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Micardis(R) - Micardis Plus(R) - Klinische Wirksamkeit (39 Abbildungen)




Abbildung
 
FÜR ÖSTERREICH: Weitere Informationen: Merck Gesellschaft mbH, Zimbagasse 5, 1147 Wien, Tel.: 01/576 00-0
Abbildung 0


 
 
Micardis(R) - Klinische Wirksamkeit
Abbildung 1


 
 
Micardis - Vergleichsstudien
Abbildung 2: Telmisartan has be extensively studied in comparative clinical trials. This slide provides a summary of the comparisons that have been assessed. The results are provided in the following slides.


Keywords: ACE-HemmerAngiotensin-I-RezeptorblockerBetablockerCa-KanalblockerDiuretikumStudie
 
 
Datenbestand - Langzeitmessung
Abbildung 3: Clinical trials of telmisartan have extensively used ABPM, which is widely considered to be the most relevant measure of blood pressure. This extensive use of ABPM has resulted in the largest body of ABPM data currently available. This slide provides a list of studies that have been conducted to date, and which are detailed in the following slides. Additional ABPM studies are ongoing, which will increase further the body of available data.


Keywords: DatenLangzeitmessung
 
 
Blutdrucksenkung - 24 Stunden
Abbildung 4: This slide shows the result of a meta-analysis of five multicentre trials that used ABPM to compare the antihypertensive efficacy of telmisartan, losartan, valsartan and amlodipine.1 Telmisartan 80 mg was significantly superior to losartan 50 mg and valsartan 80 mg in the reduction of 24-h mean SBP and DBP. 1. Neutel JM, Smith DHG. Evaluation of angiotensin II receptor blockers for 24-hour blood pressure control: meta-analysis of a clinical database. J Clin Hypertens 2003; 5: 58–63.


Keywords: BlutdrucksenkungDiagrammHypertonieMetaanalyse
 
 
Morgendliche Blutdrucksenkung
Abbildung 5: This slide shows the result of a meta-analysis of five multicentre trials that used ABPM to compare the antihypertensive efficacy of telmisartan, losartan, valsartan and amlodipine.1 The data show that telmisartan 80 mg was significantly superior to losartan and valsartan in the reduction of SBP and DBP during the risky, early morning period (06:00–11:59). 1. Neutel JM, Smith DHG. Evaluation of angiotensin II receptor blockers for 24-hour blood pressure control: meta-analysis of a clinical database. J Clin Hypertens 2003; 5: 58–63.


Keywords: BlutdrucksenkungDiagrammTageszeit
 
 
Morgendliche Blutdrucksenkung - Angiotensin-I-Rezeptorblocker
Abbildung 6: Telmisartan has consistently shown superior reductions in blood pressure in the last 6 h of the dosing interval compared with other ARBs. This superiority is a consequence of telmisartan’s long duration of action. The evidence for this superiority is detailed in the following slides.


Keywords: Angiotensin-I-RezeptorblockerBlutdrucksenkungTageszeit
 
 
Telmisartan - Losartan
Abbildung 7: Two fixed-dose studies have compared low doses of telmisartan and losartan. They both found telmisartan to be superior in the last 6 h of the dosing interval. Mallion et al. recruited 223 patients with mild-to-moderate hypertension for a 6-week trial of telmisartan 40 mg or 80 mg and losartan 50 mg.1 Telmisartan 40 mg gave significantly superior reductions in SBP and DBP. The reduction in SBP in the last 6 h of the dosing interval was 10.7 mmHg with telmisartan 40 mg and 6.0 mg with losartan 50 mg (p<0.05). Telmisartan 80 mg was also superior to losartan 50 mg. Ding et al. compared telmisartan 40 mg with losartan 50 mg in 56 Taiwanese patients with mild-to-moderate hypertension.2 The reduction in DBP in the last 6 h of the dosing interval was superior with telmisartan compared with losartan. Reductions in SBP in the last 6 h of the dosing interval (16.0 mmHg with telmisartan and 11.8 mmHg with losartan) did not reach statistical significance. 1. Mallion JM, et al. ABPM comparison of the antihypertensive profiles of the selective angiotensin II receptor antagonists telmisartan and losartan in patients with mild-to-moderate hypertension. J Hum Hypertens 1999; 13: 657–664. 2. Ding PY, et al. A double-blind ambulatory blood pressure monitoring study of the efficacy and tolerability of once-daily telmisartan 40 mg in comparison with losartan 50 mg in the treatment of mild-to-moderate hypertension in Taiwanese patients. Int J Clin Pract Suppl 2004; 58: 16–22.


Keywords: DiagrammLosartanStudieTelmisartan
 
 
Telmisartan - Losartan
Abbildung 8: The two fixed-dose studies comparing low doses of telmisartan and losartan also found telmisartan to be superior in 24-h mean ambulatory blood pressure reductions. Mallion et al. recruited 223 patients with mild-to-moderate hypertension for a 6-week trial of telmisartan 40 mg or 80 mg and losartan 50 mg.1 Telmisartan 40 mg gave significantly superior reductions in SBP and DBP. The reduction in 24-h mean SBP was 11.5 mmHg with telmisartan 40 mg and 8.0 mg with losartan 50 mg (p<0.05). Telmisartan 80 mg was also superior to losartan 50 mg. Ding et al. compared telmisartan 40 mg with losartan 50 mg in 56 Taiwanese patients with mild-to-moderate hypertension.2 The reduction in 24-h mean DBP was superior with telmisartan compared with losartan. Reductions in 24-h mean SBP (14.6 mmHg with telmisartan and 11.2 mmHg with losartan) did not reach statistical significance. 1. Mallion JM, et al. ABPM comparison of the antihypertensive profiles of the selective angiotensin II receptor antagonists telmisartan and losartan in patients with mild-to-moderate hypertension. J Hum Hypertens 1999; 13: 657–664. 2. Ding PY, et al. A double-blind ambulatory blood pressure monitoring study of the efficacy and tolerability of once-daily telmisartan 40 mg in comparison with losartan 50 mg in the treatment of mild-to-moderate hypertension in Taiwanese patients. Int J Clin Pract Suppl 2004; 58: 16–22.


Keywords: LosartanStudieTelmisartan
 
 
Telmisartan - Losartan
Abbildung 9: The superiority of telmisartan over losartan is also evident when a flexible-dosing regimen is employed. This slide shows the results of an 8-week study in 331 patients with mild-to-moderate hypertension.1 Patients were started at the lower dose, with up-titration to the higher dose allowed if seated trough cuff DBP was ≥90 mmHg at Week 4. By Week 8, the reduction in SBP and DBP in the last 6 h of the dosing interval was greater in the telmisartan arm than in the losartan arm. 1. Data on file. Boehringer Ingelheim GmbH.


Keywords: DosisLosartanStudieTelmisartan
 
 
Telmisartan - Losartan
Abbildung 10: In a meta-analysis of two flexible-dose studies, telmisartan produced superior reductions in blood pressure than losartan. These data are from two 8-week studies in 720 patients with mild-to-moderate hypertension.1 Patients were started at the lower dose, with up-titration to the higher dose allowed if seated trough cuff DBP was ≥90 mmHg at Week 4. By Week 8, the reduction in SBP and DBP in the last 6 h of the dosing interval was greater in the telmisartan arm than in the losartan arm. Telmisartan-induced reductions were also greater for the majority of the observed hourly mean ambulatory SBP and DBP values over the entire 24-h dosing interval. 1. Smith DH, et al. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Press Monit 2003;8:111–117.


Keywords: DosisLosartanStudieTelmisartan
 
 
Telmisartan - Losartan - Studienverlauf
Abbildung 11: In a meta-analysis of two flexible-dose studies, telmisartan-induced reductions in DBP during the last 6 h of the dosing interval were greater than those with losartan.1 Reductions with telmisartan were greater than with losartan for the majority of the observed hourly mean values over the entire 24-h dosing interval.1 These data are from two, 8-week studies in 720 patients with mild-to-moderate hypertension.1 Patients were started at the lower dose, with up-titration to the higher dose allowed if seated trough cuff DBP was ≥90 mmHg at Week 4. The 24-h profiles of ambulatory SBP hourly mean reductions were similar to those for DBP. 1. Smith DH, et al. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Press Monit 2003; 8: 111–117.


Keywords: DiagrammLosartanStudieTelmisartan
 
 
Telmisartan - Losartan - Systolischer Minimaldruck
Abbildung 12: In flexibly dosed studies using trough cuff blood pressure as the primary outcome, telmisartan was found to be superior to losartan. Lee et al. compared telmisartan 40–80 mg with losartan 50–100 mg in an 8-week study of 180 Taiwanese patients with mild-to-moderate hypertension.1 Changes in SBP were statistically superior with telmisartan compared with losartan. Changes in DBP (amounting to 11.1 mmHg with telmisartan and 8.7 mmHg with losartan) did not reach statistical significance. Zhu et al. compared telmisartan 40–80 mg with losartan 50–100 mg in an 8-week study of 330 Chinese patients with mild-to-moderate hypertension.2 Changes in SBP were statistically superior with telmisartan compared with losartan. Changes in DBP (amounting to 10.9 mmHg with telmisartan and 9.3 mmHg with losartan) were also statistically significant (p=0.03). 1. Lee YT, et al. A double-blind comparison of the efficacy and tolerability of telmisartan 40-80 mg vs. losartan 50-100 mg in Taiwanese hypertensive patients. Int J Clin Pract Suppl 2004; 58: 40–45. 2. Zhu JR, et al. Efficacy and safety of telmisartan vs. losartan in control of mild-to-moderate hypertension: a multicentre, randomised, double-blind study. Int J Clin Pract Suppl 2004; 58: 46–49.


Keywords: DosisLosartanMetaanalyseSBDTelmisartan
 
 
Telmisartan - Valsartan
Abbildung 13: The results of a study comparing the effects of telmisartan (40–80 mg) with valsartan (80–160 mg) on BP in the last 6 hours of the dosing interval are shown here.1 Telmisartan was superior to valsartan at reducing DBP and SBP at the end of the dosing interval. 1. White WB, et al. Effects of the angiotensin II receptor blockers telmisartan versus valsartan on the circadian variation of blood pressure. Impact on the early morning period. Am J Hypertens 2004; 17: 347–353.


Keywords: DBDDiagrammMICADO-II-StudieSBDTelmisartanValsartan
 
 
Telmisartan - Valsartan
Abbildung 14: This was a double-blind, forced-titration, crossover, randomized trial that compared telmisartan 80 mg/day with valsartan 160 mg/day in 490 patients with hypertension.1 Ambulatory blood pressure recordings were made at baseline and at 8 weeks. Telmisartan reduced SBP/DBP during the last 6 h of the dosing period by 11/7.6 mmHg, compared with 8.7/5.8 mmHg with valsartan (P=0.02). 1. White WB, et al. Effects of the angiotensin II receptor blockers telmisartan versus valsartan on the circadian variation of blood pressure. Am J Hypertens 2004; 17: 347–353.


Keywords: DiagrammMICADO-II-StudieSBDTelmisartanValsartan
 
 
Telmisartan - Valsartan
Abbildung 15: Telmisartan 80 mg provides superior blood pressure reductions than valsartan 160 mg following a missed dose. The combined data from two, double-blind, crossover, forced-titration studies are shown.1 Patients with hypertension (n=877) received either telmisartan 80 mg/day or valsartan 160 mg/day. After 4-weeks’ treatment, patients received either double-blind active therapy or placebo (missed dose) for 1 day. After a further 2 weeks’ therapy, patients were crossed over and again received either active therapy or placebo for 1 day. After a missed dose, 24-h mean SBP/DBP was reduced by 10.7/7.2 mmHg with telmisartan, compared with 8.7/5.5 mmHg with valsartan (P<0.05). 1. Lacourcière Y, et al. Sustained antihypertensive activity of telmisartan compared with valsartan. Blood Press Monit 2004; 9: 203–210.


Keywords: DiagrammTelmisartanValsartan
 
 
Telmisartan - Ramipril
Abbildung 16: Telmisartan 80 mg provides superior reductions in SBP and DBP in the last 6 h of the dosing interval compared with ramipril 10 mg. Data shown are from two independent, fixed-dose, 14-week studies: Prospective, Randomized Investigation of the Safety and efficacy of Micardis versus ramipril using ABPM (PRISMA) I and II. PRISMA I was conducted in Europe and South Africa, and recruited 801 patients.1 PRISMA II was conducted in the USA and Canada, and recruited 812 patients.2 Patients were started on telmisartan 40 mg or ramipril 2.5 mg, and force titrated to telmisartan 80 mg or ramipril 5 mg after 2 weeks. At Week 8, ramipril was further up titrated to 10 mg. Blood pressure was measured using ABPM. As well as superiority in the early morning period, in both studies telmisartan was significantly superior to ramipril over the 24-h mean and other time periods: morning (06:00–11:59), daytime (06:00–21:59), and night-time (22:00–05:59). 1. Williams B, et al. Superior blood pressure reduction in the last 6 h of the dosing interval with once-daily telmisartan versus ramipril. Hypertension 2004; 44: 576. 2. Lacourcière Y, et al. A prospective, randomized investigation of the safety and efficacy of telmisartan vs ramipril in mild-to-moderate hypertensives using ambulatory blood pressure monitoring. Hypertension 2004; 44: 576.


Keywords: DiagrammPRISMA-I-StudiePRISMA-II-StudieRamiprilTelmisartan
 
 
Telmisartan - Ramipril
Abbildung 17: Telmisartan 80 mg reduces blood pressure over the full 24-h dosing interval compared with ramipril 10 mg. Data shown are from a fixed-dose, 14-week study: PRISMA II.1 Patients were started on telmisartan 40 mg or ramipril 2.5 mg, force titrated to telmisartan 80 mg or ramipril 5 mg after 2 weeks. At Week 8, ramipril was further up titrated to 10 mg. Blood pressure was measured using ABPM. Telmisartan was significantly superior to ramipril (p<0.0001) over the 24-h mean and other time periods: morning (06:00–11:59), daytime (06:00–21:59), and night-time (22:00–05:59). 1. Lacourcière Y, et al. A prospective, randomized investigation of the safety and efficacy of telmisartan vs ramipril in mild-to-moderate hypertensives using ambulatory blood pressure monitoring. Hypertension 2004; 44: 576.


Keywords: DiagrammPRISMA-II-StudieRamiprilTelmisartan
 
 
Morgendlicher Blutdruckanstieg
Abbildung 18: Patients with a high EMBPS have been shown to be at increased risk of stroke.1 In the study that demonstrated this connection, the EMBPS was defined as the difference between the early morning mean (the average blood pressure in the first 2 hours after waking) and the night-time low (the average of three blood pressure readings centred on the lowest night-time reading).1 These definitions were used to calculate the EMBPS of patients in two studies of identical design that compared telmisartan 80 mg with ramipril 10 mg (PRISMA I and II).2 The 25% of patients with the highest EMBPS of DBP all had an EMBPS ≥35 mmHg.2 In these patients, telmisartan reduced the magnitude of the EMBPS by a significantly greater amount than did ramipril.2 1. Kario K, et al. Morning surge in BP as a predictor of silent and clinical cerebrovascular disease in elderly hypertensives. Circulation 2003; 107: 1401–1406. 2. Data on file. Boehringer Ingelheim GmbH.


Keywords: DiagrammRamiprilTelmisartan
 
 
Telmisartan - Perindopril
Abbildung 19: Telmisartan 80 mg reduced mean DBP in the last 8 h of the dosing interval compared with perindopril 4 mg (P≤0.05).1 This study was a 6-week, double-blind, ABPM trial in 60 patients with mild-to-moderate hypertension. DBP control (24-h mean DBP <85 mmHg) was observed in 66.6% of telmisartan-treated patients but only 46.6% of perindopril-treated patients (P<0.05). 1. Nalbantgil I, et al. The efficacy of telmisartan compared with perindopril in patients with mild-to-moderate hypertension. Int J Clin Pract 2004; 58: 50–54.


Keywords: DiagrammPerindoprilStudieTelmisartan
 
 
Telmisartan - Perindopril
Abbildung 20: The EValuation de l’Efficacité RESiduelle du Telmisartan (EVEREST) study compared telmisartan (n=217) with perindopril (n=218) over 12 weeks.1 Initial treatment was telmisartan 40 mg and perindopril 4 mg, with the dose doubled at Week 6 for those patients who failed to reach target blood pressure (DBP <90 mmHg). More patients required a dose doubling of perindopril (55%) than of telmisartan (41%, p=0.005) Despite the higher rate of dose doubling with perindopril, telmisartan still reduced blood pressure measured at home compared with perindopril. Telmisartan also significantly reduced clinic blood pressure compared with perindopril. More patients had a clinic DBP <90 mm Hg with telmisartan than with perindopril (58% versus 46%, respectively, P<0.01), and more patients had an SBP <140 mmHg (46% versus 32%, respectively, P<0.005). 1. Ragot S, et al. Comparison of trough effect of telmisartan vs perindopril using self blood pressure measurement: EVERESTE study. J Hum Hypertens 2002; 16: 865–873.


Keywords: DBDDiagrammPerindoprilSBDTelmisartan
 
 
Telmisartan - Enalapril
Abbildung 21: The efficacy of telmisartan at doses of 40 mg and 80 mg was compared with that of enalapril 20 mg in a 12-week multicentre, randomized, parallel-group, placebo-controlled study that included 440 patients with mild-to-moderate hypertension.1 The reduction in blood pressure with telmisartan was greater than with enalapril and reached statistical significance for the telmisartan 80 mg arm. Maximal blood pressure reductions were apparent by week 4 and were maintained through to week 12. 1. Smith DHG, et al. Once-daily telmisartan compared with enalapril in the treatment of hypertension. Adv Ther 1998; 15: 229–240.


Keywords: DBDDiagrammEnalaprilSBDTelmisartan
 
 
Telmisartan - Amlodipin
Abbildung 22: Telmisartan produced reductions in DBP in the last 4 h of the dosing interval that were superior to amlodipine in this 12-week, double-blind, titration-to-response, ABPM study.1 Patients (n=232) had mild-to-moderate hypertension. They were randomized to placebo (n=81) or active dose, which comprised telmisartan 40 mg or amlodipine 5 mg titrated as required up to a maximum of telmisartan 120 mg or to amlodipine 10 mg. Compared with amlodipine, telmisartan resulted in a 26% reduction in SBP and an almost 40% reduction in DBP during the last 4 h of the dosing interval. 1. Lacourcière Y, et al. A comparison of the efficacies and duration of action of the angiotensin II receptor blockers telmisartan and amlodipine. Blood Press Monit 1998; 3: 295–302.


Keywords: AmlodipinDBDDiagrammSBDTelmisartan
 
 
Telmisartan - Amlodipin
Abbildung 23: The efficacy of telmisartan at doses of 40 mg and 80 mg was compared with that of enalapril 20 mg in a 12-week multicentre, randomized, parallel-group, placebo-controlled study that included 440 patients with mild-to-moderate hypertension.1 The reduction in blood pressure with telmisartan was greater than with enalapril and reached statistical significance for the telmisartan 80 mg arm. Maximal blood pressure reductions were apparent by week 4 and were maintained through to week 12. 1. Smith DHG, et al. Once-daily telmisartan compared with enalapril in the treatment of hypertension. Adv Ther 1998; 15: 229–240.


Keywords: AmlodipinDBDDiagrammTageszeitTelmisartan
 
 
Blutdrucksenkung - Nephropathie
Abbildung 24: The Efficacy and Safety in Patients with Renal Impairment treated with Telmisartan (ESPRIT) trial was an 8-week, open-label study of telmisartan 40–80 mg in 82 patients with hypertension (DBP 90–109 mmHg) and chronic mild/moderate (GFR 30–74 ml/min/1.73 m2) or severe renal impairment (GFR <30 ml/min/1.73 m2), or requiring maintenance haemodialysis.1 Blood pressure was significantly reduced in all groups, and there were no statistically significant between-group differences in the magnitude of the reduction. Drug-related adverse events were uncommon, and were typical class effects of ARBs. There were few notable changes in laboratory parameters following telmisartan treatment. 1. Sharma AM, et al. Telmisartan in patients with mild/moderate hypertension and chronic kidney disease. Clin Nephrol 2005; 63: 250–257.


Keywords: BlutdrucksenkungDiagrammNephropathie
 
 
Niereninsuffizienz - Wirksamkeit
Abbildung 25: 148 haemodialysis patients with chronic renal failure and arterial hypertension were given telmisartan 80 mg or losartan 100 mg daily at 08:00 for 8 weeks.1 Telmisartan provided a better and faster antihypertensive effect than losartan. At 4 weeks, the reduction in SBP/DBP was significantly greater with telmisartan than with losartan (-11.1/-6.2 mmHg versus -4.6/+0.3 mmHg, P<0.05). The superiority of telmisartan increased by Week 8 (-30.6/-10.9 versus -12.3/-4.9 mmHg, P<0.05). 1. Cice G, et al. Unexpected heart rate reduction and antihypertensive efficacy of telmisartan in haemodialysis patients. Presented at the XLI Congress of the European Renal Association, Lisbon, Portugal. May 15–18, 2004.


Keywords: DBDDiagrammLosartanNiereninsuffizienzSBDTelmisartan
 
 
Telmisartan - Eigenschaften
Abbildung 26


Keywords: Telmisartan
 
 
Morgendliche Blutdrucksenkung
Abbildung 27: This slide gives a summary of the benefits of telmisartan over active comparators in the early morning period. Except where indicated, all these studies used ABPM to measure the changes from baseline in the last 6 h of the dosing interval. Telmisartan was superior to losartan in a fixed-dose1 and a titration-to-response study.2 Telmisartan was superior to valsartan in two forced-titration studies.3,4 Telmisartan reduced DBP compared with amlodipine in the last 4 h of the dosing interval (assessed using ABPM).5 Telmisartan reduced trough blood pressure measured at home in the morning compared with perindopril.6 Two studies showed that telmisartan reduces early morning blood pressure compared with ramipril.7,8 1. Ding PY, et al. A double-blind ambulatory blood pressure monitoring study of the efficacy and tolerability of once-daily telmisartan 40 mg in comparison with losartan 50 mg in the treatment of mild-to-moderate hypertension in Taiwanese patients. Int J Clin Pract Suppl 2004; 58: 16–22. 2. Smith DH, et al. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Press Monit 2003; 8: 111–117. 3. White WB, et al. Effects of the angiotensin II receptor blockers telmisartan versus valsartan on the circadian variation of blood pressure. Impact on the early morning period. Am J Hypertens 2004; 17: 347–353. 4. Lacourcière Y, et al. Sustained antihypertensive activity of telmisartan compared with valsartan. Blood Press Monit 2004; 9: 203–210. 5. Lacourcière Y, et al. A comparison of the efficacy and duration of action of the angiotensin II receptor blocker telmisartan to amlodipine. Blood Press Monit 1998; 3: 295–302. 6. Ragot S, et al. Comparison of trough effect of telmisartan vs perindopril using self blood pressure measurement: EVERESTE study. J Hum Hypertens 2002; 16: 865–873. 7. Williams B, et al. Superior blood pressure reduction in the last 6 h of the dosing interval with once-daily telmisartan versus ramipril. Hypertension 2004; 44: 576. 8. Lacourcière Y, et al. A prospective, randomized investigation of the safety and efficacy of telmisartan vs ramipril in mild-to-moderate hypertensives using ambulatory blood pressure monitoring. Hypertension 2004; 44: 576.


Keywords: BlutdrucksenkungTageszeit
 
 
Klinische Wirksamkeit - MicardisPlus
Abbildung 28


 
 
Telmisartan - HCTZ
Abbildung 29: Reported here are selected arms from an 8-week, 4 x 5 factorial, multicentre, double-blind, placebo-controlled, dose-finding study conducted in 818 patients with mild-to-moderate hypertension.1 Patients were randomized to telmisartan 20 mg, 40 mg, 80 mg or 160 mg alone or in combination with HCTZ 6.25 mg, 12.5 mg, or 25 mg, giving a total of 20 treatment groups. SBP was significantly lowered with telmisartan 40 mg/HCTZ 12.5 mg compared with telmisartan 40 mg or HCTZ 12.5 mg monotherapies (P<0.01), and was significantly lowered with telmisartan 80 mg/HCTZ 12.5 mg compared with telmisartan 40/80 mg or HCTZ 12.5 mg monotherapies (P<0.01). 1. McGill JB, Reilly PA. Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Clin Ther 2001;23:833–850.


Keywords: DiagrammHCTZSBDTelmisartan
 
 
Telmisartan - HCTZ
Abbildung 30: Reported here are selected arms from an 8-week, 4 x 5 factorial, multicentre, double-blind, placebo-controlled, dose-finding study conducted in 818 patients with mild-to-moderate hypertension.1 Patients were randomized to telmisartan 20 mg, 40 mg, 80 mg or 160 mg alone or in combination with HCTZ 6.25 mg, 12.5 mg, or 25 mg, giving a total of 20 treatment groups. Combination therapy significantly improved the SBP response rate compared with monotherapy (P<0.01). 1. McGill JB, Reilly PA. Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Clin Ther 2001; 23: 833–850.


Keywords: DiagrammHCTZSBDTelmisartan
 
 
Telmisartan - HCTZ
Abbildung 31: This was an 8-week study in 491 patients with mild-to-moderate hypertension who were non-responders (DBP 90 mmHg) in an open-label period of telmisartan 80 mg monotherapy.1 Patients were randomized to either continuation of monotherapy or fixed-dose combination with HCTZ 12.5 mg. After 8 weeks, mean DBP changes were -4.9 and -8.0 mmHg in the monotherapy and combination therapy groups, respectively (p<0.01). Mean SBP changes were -7.0 and -12.6 mmHg in the monotherapy and combination therapy groups, respectively (p<0.01). Most of the relative improvements with combination therapy occurred in the first 4 weeks. By endpoint, blood pressure was normalized (SBP/DBP <140/<90 mmHg) in 41.5% of patients on combination therapy and 26.1% of patients on monotherapy (P<0.05). 1. Lacourcière Y, et al. Efficacy and tolerability of a fixed-dose combination of telmisartan plus hydrochlorothiazide in patients uncontrolled with telmisartan monotherapy. J Hum Hypertens 2001; 15: 763–770.


Keywords: BlutdrucksenkungDiagrammHCTZTelmisartan
 
 
Telmisartan - Losartan - HCTZ
Abbildung 32: Telmisartan 40 mg in combination with HCTZ was superior to losartan 50 mg in combination with HCTZ in two 6-week, prospective, randomized, open-label, blinded endpoint (PROBE) studies.1,2 The studies compared telmisartan 40 mg + HCTZ 12.5 mg, telmisartan 80 mg + HCTZ 12.5 mg and losartan 50 mg + HCTZ 12.5 mg. Both telmisartan groups were also significantly superior to losartan in the mean change from baseline in SBP in the last 6 h of the dosing interval. 1. Neutel JM, et al. Telmisartan 40 or 80 mg/HCT 12.5 mg fixed-dose combinations provide superior BP reductions compared with losartan 50 mg/HCT 12.5 mg fixed-dose combination: an ABPM comparison. Am J Hypertens 2004; 17(5 pt 2): 118A. 2. Lacourcière Y, et al. Efficacy and tolerability of fixed-dose combinations of telmisartan plus HCTZ compared with losartan plus HCTZ in patients with essential hypertension. Int J Clin Pract 2003; 57: 273–279.


Keywords: DiagrammHCTZLosartanSBDStudieTelmisartan
 
 
Telmisartan - Losartan - HCTZ
Abbildung 33: Shown here are the combined data from two 6-week, prospective, randomized, open-label, blinded endpoint (PROBE) study comparing telmisartan 40 mg + HCTZ 12.5 mg (n=485), telmisartan 80 mg + HCTZ 12.5 mg (n=356) and losartan 50 mg + HCTZ 12.5 mg (n=489).1 Control/response rates were defined as follows: DBP control = 24-h mean DBP <85 mmHg DBP response = 24-h mean DBP <85 mmHg or reduction from baseline ≥10 mmHg SBP response = 24-h mean SBP <130 mmHg or reduction from baseline ≥10 mmHg There was a trend towards superiority in DBP control, DBP response and SBP response rates with telmisartan/HCTZ, and telmisartan 80 mg/HCTZ produced significantly greater DBP control and SBP response rates than losartan/HCTZ. 1. Data on file. Boehringer Ingelheim, GmbH.


Keywords: DiagrammHCTZLosartanStudieTelmisartan
 
 
Telmisartan - Valsartan - HCTZ
Abbildung 34: The fixed-dose combination of telmisartan 80 mg/HCTZ 25 mg has been compared with valsartan 160 mg/HCTZ 25 mg in an 8-week placebo-controlled study.1 The study recruited 1109 patients with mild-to-moderate hypertension. Telmisartan/HCTZ significantly reduced trough cuff SBP and DBP compared with valsartan/HCTZ. 1. Data on file. Boehringer Ingelheim GmbH.


Keywords: BlutdrucksenkungDiagrammHCTZTelmisartanValsartan
 
 
Telmisartan - HCTZ
Abbildung 35: This study, A comparison of Telmisartan plus HCTZ with amlodipine plus HCTZ in Older patients with predominantly Systolic hypertension (ATHOS) compared telmisartan 40–80 mg + HCTZ 12.5 mg with amlodipine 5–10 mg + HCTZ 12.5 mg.1 On entry, the patients had seated SBP >140 mmHg, seated DBP ≤95 mmHg and 24-h mean ambulatory SBP 125 mmHg. They were elderly (≥60 years old). The primary endpoint, the change from baseline in SBP in the last 6 h of the dosing interval, was not significantly different between the two groups. However, SBP was significantly reduced with telmisartan + HCTZ compared with amlodipine + HCTZ over the 24 h, morning and daytime periods. SBP control rates (24-h mean SBP <140 mmHg) were also significantly greater (p=0.0175) with telmisartan + HCTZ (65.9%) than with amlodipine + HCTZ (58.3%). 1. Data on file. Boehringer Ingelheim, GmbH.


Keywords: DiagrammHCTZSBDsystolische HypertonieTelmisartan
 
 
Telmisartan - HCTZ
Abbildung 36: In a study comparing enalapril with telmisartan in the elderly, patients were given HCTZ 12.5–25 mg in addition to study medication if their response was insufficient (trough DBP ≥90 mmHg) after Week 12.1 In patients who received add-on HCTZ to telmisartan, SBP/DBP was significantly reduced. In a factorial study comparing different doses of telmisartan, HCTZ and the combination, the blood pressure response to telmisartan/HCTZ in elderly patients was similar to that in younger patients.2 SBP was reduced by 25.3 mmHg in elderly patients, compared with 23.5 mmHg in younger patients. In the ATHOS trial of elderly patients with ISH, 24-h mean reductions in SBP were greater with telmisartan/HCTZ than with amlodipine/HCTZ.3 1. Karlberg BE, et al. Efficacy and safety of telmisartan, a selective AT1 receptor antagonist, compared with enalapril in elderly patients with primary hypertension. J Hypertens 1999; 17: 293–302. 2. Fenton C, et al. Telmisartan/hydrochlorothiazide: in the treatment of essential hypertension. Drugs 2003; 63: 2013–2026. 3. Data on file, Boehringer Ingelheim, GmBH.


Keywords: AlterHCTZTelmisartan
 
 
Telmisartan - HCTZ - Diabetes
Abbildung 37: In a pooled analysis of randomized clinical trials, mean reductions in SBP/DBP were 26.1/12.6 mmHg in diabetic patients treated with telmisartan 80 mg/HCTZ 12.5 mg for a mean of 148 days.1 This compares with mean reductions of 15.9/9.4 mmHg with telmisartan 80 mg monotherapy for a mean of 115.7 days. 1. Fenton C, et al. Telmisartan/hydrochlorothiazide: in the treatment of essential hypertension. Drugs 2003; 63: 2013–2026.


Keywords: DBDDiabetes mellitusDiagrammHCTZSBDTelmisartan
 
 
Telmisartan - HCTZ
Abbildung 38: Because African-American (black) patients may have low plasma renin activity, they can show an especially improved response to ARBs when HCTZ is added. Reported here are the results from 222 African-American patients who took part in an 8-week, 4 x 5 factorial, multicentre, double-blind, placebo-controlled, dose-finding study conducted in patients (total n=818) with mild-to-moderate hypertension.1 Patients were randomized to telmisartan 20 mg, 40 mg, 80 mg or 160 mg alone or in combination with HCTZ 6.25 mg, 12.5 mg, or 25 mg, giving a total of 20 treatment groups. Key arms are shown in this slide. Telmisartan/HCTZ reduced blood pressure compared with HCTZ monotherapy. The magnitude of the response was similar to that observed in the full patient population. 1. McGill JB, Reilly PA. Combination treatment with telmisartan and hydrochlorothiazide in black patients with mild to moderate hypertension. Clin Cardiol 2001; 24: 66–72.


Keywords: DBDDiagrammHCTZSBDTelmisartan
 
 
Telmisartan - HCTZ
Abbildung 39


Keywords: HCTZTelmisartan
 
 
 
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