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Original Article Journal of Human Hypertension (2006) 20, 177–185 & 2006 Nature Publishing Group All rights reserved 0950-9240/06 $30.00 www.nature.com/jhh ORIGINAL ARTICLE Effect of telmisartan/hydrochlorothiazide vs lisinopril/hydrochlorothiazide combination on ambulatory blood pressure and cognitive function in elderly hypertensive patients R Fogari, A Mugellini, A Zoppi, P Lazzari, M Destro, A Rinaldi and P Preti Department of Internal Medicine and Therapeutics, Clinica Medica II, IRCCS Policlinico S. Matteo, University of Pavia, Pavia, Italy The aim of this study was to compare the effects cantly reduced ambulatory BP. However, the telmisar- of telmisartan/hydrochlorothiazide (HCTZ) vs lisinopril/ tan/HCTZ combination produced a greater reduction in HCTZ combination on ambulatory blood pressure and 24-h, day-time and night time ABPM values. Lisinopril/ cognitive function in elderly hypertensive patients. A HCTZ did not induce significant changes in any of the total of 160 patients, 76 men and 84 women, aged 61–75 cognitive function test scores at any time of the study, years, with sitting diastolic blood pressure (DBP) whereas at both 12 and 24 weeks telmisartan/HCTZ 490 mmHg and o110 mmHg and systolic blood pres- significantly improved the word-list memory score sure (SBP) 4140 mmHg were randomized to receive ( þ 17.1 and þ 15.7%, respectively, Po0.05 vs baseline), temisartan 80 mg/HCTZ 12.5 mg o.d. or lisinopril the word-list recall score ( þ 13.5 and þ 16.9%, Po0.05) 20 mg/HCTZ 12.5 mg o.d. for 24 weeks, according to and the Trails B score (À33 and À30.5%, Po0.05). These a prospective, open-label, blinded end point, parallel- results suggest that in elderly hypertensive patients group design. At the end of a 2-week wash-out period treatment with telmisartan/HCTZ produces a slightly and after 12 and 24 weeks of active treatment, 24-h greater reduction in ambulatory BP than lisinopril/HCTZ noninvasive ambulatory BP monitoring (ABPM) was combination and, unlike this latter, improves some of performed and cognitive function was evaluated the components of cognitive function, particularly through six different tests (verbal fluency, Boston episodic memory and visuospatial abilities. naming test, word-list memory, word-list recall, word- Journal of Human Hypertension (2006) 20, 177–185. list recognition and Trails B). Both treatments signifi- doi:10.1038/sj.jhh.1001964; published online 24 November 2005 Keywords: telmisartan/HCTZ; lisinopril/HCTZ; hypertensive elderly; cognitive functions Introduction Growing evidence has suggested that the renin– angiotensin system (RAS) in the central nervous Longitudinal and epidemiological studies have system participates in the processing of sensory shown a relationship between high blood pressure 9,10 1–3 information, learning and memory. Brain angio- (BP) and cognitive impairment later in life. This tensin II (Ang II) and its fragments Ang IV and Ang suggests that, in addition to being a powerful risk III have been shown to influence performance in factor for cardiovascular disease, hypertension in learning and memory paradigms directly or by elderly patients increases the risk of decline in modulating the activity of other neurotransmitters, cognitive function. Active lowering of BP should like acetylcholine, catecholamines, serotonin and prevent or reduce cognitive impairment, although other peptides.11–13 Beyond being implicated in not all antihypertensive agents seem to be equally 4–8 neuronal functions regulation, these neurotransmit- effective in this regard. ters also regulate local vasomotility and endothe- lium-dependent relaxation, which is of relevance for maintaining the physiological self-regulation Correspondence: Dr R Fogari, Department of Internal Medicine of brain flow, that is presumed to be necessary to and Therapeutics, Clinica Medica II, IRCCS Policlinico S. Matteo, correct performance of cerebral functions.14 Owing University of Pavia, Piazzale Golgi 19, 27100 Pavia, Italy. to the role of the RAS in modulating cognitive E-mail: [email protected] Received 21 July 2005; revised 27 September 2005; accepted 1 processes, drugs that interfere with the RAS like October 2005; published online 24 November 2005 angiotensin-converting enzyme inhibitors (ACE-I) Antihypertensive treatment and cognitive functions in the elderly R Fogari et al 178 and Ang II AT1 receptor blockers (ARB) possess Patients were checked at the end of the wash-out the potential of preventing cognitive decline and period and after 12 and 24 weeks of active treatment. even improving cognitive function in hypertensive At each visit, 24-h ambulatory BP monitoring patients. Indeed experimental and clinical studies (ABPM) was performed, using a portable, noninva- have shown that these drugs may influence cogni- sive, fully automatic BP recorder (ICR 90207; Space- tive performance positively, improving learning labs Inc., Bellevue, CA, USA), validated against and memory.15–22 intra-arterial BP measurements.31 The recorder was Both ACE-I and ARB are used in the treatment set to take readings at 15-min intervals throughout of hypertension in the elderly, due to their good the 24-h period. Recordings were always started at efficacy/tolerability profile. However, in order to the same hour in the morning and were performed achieve the newly recommended BP goals, the use throughout the 24-h period, during which patients of combination therapy has been advocated on the were allowed to follow their normal daily routine grounds that its individual components may exert after they left the laboratory. Recordings were additive if not synergistic effect on BP.23,24 In this excluded from the analysis when more than 10% regard, since the pharmacological effects of hydro- of all readings or more than one reading per hour chlorothiazide (HCTZ) include the activation of the were missing or incorrect. RAS, its association with an ACE-I or an ARB is a For each patient, the following data relating to rational and useful approach, affording effective BP SBP, DBP and heart rate (HR) were provided by the control while minimizing possible side effects.25,26 analysis of the recordings: 24-h mean values, day- To date, at our knowledge, no data have been time (0700–2300) mean values, night time (2300– reported about the influence of this type of combi- 0700) mean values and hourly mean values. nation therapy on cognitive performance. Furthermore, for each patient the percentage of With this background, the present study was 24-h, day time and night time SBP and DBP readings undertaken to compare the effects of the fixed 4140 and 490 mmHg, respectively, was provided combination of the ARB telmisartan27 and HCTZ by the system. with those of the fixed combination of the ACE-I Following the recommendations of US Food and lisinopril28 and HCTZ on ambulatory BP and Drug Administration (FDA),32 the trough-to-peak cognitive function of elderly hypertensive patients, (T/P) ratio, defined as the ratio between the effect who are likely to be the most susceptible to the of an antihypertensive agent at the end of the effects of antihypertensive drugs on cognitive func- interval between doses (trough) and at the time of tion.29 its maximum effect (peak), was evaluated in each treatment group. For each ABPM recording, trough SBP and DBP levels were calculated as the average Patients and methods of the BP readings taken 22–24 h after the dose, whereas the peak values were calculated as the This was a prospective, randomized, open-label, average of the hour that showed the maximal blinded end point (PROBE),30 parallel group study average decrease in BP between 2 and 8 h after the with two treatment arms. A total of 160 outpatients dose plus the preceding or the following hour aged 61–75 years entered a 2-week wash-out period, depending on which showed the greater decreae in after which they were considered eligible for BP.33 Data were averaged for all patients. To quantify enrolment if they had a sitting diastolic BP the homogeneity of the antihypertensive effect over (DBP)X95 and o110 mmHg and a sitting systolic the 24 h, the smoothness index (SI) was also BP (SBP)4140 mmHg. Exclusion criteria included: computed by dividing the average of the 24 hourly secondary hypertension, myocardial infarction or change after treatment by the corresponding (s.d.).34 cerebrovascular accident within the preceding 6 This measurement has been shown to reflect months, clinically significant valvular heart disease, whether treatment smoothly reduces BP throughout heart failure, renal or hepatic insufficiency and a 24-h period and seems to provide a better known hypersensitivity to the drugs used in the assessment of homogeneity of antihypertensive study. treatment than T/P ratio.34 The study was performed in accordance with the Cognitive function was assessed at the end of the Declaration of Helsinki; the protocol was approved wash-out period and after 12 and 24 weeks of active by the local Ethical Committee and all of the treatment by means of the following six tests. patients gave their informed consent before enrol- ment. At the end of an initial 2-week wash-out period, during which any eventual antihypertensive Verbal fluency drug was discontinued, patients fulfilling the inclu- The subjects were asked to name as many animals as sion criteria were randomized to the telmisartan possible in 1 min and the score was the total number (80 mg)/HCTZ (12.5 mg) combination or to the of different animals named. Higher scores indicated lisinopril (20 mg)/HCTZ (12.5 mg) combination, less cognitive impairment. This verbal fluency test35 both given once daily at the same hour in the measures impairments in verbal production, seman- morning (approximately at 0800) for 24 weeks. tic memory and language and is particularly sensi- Journal of Human Hypertension Antihypertensive treatment and cognitive functions in the elderly R Fogari et al 179 tive to early mental decline in older people.
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