women using the third generation (combined) pill
has long been debated. Physicians therefore may prefer a new type of combined
pill, like ethinylestradiol with drospirenone, assuming that these are safer.
However, an association of these drugs with a lower risk of thromboembolism has
not been proved by research, and our cases show that newer contraceptive pills
may have a risk of thromboembolism. At present, insufficient data on the
superiority of ethinylestradiol with drospirenone are available.
References
1.) Winkler, UH. Oral contraception in women at risk of venous disease. Gynaecol
Forum 2001; 6: 2328 .
2.) Sheldon, T. Dutch GPs warned against new contraceptive pill. BMJ 2002; 324:
869 . [PubMed][Free Full Text]
3.) Official site of Dutch medicines evaluation board. http://www.pubmedcentral.nih.gov/redirect.cgi?&&reftype=other&artid=140765&&http://www.cbg-meb.nl/nl/docs/gnsmiddl/par-yasmin.pdf
(accessed 21 October 2002).
11.)
Dutasteride.
Drugs Aging. 2003;20(12):905-16; discussion 917-8.
Evans HC, Goa KL.
Adis International Limited, Auckland, New Zealand.
Dutasteride, a potent inhibitor of type 1 and 2 5alpha-reductase, reduced
dihydrotestosterone levels by >90% in 85% of patients following 1 years'
administration of oral dutasteride 0.5 mg/day. A combined analysis of three
placebo-controlled clinical studies conducted in patients with benign prostatic
hyperplasia (BPH) found sustained improvements in American Urological
Association- Symptom Index scores and urinary flow rate and a 57% decrease in
the risk of acute urinary retention throughout the 2-year treatment period (all
p < 0.001 vs placebo). Total prostate and transition zone volume were also
reduced (both p < 0.001), as was the risk of BPH-related surgery (by 48%). A
nonblind extension study found that dutasteride maintains efficacy for up to 4
years. Dutasteride monotherapy maintained symptom relief following combination
treatment with dutasteride and tamsulosin in all patients but those with severe
symptoms. Dutasteride was generally well tolerated. Impotence, reduced libido,
gynaecomastia and ejaculation disorder occurred significantly more often in
dutasteride than placebo recipients, but incidence was generally low. With the
exception of gynaecomastia, incidence consistently decreased over time.
12.) Effect of an oral contraceptive
containing ethinyl estradiol and drospirenone on premenstrual symptomatology and
health-related quality of life.
Reprod Med. 2003 Feb;48(2):79-85
Borenstein J, Yu HT, Wade S, Chiou CF, Rapkin A.
Departments of Internal Medicine and Health Services Research (Zynx Health),
Cedars-Sinai Health System, 9100 Wilshire Boulevard, Suite 655E, Beverly Hills,
CA 90212, USA.
OBJECTIVE: To evaluate the effect of the oral contraceptive Yasmin (drospirenone,
3 mg, and ethinyl estradiol, 30 micrograms) (Berlex Laboratories, Wayne, New
Jersey) on premenstrual symptomatology and health-related quality of life (HRQoL).
STUDY DESIGN: Participating health care providers received 11,260
self-administered surveys for distribution to women initiating use of Yasmin. Of
these, 1,932 (17.2%) baseline surveys and 1,104 follow-up surveys (57.1%) were
returned, with 858 (44.4%) of the returns evaluated as suitable for analysis.
RESULTS: Premenstrual symptomatology, as measured with the negative affect and
water retention domains of the Moos Menstrual Distress Questionnaire (MDQ),
significantly improved from baseline in all phases of the menstrual cycle (P =
.000). All individual MDQ items improved significantly in the late luteal phase
and during menses (P = .000), and the majority (76.9%) improved significantly in
the remainder of the cycle (P < .05). Improvements were also observed in general
sense of well-being (P < .05), impairment in usual activities due to
premenstrual symptomatology (P < .05) and Mental Component Summary scale (P =
.000) but not the Physical Component Summary scale of the Short Form-12 generic
HRQoL instrument. CONCLUSION: These data support the effectiveness of Yasmin in
reducing premenstrual symptomatology and improving HRQoL and general sense of
well-being.
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DATA-MEDICOS/DERMAGIC-EXPRESS /OCTOBER JOURNAL 2.003/ DR. JOSE
LAPENTA R.
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