ABSTRACT
Aim: The aim of this study was to evaluate the anti-hypertensive efficacy of a fixed-dose combination (FDC) of Efonidipine 40 mg and Telmisartan 40 mg in Stage II hypertensive patients. Study Design: Multicentric, randomized, double-blind, parallel, comparative Phase III clinical trial. Methodology: This clinical trial was conducted at six geographically distributed sites across India and enrolled 240 Stage II hypertensive patients. They were randomized into two groups in a ratio of 1:1 using computer-generated block randomization to receive E+T (FDC of Efonidipine 40 mg + Telmisartan 40mg) or C+T (FDC of Cilnidipine 10 mg + Telmisartan 40 mg) group intervention once daily for a period of 90 days. The study site staff, investigator and patients were blinded to the treatment allocation. The primary endpoint of the study evaluated the mean reduction in sitting systolic BP (SBP) and diastolic BP (DBP) from baseline to day 90 whereas the secondary endpoints assessed were mean reduction in BP from baseline to day 30 & 60, patients achieving target BP (<140/90 mmHg) and the safety and tolerability of the investigational products based on the incidences of adverse events (AEs) reported. Results: A total of 118 subjects were randomized to the E+T group wherein the mean (±SD) SBP and DBP at baseline was 167.25 ± 4.68/107.26 ± 5.19 mmHg. After 30 days of treatment with the E+T group, the mean reduction in SBP/DBP of 29.37/18.06 mmHg was observed whereas at Day 60 reduction of 38.55/22.69 mmHg was seen from the baseline. At Day 90, SBP/DBP decreased to 119.41±14.99/81.67±4.29 mmHg with a mean reduction of 47.94/25.89 mmHg in the E+T group. During the study period, the difference in systolic blood pressure between the treatments with E+T and C+T was -0.48 mmHg, with the two-sided 95% confidence interval (CI) ranging from -4.54 to 3.58?mmHg. The corresponding difference in diastolic blood pressure was -0.77 (95% CI: -2.60 to 1.06) mm?Hg. The upper boundary of the 95% CI was below the margin of 10?mmHg, confirming the non-inferiority of E+T to C+T. A total of 92% of patients who had been assigned to E+T treatment achieved their target BP goal. Only one patient reported an adverse event with E+T treatment. No unexpected AEs were reported in the E+T group suggesting its good safety and tolerability. Overall, the E+T treatment was effective, safe and well-tolerated by the patients for 90 days. Conclusion: It was concluded that the FDC of Efonidipine 40 mg and Telmisartan 40 mg was efficacious in the management of Stage II hypertension.
ABSTRACT
Aim: To evaluate the antihypertensive efficacy and safety of the fixed-dose combination (FDC) of Efonidipine and S (-) Metoprolol in adult patients with hypertension. Study Design: Multicentric, double-blind, randomized, parallel, comparative Phase III trial. Methodology: This clinical trial was conducted at five geographically distributed sites across India and enrolled 240 hypertensive patients. They were randomized (1:1) to receive either FDC of Efonidipine 40 mg + S (-) Metoprolol 25 mg tablet (E+S(-)M group) or FDC of Cilnidipine 10 mg + Metoprolol 50 mg tablet (C+M group) once daily for 90 days. Patients were evaluated for changes in their blood pressure (BP) from baseline to Day 30, 60 and 90. The study site staff, investigator and patients were blinded to the treatment allocation. Blood pressure was recorded as the mean of 3 consecutive measurements taken in a sitting position. Patients achieving target BP (<140/90 mmHg) were evaluated and the safety and tolerability were assessed based on the incidences of adverse events (AEs). Results: This study focused on evaluating the mean Systolic BP (SBP) and Diastolic BP (DBP) reduction from baseline to Day 30, 60 and 90. At baseline, patients had a mean (±SD) SBP and DBP of 154.60 (±11.33) mmHg and 98.68 (±8.18) mmHg respectively. After 30 days of the E+S(-)M treatment, the mean SBP/DBP was 136.06±10.55/ 86.68±5.51 mmHg (p<0.0001) and on Day 60 it was 129.48±10.51/ 84.17±5.51mmHg (P <0.0001), corresponding to mean reductions in SBP/DBP of 18.09/11.66 and 24.78/14.17 mmHg, respectively. There was a statistically significant (p <0.0001) reduction to 123.59 ± 15.21 mmHg in SBP and 82.38 ± 5.05 mmHg in DBP observed on Day 90 as compared to baseline. Post-treatment with E+S(-)M group, SBP/DBP reduction of 31.01/16.29 mmHg in hypertensive patients was observed. A total of 95% of the patients achieved a pre-defined target BP <140/90 mmHg on the administration of E+S(-)M. Furthermore, it was observed that 93% of Stage I and 96% of Stage II hypertensive patients achieved the target BP goal. A total of 5.78% of patients experienced adverse events (AEs) in the E+S(-)M group which was similar to that of C+M group. All AEs were mild in severity and resolved without any sequelae at the end of the study. No unexpected adverse events were reported, and the E+S(-)M dosage regimen was well tolerated by the patients. Both the treatment groups were non-inferior to each other. Conclusion: The study results demonstrated clinically meaningful reductions in blood pressure after administration of FDC of Efonidipine 40 mg + S(-) Metoprolol 25 mg over a period of 90 days. The treatment was efficacious, safe, and well?tolerated in the study population.