الفهرس 
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Abstract
Combination Therapy For Hypertension With Separate Agents Or A Single-Pill Combination (SPC) Has The Ability To Lower Blood Pressure In A Short Period Of Time And Obtain Target Blood Pressure, So It Is Recommended To Start Within Patients With Grade 2 Or More Hypertension. There Were Many Recommended Combination Therapies In Hypertension Guidelines, Among Them The Combination Of Calcium Channel Blocker (CCB) Or Beta Blocker (BB) With Angiotensin II Receptor Blocker (ARB). It Is Proven That Anti-Hypertensive Therapy Is Effective In Controlling Patients’ Peripheral Blood Pressure And Protecting Them from End-Organ Damage And Cardiovascular Events.
Central Pressure And Arterial Stiffness Are Independent Predictors Of Target Organ Damage That Mainly Because They Better Represent The Load Imposed On The Coronaries And Cerebral Arteries And Thus Having A Strong Relationship To Vascular Damage And Prognosis. Also, The Anti-Hypertensive Drugs Vary In Their Ability To Decrease Central Blood Pressure Despite Having The Same Effect On Peripheral BP. Therefore, Both Peripheral And Central Blood Pressure Should Be Considered When Choosing Blood-Pressure-Lowering Medicines. Also ABPM Is A Powerful Tool For Predicting Either Target Organ Damage Or Morbid Events. So, Reducing Both Central And Peripheral BP (Including ABPM) Is The Optimal Choice.
Our Aim Was To Evaluate The Efficacy Of Amlodipine/Valsartan And Nebivolol/Valsartan On Central Indices And 24-Hr Ambulatory Blood Pressure. And To Adjust Both Peripheral BP (Including ABPM) And Central BP No Matter Was The Peripheral Blood Pressure.
Method
• Prospective, Randomized, Open-Label Clinical Study Conducted In The Outpatient Clinic Of The Cardiology Department At Beni-Suef University Hospital from October 2016 To December 2017.
• A Total Of 160 Patients With Grade 2 Or More Hypertension (Defined As Either Systolic Blood Pressure ≥160 Mmhg Or Diastolic Blood Pressure ≥100) And Patients Uncontrolled On Their Hypertension Treatment (BP< 140/90 Mmhg) Were Randomized In 1:1 Basis Into Two Groups:
group I (A/V) N=81 Received A Combination Of Amlodipine 10mg Plus Valsartan 160mg “Single Pill Combination” Once Daily.
group II (N/V) N=79 Received Nebivolol 5mg Plus Valsartan 160mg “One Tablet For Each” Once Daily.
• Demographic Data And Laboratory Tests Were Done At The Randomization.
• 24-Hour Ambulatory Blood Pressure Was Measured Within The First Week Of Randomization, As Soon As There Was A Scheduled Appointment, And After 12 Weeks.
• Peripheral And Central Blood Pressure Was Measured Three Times: At Randomization, After 6 Weeks And After 12 Weeks.
• Questionnaires, Physical Examinations, Laboratory Data Were Collected At Randomization. BMI Was Calculated Using The Following Formula: Weight / Height2 (Kg/M2). Fasting Serum Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), Triglyceride (TG) Was Included. Blood Urea (BU) And Serum Creatinine (S.Cr.) Were Performed At Randomization And After 12 Weeks. Electrocardiogram Was Performed For All Patients. Also, Patients Were Asked To Do Echocardiography At Randomization.
The Present Study Showed The Following Results;
• In The Present Study, Both Treatment Groups Showed A Highly Statistical Significant Difference In Reducing SBP, DBP And MAP (P ˂ 0.0001), Although The Mean Reduction Was Higher In group I (A/V).
• Also, Both Treatment Groups Showed A Highly Statistical Significant Difference In Reducing Csbp, Cdbp (P ˂ 0.0001), Although The Mean Reduction Was Higher In group I (A/V).
• After 6 Weeks, group I (A/V) Showed A High Statistical Significant Difference In Reducing Central PP -8.53 ±13.80 Mmhg (P ˂0.0001) Although, group II Showed No Statistical Significant Difference In Reducing Central PP (P= 0.304). After 12 Weeks, group I Continued To Show The Same Efficacy -10.17 ±11.29 Mmhg (P ˂0.0001) And group II Started To Show Statistical Significant Difference In Reducing Central PP -7.03 ±13.10 Mmhg (P= 0.005).
• There Was No Statistical Significant Difference In Reducing The HR In Both Groups After 6 And 12 Weeks; (P= 0.957) And (P=0.980) In group I Vs. (P= 0.058) And (P=0.254) In group II Respectively.
• Regarding Arterial Stiffness Markers; Aix And PWV.
After 6 Weeks, group II (N/V) Showed More Efficacy In Reducing Aix Than group I (A/V); -6.00±10.94% (P= 0.002) Vs. 3.44± 9.80% (P= 0.026) After 6 Weeks. After 12 Weeks group II Significantly Lowered Aix - 6.56±12.64 % (P=0.006), While group I (A/V) Didn’t Show Any Significance (P=0.085).
The Degree In Reducing PWV After 6 And 12 Weeks Of Treatment “from Strongest To Weakest” Was group I (A/V) And group II (N/V) ((P ˂0.0001) And (P= 0.004)).
• The Two Drug Combination Reaches The Target Goal Ranges Of ABPM. After 12 Weeks Of Treatment:
Both Groups Showed High Efficacy In Reducing All SBP Average; -4.67 ± 10.85 Mmhg (P=0.008) In group I Vs. And -4.93 ± 9.441 Mmhg (P= 0.005) In group II. group II Showed A Superior Effect In Reducing Day SBP Average (-6.33 ± 11.77 Mmhg (P= 0.004) Vs. -6.16 ± 14.94 Mmhg (P= 0.011). But, group I Showed More Efficacy In Reducing Night SBP Average (-4.75 ± 11.07 Mmhg (P= 0.008) Vs. -4.78± 10.33 Mmhg (P=0.012)).
In Terms Of DBP, group I Reduced All DBP -4.271± 12.503 Mmhg (P=0.032), But group II Showed No Effect (P= 0.105). group II Showed A Statistical Significance Difference In Reducing Day DBP Average Compared With group I (P= 0.046) Vs. (P= 0.097). Both Groups Had No Significant Difference In Reducing Night DBP Average; (P= 0.087) In group I And (P= 0.091) In group II.
• Both Treatment Groups Were Safe And Tolerable By Patients; There Was No Statistical Significance Difference Between Both group Regarding Adverse Effects After 6 (P= 0.091) And 12 Weeks (P= 0.196).
Conclusion:
Both Treatment Groups Lowered Patients’ Peripheral, Central Blood Pressure And Mean Arterial Pressure After 6 And 12 Week Of Treatment, But Amlodipine / Valsartan Combination Was More Effective. Both Treatments Exerted Different Effects On Central Indices (Central PP, Aix, And PWV). The Two Drug Combination Reached Target Goal Ranges Of ABPM. After 12 Weeks, Both Treatment Groups Reduced All SBP Average, But Only Amlodipine/Valsartan Reduced All DBP. Nebivolol / Valsartan Showed A Superior Effect In Reducing Day SBP And DBP Average And Both Had No Effect In Reducing Night DBP Average. As Regard Safety, There Was No Statistical Significant Difference Between Treatments.