MANUEL ANDRÉ VIRÚ LOZA
Tesista de pregrado
Asociación para el Desarrollo de la Investigación Estudiantil en Ciencias de la...
ARTÍCULO
Independent and Additive Impact of Blood
Pressure Control and Angiotensin II
Receptor Blockade on Renal Outcomes ...
EL PROBLEMA
Los pacientes con diabetes mellitus tipo 2 e
hipertensión tienen 2 a 4 veces mayor riesgo
de desarrollar secue...
CONTROLES PAREADOS
Los diseños (sólo existen tres, los demás son variaciones o
«alteraciones» de los mismos):
• Cross-sect...
MATERIALES Y MÉTODOS
El estudio está basado en el análisis de los
datos del Irbesartan in Diabetic Nephropathy
Trial.
Entry criteria:
 Age between 30 and 70
years
 Documented type 2
diabetes
 Hypertension defined as
any of the following:...
The institutional review board
or appropiate ethics
committee at each center
approved the study protocol.
Consenting eligible patients
were randomized 1:1:1 into
one of three treatment arms:
 Irbesartan 300 mg/d
 Amlodipine 10...
1st
Week
2nd
Week
4th
Week
8th
Week
3rd
month
6th
month
9th
month
12th
month
Until
reaching
endpoint or
administrativ
e ce...
The target for SBP control was:
 <135 mmHg when baseline SBP was 145 mmHg or less
 10 mmHg below the baseline SBP when b...
Analysis for each end point
was on an intention-to-
treat basis. Patients who
reached an end point
stopped coded medicatio...
RESULTADOS
IRBESARTÁN, AMLODIPINO Y PLACEBO POR
SEPARADO…FORMAR ESTOS TRES GRUPOS ES REALMENTE
BUENA IDEA PARA LOS OBJETIVOS DEL ESTU...
ADMINISTRAR IRBESARTÁN Y AMLODIPINO JUNTOS
SERÍA BUENA IDEA PARA FORMAR UNO DE LOS
GRUPOS DE ESTUDIO EN UN ENSAYO CLÍNICO ...
REFORMULANDO LA PREGUNTA:
Administrar dos drogas juntas sería buena idea para
formar uno de los grupos de estudio en un en...
A LO QUE VIENE ESA PREGUNTA:
Las recomendaciones para la hipertensión dadas en
Agosto de 2004 por el Joint Nacional Commit...
Taal:
Brenner and Rector’s The
Kidney,
Hypertensive patients can be characterized as follows:
 Those with PAR levels of less than 0,65 ng/ml/h with predominantl...
Taal: Brenner and Rector’s The Kidney, 9th ed. 2011 –
The antihypertensive drug classes are divided into two major
categories:
 Drugs that reduce BP because of primary or seco...
CASO REPRESENTATIVO DE UNO DE LOS
ERRORES QUE SE PUEDE DAR EN LOS ENSAYOS
CLÍNICOS EN ESTE CAMPO
Renal outcomes in high-ri...
«In summary, parallel design treatment trials, in wich hypertensive
drugs are added in stepwise or simultaneous fashion wi...
OTRO EJEMPLO CLÁSICO DE «ERRORES» QUE SE
PUEDEN COMETER NO SÓLO EN ESTE CAMPO
Yet overall, data clearly show that with equ...
OTRO EJEMPLO CLÁSICO DE «ERRORES» QUE SE
PUEDEN COMETER NO SÓLO EN ESTE CAMPO
This applies to the widely touted Anglo-Scan...
GRACIAS POR SU ATENCIÓN
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
Journal Club ADIECS
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Journal Club ADIECS

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Journal Club realizado en enero de 2012 como parte de las actividades de ADIECS-UNMSM (Asociación para el Desarrollo de la Investigación Estudiantil en Ciencias de la Salud)

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Journal Club ADIECS

  1. 1. MANUEL ANDRÉ VIRÚ LOZA Tesista de pregrado Asociación para el Desarrollo de la Investigación Estudiantil en Ciencias de la Salud (ADIECS) Facultad de Medicina San Fernando Universidad Nacional Mayor de San Marcos Enero, 2012
  2. 2. ARTÍCULO Independent and Additive Impact of Blood Pressure Control and Angiotensin II Receptor Blockade on Renal Outcomes in the Irbesartan Diabetic Nephropathy Trial: Clinical Implications and Limitations J Am Soc Nephrol 16: 3027-3037, 2005
  3. 3. EL PROBLEMA Los pacientes con diabetes mellitus tipo 2 e hipertensión tienen 2 a 4 veces mayor riesgo de desarrollar secuelas cardiacas como infarto de miocardio, stroke o muerte y tienen una probabilidad 7 veces mayor de desarrollar insuficiencia renal comparado con sujetos controles pareados.
  4. 4. CONTROLES PAREADOS Los diseños (sólo existen tres, los demás son variaciones o «alteraciones» de los mismos): • Cross-sectional • Case-control • Cohort A1, A2, A3, A4, A5, A6, A7, A8, A9, A10, A11, A12, A13, A14 B1, B2, B3, B4, B5, B6, B7, B8, B9, B10, B11, B12, B13, B14 C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14 I1: D: I2: I1: D: I2: A1, A2, A3, A4, A5, A6, A7 B1, B2, B3, B4, B5, B6, B7 C1, C2, C3, C4, C5, C6, C7 A8, A9, A10, A11, A12, A13, A14 B8, B9, B10, B11, B12, B13, B14 C8, C9, C10, C11, C12, C13, C14 I1’: D: I2’: A1, A2, A3, A4, A5, A6, A7 B1, B2, B3, B4, B5, B6, B7 C1’, C2’, C3’, C4’, C5’, C6’, C7’ A8, A9, A10, A11, A12, A13, A14 B8’, B9’, B10’, B11’, B12’, B13’, B14’ C8’, C9’, C10’, C11’, C12’, C13’, C14’ Grupo 1 Grupo 2 Grupo 1 Grupo 2 I1: B1’, B2’, B3’, B4’, B5’, B6’, B7’ B8, B9, B10, B11, B12, B13, B14 I2: C1, C2, C3, C4, C5, C6, C7 C8, C9, C10, C11, C12, C13, C14 D’: A1’, A2’, A3’, A4’, A5’, A6’, A7’A8’, A9’, A10’, A11’, A12’, A13’, A14’ Tiempo
  5. 5. MATERIALES Y MÉTODOS El estudio está basado en el análisis de los datos del Irbesartan in Diabetic Nephropathy Trial.
  6. 6. Entry criteria:  Age between 30 and 70 years  Documented type 2 diabetes  Hypertension defined as any of the following:  seated office systolic BP (SBP) > 135 mmHg  seated office diastolic BP (DBP) > 85 mmHg  documented treatment with antihypertensive agents.  All participants had established diabetic nephropathy with  Overt proteinuria (>900 mg/24h)  Mild to moderate renal insufficiency (serum creatinine between 88 and 266 umol/L [1.0 and 3,0 mg/dl] in women and between
  7. 7. The institutional review board or appropiate ethics committee at each center approved the study protocol.
  8. 8. Consenting eligible patients were randomized 1:1:1 into one of three treatment arms:  Irbesartan 300 mg/d  Amlodipine 10 mg/d  Placebo
  9. 9. 1st Week 2nd Week 4th Week 8th Week 3rd month 6th month 9th month 12th month Until reaching endpoint or administrativ e censoring of the study (December 31, 2000) Clinical Management Committee (CMC) Screening Enrollment Randomization Stable BP Mean follow-up BPBaseline BP BaselineGFR Baseline proteinuria SBP control
  10. 10. The target for SBP control was:  <135 mmHg when baseline SBP was 145 mmHg or less  10 mmHg below the baseline SBP when baseline SBP was between 146 and 170 mmHg  160 mmHg, the maximum allowable SBP, for all patients with baseline SBP>170 mmHg. The seated DBP target for all participants was ≤85 mmHg. To achieve these goals, patients were prescribed additional antihypertensive therapy. The use of other angiotensin receptor blockers, angiotensin-converting enzyme inhibitors, or calcium channel blockers was excluded. The primary outcome for the IDNT was the time to a composite end point of doubling of the baseline serum creatinine, ESRD (defined as a serum creatinine ≥530 umol/L [6 mg/dl] or renal replacement therapy), or all-cause mortality. For the purposes of this study, the term renal end point refers to patients who reached a doubling of serum creatinine (SCr) or end-stage renal failure.
  11. 11. Analysis for each end point was on an intention-to- treat basis. Patients who reached an end point stopped coded medication but continued to be followed until the closing date of the trial.
  12. 12. RESULTADOS
  13. 13. IRBESARTÁN, AMLODIPINO Y PLACEBO POR SEPARADO…FORMAR ESTOS TRES GRUPOS ES REALMENTE BUENA IDEA PARA LOS OBJETIVOS DEL ESTUDIO?
  14. 14. ADMINISTRAR IRBESARTÁN Y AMLODIPINO JUNTOS SERÍA BUENA IDEA PARA FORMAR UNO DE LOS GRUPOS DE ESTUDIO EN UN ENSAYO CLÍNICO DE EFECTIVIDAD DE TRATAMIENTO ANTIHIPERTENSIVO?
  15. 15. REFORMULANDO LA PREGUNTA: Administrar dos drogas juntas sería buena idea para formar uno de los grupos de estudio en un ensayo clínico de efectividad de tratamiento antihipertensivo?
  16. 16. A LO QUE VIENE ESA PREGUNTA: Las recomendaciones para la hipertensión dadas en Agosto de 2004 por el Joint Nacional Commitee on Prevention, Evaluation, and Treatment of High Blood Pressure…¿Tuvieron fundamentos sólidos?
  17. 17. Taal: Brenner and Rector’s The Kidney,
  18. 18. Hypertensive patients can be characterized as follows:  Those with PAR levels of less than 0,65 ng/ml/h with predominantly Na volume- mediated hypertension.  Those with PAR levels of 0,65 ng/ml/h or higher with predominantly plasma renin-angiotensin-mediated vasoconstrictor hypertension.
  19. 19. Taal: Brenner and Rector’s The Kidney, 9th ed. 2011 –
  20. 20. The antihypertensive drug classes are divided into two major categories:  Drugs that reduce BP because of primary or secondary actions to reduce body Na and volume content by enhancing renal Na excretion (V drugs)  Drugs that lower BP by reducing or blocking the activity of the renin-angiotensin system (R drugs) Taal: Brenner and Rector’s The Kidney, 9th ed. 2011 – Saunders,
  21. 21. CASO REPRESENTATIVO DE UNO DE LOS ERRORES QUE SE PUEDE DAR EN LOS ENSAYOS CLÍNICOS EN ESTE CAMPO Renal outcomes in high-risk hypertensive patients treated with an angiotensin-converting enzyme inhibitor or a calcium channel blocker vs a diuretic: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
  22. 22. «In summary, parallel design treatment trials, in wich hypertensive drugs are added in stepwise or simultaneous fashion with no opportunity to discontinue an ineffective drug, will predictably lead to the conclusion that multiple drugs are required to control BP even when monotherapy may have been effective. This outcome underscores the pathophysiologic heterogeneity of hypertensive disorders. The JNC 7 treatment guidelines, unlike those of some other organizations, are limited because THEY FAIL TO INCORPORATE THESE BASIC PRINCIPLES». Taal: Brenner and Rector’s The Kidney, 9th ed. 2011 – Saunders, Elsevier
  23. 23. OTRO EJEMPLO CLÁSICO DE «ERRORES» QUE SE PUEDEN COMETER NO SÓLO EN ESTE CAMPO Yet overall, data clearly show that with equal reductions in achieved BP, most drugs are equally effective in the hypertensive population. One apparent exception in showing a significant difference, the LIFE trial, compared an angiotensin II receptor blocker (losartan) to a beta blocker (atenolol), but 80% of the subjects were also given a diuretic. Once-daily atenolol has been found to be inferior to other classes of drugs, making it an attractive comparator to MAKE THE OTHER DRUG LOOK BETTER.[ Bonow: Braunwald’s Heart Disease – A Textbook of Cardiovascular Medicine, 9th ed. 2011. Saunders
  24. 24. OTRO EJEMPLO CLÁSICO DE «ERRORES» QUE SE PUEDEN COMETER NO SÓLO EN ESTE CAMPO This applies to the widely touted Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA), which compared therapy based on a long-acting calcium channel blocker (CCB; amlodipine) with the short-acting atenolol, both given once daily. Moreover, the superior outcomes with the CCB could have resulted from the lower blood pressures it achieved. Bonow: Braunwald’s Heart Disease – A Textbook of Cardiovascular Medicine, 9th ed. 2011. Saunders
  25. 25. GRACIAS POR SU ATENCIÓN

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