Abstract:Uncontrolled hypertension is the major risk factor for cardio vascular disease. The economic burden of disease is enor mous in developed as well as in developing countries. The epidemiological studies have explained many etiological factors associated with chronic untreated hypertension, which varies according to geography and ethnicity.In last five decades, many classes and types of antihyper tensive drugs have been developed. This pharma cological review provides an update on new molecules belonging to three… Show more
Hypertension and diabetes mellitus (DM) are two of the leading lifestyle diseases in the Indian and South Asian populations that often co-exist due to overlapping pathophysiological factors. Obesity, insulin resistance, inflammation, and oxidative stress are thought to be some common pathways. Up to 50% of hypertensive cases in India are diagnosed with type 2 diabetes mellitus (T2DM), which defines the need for a comprehensive guideline for managing hypertension in diabetic patients. These RSSDI guidelines have been formulated based on consultation with expert endocrinologists in India and Southeast Asia, acknowledging the needs of the Indian population. Ambulatory blood pressure monitoring and office and home-based blood pressure (BP) monitoring are recommended for the early analysis of risks. Cardiovascular risks, end-organ damage, and renal disorders are the primary complications associated with diabetic hypertension that needs to be managed with the help of non-pharmacological and pharmacological interventions. The non-pharmacological interventions include the nutrition education of the patient to reduce the intake of salt, sodium, and trans fats and increase the consumption of nuts, fresh fruits, vegetables, and potassium-rich foods. It is also recommended to initiate 50 to 60 min of exercise three to four times a week since physical activity has shown to be more beneficial for hypertension control in Indian patients than dietary modulation. For the pharmacological management of hypertension in patients with T2DM, angiotensin II receptor blockers (ARBs) are recommended as the first line of therapy, demonstrating their superiority over other antihypertensive agents such as ACEi. However, most of the global hypertension guidelines recommend initiation with combination therapy to achieve better BP control in most patients and to reduce the risk of adverse events. For combination therapy, calcium channel blockers (CCBs) are recommended to be administered along with ARBs instead of beta-blockers or diuretics to avoid the risk of cardiovascular events and hyperglycaemia. Among the CCBs, novel molecules (e.g. cilnidipine) are recommended in combination with ARBs for better cardiovascular and reno-protection in diabetic hypertensive patients.
Hypertension and diabetes mellitus (DM) are two of the leading lifestyle diseases in the Indian and South Asian populations that often co-exist due to overlapping pathophysiological factors. Obesity, insulin resistance, inflammation, and oxidative stress are thought to be some common pathways. Up to 50% of hypertensive cases in India are diagnosed with type 2 diabetes mellitus (T2DM), which defines the need for a comprehensive guideline for managing hypertension in diabetic patients. These RSSDI guidelines have been formulated based on consultation with expert endocrinologists in India and Southeast Asia, acknowledging the needs of the Indian population. Ambulatory blood pressure monitoring and office and home-based blood pressure (BP) monitoring are recommended for the early analysis of risks. Cardiovascular risks, end-organ damage, and renal disorders are the primary complications associated with diabetic hypertension that needs to be managed with the help of non-pharmacological and pharmacological interventions. The non-pharmacological interventions include the nutrition education of the patient to reduce the intake of salt, sodium, and trans fats and increase the consumption of nuts, fresh fruits, vegetables, and potassium-rich foods. It is also recommended to initiate 50 to 60 min of exercise three to four times a week since physical activity has shown to be more beneficial for hypertension control in Indian patients than dietary modulation. For the pharmacological management of hypertension in patients with T2DM, angiotensin II receptor blockers (ARBs) are recommended as the first line of therapy, demonstrating their superiority over other antihypertensive agents such as ACEi. However, most of the global hypertension guidelines recommend initiation with combination therapy to achieve better BP control in most patients and to reduce the risk of adverse events. For combination therapy, calcium channel blockers (CCBs) are recommended to be administered along with ARBs instead of beta-blockers or diuretics to avoid the risk of cardiovascular events and hyperglycaemia. Among the CCBs, novel molecules (e.g. cilnidipine) are recommended in combination with ARBs for better cardiovascular and reno-protection in diabetic hypertensive patients.
“…AZL is an angiotensin II receptor blocker and the addition of CLN can provide a synergistic effect on the reduction of high blood pressure. The combination provides an optimal level of controlled blood pressure that is effectively better than using monotherapy [3].…”
A combination of Azilsartan Medoxomil and Cilnidipine is prescribed in the treatment of Hypertension. An accurate and precise high‐performance liquid chromatographic method has been developed for the estimation of Azilsartan Medoxomil and Cilnidipine in a combined tablet dosage form. Symmetry C18 (250 × 4.6 mm, 5 μm) column was used as the stationary phase, and methanol:water (85:15 v/v; pH 3.5) was used as the mobile phase. The method was linear in the concentration range of 4–20 μg/ml for Azilsartan Medoxomil and 1–5 μg/ml for Cilnidipine with a correlation coefficient (r2) 0.995 for Azilsartan Medoxomil and 0.995 for Cilnidipine. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per International Council on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of Azilsartan Medoxomil and Cilnidipine in combined tablet formulation.
“…Thus, the dual mode of action of cilnidipine permits vasodilation and sympathetic blockade. Due to its lipophilic and avidly binding property, cilnidipine has shown prolonged and desirable antihypertensive effect [ 15 ].…”
Background
The antihypertensive agent telmisartan is an angiotensin II receptor blocker with a terminal elimination half-life of 24 h and has a high lipophilicity, thereby enhancing its bioavailability. Another antihypertensive agent, cilnidipine is a calcium antagonist and has dual mode of action on the calcium channels. This study aimed at determining effect of these drugs on ambulatory blood pressure (BP) levels.
Methods
A randomized, open-label, single-center study was conducted during 2021 - 2022 on newly diagnosed adult patients with stage-I hypertension, in a mega city of India. Forty eligible patients were randomized to telmisartan (40 mg) and cilnidipine (10 mg) groups, with once daily dose administered for 56 consecutive days. Ambulatory blood pressure monitoring (ABPM) (24 h) was performed pre- and post-treatment, and the ABPM-derived parameters were compared statistically.
Results
Statistically significant mean reductions were observed in all BP endpoints in telmisartan group but only in 24-h systolic blood pressure (SBP), daytime and nighttime SBP, and manual SBP and diastolic blood pressure (DBP) in cilnidipine group. The mean change from baseline to day 56 between two treatment groups showed statistical significance in last 6-h SBP (P = 0.01) and DBP (P = 0.014), and morning SBP (P = 0.019) and DBP (P = 0.028). The percent nocturnal drop within and between groups was statistically nonsignificant. Also, the between group mean SBP and DBP smoothness index differed nonsignificantly.
Conclusions
Telmisartan and cilnidipine once daily were effective and well tolerated in the treatment of newly diagnosed stage-I hypertension. Telmisartan provided sustained 24-h BP control and may offer advantages over cilnidipine in terms of BP reductions, particularly over the 18- to 24-h post-dose period or critical early morning hours.
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