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Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin
Azilsartan medoxomil (AZL M) is a newly developed angiotensin II receptor blocker with high efficacy and good tolerability. The primary endpoint was change in trough, seated, clinic SBP. Mean patient age was 57 years, 52.4 were male, 99.5 were Caucasian. Adverse events leading to discontinuation were less frequent with AZL M 40 and 80 (2.4 and 3.1 respectively) than with RAM (4.8 These data demonstrated that treatment of stage 1 hypertension with AZL M was more effective than RAM and better tolerated. For example, angiotensin converting enzyme (ACE) inhibitors are very effective at lowering BP by inhibition of the renin system (RAAS); however, these agents are often associated with significant cough and more rarely with angioedema.10 To achieve better BP control and to improve patient adherence with the treatment, it is necessary to prescribe more potent, yet well tolerated antihypertensive agents. As a class, angiotensin II receptor blockers (ARBs) have similar or greater efficacy compared with other classes of hypertensive agents but are much more tolerable.11, 12, 13 The epidemiological data demonstrate that in spite of the available potent drugs, there is still a need for compounds with improved efficacy for the treatment of hypertension.9
Azilsartan medoxomil (AZL M) is a prodrug that is rapidly hydrolyzed in the gastrointestinal tract during absorption to azilsartan, which has high affinity for the angiotensin II type 1 receptor.14 Azilsartan has an estimated bioavailability of 60 which is not affected by food, and an elimination half life of approximately 11 No drug interactions have been observed in price of cartier love ring replica studies of AZL M cartier diamond ring price knock off or azilsartan.15 The present study was designed to compare the efficacy, safety and tolerability of once daily (QD) AZM L 40 and 80 with QD ramipril (RAM) 10 the most commonly used dose strength and the highest dose approved in Europe.
Top of pageMaterials and MethodsEthical considerationThis study was performed in accordance with the principles of International Conference on Harmonisation Clinical Practice, the Declaration of Helsinki, the current CPMP for Guidance on Clinical Investigation of Medical Products in the Treatment of Hypertension and all national and country specific legal requirements. The study protocol was approved by all relevant ethics committees before enrollment of patients. The patient written informed consent was required before the start of study related procedures. Patients currently taking antihypertensive drugs had to be willing to discontinue these drugs at screening.
Study designThis phase 3 study cartier gold ring price fake was a randomised, double blind, multicenter trial designed to evaluate the efficacy and safety of QD AZL M 40 and 80 compared with QD RAM 10 in patients with stage 1 or 2 hypertension after 24 weeks of treatment. Qualifying subjects underwent a 3 to 4 week wash out period of their former antihypertensive drugs, which coincided with a 2 week single blind placebo run in period, 24 weeks of double blind treatment, and 1 week for follow up. Eligible patients were randomised in a double blind manner to one of the three treatment groups: AZL M 20 QD force titrated to 40 QD after 2 weeks, AZL M 20 QD force titrated to 80 QD after 2 weeks, or RAM 2.5 QD force titrated to 10 QD after 2 weeks, with continued treatment for an additional 22 weeks. Patients were evaluated for efficacy and safety endpoints at baseline and at weeks 2, 4, 8, 12, 16, 20 and 24 after randomisation. Trough, seated, clinic systolic and diastolic blood pressure (SBP and DBP) were assessed at each visit. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and at the end of week 24. Data at the 1 week follow up were generated by telephone call. Pregnant or nursing women and woman of child bearing potential not using approved means of contraception were also excluded.
ProceduresClinic BP measurements were made in triplicate in the nondominant arm after the patient was seated for 5 using a semiautomated digital BP recorder (Omron HEM 705 CP, Vernon Hills, IL, USA). Every effort was made to ensure that the clinic BP readings were obtained approximately 24 after the last dose of study medication and before any procedures, including venipuncture.
ABPM was performed on day before randomisation and at the end of week 24, using the Spacelabs Medical Model 90207 (Spacelabs Healthcare, Issaquah WA, USA).
Safety assessments included physical examination findings, vital signs and weight, adverse events, clinical laboratory tests and electrocardiographic data. Laboratory parameters were analyzed at a central laboratory. Tolerability and safety were assessed by recording adverse events at all visits. An adverse event was defined as the development of an undesirable medical condition or a deterioration of a pre existing medical condition. A serious adverse event was an adverse event that resulted in death, was immediately life threatening, required hospitalisation, resulted in persistent disability, jeopardised the patient or required medical intervention.
Statistical methodsThe primary endpoint was the change from baseline to week 24 in trough, seated, clinic SBP. The primary analysis was an analysis of covariance model for change from baseline to week 24 for clinic SBP. The model included treatment as a fixed effect and baseline clinic SBP as covariate; mean treatment effects and treatment differences (including P values and two sided 95 confidence intervals) were obtained from the framework of the analysis of covariance model. Similar inferential statistical methods were applied to the secondary endpoints. Safety parameters were summarized using descriptive statistics.
All randomised subjects were included in the analysis of the primary and secondary endpoints (intent to treat), provided subjects had both a baseline and at least 1 post baseline value. Missing data for the primary and secondary endpoints were handled using last observation carried forward methodology. and a 20 dropout rate.
Top of pageResultsPatientsA total of 1229 patients were screened at 106 sites in Europe and Russia, and 1089 patients entered the single blind period. Of these 1089 price of cartier love ring copy patients, 884 met the entry criteria and were randomised to 1 of 3 treatment arms: 295 patients to AZL M 40 294 patients to AZL M 80 and 295 patients to RAM 10 A total of 784 of the 884 randomised patients completed the 24 weeks of treatment with double blind study medication: 265(89.8 in the AZL M 40 group, 264 (89.8 in the AZL M 80 group and 255 (86.1 in the RAM group. The demographics and the baseline characteristics of study population are given in Table 1. There was no significant difference in any parameters. Nearly half of the subjects were male. Medical history did not differ among the groups. The most common cardiac conditions were coronary artery disease, angina pectoris and myocardial ischemia.
Antihypertensive agents were the most common previous medications: 47.7 of patients were taking RAAS inhibitors, 19.2 beta blockers, 14.2 diuretics and 13.0 calcium channel blockers. AZL M 40 and 80 reduced ambulatory SBP and DBP significantly more than RAM for all ABPM time intervals evaluated, including 24 hour mean, mean daytime, mean nighttime and mean trough pressure. The hourly reductions in ambulatory measures of SBP at (a) baseline and (b) final visit 24 are displayed in Figure 2. AZL M 40 and 80 lowered ambulatory SBP to a greater extent than RAM 10 at every hour of the 24 h dosing interval.
Response ratesThe proportion of subjects achieving SBP and DBP response criteria is shown in Table 3.
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