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Int J Clin Pharm (2011) 33:132140 DOI 10.1007\/s11096-010-9474-x

ARTCULO DE INVESTIGACIN

Programa de intervencin del farmacutico para mejorar la hipertensin control: a randomised controlled trial
Manuel Morgado Sandra Rolo Miguel Castelo-Branco

Recibido: 17 de julio de 2010 \/ aceptado: 07 de diciembre de 2010 publicado en lnea: 13 de enero de 2011  El autor (es) de 2010. Este artculo se publica con acceso abierto en Springerlink.com

fueron realizadas por enfermeras cegados. Cumplimiento con la medicaci Resumen Objetivo Estudios tienen demostrado que Tambin se evalu, utilizando un cuestionario validado en la hipertensin sigue siendo inadecuadamente gestionada a travs de el mundo, con falta de adherencia a bajar por el BP medi- lnea de base y al final de la investigacin. Resultados total de Un cacin siendo un factor importante. El objetivo del presente estudio pacientes hipertensos fueron asignados aleatoriamente a la 197 fue evaluar si un programa de atencin farmacutica podra estudio (99 en el grupo control y 98 en la intervencin mejorar la sangre y el cumplimiento de la medicacin antihipertensiva Grupo). Aunque no hubo diferencias signicativo (P [ 0.05) en ambos grupos sobre la edad media, gnero, control de la presin. Ajuste Este estudio se realiz en un clnica ambulatoria de atencin secundaria hipertensin arterial\/dislipemiamasa corporal y la farmacoterapia antihipertensiva, ndice de en el hospital universitario de enseanza de Cova da Beira Hoscontrol de la presin arterial fue mayor en el grupo de intervencin Centro de Pital, Covilha, ubicado en la regin Central Oriental = 0,005) al final del estudio. Signicativo inferior (P de Portugal. todoEste informe evala el farmacutico presin arterial sistlica) - 6,8 mmHg, P = 0.006) y M intervenciones durante un prospectivos aleatorizados controladas(presin arterial diastlica- 2,9 mmHg, P = niveles de 0,020) juicio, desde julio de 2009 a junio de 2010. Pacientes con diagnstico se observaron en el grupo intervencin. Medicamento de la hipertensin esencial que asisten a la clnica de rutina adherencia tambin fue mayor en la intervencin de signicantly seguimiento fueron asignados al azar a un control Grupo al final del estudio (74,5% vs 57,6%, Grupo (no hay atencin farmacutica) o a un grupo de intervencin 0,012). onclusin Intervencin farmacutica puede sigP= C (seguimiento trimestral por un farmacutico de hospital durante 9-nicantly mejorar la medicacin adherencia y sangre de presperodo de meses). Las intervenciones del farmacutico, destinadas a seguro en los pacientes tratados con antihipertensivos control aumentar el cumplimiento con la medicacin y control de la presin arterial, agentes. las intervenciones educativas involucradas y consejos de asesoramiento  dirigida al paciente. Principal medida de resultado Sistlica P Ensayo clnico Hospital Palabras claveresin arterial    la presin arterial, presin arterial diastlica y presin arterial farmacutico Hipertensin  Cumplimiento con la medicacin   control (segn las pautas de la JNC 7) evaluado en la Atencin farmacutica Intervencin farmacuticaPortugal referencia visita y al final de la atencin farmacutica fueron las medidas de resultado principales. Mediciones de presin arterial Impacto de la idea en prctica
M. Morgado ( )  Castelo Branco M. Centro de investigacin de Ciencias de la salud, Universidad de Beira Interior, Av. Infante D. Henrique, 6200-506 Covilha, Portugal correo electrnico: manuelaugustomorgado@gmail.com URL: www.fcsaude.ubi.pt M. Morgado  Rolo  Castelo Branco S. M. Hospital centro de Cova da Beira, E.P.E., Quinta do Alvito, 6200-251 Covilha, Portugal

Farmacuticos de hospital clnico pueden complementar physio en la gestin de pacientes hipertensos. Intervenciones farmacuticas son eficaces para mejorar cumplimiento con la medicacin antihipertensiva y reducir presin arterial sistlica y diastlica. Farmacuticos clnicos pueden participar efectivamente en Educacin para la salud y promocin para mejorar la sangre control de la presin.

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Int J Clin Pharm (2011) 33:132140 133

Introduccin

los participantes eran todos los adultos de 18 aos o ms con un estab publica el diagnstico mdico de hipertensin arterial, si La hipertensin es un factor de riesgo importante en el desarrollo su BP estaba controlado o no. Segn el JNC 7 de las enfermedades cardiovasculares y una importante de salud pblica directrices, control de BP fue dened como mediciones de BP en \\ 140 problema en todo el mundo. Se estima que ms de 3 millones la clnica de BP sistlica (SBP) mmHg y diastlica BP Portugus adultos (aproximadamente el 30% de las poblaciones(DBP)\\ 90 mmHg en pacientes sin diabetes o crnica portuguesas\\ 130 cin) sufren de hipertensin. En una reciente publicacin enfermedad del rin (ECR) y de la SBP mmHg y pad \\ 80 mmHg en pacientes con diabetes o CKD. Mshipertensos de 11,2% nica encuesta [1] tenan en su sangre (BP) controlada por presin. Esta gure es an menor en el ms, todos los pacientes incluidos haban sido establecidas antihyRegin central de Portugal, donde slo el 9,7% del total pertensive tratamiento farmacolgico durante al menos 6 meses. Exclusi nmero de hipertensos tiene su BP controlado [1]. los criterios fueron demencia, el embarazo y la lactancia. El Aunque se ha demostrado que el tratamiento de la hipertensin estudio se llev a cabo desde julio de 2009 a junio de 2010 en un prevenir enfermedades cardiovasculares y para ampliar y mejorar clnica de hipertensin\/dislipidemia en el hospital universitario de vida [2, 3], hipertensin sigue siendo inadecuadamente gestionada la Cova da Beira Hospital centro, Covilha, ubicado en el en todo el mundo, con falta de adherencia a BP-bajo Regin Central Oriental de Portugal. El estudio fue aprobado ofrece medicamentos siendo un factor importante [4]. Hipertensiva el Comit de tica institucional para el uso de seres humanos por los pacientes pueden no tomar sus medicamentos a causa de la investigacin, y se obtuvo el consentimiento informado por escrito de en la naturaleza asintomtica de la condicin, la larga duracin de todos los participantes antes de su inscripcin en el estudio. terapia, efectos secundarios de medicamentos, drogas complicado regPacientes ambulatorios que asisten a la clnica mdica de rutina imens, falta de entendimiento sobre hipertensin administrar- seguimiento fueron asignados al azar a un control llo y riesgos,y costos de medicamento[8, [9]. grupo [(CG) atencin habitual, donde no hay atencin farmacutica es Las tasas de adherencia de medicacin antihipertensiva han diferido siempre] o a un grupo de intervencin [farmacutico (IG) atencin, que consiste en un seguimiento trimestral por un hospital clnico ampliamente segn la poblacin estudiada y es estiapoyadas en el rango entre 50 y 70% [6, 10, 11]. farmacutico durante un perodo de 9 meses]. Los participantes fueron La importancia de mejorar la adherencia al antihyperten- asignadossiguientes simple asignacin al azar procedimientos (asignacin de igualdad y sin restricciones) utilizando un com medicamento sive ha sido abordada por '' el sptimo informe del el Comit Nacional conjunto sobre prevencin, deteccin, generados por ordenador la lista de nmeros aleatorios. La asignacin evaluacin y tratamiento de alta BP'' (JNC 7) [2] y secuencia se ocult del farmacutico clnico ha hecho hincapi en el papel de todos los profes salud- inscripcin y evaluacin de los participantes en forma secuencial numprofesiona para mejorar la adherencia al tratamiento [2]. Anterior comprometido, opaco, sobres cerrados. Las generados por computadora los estudios han demostrado que introduciendo la atencin farmacutica a la secuencia de asignacin y los sobres se prepararon los pacientes hipertensos en farmacias comunitarias mejorado por un investigador con ningn compromiso clnico en el juicio. resultados adherencia y paciente medicacin [16]. Cmo- Basado en la naturaleza de la intervencin, no es factible nunca, thistypeofcareforhypertensiveoutpatientsinahospital pacientes hipertensos ciego en intervencin farmacutica configuracin, donde la colaboracin entre el mdico y pharma modelos. As, mientras que los pacientes, farmacuticos y physi Cista es ms factible, previamente no se ha emprendido eneran conscientes del paciente asignado brazo, enfermeras o Portugal y el studypresentedhere es nico en este sentido. evaluacin de BP se mantuvieron cegados a la asignacin. La atencin farmacutica que suministr el IG una clnica farmacutico consisti en la visita de la lnea de base (duradera despusObjetivo del estudio aproximadamente 30 min) y el seguimiento de visitas (duradera despusaproximadamente 20 min) llev a cabo con cada paciente de intervencin Los objetivos del presente estudio fueron evaluar la 3 y 6 meses. Tambin se puede programar el farmacutico clnico intervenciones del farmacutico de hospital clnica durante un provisitas opcionales adicionales entre las visitas programadas en su novedad aleatorizado controlados ensayo clnico (ECA), dirigido discrecin. En cada visita, el farmacutico clnico llevado a cabo un para mejorar el cumplimiento de la medicacin antihipertensiva y BP entrevista completa de los paciente, problemas identied control en pacientes hipertensos en el ambulatorio seg- conduce al deficiente control de BP, proporciona educacin al paciente establecimiento de cuidado de la ondary. (educacin de hipertensin, BP autocontrol recomendacionescin, meta BP para alcanzar, estilo de vida educacin y asesoramiento, educacin de medicamentos y asesoramiento consejos para mejorar Mtodo adherencia) y presenta recomendaciones para la physi cian cambios en la terapia de drogas. El recomendado Esto fue un ECA, con participantes individualmente aleatorizados cambios de estilo de vida para el control de la BP estaban en conformida a uno de dos grupos paralelos (proporcin 1:1 de asignacin). Elegibles Directrices de la JNC 7 [2]. Tambin se proporcionaron los pacientes en e

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134 Int J Clin Pharm (2011) 33:132140

con material educativo escrito sobre hipertensin y varios estudios, con un nivel de signicance de 5% por las dos caras y las posibles complicaciones, as como prcticas de estilo de vidauna potencia de 80%, un tamao de muestra de 90 pacientes por grupo saludable. Adems se anim a llevar pacientes de intervencin (total 180) era necesaria, dada una tasa de desercin anticipada todas las ampollas vacas y cajas de medicamentos antihipertensivos del 10%. Contratar a este nmero de pacientes al mes 3 (ya a clnica visitas para el reciclaje y para verificar el cumplimiento a Septiembre de 2009) se anticip el perodo de insercin. terapia. La CG no tenido ninguna participacin del farmacutico clnico variables demogrficas, datos clnicos, medicamentos adherLas y los pacientes de control recibieron el tradicional servicio prestado ENCE y valores de BP de pacientes incluidos en el estudio, as como por la clnica del hospital. como mtricas de prescripcin se analizaron de forma descriptiva Medidas de resultado primarias respecto pharmay expresado como la media SD, frecuencia y por ciento edades. Prueba y prueba de suma de rango de MannWhitney del estudi c.s. cuidado efcacy fueron la proporcin de pacientes v2 prueba y Fisher lograr control de BP y reduccin en instantnea SBP y utilizado para comparar las variables continuas y DBP. Se realiz la medicin de la clnica de BP por capacitados prueba de probabilidad exacta se utilizaron para probar las diferencias enfermeras ciegos al estudio, de acuerdo con lo publicado entre las variables categricas. Todos los anlisis estadsticos fueron directrices sobre la medicin adecuada de BP expedido por el Portu- utilizando SPSS para Windows, versin 17.0 (SPSS Inc., hecho guese sociedad de hipertensin [17]. BP automtico validado Chicago, IL) y un P-valor \\ se consider 0.05 indidispositivos de medicin (Omron M4-I, validado por los britnicos Cate signicance estadstica. Sociedad de hipertensin [18]) y puos apropiados fueron utilizado, la media de dos mediciones consecutivas siendo grabado. La medida de resultado secundaria fue antihyper- Resultados cumplimiento con la medicacin tensive, que se determin en ambos brazos por un farmacutico mediante un elemento de veUn total de 222 pacientes asistieron a la clnica mdica durante validado escala de la adhesin [19, 20], derivado de la escala de cuatro elementos de contratacin (desde julio de 2009 a septiembre de 2009) el perodo desarrollado por Morisky et al [21, 22]. Bajo medicacin y todos se evaluaron la elegibilidad. De estos, fueron 17 la adhesin es dened como contestar s a 3 o ms de 5 excluido del estudio porque no cumplan los preguntas [23]. Paciente conocimiento de los valores de BP de destino y de inclusin, 1 fue excluido debido a la lactancia materna criterios Tambin se evaluaron los riesgos de hipertensin. Los pacientes fueron cony 7 fueron excluidos porque neg a participar. conocedor de los valores objetivo BP si saban ambos agujereados 197 pacientes hipertensos reunin la inclusin De las destino (gures) BP \\ 140 \\ 90 mmHg para hipertensos \/ criterios y consintiendo a participar, 99 fueron asignados a los pacientes sin diabetes y CKD y \\ 130 \\ 80 mmHg atencin habitual (CG) y 98 fueron asignados a la industria farmacutica \/ para pacientes hipertensos con diabetes o CKD). Eran cuidado (IG) (Fig. 1). considerado como conocedor de los impactos negativos de El IG y la CG fueron comparables con respecto a edad, hipertensin a salud si mencionaron al menos dos gnero, educacin, estado civil, ndice de masa corporal, smokconsecuencias negativas importantes de descontrolada Estado de ING, prevalencia de enfermedades crnicas, nmero de antihipertensin a la salud. Niveles de Pas y pad, control de BP, frmacos hipertensivos por paciente y el nmero de aos en cumplimiento con la medicacin, paciente conocimiento de destino BP val- antihipertensivo (tabla 1). tratamiento UES y de la hipertensin se evaluaron los riesgos de ambos grupos porcentaje de pacientes en los receptores de angiotensina II El y en comparacin al inicio y al final de un perodo de 9 meses. antagonistas fue la diferencia de slo signicativo detectada En el estudio de nal no recibi visita (9 meses) el IG entre los dos grupos en la lnea de base (tabla 2). atencin farmacutica y ambos brazos tenan BP medido por un Baseline SBP y DBP, control de BP, fase 1 y fase 2 enfermera de investigacin, y haba evaluado en cumplimiento con la medicacin por un y medicacin hizo signiadhesin de hipertensin farmacutico. Si un tema no se ha podido asistir a la salida visitacativamente difieren en ambos grupos cualquiera (tabla 3). a pesar de varios intentos de contactos (es decir, abandono), la ltima disponible Como se ve en la figura 1, retiraron un total de 7 temas (3,6%) clnica de BP se extrajo para anlisis de intencin de tratar (ITT). desde el estudio siguiente asignacin, 4 (2.0%) de la Datos clnicos para este estudio, incluyendo medidas de BP, brazo de intervencin y 3 (1.5%) del brazo de control. En problemas de medicamentos prescritos y mdicos fueron pro- IG, 95 complet la visita de 3 meses y 94 complet la respectivamente obtenido de la mdica electrnica de hospital visita de 6 meses, as como el estudio de nal. La clnica base de datos de registros (HEMR). La base de datos HEMR es comfarmacutico programada una media de 0,6 addi 0,6 SD Adems del detallado a nivel de paciente clnica y administrativa visitas adicionales por paciente en el IG, con un total de 51 informacin de todos los pacientes que han utilizado el hospital pacientes (7 pacientes tuvieron 2 visitas adicionales). como mnimo una vez. Esta base de datos est autorizado por los portugueses del estudio, slo 30 de 98 (30,6%) Al comienzo condentiality de datos de pacientes y el Gobierno qued asegurada.pacientes en el IG tenan PAS y PAD controlado. Esto los Para detectar una reduccin en la SBP de 8 a 10 mmHg [estndarera signicantly distinto del nmero en el no (desviacin) 16 a 18 mmHg], que est de acuerdo con CG, donde 35 de 99 (35,4%) pacientes tuvieron su BP

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Int J Clin Pharm (2011) 33:132140 Fig. 1 Flow diagram of patients through the study protocol (according to CONSORT 2010 Statement). BP blood pressure, BP D diastolic blood pressure, SBP systolic blood pressure

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Assessed for eligibility (n=222)

Enrollment

Excluded (n=25) Not meeting inclusion criteria (n=17) 5 had been on antihypertensive medication for less than 6 months 5 had diagnosis of arterial hypertension but were not prescribed antihypertensives 7 had diagnosis of dyslipidemia but not arterial hypertension Declined to participate (n=7) Other reasons (breastfeeding) (n=1)

Randomized (n=197)

Allocation
Allocated to control group (n=99) (all patients allocated to control group did not receive pharmaceutical intervention) Allocated to intervention group (n=98) (all patients allocated to intervention group received pharmaceutical intervention)

Follow-Up
Lost to follow-up (did not completed the 9month final study visit) (n=3) Lost to follow-up (4 patients did not completed the 9-month final study visit; 3 of them completed the baseline visit only and 1 completed the 3-month visit only) (n=4)

Analysis
Analysed (n=99) (99 patients were included in the intent-to-treat analyses: SBP, DBP, BP control, medication adherence) Analysed (n=98) (98 patients were included in the intent-to-treat analyses: SBP, DBP, BP control, medication adherence)

controlled (P = 0.480). At the end of the study, BP was in the IG (P = 0.020 for between-group DBP comparison) controlled among signicantly more patients in the IG (Table 3). (66.0%) than in the CG (41.7%) ( P = 0.0008), with an The intervention pharmacist made 118 recommendaodds ratio of 2.7 (95% CI, 1.54.9) (Table 3). tions about antihypertensive therapy, of which 90 (76.3%) The SBP was reduced by 0.8 mmHg in the CG and were accepted by physicians. These recommendations 7.6 mmHg in the IG ( P = 0.005 for between-group SBP included maintaining current antihypertensive medication comparison). The DBP was reduced by 1.1 mmHg in the (54.2%), introduction of additional medication (25.4%), CG and 3.0 mmHg in the IG ( P = 0.016 for betweendosage increase of existing medication (13.5%), cessation group DBP comparison) (Table 3). of current medication (5.9%) and dosage decrease of A sensitivity analysis to determine the robustness of our existing medication (0.8%). Despite these recommendandings in the presence of informative dropout was per- tions, the mean of overall changes in antihypertensive formed. The analysis was repeated under the most pessi- medication did not differ in IG and CG (0.65 vs. 0.72 mistic scenario in which all 4 dropouts in the IG had changes per subject in the IG and CG, respectively, P = 0.693), neither did the number of new antihypertenuncontrolled BP and all 3 dropouts in the CG had controlled BP. In this situation, the respective BP control ratessive medications (0.34 vs. 0.37, = 0.768) or the number P would be 63.3 and 43.4% (odds ratio of 2.2; 95% CI of discontinued antihypertensive medications (0.20 vs. 1.34.0; P = 0.005). Similarly, if we consider the last 0.19, P = 0.879). Likewise, the mean SD number of available clinic BP extracted in all 7 dropouts, SBP was antihypertensive medications was not different between the reduced by 0.9 mmHg in the CG and 7.4 mmHg in the IG IG (2.8 1.3 medications) and the CG (2.7 1.4 (P = 0.006 for between-group SBP comparison). The medications) at the end of the study (P = 0.682). SimiDBP was reduced by 1.0 mmHg in the CG and 2.7 mmHg larly, the antihypertensive medications prescribed did not

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136 Table 1 Patients demographics and clinical characteristics at baseline (n = 197) Demographic/clinical Gender, n (%) Male Female Age, mean (SD) Body mass index (kg/m ), mean (SD) Married, n (%) Education, n (%) Illiterate Elementary schooling High schooling University education Current smoker, n (%) Comorbid conditions, n (%) Cerebrovascular disease Chronic kidney disease Diabetes Heart failure Ischemic heart disease Myocardial infarction Left ventricular hypertrophy Dyslipidemia Metabolic syndrome Obesity (body mass index 30) C Advanced age C65 years), n (%) ( None of the above, n (%) Number of antihypertensive drugs per patient, mean (SD)
a 2 a

Int J Clin Pharm (2011) 33:132140 Control group (n = 99) 35 (35.4) 64 (64.4) 60.7 (11.8) 29.0 (4.7) 85 (85.9) 5 (5.1) 79 (79.8) 10 (10.1) 5 (5.1) 8 (8.1) 15 (15.2) 6 (6.1) 18 (18.2) 1 (1.0) 4 (4.0) 2 (2.0) 2 (2.0) 70 (70.7) 3 (3.0) 43 (43.4) 34 (34.3) 11 (11.1) 2.6 (1.4) 9.1 (6.6) Intervention group (n = 98) 44 (44.9) 54 (55.1) 58.3 (11.6) 29.8 (4.9) 75 (76.5) 5 (5.1) 77 (78.6) 10 (10.2) 6 (6.1) 9 (9.2) 11 (11.2) 5 (5.1) 18 (18.4) 0 (0.0) 1 (1.0) 1 (1.0) 3 (3.1) 78 (79.6) 1 (1.0) 40 (40.8) 30 (30.6) 8 (8.2) 2.7 (1.3) 8.6 (6.4) 0.777 0.417 0.764 1.000 1.000 0.369 1.000 0.683 0.149 0.621 0.708 0.578 0.484 0.437 0.572 0.155 0.261 0.094 0.991 P value 0.171

SD standard deviation

Number of years in antihypertensive drug treatment, mean (SD)

signicantly differ in both groups at the end of the study Both differences remained signicant when data were (Table 2). Body mass index (BMI) did not signicantly assessed by ITT analysis (Table 3). differ at the end of the study either (end BMI was 29.9 and 29.3 for IG and CG, respectively,P = 0.364) despite the pharmacists recommendation of lifestyle changes. Discussion Baseline low medication adherence did not signicantly differ in both groups (53.1% in the IG and 50.5% in the The pharmacist intervention program developed for this 9CG, P = 0.718). However, at the end of the study there month study resulted in signicant reduction of SBP and was a signicant difference (= 0.0017) in the percentage DBP and in an increase in the proportion of patients with P of patients with low medication adherence between the IGcontrolled BP according to JNC-7 guidelines. The odds of (22.3%, within group P \ 0.0001) and the CG (43.8%, achieving BP target in the IG were 2.7 times higher than within group P = 0.345). the CG (95% CI, 1.54.9; P \ 0.001). These differences Similarly, baseline patient knowledge of target BP val- remained signicant when data were assessed by ITT ues and of the potential complications of high BP to their analysis. Among hypertensive patients aged 6069 years, health did not signicantly differ in both groups (Table 3). the additional 6.8 mmHg reduction in SBP observed in However, at the end of the study there was a signicant intervention arm would be expected to yield a 22% difference in the percentage of patients reporting correctly reduction in stroke mortality and a 17% reduction in both target BP gures and hypertension risks (Table 3). mortality from ischemic heart disease [24]. Thus, inclusion

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Int J Clin Pharm (2011) 33:132140 Table 2 Antihypertensive Antihypertensive drug class medication prescribed to hypertensive patients at baseline and at the end of the study Loop diuretics (%) Thiazide diuretics (%) Potassium-sparing diuretic (%) Renin inhibitor (%) ACE inhibitors (%)

137 P Control group (Baseline,Intervention group (Baseline, value n = 99) (End of study, n = 98) (End of study, a a n = 98) n = 99) 18.2 18.2 59.6 63.6 6.1 6.1 3.0 3.0 32.3 32.3 11.2 12.2 64.3 67.3 3.1 4.1 2.0 4.1 33.7 35.7 64.3 64.3 45.9 44.9 41.8 42.9 7.1 6.1 0.168 0.247 0.498 0.584 0.498 0.747 1.000 0.721 0.841 0.617 0.018 0.094 0.131 0.729 0.427 0.517 0.806 0.590

Angiotensin II receptor antagonists (%) 47.5 52.5 Calcium channel blockers (%) Bold means that there is a statistically signicant difference ( value\ 0.05) P
a

35.4 42.4 47.5 47.5 8.1 8.1

Beta blockers (%)

Includes last medication Central alpha-2 agonists (%) prescribed before the nal study visit (including to dropouts)

of a clinical pharmacist on the hypertension care team may be attributed to an intensication of antihypertensive represents one possible strategy to address this importantmedication and some pharmacist interventions led to a public health issue. signicant improvement in BP control by this mechanism, Previously reported reduction of SBP and DBP levels ini.e., overcoming clinical inertia [23, 29, 30]. However, most patients receiving pharmaceutical care varied between 6.0studies that reported a statistically signicant increase in and 31.0 mmHg and 3.0 and 14.2 mmHg, respectively [23,medication adherence also reported a statistically signi25, 26]. In the present study, a 7.6/3.0 mmHg reduction cant improvement in treatment outcomes, which reveals was observed in the IG; this may be partly explained by the medication adherence is a key factor (although not the that low mean SBP and DBP level of the study population at only one) to achieve BP control [12, 13, 15, 3134]. When [ 75%), pharmacist baseline (141.8/85.8 mmHg). Indeed, most of those studies baseline medication adherence is high ( only enrolled hypertensive patients with uncontrolled BP, interventions are not likely to nd a statistically signicant contrary to the current study in which all hypertensive improvement in this outcome [14, 23, 28, 30]. In the current \ 50%) patients taking antihypertensive medications for at least study, the low baseline medication adherence ( made 6 months were included (whether their BP was controlled it feasible for pharmaceutical intervention to have a positive effect in this outcome and hence in treatment outcomes. or not); this approach is closer to the actual context in which the pharmacist could work in our clinic. Neverthe- Increase in medication adherence obtained could be less, the pharmacist intervention was effective in the attributed to the hypertension and drug education given to management of BP and was consistent with the chronic patients. Lack of knowledge about BP targets, hypertension care model in which the hypertension clinic uses team- complications and the benets of antihypertensive medibased care. cation have been recognized as a barrier to adherence The intervention program reported here resulted in sig- [3537]. nicant improvement in antihypertensive medication Several limitations of this study must be mentioned. adherence, which is a likely reason for better BP control inFirst, although RCTs provide the highest internal validity the IG because antihypertensive medications additions did controlling confounding bias, their use is limited by by not differ. It must be acknowledged that some studies contaminating the CG by contact with the intervention reported statistically signicant improvements in treatmentprogram. In the present study, randomisation at the patient outcomes (SBP, DBP and/or percentage of participants with level, as opposed to pharmacist or physician, may have controlled BP at the end of the study) without signicant resulted in contamination bias. Several patients in the increases in medication adherence [14, 16, 23, 2730]. This asked the pharmacist about their goal BP targets and CG

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Int J Clin Pharm (2011) 33:132140

Table 3 Clinic BP gures, BP control, antihypertensive medication adherence and knowledge about hypertension (baseline, end of the study and ITT analysis) Variable Baseline Baseline SBP, mean (SD), mmHg Baseline DBP, mean (SD), mmHg Baseline BP control, n (%) Baseline stage 1 HT, n (%) Baseline stage 2 HT, n (%) Baseline low medication adherence, n (%) Knowledge of target BP values, n (%) Knowledge of hypertension risks, n (%) End of the study End SBP, mean (SD), mmHg End DBP, mean (SD), mmHg End BP control, n (%) End low medication adherence, n (%) Knowledge of target BP values, n (%) Knowledge of hypertension risks, n (%) ITT analysis ITT SBP (includes last value carried forward), mean (SD), mmHg ITT DBP (includes last value carried forward), mean (SD), mmHg ITT BP control , n (%) ITT low medication adherence , n (%) ITT knowledge of target BP values , n (%) b ITT knowledge of hypertension risks , n (%) Bold means that there is a statistically signicant difference value\ 0.05) P (
a b b a

Control group (n = 99) 141.9 (16.8) 86.4 (11.7) 35 (35.4) 39 (39.4) 22 (22.2) 50 (50.5) 59 (59.6) 54 (54.5) (n = 96) 141.1 (18.0) 85.3 (8.9) 40 (41.7) 42 (43.8) 61 (63.5) 63 (65.6) (n = 99) 141.0 (18.0) 85.4 (9.1) 43 (43.4) 42 (42.4) 64 (64.6) 66 (66.7)

Intervention group (n = 98) 141.6 (16.3) 85.2 (10.2) 30 (30.6) 43 (43.9) 20 (20.4) 52 (53.1) 58 (59.2) 54 (55.1) (n = 94) 134.0 (16.0) 82.2 (8.7) 62 (66.0) 21 (22.3) 77 (81.9) 79 (84.0) (n = 98) 134.2 (16.0) 82.5 (8.6) 62 (63.3) 25 (25.5) 77 (78.6) 79 (80.6)

P value 0.873 0.438 0.480 0.522 0.752 0.718 1.000 0.920 0.005 0.016 0.0008 0.0017 0.005 0.003 0.006 0.020 0.005 0.012 0.030 0.026

Admitting that all patients from control group lost to follow-up had their BP controlled at the end of the 9-month study and that all patients from intervention group lost to follow-up had their BP uncontrolled at the end of the 9-month study
b

Admitting that all patients from control group lost to follow-up were adherent and knew target BP values and hypertension risks at the end of the 9-month study and that all patients from intervention group lost to follow-up were no adherent and did not known target BP values and hypertension risks at the end of the 9-month study BP blood pressure, BP diastolic blood pressure, hypertension, TT intention-to-treat,SBPsystolic blood pressure, standard deviation D HT I SD

of about the possible serious consequences of high BP at the a longer duration to determine if the effect of pharmacist beginning of the study, and, further, physicians in the study management of hypertension is sustainable. cared for patients in both groups. Although contamination was considered during the study design, researchers recognized that it would conservatively represent bias toward the null hypothesis. Second, the evaluation of BP control Conclusion was based on the measurements performed in two single clinic appointments (baseline and after a 9-month follow- Pharmacist intervention can modify factors affecting up period). These BP measurements may or may not be adherence, improve adherence and reduce BP levels in representative of the adequacy of BP control in hyperten- patients treated with antihypertensive agents. This study sive patients, even though they were performed by blinded suggests that one effective method of improving BP control nurses, which contributes to the validity of observed is for pharmacists to recognize inadequate hypertension effects. Third, medication adherence was measured by the knowledge and medication adherence and develop strateresearch (not blinded) pharmacist, which is potentially gies that enlist the patient as a participant in the managebiased in situations where the patient does not respond with ment of his/her health. Thereby, this report also reinforces determination to the questionnaire. Finally, the intervention pharmacists role in improving the health care system, the was short, lasting only 9 months. Future research should be leading to superior hypertensive patient outcomes.

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Funding This work was supported by Fundacao para a Ciencia e a Sookaneknun P, Richards RM, Sanguansermsri J, Teerasut C. 15. Tecnologia (SFRH/BD/36756/2007) through a fellowship grant Pharmacist involvement in primary care improves hypertensive attributed to MM. patient clinical outcomes. Ann Pharmacother. 2004;38(12): 20238. 16. Zillich AJ, Sutherland JM, Kumbera PA, Carter BL. HypertenConict of interest None. sion outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). J Gen Intern Med. 2005; Open Access This article is distributed under the terms of the 20(12):10916. Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any 17. Polonia J, Ramalhinho V, Martins L, Saavedra J. Portuguese society of cardiology recomendations, assessment and treatment medium, provided the original author(s) and source are credited. of hypertension. Rev Port Cardiol. 2006;25(6):64960. 18. 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