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PubMed2026

Efficacy and Safety Profile of a Triple Single-Pill Combination of Valsartan/Amlodipine/Chlorthalidone in Patients with Uncontrolled Hypertension.

PURPOSE: This randomized, double-blind, multicenter Phase III study evaluated the efficacy and safety profile of a single-pill triple combination of valsartan/amlodipine/chlorthalidone (KDF1901, Valdipine Plus) compared with a dual combination of valsartan/amlodipine (KDF1901-R) in patients with essential hypertension. METHODS: Patients (n = 294) with inadequately controlled hypertension after a 4-week run-in phase with valsartan/amlodipine (80/5 mg) were randomized to receive KDF1901 (valsartan/amlodipine/chlorthalidone 160/10/25 mg, n = 147) or KDF1901-R (valsartan/amlodipine 160/10 mg, n = 147) for 8 weeks. The primary efficacy endpoint was the change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8. Secondary endpoints included changes in mean sitting diastolic blood pressure (MSDBP), BP normalization rates, and response rates. Safety profile outcomes assessed treatment-emergent adverse events (TEAEs), laboratory parameters, and serious adverse events. FINDINGS: At week 8, the KDF1901 group exhibited a significantly greater reduction in MSSBP (-22.8 ± 1.0 mmHg) compared with the dual therapy group (-16.7 ± 1.0 mmHg, P < 0.0001). Similarly, the mean MSDBP reduction was significantly greater with KDF1901 (P = 0.0006). BP normalization rates (75.9% vs 54.5%, P < .0001) and response rates (73.8% vs 51.7%, P < 0.0001) were significantly higher in the triple combination group. Overall, the incidence of TEAEs was similar between groups (24.7% vs 21.5%, P = 0.5783), with mild cases of dizziness were most commonly reported. Exploratory ad hoc analyses showed statistically greater changes in sodium, potassium, and uric acid levels with triple therapy, but clinically meaningful extreme electrolyte abnormalities were rare in both groups, and the overall laboratory profile remained acceptable. IMPLICATIONS: This trial reported that the single-pill triple combination KDF1901 significantly improved BP control compared with dual therapy without compromising tolerability. GOV IDENTIFIER: NCT07116863.

Humans↗

PubMed2026

Efficacy and Safety of a Single-Pill Triple Combination of Valsartan, Amlodipine, and Chlorthalidone in Patients With Essential Hypertension Inadequately Controlled on Dual Therapy With Valsartan and Amlodipine: A Randomized, Double-Blind, Multicenter, Phase 3 Trial.

Many hypertensive patients require three or more antihypertensive agents to achieve target blood pressure. This randomized, double-blind, multicenter phase 3 trial conducted in South Korea evaluated the efficacy and safety of a single-pill triple combination therapy with valsartan (Val), amlodipine (Aml), and chlorthalidone (CTD) in patients whose blood pressure remained inadequately controlled on Val/Aml dual therapy. Patients uncontrolled after 4 weeks of Val/Aml 80/5 mg were randomized 1:1 to either Val/Aml/CTD 80/5/12.5 mg or Val/Aml 80/5 mg using a double-dummy design. After 2 weeks, doses were escalated to Val/Aml/CTD 160/5/25 mg or Val/Aml 160/5 mg, respectively, for a total treatment duration of 6 weeks. The primary endpoint was the change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8. Of 193 randomized patients, 178 completed the study. The least squares mean ± SE change in MSSBP was -19.70 ± 1.31 mmHg in the Val/Aml/CTD group versus -8.71 ± 1.26 mmHg in the control group, yielding a statistically significant between-group difference of -10.99 ± 1.81 mmHg (95% CI, -14.56 to -7.41; p < 0.0001). No serious adverse events occurred in the Val/Aml/CTD group, compared with an incidence of 1.98% in the control group (p = 0.4985). Triple combination therapy with Val/Aml/CTD demonstrated superior blood pressure reduction and a favorable safety profile in patients with essential hypertension inadequately controlled on Val/Aml dual therapy, supporting its use as an effective treatment option in this population. Trial Registration: This trial was prospectively registered at ClinicalTrials.gov (identifier: NCT06416865).

Humans↗

PubMed1976

Long-term follow-up of a hypertension screening program.

Of 185 people found to be hypertensive in a shopping centre screening program who went to their physician and had medication prescribed, then were contacted 18 months later, 33 had discontinued the medication at their physician's request. But of 152 who were to continue taking medication 139 (91.4%) had complied. Blood pressure had decreased to less than 160 mm Hg systolic or less than 95 mm Hg diastolic, or both, in 65.1% of the 152; was 160 to 169 mm Hg systolic or 95 to 99 mm Hg diastolic, or both, in 13.8%; was mildly or moderately decreased but still above 169 mm Hg systolic or 99 mmHg diastolic, or both, in 8.6%; and was higher than before the onset of treatment in 3.9%. Adequacy of blood pressure control was not related to age, sex, initial blood pressure values, awareness before the screening of having hypertension, or treatment for hypertension before the screening. Diuretics had been prescribed for 93.5% of the 139 patients, most often as single-pill combinations with other antihypertensive agents.

Alberta↗

PubMed2026

Seasonal variation in the office and ambulatory blood pressure control in patients treated with two dual antihypertensive therapies.

We investigated seasonal variation in the office and ambulatory blood pressure control in hypertensive patients treated with two single-pill dual-combination antihypertensive therapies. The study participants (n = 560) were hypertensive patients enrolled in a 24-week therapeutic study. Antihypertensive treatment was initiated with amlodipine/benazepril 5/10 mg/day or benazepril/hydrochlorothiazide 10/12.5 mg/day, with the possible up-titration to 10/20 mg/day or 20/25 mg/day during follow-up, respectively. Office blood pressure was measured at each clinic visit, and ambulatory blood pressure monitoring was performed at baseline and 24-week follow-up. At 24 weeks of follow-up, in patients who continued antihypertensive treatment (n = 511), the proportion of up-titration to higher dosages was significantly different across seasons of treatment commencement in the benazepril/hydrochlorothiazide group (P = 0.002), but not in the amlodipine/benazepril group (P = 0.84). The between-group difference was significantly different in 134 patients who commenced treatment in winter (18.9% vs. 5.0%, P = 0.02), but not in 377 patients who commenced treatment in the other seasons (P ≥ 0.33). The control rate of office blood pressure (<140/90 mmHg) was significantly different across seasons of treatment commencement in the amlodipine/benazepril group (P = 0.01), but not in the benazepril/hydrochlorothiazide group (P = 0.16). The mean changes from baseline to 24-week follow-up tended to be smaller in the benazepril/hydrochlorothiazide than amlodipine/benazepril group in 24-h (mean between-group difference, -2.8 mmHg) and daytime diastolic blood pressure (mean between-group difference, -3.2 mmHg) in patients who commenced treatment in winter, though statistical significance was not achieved (P ≥ 0.07). In conclusion, there was seasonality in the clinic and ambulatory blood pressure-lowering effect of antihypertensive drug combinations, with a marginally significant difference in treatment intensity and blood pressure control between treatment with amlodipine or hydrochlorothiazide in combination with benazepril.

Ambulatory blood pressure↗