European Journal of Cardiovascular Medicine

Type 2 diabetes mellitus (T2DM) is a leading non-communicable disorder associated with premature cardiovascular disease, chronic kidney disease, and substantial health-care cost. Hypertension frequently coexists with T2DM and magnifies cardiovascular risk through additive haemodynamic stress, endothelial dysfunction, oxidative stress, and accelerated atherosclerosis. The combined burden of hyperglycaemia and elevated blood pressure also aggravates microvascular injury, including nephropathy and retinopathy, and increases the likelihood of polypharmacy and treatment fatigue [5].

India carries a high and rising burden of dysglycaemia and hypertension. Phase I results of the ICMR–INDIAB study reported a considerable prevalence of diabetes and prediabetes across Indian states, indicating large numbers of individuals requiring sustained, long-term therapy and monitoring [6]. In parallel, a meta-analysis on hypertension in India showed that a substantial proportion of adults remain unaware of their hypertensive status and that blood pressure control rates are low, creating a large pool of preventable cardiovascular events [7]. In routine tertiary care, many patients present with longer disease duration, overweight or obesity, and multiple comorbidities that influence drug choice, intensification, and adherence.

Guidelines endorse metformin as first-line therapy for most adults with T2DM, with early intensification using additional oral agents or insulin when targets are not achieved [1]. Newer drug classes are increasingly used to improve glycaemic control while limiting hypoglycaemia and weight gain. For hypertension management in diabetes, contemporary recommendations prioritize renin–angiotensin system blockade (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) and advocate combination therapy when required to reach targets [2]. Evidence from the UK Prospective Diabetes Study (UKPDS) also established that intensive control of blood pressure reduces diabetes-related endpoints and microvascular complications, highlighting the clinical value of achieving dual control in T2DM with hypertension [4].

Drug utilization and prescribing pattern studies from India have demonstrated a predominance of metformin-based regimens, variable use of sulfonylureas, and growing adoption of DPP-4 inhibitors and SGLT2 inhibitors [8-10]. Antihypertensive prescribing audits among diabetic cohorts have commonly reported ACE inhibitor/ARB and calcium channel blocker-based therapy, with frequent multidrug use to achieve control [11]. However, prospective observational work that concurrently documents prescribing patterns and short-term clinical outcomes, adherence, and adverse drug reactions (ADRs) remains useful for identifying quality gaps and strengthening rational use of medicines.

Therefore, this prospective observational study was undertaken to (i) describe the prescription patterns of antidiabetic and antihypertensive drugs among patients with T2DM and coexisting hypertension, and (ii) assess follow-up changes in glycaemic control, blood pressure, medication adherence, and ADR profile.

Study design and setting: A prospective observational study was conducted in the Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India, from January 2022 to June 2022. The study was coordinated with outpatient services providing routine care for patients with T2DM and hypertension.

Sample size and sampling: A sample size of 100 was planned based on feasibility within the study period. Consecutive eligible patients attending outpatient services were enrolled until the target was achieved.

Participants: Adults aged ≥18 years with established T2DM and diagnosed hypertension, receiving pharmacotherapy for at least 3 months, and willing to provide written informed consent were included. Patients with type 1 diabetes, gestational diabetes, secondary hypertension, acute hyperglycaemic emergencies, severe systemic illness requiring intensive care, or incomplete baseline records were excluded.

Data collection: A structured case record form was used to document demographic data (age, sex), clinical history (duration of diabetes and hypertension), anthropometry (body mass index), and baseline parameters (fasting plasma glucose, HbA1c, systolic and diastolic blood pressure). Blood pressure was measured after at least 5 minutes of rest using a standardized technique, and the average of two readings was recorded. Prescribed medicines were recorded from prescriptions and case notes, including drug name, dose, frequency, and categorized into standard antidiabetic and antihypertensive classes.

Follow-up and outcomes: Patients were reviewed at follow-up (approximately 12 weeks after baseline within the study period). Primary outcomes were change in fasting plasma glucose, HbA1c, systolic blood pressure, and diastolic blood pressure from baseline to follow-up, and the proportions achieving HbA1c <7% and blood pressure <140/90 mmHg, consistent with commonly applied treatment targets [1,2]. Secondary outcomes included adherence and ADR profile.

Adherence and safety assessment: Medication adherence was assessed through patient interview and review of available medication strips, and categorized as satisfactory when adherence was ≥80% of prescribed doses. ADRs were actively enquired at follow-up visits and recorded. Causality was assessed using the Naranjo adverse drug reaction probability scale [12].

Statistical analysis: Data were entered into a spreadsheet and analyzed using descriptive statistics. Continuous variables are presented as mean ± standard deviation, and categorical variables as number (percentage).

Ethical considerations: Institutional ethics committee approval was obtained prior to study initiation. Written informed consent was taken from all participants. Patient confidentiality was ensured by anonymizing identifiers during analysis and reporting.

A total of 100 patients with T2DM and coexisting hypertension were included. The mean age was 56.4 ± 9.8 years and 58% were males. Most participants were aged 51 years and above. Overweight/obesity (BMI ≥25 kg/m²) was present in 64%. Baseline mean fasting plasma glucose was 156.2 ± 28.5 mg/dL with mean HbA1c 8.2 ± 1.1%. Mean baseline blood pressure was 148.6 ± 12.4/92.1 ± 8.6 mmHg (Table 1).

Table 1. Baseline demographic and clinical characteristics (N = 100)

Antidiabetic prescribing was dominated by metformin (82%). Sulfonylureas (46%) and DPP-4 inhibitors (34%) were frequently used, while SGLT2 inhibitors were used in 28% and insulin in 22%. Combination antidiabetic therapy was prescribed in 62%, commonly metformin plus sulfonylurea (26%) and metformin plus a DPP-4 inhibitor (18%) (Table 2).

Table 2. Prescription pattern of antidiabetic drugs (N = 100)

Among antihypertensive drugs, ACE inhibitor/ARB therapy was most common (68%), followed by calcium channel blockers (44%), beta-blockers (36%), and diuretics (30%). Two or more antihypertensive agents were used in 59%. The commonest combination documented was ARB plus calcium channel blocker (21%) (Table 3).

Table 3. Prescription pattern of antihypertensive drugs (N = 100)

Figure 1: Prescription pattern of Antihypertensive Drugs (N = 100)

At the end of follow-up, glycaemic and blood pressure parameters improved. Mean fasting plasma glucose decreased to 128.4 ± 22.6 mg/dL and mean HbA1c reduced to 7.4 ± 0.9%, with 44% achieving HbA1c <7%. Mean systolic and diastolic blood pressure decreased to 132.8 ± 10.6 mmHg and 84.3 ± 7.2 mmHg, respectively, and 52% achieved blood pressure <140/90 mmHg. Satisfactory adherence was documented in 74%. Any ADR occurred in 18%, most commonly hypoglycaemia (8%) and metformin-related gastrointestinal intolerance (6%); no serious ADR requiring hospitalization was recorded (Table 4).

Table 4. Clinical outcomes, adherence, and safety (N = 100)

This prospective observational study describes prescribing practices and short-term outcomes among patients with T2DM and coexisting hypertension. Metformin was the most frequently prescribed antidiabetic drug, supporting its continued role as foundational therapy in routine clinical practice [1]. Metformin predominance and the high proportion of combination therapy observed in this cohort align with Indian prescribing pattern studies reporting metformin-based regimens as the most common strategy for achieving glycaemic control [8-10]. The baseline mean HbA1c of 8.2% also reflects a clinical context in which therapeutic intensification is required for target achievement.

Sulfonylureas remained widely used as add-on therapy, which is consistent with their accessibility and established glucose-lowering efficacy. However, sulfonylurea exposure is associated with increased hypoglycaemia risk compared with metformin, particularly in the presence of renal impairment or higher doses [13]. In the present cohort, hypoglycaemia was the most frequent ADR, reflecting real-world safety considerations that necessitate patient education, individualized selection, and careful titration. The observed use of DPP-4 inhibitors and SGLT2 inhibitors suggests gradual uptake of newer agents in line with contemporary practice, where improved tolerability and cardiorenal benefits have influenced prescribing decisions [1].

Regarding antihypertensive therapy, ACE inhibitor/ARB usage was highest, consistent with guideline recommendations that prioritize renin–angiotensin system blockade in diabetes for blood pressure control and renal protection [2]. Similar patterns have been reported in Indian cohorts, where ACE inhibitor/ARB and calcium channel blockers frequently constitute the backbone of therapy [11]. More than half of the patients required two or more antihypertensive agents, reinforcing the concept that combination therapy is often necessary to achieve blood pressure targets in diabetic hypertension [2,11]. Evidence from UKPDS 38 further supports the clinical importance of achieving tighter blood pressure control for reducing diabetes-related endpoints and microvascular complications [4].

Short-term follow-up demonstrated clinically meaningful improvements in both glycaemic indices and blood pressure, with 44% achieving HbA1c <7% and 52% achieving blood pressure <140/90 mmHg. These findings highlight the practical challenges of achieving simultaneous control of two major cardiometabolic risk factors in routine settings, particularly when obesity, longer disease duration, and medication burden coexist [5,7]. Adherence was satisfactory in 74%, indicating that most patients maintained regular dosing over the follow-up interval. Nonetheless, adherence and persistence remain key determinants of sustained control, and structured counselling with reinforcement at each follow-up visit can further improve long-term outcomes. Overall, the safety profile was acceptable, with mainly mild ADRs and no serious hospitalization, consistent with established safety patterns of commonly used agents such as metformin and standard antihypertensives [12,14].

Limitations

This single-centre study included 100 participants and the findings reflect local prescribing practices. The follow-up period was short and long-term cardiovascular and microvascular outcomes were not evaluated. Adherence assessment relied on interview and review of available medication strips, which introduces reporting bias. Biochemical monitoring was restricted to fasting plasma glucose and HbA1c, and lipid and renal outcome measures were not analyzed

In this prospective observational cohort of patients with type 2 diabetes mellitus and coexisting hypertension, metformin remained the most commonly prescribed antidiabetic drug and combination therapy predominated. Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and insulin were used as add-on therapies reflecting stepwise intensification. For hypertension, ACE inhibitor/ARB-based treatment was most frequent and a majority required multidrug regimens. Follow-up demonstrated improvements in fasting plasma glucose, HbA1c, and blood pressure, with nearly half achieving HbA1c <7% and over half attaining blood pressure <140/90 mmHg. Adherence was satisfactory in three-fourths of participants, and adverse drug reactions were infrequent and non-serious. Routine prescription audits linked to outcome monitoring can support rational pharmacotherapy and patient-centred care

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