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Fogari R.,Centro Ipertensione e Fisiopato logia Cardiovascolare | Zoppi A.,Centro Ipertensione e Fisiopato logia Cardiovascolare | Ferrari I.,Centro Ipertensione e Fisiopato logia Cardiovascolare | Mugellini A.,Centro Ipertensione e Fisiopato logia Cardiovascolare | And 2 more authors.
Clinical and Experimental Hypertension | Year: 2010

The time to achieve a blood pressure (BP) goal ≤13085 mmHg with a combination versus a conventional monotherapy approach was evaluated in 308 hypertensive patients with metabolic syndrome. They were randomized to valsartan (V) 8 mgamlodipine (A) 5 mg combination or to V 160 mg monotherapy for 12 weeks and every 2 weeks, there was a titration in nonresponder patients: in the combination group VA was progressively increased to V 160A 5 mg; V160A 7.5 mg; V160A 10 mg; V 240A 10 mg, and V 320A 10 mg. In the monotherapy group, the regimen was progressively modified as following: V 240 mg; V 320 mg; V 320A 5 mg; V 320A 7.5 mg, and V 320A 10 mg. The mean time to achieve the BP goal was shorter in patients randomized to combination therapy compared to those randomized to conventional monotherapy (4.7 ± 2.7 weeks vs. 7.1 ± 3.9 weeks, respectively, p < 0.001). The percentage of patients who achieved target BP in the combination approach group statistically exceeded that of the monotherapy treated one already after 2 weeks of treatment (30.5 vs. 14.9, p < 0.01) and again after 4, 6, 8, and 10 weeks of treatment. Only at 12 weeks the percentage of normalized patients was similar in the two treatment groups (78.8 vs. 75.3, ns). These results suggest that initial therapy with a VA combination approach may be more quickly effective than a conventional sequential monotherapy approach in achieving target BP in hypertensive patients with metabolic syndrome. © Informa UK, Ltd.ComparativeDrug:Valsartan was initially given at 160 mg once daily in the morning for 12 weeks, it was then modified every 2 weeks until patients achieved target blood pressure: 240 mg once daily up to 320 mg once daily.Results:The mean-time to achievement of treatment goal was significantly shorter in the Exforge group vs. the conventional approach with valsartan monotherapy: 4.7 weeks vs. 7.1 weeks, respectively. The percentage of Exforge treated patients who achieved goal BP exceed that of a conventional approach after 2, 4, 6, and 8 weeks. By week 12, the percentage of participants achieving a treatment goal was 78.8% (n=121) in the Exforge group vs. 75.3% (n=116) in the conventional monotherapy group. The Exforge group experienced greater reductions in SBP and DBP vs. valsartan monotherapy group. At week 12, the Exforge group experienced a significantly greater reduction in SBP (-22.7 mmHg) and DBP (-17.6 mmHg) vs. the valsartan monotherapy group (19.9 mmHg and -15.2 mmHg, respectively). TG were significantly lowered in the Exforge group (from 153.0 to 129.1 mg/dl) but not in the valsartan monotherapy group (from 156.4 to 147.3 mg/dl). Changes from baseline for FPG and HDL-C were comparable between both groups. 98% of patients completed the study. 2% of patients withdrew consent. The number of patients reporting AEs was similar in both groups: 15 (9.7%) in the Exforge group and 18 (11.6%) in the valsartan monotherapy group. The AEs were mild-to-moderate in severity and the most frequently reported were ankle edema (n=8 [3 males and 5 females] Exforge group; n=7 [4 males and 3 females] valsartan monotherapy group) and headache (n=4 [2 males and 2 females] Exforge group; n=5 [3 males and 2 females] valsartan monotherapy group). No serious AEs were reported in both groups.AdverseEffects:15 (9.7%) patients had mild to moderate side effects. The most frequently reported side effects were ankle edema (n=8) and headache (n=4).AuthorsConclusions:The results of this study indicated that in hypertensive patients with metabolic syndrome therapy with a valsartan/amlodipine combination afforded more prompt BP control than monotherapy approach with a good tolerability profile. Thus, initiating treatment with such a combination seems to be a useful strategy to achieve BP goals in these high risk patients.FreeText:The mean seated diastolic blood pressure (SeDBP) and systolic blood pressure (SeSBP) were measured with a standard mercury sphygmomanometer. Time to the first treatment success (target BP of <130/85 mmHg) was evaluated. All adverse effects (AEs), including serious AEs, were monitored and their severity and relationship to study medication were assessed. Heart rate, FPG, TG, HDL-C and waist circumference were evaluated. In the nonresponders for the valsartan monotherapy group, the regimen was progressively modified as follows: valsartan 240 mg; valsartan 320 mg; valsartan 320 mg/amlodipine 5 mg; valsartan 320 mg/amlodipine 7.5 mg; valsartan 320 mg/amlodipine. 10 mg.Indications:154 patients with arterial hypertension. Coexisting disease was metabolic syndrome in 154 patients.Patients:308 patients. Exforge group: n=154, 67 males and 87 females, mean age 59 years, fasting plasma glucose (FPG) was 100.4 mg/dl, triglyceride level (TG) was 153.0 mg/dl and high density lipoprotein cholesterol (HDL-C) was 35.2 mg/dl. Valsartan monotherapy group: n=154, 69 males and 85 females, mean age 58 years, FPG was 99.0 mg/dl, TG was 156.4 mg/dl and HDL-C was 36.1 mg/dl. Follow-up was 24 weeks.TypeofStudy:A 24-week prospective, randomized, open label, blind (masked) endpoint evaluation (PROBE), parallel arm study comparing the time to achieve a blood pressure (BP) goal of ≤130/85 mmHg in hypertensive patients with metabolic syndrome who were treated with Exforge or valsartan monotherapy (conventional monotherapy approach).DosageDuration:Initially amlodipine 8 mg plus valsartan 160 mg once daily in the morning for 12 weeks, it was then modified every 2 weeks until patients achieved target blood pressure: amlodipine 5 mg/valsartan 160 mg, amlodipine 7.5 mg/valsartan 160 mg, amlodipine 10 mg/valsartan 160 mg, amlodipine 10 mg/valsartan 240 mg, and amlodipine 10 mg/valsartan 320 mg once daily. Duration was 24 weeks. Source

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