Hypertension and Diabetes are life style disease and are the major burden of global Health due to complications. India currently has 40.9 million diabetic patients and it is expected to rise to is expected to rise to 69.9 million by 2025 unless urgent and effective preventive steps are taken.1 One and half billion people will suffer from hypertension2 and 300 million will suffer from diabetes by 2025.3 Prevalence of hypertension is 60% in type 2DM.4 Patients with T2DM has two fold higher chances of suffering from hypertension in comparison to age match subjects without diabetes.5 Hypertension has been shown as a major risk factor not only for the development of diabetes but also for the development of micro and macro vascular complications like neuropathy, nephropathy, retinopathy, coronary artery disease, stroke, Peripheral Vascular Disease (PVD) in diabetic patients. The benefits of Blood Pressure (BP) control in diabetic patients exceed the benefits of tight glycaemic control and vital to the prevent and retard progression of both microvascular and macrovascular complications of hyperglycemias.6 Therefore, all of the hypertension management guidelines, that is, eighth report of Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure-2013 (JNC-8),7 American Diabetes association (ADA) 2015 8 and European Society of Hypertension (ESH 2013)9 focused aggressively on Blood Pressure (BP) control in diabetic patient to below 140/80-90 mmHg. JNC 8 recommended target of diastolic BP <90 mmHg and ESC 2013 recommended <85 mmHg. But ADA recommended target of DBP <80 mmHg. There are limited data from India regarding physician’s choices of anti-hypertensive therapies for a patient with diabetes in single- and multiple-drug based regimens. Therefore, we undertook this study to evaluate treatment patterns in diabetic patients with hypertension, those are being followed at our institute. Our objectives were: 1. To evaluate the utilization of ACEI or Angiotensin Receptor Blockers (ARBs) and other preferred antihypertensive therapies based on the JNC VIII guidelines as agents to treat diabetic hypertension, 2. To compare utilization of different types of antihypertensive therapies in other comorbid conditions 3. To assess BP control in this population. 4. To assess awareness about hypertension in the study group.

This study was conducted on diabetic patients who had hypertension as well. Prescribing Pattern of Antihypertensive drugs was analysed on all diabetic patients reporting to medicine OPD from June 2014 to May 2015 at our institute were screened. Around n=446 patients were recruited on the basis of inclusion and exclusion criteria. Patients with advance renal failure (serum creatinine >3.5 mg %) and patients with malignant hypertension were excluded. Patients were diagnosed hypertensive if they had at least 2 visits with diagnosis of hypertension or they had prescription of antihypertensive drug with one recording of elevated BP or they had elevated BP on two visits. Elevated BP was defined as systolic BP >139 mmHg and Diastolic BP (DBP) >89 mmHg.7 Patients were diagnosed as diabetic if they had two visits with diagnosed of diabetes or they had prescription of antidiabetic drugs or insulin or raised glycosylated haemoglobin. Patients were diagnosed with CAD if they had symptoms suggestive of CAD with ECG evidence or echocardiographic evidence or positive treadmill test or evidence in coronary arteriography. Data of antihypertensive drugs was recorded and grouped according to class of drug. Antihypertensive drugs were grouped in to seven groups - Calcium channel blockers, beta blockers, diuretics, Alfa blockers, Angiotensin Convertase Enzyme Inhibitors (ACEI), Angiotensin Receptor Blockers (ARB), centrally acting drugs. Data for antihypertensive drugs was recorded in form of need of monotherapy, two drugs or three drugs therapy. Data for non-pharmacological therapy was also recorded like salt restriction, loss of weight or exercise. Table-1. Showing epidemiology data. Age (years) No. % Male Female Mono Therapy Dual Therapy Triple Therapy Quadruple Therapy <35 56 12.55 38 18 24 26 6 0 35-50 166 36.77 90 76 82 52 26 6 50-75 182 40.8 92 90 80 56 38 8 >75 42 9.41 22 20 20 12 8 2 Total 446 100 242 204 206 146 78 16 Table 2: Showing utilization of various drugs. Drug No. of patients Percentage Angiotensin receptor blocker 198 44.39 Calcium channel blocker 168 37.66 Diuretic 156 34.97 ACE inhibitor 118 26.45 Beta blocker 116 26 Alfa blocker 24 5.38 Central agonist 16 3.58 Table 3: Description of combination utilization (Dual drug). Drug Combination Number Percentage ARB+D 44 30.13 CCB+BB 30 20.55 ARB+CCB 28 19.17 ACEI+D 24 16.43 ACEI+BB 20 13.69 Total 146 100

There were 446 patients in this study. Our study group comprised of n=242 males and n = 204 females. Gender ratio of study group was 1.18:1(males: females). Demographic data of patients has been described in Table 1. Two hundred patients (46.18%) were on monotherapy and remaining n=240 patients were on combination antihypertensive drugs. There were total n=796 antihypertensive drug exposures Table 2. Patient needed mean antihypertensive drug of 1.78. Number of drugs - Monotherapy was needed in 46.18% (n =206) patients and dual therapy was required in 32.73% (n=146) patients. Seventy eight patients (17.48%) were on triple drug therapy and n=16 (8.07%) were on quadruple drug therapy. Type of drug - Angiotensin receptor blockers were the most commonly prescribed drugs. Angiotensin inhibitors (angiotensin receptor blockers and ACE inhibitors) were utilized in 71% patients. These were followed by calcium channel blockers, diuretics, and beta blockers Table 2. Combination Utilization pattern - Angiotensin receptor blocker with diuretics was the most commonly used dual drug combination strategy in our study. It was followed by combination of beta blocker with calcium channel blocker, calcium channel blocker with angiotensin receptor blocker, ACE inhibitor with diuretic and ACE inhibitor with beta blocker. Combination utilization pattern has been shown in Table 3. Combination of Beta blocker with calcium channel blocker and diuretic was most commonly (51.28%) used in patients on triple drug combination. Combination of ARB, diuretic with CCB was used in 33.3% and combination of Alfa blocker, BB and diuretic was used in 10.24%. Combination of ACEI, CCB with diuretic was used in 5.12% patients. Combination of ACEI/ARB, diuretic with centrally acting drugs was used in 15.9% patients. Majority patients (50%) on quadruple therapy were on combination of Alfa blocker, diuretic, ACE inhibitor and central agonist. Combination of Alfa blocker, diuretic, central agonist with CCB or ARB was used in remaining 50% patients. Awareness about hypertension - About 81.2% patients were aware about the disease. Only 52% patients knew about systolic and diastolic pressure. There was awareness in 38.56% patients about target blood pressure. Control of hypertension - Hypertension control was achieved in (37.66%) patients. BP control was taken as office BP recording of <140/90 mmHg. Sixteen patients with diabetic nephropathy had office BP recording of <140/90 mmHg.

Our study tried to find utilization of various antihypertensive drugs in diabetic hypertensive patients and awareness about hypertension. A prescription based study is an effective way to assess and evaluate prescribing altitude of physicians.10 Majority of patients in our study were on multidrug regimens. Only 46% patients were on single drug therapy. It is consistent with other studies.11,12 Berlowitzet al.13 have shown worse BP control in patients with diabetes and less intensive antihypertensive medication therapy. ARB was the most common drug prescribed in 44.39% patients either alone or in combination. ACEI/ARB were used in 158 (71%) patients either alone or in combination. Most of the patients (76.6%) on single drug were receiving either ACEI or ARB. There is suggestion that ARBs should be a regular component of combination treatment and preferred drug in patients on monotherapy in diabetics.14 It has been described that initial monotherapy ACE inhibitors may be superior to dihydropyridine CCB in reducing cardiovascular events.15,16 Calcium channel blockers were used in 37.66% patients either in combination or as monotherapy. JNC 8 also recommends calcium channel blockers as first line drug in diabetic hypertensive patient. CCBs ranked second followed by diuretics when considering overall utilization pattern of various antihypertensive drugs but Johnson et al found thiazide was second most frequently prescribed drug followed by CCBs and beta blocker. CCBs ranked second followed by diuretics when considering overall utilization pattern of various anti-hypertensive drugs in Indian study.17 Diuretics were used in 34% patients either as single or combination therapy. Diuretic use ranked third after CCBs and these were more commonly used as part of multidrug regimen. Dhanraj et al. described same pattern in their study on diabetic hypertensives.18 Beta Blockers were used in 26% patients. Usage of BB was significantly higher in patients with CAD in our study. BB has protective effect in CAD and other studies 19,20 also found higher use of BB in patients with CAD. ARB/ACEI with diuretic was the most commonly used combination therapy. It is consistent with other study.21 Patients with nephropathy needed higher no of antihypertensive drugs. Use of ACEI/ARB was higher in patients with nephropathy than without nephropathy. Use of ACEI and ARB has been recommended by ADA9 also. Blood pressure control was achieved in 37.66% patients. Our control rates are better than other studies 19,22 with control rate of 25-32%. Which may be due to difference in sample size. Patients with nephropathy had lesser percentage of patients with control of hypertension than patients without nephropathy. Awareness about hypertension was found in 81% patients. Asfaq et al. also found awareness in 80% patients attending tertiary care hospital.22

Our study showed that majority of diabetic hypertensive patients needed multiple drug therapy to control hypertension. Most of the patients were on ARBs/ACE inhibitors. This was according to recommendation by ADA or JNC8. Patients with diabetes had lesser chance of control of hypertension. Hypertension control was achieved in 37% patients. We found awareness rate of 81% in our study group. Still there is room for better control of hypertension and optimization of antihypertensive therapy.

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