sábado, 20 de diciembre de 2014

hi, Fernando Rodriguez 83


...

12/20/2014 9:18:10 AM, Fernando Rodriguez 83 wrote :

My motto is: contented with little, yet wishing for more.

martes, 1 de noviembre de 2011

drugs son seguras para ADHD

Original Article

ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults

William O. Cooper, M.D., M.P.H., Laurel A. Habel, Ph.D., Colin M. Sox, M.D., K. Arnold Chan, M.D., Sc.D., Patrick G. Arbogast, Ph.D., T. Craig Cheetham, Pharm.D., Katherine T. Murray, M.D., Virginia P. Quinn, Ph.D., M.P.H., C. Michael Stein, M.B., Ch.B., S. Todd Callahan, M.D., M.P.H., Bruce H. Fireman, M.A., Frank A. Fish, M.D., Howard S. Kirshner, M.D., Anne O'Duffy, M.D., Frederick A. Connell, M.D., M.P.H., and Wayne A. Ray, Ph.D.

November 1, 2011 (10.1056/NEJMoa1110212)

Comments open through November 8, 2011

Abstract
Article
References
Comments

Medications that are used to treat attention deficit–hyperactivity disorder (ADHD) are prescribed for more than 2.7 million children in the United States each year1 and have been considered to be relatively safe.2-5 However, reports of adverse events from Canada and the United States that have included cases of sudden death, myocardial infarction, and stroke in conjunction with the use of these drugs have raised concern about their safety.6,7 Although case reports from adverse-event reporting systems can be an important source for identifying medication safety signals, they cannot reliably quantify risk. Thus, there is a compelling need to obtain better safety data for these drugs. We used data from four large, geographically and demographically diverse U.S. health plans to conduct a retrospective cohort study of the use of ADHD drugs and the risk of serious cardiovascular events in children and young adults, with review of medical records to validate study end points. The study was conducted in parallel with a study of ADHD drug use and serious cardiovascular events in adults between the ages of 25 and 64 years.

Methods

Data Sources

We obtained study data from computerized health records of four health plans that together annually covered 22.4 million persons during the study period: Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California (Northern and Southern regions), and OptumInsight Epidemiology (national private insurance health-plan data). We augmented health-plan data with linkage to state death certificates and the National Death Index. Health-plan data included enrollment records, outpatient and inpatient claims, and records of filled prescriptions (including the dispensing date, drug name, dose, quantity, and duration of supply), which have been shown to be good measures of medication use.8-11 The initiation of the study differed according to site on the basis of the earliest availability of the site's computerized data (ranging from 1986 to 2002). Follow-up concluded for all sites at the end of 2005. Each site prepared standardized files from health-plan data and used computer programs from the lead site (Vanderbilt University) to define study variables and create files in which identifiers of patients had been removed. These files were sent to the lead site for analyses.

Study Population

To assemble the cohort, we identified patients who met the following criteria: use of an ADHD drug (methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, or pemoline) during the study period; an age of 2 to 24 years on the first day of qualifying use; continuous enrollment with drug benefits for 365 days preceding the first day of qualifying use (allowing for short administrative gaps in enrollment); and the absence of possibly life-threatening serious illness (Section 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). Because patients with congenital heart disease may be vulnerable to the effects of ADHD medications, such patients were included in the study. Exclusion criteria included a hospital discharge during the preceding 365 days with a primary diagnosis of acute myocardial infarction or stroke. The last day of study follow-up was the last day of the study or the date on which the patient no longer met study criteria. A given patient was allowed to reenter the cohort as long as all the cohort eligibility requirements were met.

For each patient receiving an ADHD medication, we randomly selected up to two nonuser control subjects from health-plan members at the same site who were enrolled on the first day of qualifying use at the age of 2 to 24 years, who met continuous-enrollment requirements, and who did not have a serious illness. Nonusers were matched with users on the basis of calendar year, age, and sex and were allowed to have previous nonqualifying use of ADHD drugs before the first day of qualifying use. Follow-up for nonusers began on the first day of qualifying use for the matched users of ADHD drugs and ended on the nonuser's last day of study follow-up (Section 2 in the Supplementary Appendix). Follow-up time did not include the time during hospitalization and the 30 days after discharge because in-hospital deaths were not considered to be study end points and health-plan files did not include drugs dispensed in the hospital.

Use of Study Drugs

Every person-day during study follow-up was classified according to use of ADHD drugs (Section 2 in the Supplementary Appendix). Current use was defined as use during the period between the prescription start date and the end of the days of supply (including up to a 7-day carryover from previous prescriptions). Former use was defined as use during the period after current use through the end of study follow-up. Nonuse was defined as no prescribed use of ADHD drugs on the day being classified or any preceding days. Former users and nonusers could become current users of ADHD drugs during follow-up, and when this occurred, their user person-time was classified as described above.

Study End Points

The primary study end point was a serious cardiovascular event, which was defined as sudden cardiac death, myocardial infarction, or stroke. Sudden cardiac death was defined as a sudden, pulseless condition or collapse consistent with a ventricular tachyarrhythmia occurring in a community setting and including both fatal and resuscitated cardiac arrest (cases in which an arrest occurred in the community but the patient was successfully resuscitated).12-16 The diagnosis of acute myocardial infarction required hospitalization and met the international diagnostic criteria for myocardial infarction.17-19 Stroke was defined as an acute neurologic deficit of sudden onset that persisted for more than 24 hours, corresponded to a vascular territory, and was not explained by other causes (e.g., trauma, infection, vasculitis, or profound systemic hypotension).17,20,21

Potential end points were identified from claims and vital records and adjudicated through review of all pertinent medical records, including hospitalizations, reports of emergency medical services, autopsies, and death certificates (Section 3 in the Supplementary Appendix). Criteria for potential cases were intentionally broad to increase sensitivity because we anticipated that study end points would be rare and planned to review medical records for all potential cases. All events were adjudicated by two cardiologists (for sudden cardiac death and acute myocardial infarction) or two neurologists (for stroke). These adjudicators reviewed cases from all sites and were unaware of exposure status (Section 4 in the Supplementary Appendix). Disagreements among adjudicators (<5% of cases) were resolved by consensus with the study principal investigator.

Cases were excluded if the documentation suggested a cause other than a cardiovascular cause (e.g., motor-vehicle accident or drug overdose) or for sudden cardiac death, if clinically severe heart disease was present and sudden cardiac death was not unexpected (e.g., end-stage congestive heart failure). Congenital heart defects that had not been diagnosed until autopsy were noted but did not result in the exclusion of the potential case. In cases in which we were unable to obtain pertinent medical records or had insufficient information for adjudication (21% of cases), we determined the case status using a computer case definition, derived from cases with completed adjudication. The positive predictive value of the computerized case definition for serious cardiovascular events was 91% (Section 5 in the Supplementary Appendix).

Study Oversight

The study was approved by the institutional review board at each of the participating institutions and by the Food and Drug Administration (FDA) Research in Human Subjects Committee. In addition, permission was obtained from the data sources for each site. In all cases the need for informed consent was waived. The study was planned by the authors. Data were gathered from each site and analyzed by the study biostatistician, who vouches for the data and the analysis along with the first author.

Statistical Analysis

We calculated the hazard ratio for users of ADHD drugs, as compared with nonusers, using Cox regression models with robust sandwich variance estimators to account for the matched study design and for persons entering the cohort multiple times.22 The hazard ratio was adjusted for both baseline characteristics and changes in characteristics that occurred during follow-up. We calculated the adjusted incidence of end points by multiplying the incidence rate in the nonusers by the hazard ratio.

Because the number of covariates that reflected baseline cohort characteristics was large in comparison to the number of end points, we adjusted for these covariates by including a site-specific propensity score in the regression models. The propensity score was defined as the probability that the patient was currently receiving an ADHD drug on the first day of study follow-up, estimated for each site by means of logistic regression.23 The baseline variables in the propensity score included sociodemographic characteristics as well as information on medical care encounters consistent with psychiatric disorders, asthma and other respiratory illnesses, seizure and other neurologic disorders, unintentional injuries, cardiovascular diseases, and other diseases. For each site, we tested the adequacy of the propensity-score models by calculating the propensity-score adjusted means of baseline variables for users and nonusers of ADHD drugs; these values were similar (Section 6 in the Supplementary Appendix).

In our primary analysis, we adjusted for study site, propensity-score decile, and several time-dependent covariates (medical and psychiatric conditions, health care utilization, age, and calendar year) (Section 7 in the Supplementary Appendix). In order to test key study assumptions, we performed additional analyses that were stratified according to age group (2 to 17 years and 18 to 24 years) and that used alternative exposure groups, cohort inclusion criteria, and end-point exclusions. We performed all statistical analyses using SAS software, version 9.1 (SAS Institute).

Results

Study Population

The study cohort included 1,200,438 children and young adults. The mean age of cohort members at baseline was 11.1 years (mean range at the study sites, 8.7 to 12.0) (Table 1Table 1Study Cohorts, According to Site.). The mean length of follow-up for the cohort was 2.1 years (mean range at the study sites, 1.5 to 3.9) for a total follow-up of 2,579,104 person-years. The characteristics of current users and nonusers at baseline are shown in Table 2Table 2Characteristics of Cohort Members, According to the Use of ADHD Drugs at Baseline.. Generally, current users had more evidence of health care utilization of all types. In addition, they had greater prevalence of psychiatric illnesses and greater use of psychotropic medications. Current users were also more likely to have asthma, seizures, and congenital heart defects. For both current users and nonusers, alcohol and drug use, as determined from records of medical care encounters, were uncommon.

Study End Points

A total of 81 cohort members had a serious cardiovascular event, or 3.1 per 100,000 person-years, including 33 sudden cardiac deaths (1.3 per 100,000 person-years), 9 acute myocardial infarctions (0.3 per 100,000 person-years), and 39 strokes (1.5 per 100,000 person-years). Characteristics of the confirmed cases according to exposure to an ADHD drug are shown in Section 8 in the Supplementary Appendix. In the multivariate model, an older age, current use of an antipsychotic drug, a major psychiatric illness, a serious cardiovascular condition, and chronic illness were associated with an increased risk of serious cardiovascular events (Section 7 in the Supplementary Appendix).

There were 7 confirmed events among 373,667 person-years of follow-up for current users, 25 confirmed events among 607,475 person-years of follow-up for former users, and 49 confirmed events among 1,597,962 person-years of follow-up for nonusers. As compared with the nonusers, the adjusted rate of serious cardiovascular events did not differ significantly among current users of ADHD drugs (hazard ratio, 0.75; 95% confidence interval [CI], 0.31 to 1.85) or among former users (hazard ratio, 1.03; 95% CI, 0.57 to 1.89) (Figure 1Figure 1Adjusted Rates of Serious Cardiovascular Events, According to the Use of ADHD Drugs.). When former users served as the reference group (in which the possible effect of unmeasured confounding was assessed), there was no increased risk of serious cardiovascular events among current users (hazard ratio, 0.70; 95% CI, 0.29 to 1.72) (Section 9 in the Supplementary Appendix). There was also no evidence of increased risk for the individual end points of sudden cardiac death, acute myocardial infarction, or stroke (Table 3Table 3Adjusted Hazard Ratios for Individual Cardiovascular End Points, According to the Use of ADHD Drugs.). We found no evidence of increased risk for methylphenidate (hazard ratio, 0.96; 95% CI, 0.31 to 2.97), the most frequently used ADHD drug (Section 10 in the Supplementary Appendix). Data were too sparse for other individual drugs to fit regression models.

Alternative Analyses

We performed several alternative analyses to test the robustness of study findings (Table 4Table 4Alternative Analyses with Adjusted Hazard Ratios for Serious Cardiovascular Events, According to the Use of ADHD Drugs., and Section 11 in the Supplementary Appendix). To assess for possible bias from the inclusion of persons who used ADHD drugs before the beginning of follow-up,10 we restricted current users of ADHD drugs only to new users (which was defined as no use of ADHD drugs during the 365 days preceding the first day of qualifying use). Findings were essentially identical to those of the primary analysis (hazard ratio, 0.73; 95% CI, 0.24 to 2.10). When we included seven patients who had been excluded from the primary analysis because they had evidence of severe underlying cardiac disease for which sudden cardiac death would not be unexpected, we found no increased risk for current users (hazard ratio, 0.71; 95% CI, 0.29 to 1.72). In analyses that included only children 2 to 17 years of age, we found no association between the use of ADHD drugs and serious cardiovascular events (hazard ratio, 0.98; 95% CI, 0.41 to 2.36). When children with evidence of serious psychiatric disease were excluded, we also found no significant association (hazard ratio, 0.66; 95% CI, 0.20 to 2.16).

We also performed analyses to test other key study assumptions. A site-specific analysis suggested a potential difference between Medicaid and non-Medicaid sites, although numbers were very small and we saw no evidence of significant heterogeneity in pooled analyses of rate differences between users and nonusers (Section 12 in the Supplementary Appendix). Another analysis expanded the definition of current use to include the 89 days after the end of current use to account for a possible misclassification in exposure related to the clinical use of ADHD drugs or for drugs that were discontinued after prodromal symptoms of an end point (e.g., headache preceding stroke). Finally, we performed an analysis in which time-dependent variables were fixed at baseline. The findings of these analyses were essentially identical to those reported here.

Discussion

Several regulatory and policy decisions resulted from the review of adverse-event reports of serious cardiovascular events associated with the use of ADHD drugs in Canada and the United States. In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts.6,7 In the United States, three different FDA advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients.24 In a controversial policy statement, the American Heart Association stated that obtaining electrocardiograms in children who were initiating ADHD stimulant therapy was "reasonable,"25 a recommendation that was subsequently revised on the basis of input from several pediatric organizations.24 This led to concern and confusion among health care providers, patients, and families about the risks of these drugs.26 In this context, we studied the cardiovascular safety of ADHD drugs in more than 1.2 million children and young adults from four geographically diverse health plans with more than 2.5 million person-years of follow-up. The point estimate of the relative risk provided no evidence that the use of ADHD drugs increased the risk of serious cardiovascular events, although the upper limit of the 95% confidence interval was consistent with up to a doubling in the risk.

In the study population, which excluded children with possibly life-threatening illness, the incidence of serious cardiovascular events was 3.1 per 100,000 person-years, a finding that was consistent with other studies.27-30 The low number of events limited the statistical power of the study, particularly for individual end points and individual drugs, as well as for subgroups that might be particularly vulnerable to the effects of ADHD drugs. We also had limited information for longer durations of use.

Could the study findings be the result of confounding? The comparison between current users and nonusers at baseline indicated a greater incidence of medical and psychiatric coexisting conditions among current users. The analyses were adjusted for an extensive set of cardiovascular disease variables, which were included in site-specific propensity scores. Using this method, we could account for many important risk factors for cardiovascular disease. However, differences in factors that we were unable to measure, such as adherence to a drug regimen, differential prescribing of ADHD drugs to children at lower risk for a study outcome, or illicit use of medications resulting in misclassification, may have affected the results.31,32

We performed several alternative analyses to test the robustness of our findings. We used former users as the reference group, which could address many of the issues related to comparability between current users and nonusers. We performed an analysis restricted to new users to address bias that would be introduced from the inclusion of prevalent users in the cohort.10 Another analysis included patients who had been excluded from the primary analysis because of preexisting severe cardiac disease for which sudden cardiac death would not be unexpected. We also performed analyses stratified according to age. The findings from these additional analyses were essentially identical to our primary analysis.

Our findings that the use of ADHD drugs was not associated with an increased risk of serious cardiovascular events in children and young adults are consistent with the results of several reports33-36 that have appeared since the FDA safety review of adverse-event data for ADHD drugs,6,7 although our results differed from the findings of another report.37 Our study included nearly twice the person-time of the combined person-time in four recent cohort studies and included several provisions to ensure accurate case ascertainment, including a review of medical records and autopsies.

In conclusion, in our study involving children and young adults with 2.5 million person-years of follow-up, there were 3.1 serious cardiovascular events per 100,000 person-years. Although the point estimates of the relative risks for ADHD drugs did not indicate increased risk, the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, the absolute magnitude of any increased risk would be low.

Supported by contracts (HHSA290-2005-0042, to Vanderbilt University; and HHSA290-2005-0033, to Harvard Pilgrim Health Care Institute) from the Agency for Healthcare Research and Quality, Department of Health and Human Services, as part of the Developing Evidence to Inform Decisions about Effectiveness program; and by contracts (223-2005-10100C, to Vanderbilt University; 223-2005-10012, to Kaiser Permanente Northern California; 223-2005-10006C, to OptumInsight Epidemiology; and 223-2005-10012C, to Harvard Pilgrim Health Care Institute) from the FDA.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMoa1110212) was published on November 1, 2011, at NEJM.org.

We thank the TennCare Bureau, Tennessee Department of Health, Washington State Health and Recovery Services Administration, Kaiser Permanente California (Northern and Southern regions), and OptumInsight Epidemiology for providing data needed to conduct the study; Patricia A. Gideon, Michelle DeRanieri, Leanne Balmer, Shannon D. Stratton, James R. Daugherty, Judith A. Dudley, Lynne Caples, Tracy Crowley, Ning Chen, and Eli Poe of Vanderbilt University School of Medicine; Sherry Quinn, Eva Ng, and Clorinda Hoffman of OptumInsight Epidemiology; Connie Uratsu and Ninah Achacoso of Kaiser Permanente Northern California; Chantal Avila and Yan Luo of Kaiser Permanente Southern California; and Li Zheng of the University of Washington.

Source Information

From the Divisions of General Pediatrics (W.O.C.), Adolescent Medicine (S.T.C.), and Pediatric Cardiology (F.A.F.), Department of Pediatrics; the Department of Biostatistics (P.G.A.); the Division of Pharmacoepidemiology, Department of Preventive Medicine (W.O.C., W.A.R.); the Divisions of Cardiology (K.T.M.), Rheumatology (C.M. Stein), and Clinical Pharmacology (K.T.M., C.M. Stein), Department of Medicine; and the Stroke Division, Department of Neurology (H.S.K., A.O.) — all at Vanderbilt University, Nashville; the Division of Research, Kaiser Permanente Northern California, Oakland (L.A.H., B.H.F.); the Department of Population Medicine, Harvard Pilgrim Health Care, Harvard Medical School, and the Department of Pediatrics, Boston University School of Medicine — all in Boston (C.M. Sox); OptumInsight Epidemiology, Waltham, MA (K.A.C.); Pharmacy Analytical Service (T.C.C.) and the Research and Evaluation Department (V.P.Q.), Kaiser Permanente Southern California, Pasadena; and the School of Public Health, University of Washington, Seattle (F.A.C.).

Address reprint requests to Dr. Cooper at Suite 313, Oxford House, 1313 21st Ave. S., Nashville, TN 37232-4313, or at .

martes, 4 de octubre de 2011

Revisan el Tratamiento de Control del Asma en los Niños [Archivo adjunto 1]

[Más abajo se incluyen archivos adjuntos de johnny sandoval garay]
 
Adjunto revisión original
                 Atentamente
               Johny Sandoval Garay
                        Pediatra
                         RNE 21209


----- Mensaje reenviado -----
De: "wolfmdped@yahoo.com" <wolfmdped@yahoo.com>
Para: Salud Loreto <SALUD_LORETO@yahoogroups.com>
Enviado: martes 4 de octubre de 2011 14:54
Asunto: [SALUD_LORETO] Revisan el Tratamiento de Control del Asma en los Niños


 
Saludos amigos,

http://www.bago.com/BagoArg/Biblio/pediatweb581.htm

Enviado desde mi BlackBerry de Claro.

 

 

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Archivos adjuntos de johnny sandoval garay
Archivo 1 de 1
 Pediatric_Asthma_Controller_Therapy.2.pdf

---------- Mensaje reenviado ----------
De: johnny sandoval garay <johnysanga@yahoo.es>
Fecha: 4 de octubre de 2011 15:52
Asunto: Rv: [SALUD_LORETO] Revisan el Tratamiento de Control del Asma en los Niños [Archivo adjunto 1]
Para: salud loreto <Salud_loreto@yahoogroups.com>, Pediatras <PEDIATRIA_PERU@yahoogroups.com>, ramirez felix mechato <beto1355@hotmail.com>, Huanca David <dhuancap@gmail.com>, Santos Aida Saby Borcic <aidaborcic@hotmail.com>, Roncal Marco <antonioroncal@yahoo.com>, Calle Carlos Enrique Checa <drcarloscheca@yahoo.es>, Flores Vigo Admer <aflovi100@gmail.com>, Valera Lazo Tomas <tomasvalera25@hotmail.com>, Pardo Marìa <maripardo74@hotmail.com>, Roncal Marco <marcoroncal@yahoo.es>, Rojas David <darogue1111@yahoo.es>, Vite Juarez Nora <noravitejuarez@hotmail.com>, Martinez Delgado Humberto <beto1244@hotmail.com>, OMAR JHON <jhomgavi11@hotmail.com>, Guffanti Giancarlo <gjguffantia@hotmail.com>, Contreras Carreño Jose julian <pepeju8@hotmail.com>, prado julio <juliopradoa.q.p@hotmail.com>, gonzalesS luis <Lgdlav@yahoo.com>, gonzales luis <lgdlav@yahoo.com>, Baltazar Luis <luisbar2000@hotmail.com>, flores nube <nubeflores@hotmail.com>, "carmen.armas@hotmail.com" <carmen.armas@hotmail.com>, LAVI ROSARIO REATEGUI <charlav3@hotmail.com>, Millones LLorca Luz Melina <sheccid_224@hotmail.com>, more clara <cl_more@hotmail.com>, Fernandez Loperz Graciela Angela <graciela_enf@hotmail.com>, Cordova Dersy <dersy160975@hotmail.com>, Calderon Patricia <recalmen_40@hotmail.com>, Maribel <rosamari78@hotmail.com>, Alcedo Mariella <ela_ac@hotmail.com>, Susana <susan1180@hotmail.com>, Bertha <enferberlu_2@hotmail.com>, Dioselinda <yossy882@hotmail.com>, Chapoñan Claudia <sagi18_73@hotmail.com>, Sarita <saritac19@hotmail.com>, Rubio Rubio Sonia <soniarubiorubio@yahoo.com>, Lorena <loemi01@hotmail.com>, Simbaña Rivera Aurora <asir755@hotmail.com>, ITURRIA Deysi <empera_2010@hotmail.com>, Tecnica Rosa <rosa_rpv55@hotmail.com>, Briceño Infante Cecilia Elvira <miel_y_jazmin@hotmail.com>, Pouicon Roxana <roxy312@hotmail.com>, "tatiaagu@hotmail.com" <tatiaagu@hotmail.com>


 
[Más abajo se incluyen archivos adjuntos de johnny sandoval garay]

Adjunto revisión original
                 Atentamente
               Johny Sandoval Garay
                        Pediatra
                         RNE 21209

----- Mensaje reenviado -----
De: "wolfmdped@yahoo.com" <wolfmdped@yahoo.com>
Para: Salud Loreto <SALUD_LORETO@yahoogroups.com>
Enviado: martes 4 de octubre de 2011 14:54
Asunto: [SALUD_LORETO] Revisan el Tratamiento de Control del Asma en los Niños

 
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http://www.bago.com/BagoArg/Biblio/pediatweb581.htm

Enviado desde mi BlackBerry de Claro.



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Archivos adjuntos de johnny sandoval garay

Archivo 1 de 1

 

lunes, 20 de junio de 2011

Resumen de e-farmacos, Vol 8, Envío 15

Saludos a los colegas  que son "papás" espero que hayan disfrutado su dia.
 
Les envio, por si es de su interés, algunos temas sobre fármacos y un video-musical
 
Saludos
 
Cirilo Alejandro Rojas Ochoa
Med. Integ. y Gest. en Salud
 
video-musical

Helmut Lotti - Guantanamera

 
 
 
 
Envie los mensajes para la lista e-farmacos a
e-farmacos@healthnet.org

Para subscribirse o anular su subscripción a través de WEB
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O por correo electrónico, enviando un mensaje con el texto "help" en
el asunto (subject) o en el cuerpo a:
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Puede contactar con el responsable de la lista escribiendo a:
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Si responde a algún contenido de este mensaje, por favor, edite la
linea del asunto (subject) para que el texto sea mas especifico que:
"Re: Contents of e-farmacos digest...". Ademas, por favor, incluya en
la respuesta solo aquellas partes del mensaje a las que esta
respondiendo.


Asuntos del día:

1. Therapeutics Letter en castellano: quetiapina para dormir y
la evidencia (Canas, Martin)
2. Pioglitazona suspendida en Francia (Canas, Martin)
3. pioglitazona tambien suspendida en Alemania (Canas, Martín)
4. Medicamentos para la prostata que producen cancer de prostata
(Gervas, Juan)
5. Enlace FDA: finasteride y cáncer (Figueras, Albert)
6. Inmunogenicidad de factores antihemofílicos: multifactorial
(CIMUN)
7. Anuncio de un curso de ATM (Perla- CUFAR)
8. Anuncio de un curso virtual de seleccion de medicamentos
(Perla - CUFAR)


----------------------------------------------------------------------

Message: 1
Date: Wed, 08 Jun 2011 08:21:12 -0300
From: "Canas, Martin" <farmacol@femeba.org.ar>
Subject: [e-farmacos] Therapeutics Letter en castellano: quetiapina
para dormir y la evidencia
To: Essential Drugs in Spanish <e-farmacos@healthnet.org>
Message-ID: <4DEF5B28.8020501@femeba.org.ar>
Content-Type: text/plain; charset="iso-8859-1"

Estimadas y estimados,

Juan Erviti Lopez, de la Seccion de Información y Asesoria del Medicamento del Servicio de Prestaciones Farmaceuticas. SNS-O. Pamplona (Espanha) nos comunica la publicación de otro numero de Therapeutics Letter en espanhol titulado:

¿El uso de quetiapina para dormir esta basado en la evidencia?

el enlace es:

http://ti.ubc.ca/es/newsletter/%C2%BFel-uso-de-quetiapina-para-dormir-est%C3%A1-basado-en-la-evidencia

Saludos,

Martín

Martin Cañás
Fundación Femeba
Grupo Argentino Para el Uso Racional del Medicamento (GAPURMED)
La Plata
(Argentina)


------------------------------

Message: 2
Date: Thu, 09 Jun 2011 11:02:56 -0300
From: "Canas, Martin" <farmacol@femeba.org.ar>
Subject: [e-farmacos] Pioglitazona suspendida en Francia
To: Essential Drugs in Spanish <e-farmacos@healthnet.org>
Message-ID: <4DF0D290.9080202@femeba.org.ar>
Content-Type: text/plain; charset="iso-8859-1"

Estimadas y estimados,

El anho pasado cuando se notificaba el retiro de la rosiglitazona, se anunciaba la revision de la magnitud del riesgo de cacer de vejiga asociado al uso de pioglitazona, conocido desde el ensayo PROactive pues bien Farncia tomo la posta y la decision reguladora.

Suspension de l'utilisation des medicaments contenant de la pioglitazone
(Actos®, Competact®) - Communique
09/06/2011

La Agencia Francesa del Medicamento (Afssaps), con el asesoramiento de la Comision para la Autorizacion de Comercializacion (AMM) y de la Comision Nacional de Farmacovigilancia, decidio suspender en Francia, el uso de medicamentos que contienen pioglitazona (Actos ® y Competact ®).

Los resultados del estudio realizado por el Seguro Nacional de Salud frances -Nacional Caisse d'Assurance Maladie des Travailleurs (CNAMTS)-, a peticion del Afssaps, confirmar un pequenho aumento del riesgo de cancer de vejiga en los pacientes tratados con pioglitazona.

AFSSAPS recomienda que los pacientes tratados actualmente con un medicamento que contiene pioglitazona no interrumpir su tratamiento sin
antes consultar con su medico y a fin de adecuar el tratamiento de la diabetes. Los medicos no deberian recetar mas medicamentos que contienen
pioglitazona. Afssaps informara a la empresa y a la Agencia Europea del
Medicamento (EMA) de su decision.

Pioglitazona esta indicada como tratamiento de segunda linea (despues del fracaso o intolerancia a la metformina, en combinacion con metformina y / o sulfonilureas, o en combinacion con la insulina) para el control de la glucemia en pacientes diabeticos. Este preparado fue autorizado como parte del procedimiento europeo centralizado: Actos ® (pioglitazona) en el anho 2000, y Competact ® (combinacion de pioglitazona y metformina) en 2006.
Actualmente son los unicos farmacos presentes en el mercado de esta clase de agentes antidiabeticos. Hasta la fecha, en Francia, son tratados con pioglitazona, aproximadamente 230.000 pacientes.

Una revision de los datos preclinicos, clinicos, epidemiologicos y de
farmacovigilancia senhalaban un riesgo potencial de cancer de vejiga en
los pacientes diabeticos tratados con pioglitazona. Mientras se esperaban los resultados de un estudio de cohortes de gran magnitud realizado por CNAMTS, a peticion de la Afssaps, el 19 de abril la Afssaps difundio una advertencia a los profesionales de la salud sobre las preocupaciones acerca del uso de tratamiento cronico con pioglitazona en pacientes con diabetes.

Los datos disponibles de farmacovigilancia y los resultados de este nuevo estudio presentado a los miembros del Comite de AMM, por el Seguro Nacional de Salud confirman que el uso de pioglitazona causa un riesgo bajo de aparicion de cancer de vejiga. El comite de AMM evaluo que la relacion riesgo / beneficio de este producto ahora es negativa.

La evaluacion de todos estos datos llevo a la Afssaps a suspender el uso de medicamentos que contengan pioglitazona. Los profesionales implicados recibiran una carta en los proximos dias para informarles de esta decision.
Afssaps, senhalo que cualquier efecto adverso grave y / o inesperado debe ser notificado por los profesionales de la salud en los centros regionales de farmacovigilancia (CRPV).

Resumen del estudio realizado por el Seguro Nacional de Salud
Riesgo de cancer de vejiga en personas con diabetes tratados con pioglitazona en Francia: un estudio de cohortes en los datos de la GMPC y SNIIRAM.

Este es el mayor estudio sobre este tema. Su principal objetivo fue especificar, en personas con diabetes tratados en Francia, la existencia de un posible vinculo entre la exposicion a la pioglitazona y el riesgo de desarrollar cancer de la vejiga. Este estudio se realizo sobre una cohorte de 1.491.060 pacientes con diabetes tratados con farmacos especificos, entre los 40 y 79 anhos. Abarca el periodo comprendido entre 2006 y 2009. El grupo expuesto a la pioglitazona incluyo 155 535 diabeticos y el grupo no expuesto 1.335.525 personas con diabeticos.

El analisis de esta cohorte de pacientes diabeticos seguidos en Francia entre 2006 y 2009, confirma la hipotesis de la existencia de una asociacion estadisticamente significativa entre la exposicion a la pioglitazona y la incidencia de cancer de vejiga. Los resultados observados son similares a los obtenidos en los Estados Unidos en la cohorte de Kaiser Permanente Northern California.

El comunicado original disponible en el siguiente enlace:

http://www.afssaps.fr/Infos-de-securite/Communiques-Points-presse/Suspension-de-l-utilisation-des-medicaments-contenant-de-la-pioglitazone-Actos-R-Competact-R-Communique


Saludos,

Martín

Martin Cañás
Fundación Femeba
Grupo Argentino Para el Uso Racional del Medicamento (GAPURMED)
La Plata
(Argentina)

------------------------------

Message: 3
Date: Fri, 10 Jun 2011 09:23:45 -0300
From: "Canas, Martín" <farmacol@femeba.org.ar>
Subject: [e-farmacos] pioglitazona tambien suspendida en Alemania
To: Essential Drugs in Spanish <e-farmacos@healthnet.org>
Message-ID: <4DF20CD1.7070702@femeba.org.ar>
Content-Type: text/plain; charset="iso-8859-1"

Estimadas y estimados,

La agencia de medicamentos alemana -German Federal Institute for Drugs and Medical Devices (BfArM)- tomo la misma decision que la agencia francesas y suspendio la comercializacion de la pioglitazonaen la notificación realiza un resumen de los considerandos de la resolucion en Francia y similares recomendaciones.

La notificacion oficial:
Das BfArM rät derzeit vom Gebrauch pioglitazonhaltiger Arzneimittel ab.
05/11

Disponible en:
http://www.bfarm.de/DE/BfArM/Presse/mitteil2011/pm05-2011.html?nn=1013290

Saludos,

Martín

Martin Cañás
Fundación Femeba
Grupo Argentino Para el Uso Racional del Medicamento (GAPURMED)
La Plata
(Argentina)


------------------------------

Message: 4
Date: Fri, 10 Jun 2011 20:06:58 -0300
From: "Gervas, Juan" <mpf1945@gmail.com>
Subject: [e-farmacos] Medicamentos para la prostata que producen
cancer de prostata
To: Essential Drugs in Spanish <e-farmacos@healthnet.org>
Message-ID: <BANLkTik7hs1gBAarc9fF7P806_VY5HtB6Q@mail.gmail.com>
Content-Type: text/plain; charset="iso-8859-1"

Pues eso, para reir si no fuera para llorar: medicamentos para la prostata
que producen cancer de prostata:
http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm


Prevencion que mata.
Prevencion sin limites.

Ahora lo dice la FDA (no se si esperar a ver que dice la EMA), pero ya lo
sabiamos desde 2003 y en 2004 el firmante publico sobre ello (abajo y en el
enlace).

En fin, pobres pacientes...

Son ocho años de falta de ciencia y conciencia. De morbilidad y mortalidad
innecesariamente prematura y sanitariamente evitable...!De causa médica!

Un saludo,

Juan Gérvas

http://www.equipocesca.org/actividades-preventivas/limitaciones-en-la-prevencion-del-cancer-de-prostata/

Ambos cambios explican el fracaso de los tratamientos antiandrogénicos en el tratamiento del cáncer de próstata, y la acción paradójica de finasteride, que puede provocar cánceres más agresivos y peligrosos.

------------------------------

Message: 5
Date: Tue, 14 Jun 2011 18:04:47 -0300 (UYT)
From: "Figueras, Albert" <afs@icf.uab.es>
Subject: [e-farmacos] Enlace FDA: finasteride y cáncer
To: "Essential Drugs in Spanish" <e-farmacos@healthnet.org>
Message-ID:
<9c869ef4e2519762beda140b94b90b80.squirrel@www.webmail.hc.edu.uy>
Content-Type: text/plain; charset="iso-8859-1"

Buendoa dias,

Alejandro Goyret comenta que el enlace sobre la nota de la FDA en relación con la asociación de finasteride y cáncer dice: "Página no encontrada".

Hoym el enlace correcto es:
http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm

Albert Figueras
www.icf.uab.cat

------------------------------

Message: 6
Date: Mon, 13 Jun 2011 22:26:34 -0500
From: "CIMUN" <cimun@unal.edu.co>
Subject: [e-farmacos] Inmunogenicidad de factores antihemofílicos:
multifactorial
To: e-farmacos@healthnet.org, red@redsaf.org
Message-ID: <BANLkTi=VPA3hm9AtmW6B-qOBqEg7kY2TEw@mail.gmail.com>
Content-Type: text/plain; charset="iso-8859-1"

Cordial saludo,

En respuesta a una solicitud de laboratorios Kedrion, el CIMUN ha ampliado
la discusión sobre la influencia del tipo de producto (hemoderivado o recombinante) en la inmunogenicidad de los factores antihemofílicos, planteada inicialmente en el Sabía Usted Que... de Enero de 2011. Como se puede ver en el documento, no es posible asegurar ventajas en este sentido para ningún tipo de producto. La selección se debe hacer con criterios locales, en donde el precio es determinante para el acceso en los sistemas
de salud con pocos recursos.

El documento se puede consultar en el siguiente enlace:

http://www.ciencias.unal.edu.co/unciencias/data-file/cimun/Alertas_2011/Documento_Inmunogenicidad_Factores.pdf

Muchas gracias por su atención,

Centro de Información de Medicamentos
Universidad Nacional de Colombia
(Colombia)

------------------------------

Message: 7
Date: Thu, 16 Jun 2011 10:04:21 -0700 (PDT)
From: "Perla- CUFAR" <perlacufar@yahoo.com.ar>
Subject: [e-farmacos] Anuncio de un curso de ATM
To: e-farmacos@healthnet.org
Message-ID: <514014.92714.qm@web59610.mail.ac4.yahoo.com>
Content-Type: text/plain; charset="utf-8"

ANUNCIO DEL 2o CURSO DE EDUCACION A DISTANCIA
"ENFOQUE PRACTICO DEL USO RACIONAL DE ANTIMICROBIANOS EN LA COMUNIDAD"

ORGANIZACION, COORDINACION Y SUPERVISION
Organizacion Panamericana de la Salud (OPS)/ Organizacion Mundial de la Salud (OMS), Centro Universitario de Farmacologia (CUFAR), Centro Colaborador de OPS/OMS, Facultad de Ciencias Medicas de la Universidad Nacional de La Plata, Argentina

DESTINATARIOS DEL CURSO
El curso esta destinado a los profesionales de la salud que atienden a pacientes con patologias infectologicas frecuentes en la comunidad, unidades de atencion primaria y hospitales de baja complejidad de los paises de la region de Latinoamerica y Caribe.
El perfil requerido es el de un profesional interesado en optimizar la calidad de la atencion de sus pacientes, adherido al concepto de la atencion de la salud como un derecho humano y comprometido con la responsabilidad de realizar luego del curso acciones que contribuyan a un uso racional de los antimicrobianos(ATM), mejorar la atencion de la salud y desarrollar estrategias destinadas a contener la resistencia bacteriana.

FUNDAMENTACION DEL CURSO
Esta ampliamente documentado el uso irracional de los antimicrobianos (ATM) en los paises de Latinoamerica y Caribe. Los ejemplos mas comunes y frecuentes son:
• Desarrollo de resistencia bacteriana por uso irracional de ATM
• El uso de ATM para el tratamiento de infecciones respiratorias superiores de origen viral (resfrio comun, bronquiolitis, etc.)
• El uso de antimicrobianos inyectables en situaciones que no lo requieren
• Aumento significativo de la aparicion de infecciones hospitalarias serias por bacterias resistentes, con alta tasa de mortalidad
• Aumento de resistencia por fallas en la dosificacion y/o duracion de los tratamientos con ATM, alta frecuencia de automedicacion, falta de cumplimiento de normas de higiene en la poblacion, etc.
• Uso de ATM de ultima generacion en indicaciones que no lo ameritan

OBJETIVOS GENERALES
Fortalecer la capacitacion de los profesionales de la salud de Latinoamérica y Caribe que se desempeñan en la comunidad para:
• Aplicar una vision epidemiologica en su practica medica y considerar el acceso a los medicamentos como un derecho a la salud y un atributo de equidad
• Comprender y aplicar los conceptos y principios de los medicamentos esenciales y el uso racional de los medicamentos, en el tratamiento de las enfermedades infecciosas de la comunidad.

OBJETIVOS ESPECÍFICOS
Al termino del curso los participantes tendran competencias para:
• Elegir, aplicar y monitorear los ATM , cuando son necesarios, utilizando metodologia y criterios cientificos basados en la necesidad sanitaria , eficacia, seguridad y costo de los medicamentos
• Analizar y aplicar en forma critica la informacion sobre los ATM
• Contribuir a implementar y monitorear estrategias nacionales y/o regionales de contencion de la resistencia bacteriana.
• Seleccionar , usar y monitorear los ATB en las situaciones clinicas que los requieran, teniendo en consideracion las condiciones de vida y la salud integral de las poblaciones

ESTRUCTURA, DURACION Y EVALUACION
• Estructura modular , con 7 modulos y 6 meses (144 hs) de duracion
• Se realizara evaluacion formativa y final.

COORDINADORA DEL CURSO : Prof. Dra Perla Mordujovich-Buschiazzo
Profesora extraordinaria de la Universidad Nacional de La Plata y Directora del CUFAR-UNLP-OPS/OMS-Argentina

EQUIPO DOCENTE: Dres Clara L, Levy Hara G, Espeche W, Krol, M, Desse J
Docentes, infectologos, medicos de APS de las Universidades Nacionales de La Plata y de Buenos Aires. Argentina
AUTORES DE LOS MODULOS :Dres Calmaggi A, Ferrari E, Levy-Hara G, Espeche W, Heredia V, y Krol M. Docentes, infectologos, medicos de atencion primaria de la salud y de las Universidades Nacionales de La Plata y de Buenos Aires. Argentina
ASESORES
Prof Dr.Hector O. Buschiazzo CUFAR/Centro Colaborador de OMS/OPS-Facultad de Ciencias Medicas UNLP/Fundación FEMEBA- Dra Pilar Ramon-Pardo y Dr Jose Luis Castro. Organizacion Panamericana de la Salud-WDC/OMS
DISEÑO DE MATERIALES Y ADAPTACION A LA PLATAFORMA
Miguel Prigionero. Especialista en Diseño e Informatica y Eleonora Sansosti.

PRINCIPALES CONTENIDOS
Modulo de Familiarizacion
Guia para conocer los fundamentos, objetivos, contenidos y pautas de funcionamiento de la propuesta pedagogica asi como para familiarizarse con los recursos del entorno virtual.
Modulo 1: Uso racional de antimicrobianos. Medicamentos esenciales y su relevancia en atencion primaria. Manejo critico de la información. Resistencia ATM y enfoques de contencion.
Modulo 2: Manejo racional de infecciones respiratorias superiores e inferiores mas frecuentes.
Modulo 3: Manejo racional de infecciones genitourinarias frecuentes en APS.
Modulo 4: Manejo racional de infecciones de transmisión sexual (ITS).
Modulo 5: Manejo racional de infecciones de piel y tejidos blandos.
Modulo 6: Enfoque racional del uso de los antivirales.

FUNDAMENTOS PEDAGOGICOS y PLATAFORMA VIRTUAL
Se utilizara la metodologia de aprendizaje basado en problemas desde la perspectiva constructivista del conocimiento, en la modalidad virtual.
El curso se desarrollara en el entorno educativo del Campo Virtual de Salud Publica-OPS. (CVSP)

INSCRIPCION: 20 de junio al 14 de julio; FICHA DE INSCRIPCION: cufar@aetos.med.unlp.edu.ar

INICIO DEL CURSO: 15 de julio de 2011


------------------------------

Message: 8
Date: Thu, 16 Jun 2011 10:10:55 -0700 (PDT)
From: "Perla - CUFAR" <perlacufar@yahoo.com.ar>
Subject: [e-farmacos] Anuncio de un curso virtual de seleccion de
medicamentos
To: e-farmacos@healthnet.org
Message-ID: <191970.6813.qm@web59614.mail.ac4.yahoo.com>
Content-Type: text/plain; charset="utf-8"

2do CURSO VIRTUAL PARA COMITES DE FARMACOTERAPEUTICA-2011
SELECCION DE MEDICAMENTOS Y ANALISIS CRITICO DE LA INFORMACION

Organizacion, Coordinacion y Supervision
Organizacion Panamericana de la Salud (OPS)/ Organizacion Mundial de la Salud (OMS), Centro Universitario de Farmacologia (CUFAR), Centro Colaborador de OPS/OMS, Facultad de Ciencias Medicas de la Universidad Nacional de La Plata, Argentina
Perfil de los destinatarios del curso
Este curso esta dirigido a los profesionales de la salud de la Region - America Latina y el Caribe- integrantes de los Comites de farmaco-terapeutica de los Ministerios de salud, hospitales, Municipalidades e instituciones de la Seguridad social , encargados de la elaboracion y actualizacion de Listas de medicamentos, formularios terapeuticos, Guias terapeuticas y estandarización de tratamientos. Se requiere ademas un compromiso formal de implementar y monitorear, al termino del curso, acciones que contribuyan a un uso racional de los medicamentos y a mejorar el acceso a los medicamentos con equidad por parte de la poblacion.
Una primera seleccion de los participantes en base al perfil propuesto estara a cargo de las autoridades sanitarias del pais y segun los cupos se realizara una segunda seleccion por la coordinacion del curso y OPS/OMS
Fundamentación del curso
Estan ampliamente documentados tanto la falta de acceso a los medicamentos por un porcentaje importante de nuestras poblaciones como su uso irracional en numerosos paises de Latinoamerica y Caribe (LA y Ca). Desarrollo de resistencia bacteriana por uso inadecuado de los antimicrobianos, gasto excesivo por sobre-prescripcion y/o eleccion inadecuada de medicamentos de alto costo, carencia de criterios para la adquisicion de medicamentos por parte de los sistemas de salud, aparicion frecuente de "novedades terapeuticas", publicidad no controlada, difusion de informacion no confiable y/o o deficiencia en el funcionamiento de los comites de farmaco-terapeuticas.
Surge la necesidad de fortalecer la capacitacion de los profesionales de la salud que integran los Comites de fármaco-terapeutica, con la finalidad de que sean protagonistas y colaboradores de la elaboracion, implementacion y difusion de acciones de promoción y monitoreo del uso racional de los medicamentos ,en forma integrada con otras politicas publicas.
Objetivo general
Al termino del curso se espera que los participantes posean competencias para
Contribuir al fortalecimiento del uso racional de los medicamentos, como componente de la
politica de medicamentos del pais y en el marco de las politicas publicas
Objetivos especificos
Al termino del curso se espera que los participantes posean competencias para:
• Buscar, identificar y evaluar informacion sobre medicamentos y su aplicación en la seleccion
de medicamentos
• Efectuar un analisis critico de los estudios de investigacion y considerar el acceso a los medicamentos como un derecho a la salud
• Aplicar metodologia y criterios para elaborar, actualizar y monitorear las Lista nacionales de medicamentos y los Formularios Terapeuticos en base a las mejores pruebas cientificas
disponibles, destinados al abordaje y tratamiento de las patologias relevantes para la realidad
sanitaria del pais, y para ser utilizados en los procesos de regulacion, gestion y educacion de la
Politica de Medicamentos del pais

Estructura , duracion
El presente curso tiene una estructura modular, con evaluacion , 4 modulos de trabajo y una duracion total de cuatro meses y medio (160 hs) . Se realizara un taller presencial en Guatemala en fecha a definir
Coordinación general
Dra Perla Mordujovich-Buschiazzo
Equipo docente
Dres Soledad Carlson, Martin Canhas, Cristian Dorati, Gabriel Levy Hara, Gustavo Marin
Principales contenidos
Modulo de familiarizacion: Es una guia para familiarizarse con los recursos del entorno virtual Modulo 1 Uso racional de medicamentos
Modulo 2.- Uso de fuentes de informacion y MBE.
Modulo 3.-. Analisis critico de la informacion.
Modulo 4.- Registro de la informacion. Elaboracion de informes. Uso de una matriz

Fundamentos pedagogicos
Se utilizara la metodologia de aprendizaje basado en problemas, desde la perspectiva constructivista del conocimiento, en la modalidad virtual.
Plataforma virtual
El curso se presentara en forma simultanea en la plataforma del Campo virtual de salud publica (CVSP)-OPS y en el entorno educativo de la Facultad de Ciencias Medicas de la Universidad Nacional de La Plata-
Inscripcion e inicio del curso
Inscripcion: 15 al 30 de junio cufar@med.unlp.edu.ar ;
Inicio del curso: 1 de julio

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