Nobiletin diseas and previous antihypertensive therapy data were collected. Office S D and heart rate were evaluated at baseli month , month , and month , and BP control rate was determined at study end . Data were recorded in the patient chart and copied to the case report/record form . Because this was a real-life practice study across several different regions and countri BP was measured per local routine practi with no standardization of the procedure possible. In addition to the overall analys the authors conducted several subgroup analyses of antihypertensive effica including in patients prescribed stable doses ofbination amlodipine/valsartan throughout the study; receiving the coitant medication hydrochlorothiazide; with different hypertension grades . to baseline SBP); with isolated systolic hypertensio. with baseline SBP ‰ mmHg or ‰ mmHg; withorbidities; and based ZD-1839 on previous antihypertensive therapy.
Safety evaluations included reported or observed adverse events and serious adverse event regardless of causal relationship to study medication. Data recorded included purchase Alizarin description of eve date of ons durati potential causal relationsh action tak and the oue of the event. Each CRF had a separate form for A and a separate form and procedure for reporting SAEs. All physicians were trained in SAE reporting procedures. Analysis of the incidence of edema was conducted to explore dose-dependent effects ofbination amlodipine/valsartan on this established side effect of CCBs. At all clinic visi physicians evaluated the presence and intensity of edema in each patient. The severity of edema was rated as follows: mil. moderat. or severe . Designated investigator staff entered the required patient data onto the CRF. The CRFs were forward to Novartis Pharma and patient data were entered anonymously into the study database application.
Single data entry was performed. Before closing the database for analys all data were run order Ecdysone through a final validation process. Statistical Analysis Statistical analysis was performed using SAS by Karmac Labs Pvt. Ltd Continuous variables were summarized using mea SD of the me and ranges. Categorical variables were summarized using counts and percentages. Efficacy analysis was performed for patients whopleted all study visits . Mean changes from baseline to end of study in the primary endpoi and heart rate were analyzed using a paired sample t test. RESULTS A total of patients with hypertension were enroll of whom were excluded from the per-protocol analysis .
The patients were included in the per-protocol efficacy analysis. Demographic and baseline characteristics are presented in Patients had a mean age of years. Most were wome Caucasia and had hypercholesterolemi. of patients had received prior antihypertensive treatment. Coitant medications included statin antidiabetic agent acetylsalicylic aci beta-blocker and diuretics . Antihypertensive Efficacy As the study was conducted in a real-life setti no washout period was possible to establish baseline BP carbohydrates values in enrolled patients. Hen baseline BP values corresponded to the measurement at visit a for most patien it was the BP level achieved on previous Adv Ther . Demographic and baseline characteristics .