RESUMEN
Linagliptin plus pioglitazone single-pill combinations were evaluated. Patients (n = 936) with insufficient glycaemic control, despite lifestyle interventions, were randomised for 30 weeks to either monotherapy with linagliptin 5 mg; pioglitazone 15, 30 or 45 mg; or single-pill combination with linagliptin 5 mg plus pioglitazone 15, 30 or 45 mg. An extension (⩽54 weeks) planned to evaluate linagliptin plus pioglitazone 30 or 45 mg single-pill combinations was not completed due to a protocol amendment. Adjusted mean (95% confidence interval) differences in HbA1c change from baseline at week 30 for linagliptin plus pioglitazone 15, 30 and 45 mg were -0.17% (-0.41, 0.07), -0.37% (-0.60, -0.14) and -0.41% (-0.64, -0.18) versus pioglitazone monotherapies, respectively, and -0.44% (-0.67, -0.20), -0.68% (-0.91, -0.44) and -0.89% (-1.12, -0.66) versus linagliptin monotherapy, respectively. Single-pill combinations were generally well tolerated. Hypoglycaemia frequency was ⩽1.5% per group. Linagliptin plus pioglitazone combinations were efficacious, with safety profiles comparable to the individual monotherapies.
Asunto(s)
Glucemia/efectos de los fármacos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores de la Dipeptidil-Peptidasa IV/administración & dosificación , Hipoglucemiantes/administración & dosificación , Linagliptina/administración & dosificación , Tiazolidinedionas/administración & dosificación , Administración Oral , Anciano , Biomarcadores/sangre , Glucemia/metabolismo , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Método Doble Ciego , Combinación de Medicamentos , Europa (Continente) , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemia/sangre , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Linagliptina/efectos adversos , Masculino , Persona de Mediana Edad , Pioglitazona , Comprimidos , Tiazolidinedionas/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
The subanalysis of a 4 × 4 factorial, 8-week study to evaluate the efficacy and tolerability of telmisartan (T) 40-80 mg/amlodipine (A) 5-10 mg used in treatment-naïve patients (n = 231) and patients previously treated with antihypertensive agents (n = 880). Similar blood pressure (BP) reductions were achieved with T + A, regardless of their pretreatment status. Highest reductions were achieved with T80 + A10 (treatment-naïve -26.5/-18.2 mm Hg and previously treated -25.6/-19.9 mm Hg). Most patients (treatment-naïve 72.4% and previously treated 77.6%), including those with added risk, achieved BP goal (<140/90 mm Hg) with T80 + A10. Tolerability was comparable in both groups.
Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Bencimidazoles/uso terapéutico , Benzoatos/uso terapéutico , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Amlodipino/efectos adversos , Amlodipino/farmacología , Antihipertensivos/efectos adversos , Antihipertensivos/farmacología , Bencimidazoles/efectos adversos , Bencimidazoles/farmacología , Benzoatos/efectos adversos , Benzoatos/farmacología , Presión Sanguínea/efectos de los fármacos , Presión Sanguínea/fisiología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Telmisartán , Resultado del TratamientoRESUMEN
BACKGROUND: Hypertensive patients with diabetes often require combination therapy to achieve a blood pressure (BP) goal, and evidence suggests that time to BP goal is crucial to decrease cardiovascular risk. OBJECTIVE: The aim of the study was to investigate whether the single-pill combination of telmisartan and amlodipine was superior to amlodipine alone as initial antihypertensive therapy in patients with diabetes and hypertension. METHODS: An 8-week, randomized, parallel-group, double-blind international trial comparing the once-daily single-pill combination of telmisartan 80 mg and amlodipine 10 mg (T/A; n = 352) with once-daily amlodipine 10 mg (A; n = 354) in patients with type 2 diabetes mellitus and stage 1 or 2 hypertension (systolic BP [SBP] >150 mm Hg). RESULTS: Patient demographics were similar between treatment groups, with an mean (SD) age of 60.5 (10.1) years; 51.7% were male, the mean (SD) body mass index was 32.0 (6.1) and the mean (SD) duration of hypertension was 8.8 (7.9) years. After 8 weeks (primary end point) as well as after 1, 2, and 4 weeks (key secondary end points), significantly greater decreases in the in-clinic mean seated trough cuff SBP with T/A versus A were achieved (-29.0 mm Hg vs -22.9 mm Hg at 8 weeks; P < 0.0001). After 8 weeks, 71.4% versus 53.8% of patients achieved the BP goal (<140/90 mm Hg) with T/A versus A, with mean SBPs of 131.9 and 137.9 mm Hg, respectively. Similar results were observed in the obese (metabolic syndrome) subpopulation. The more stringent goal (<130/80 mm Hg) was achieved by 36.4% and 17.9% patients in the T/A and A groups, respectively. The most common adverse events were peripheral edema, headache, and dizziness. CONCLUSIONS: In this selected population of patients with diabetes and hypertension, T/A provided prompt and greater BP decreases compared with A monotherapy, with the majority of patients achieving the BP goal (<140/90 mm Hg).
Asunto(s)
Amlodipino/administración & dosificación , Antihipertensivos/administración & dosificación , Bencimidazoles/administración & dosificación , Benzoatos/administración & dosificación , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipertensión/tratamiento farmacológico , Anciano , Amlodipino/efectos adversos , Amlodipino/farmacología , Amlodipino/uso terapéutico , Antihipertensivos/efectos adversos , Antihipertensivos/farmacología , Antihipertensivos/uso terapéutico , Bencimidazoles/efectos adversos , Bencimidazoles/farmacología , Bencimidazoles/uso terapéutico , Benzoatos/efectos adversos , Benzoatos/farmacología , Benzoatos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Índice de Masa Corporal , Diabetes Mellitus Tipo 2/complicaciones , Método Doble Ciego , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/complicaciones , Hipertensión/diagnóstico , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Telmisartán , Resultado del TratamientoRESUMEN
This randomized 4 x 4 factorial study determined the efficacy and safety of telmisartan (T) plus amlodipine (A) in hypertensive patients. Adults (N=1461) with stage 1 or 2 hypertension (baseline blood pressure [BP]: 153.2[12.1]/101.7[4.3] mm Hg) were randomized to 1 of 16 treatment groups with T 0, 20, 40, 80 mg and A 0, 2.5, 5, 10 mg for 8 weeks. In-clinic BP reductions were greater with combination therapy than respective monotherapies. The greatest least-square mean systolic/diastolic BP reductions were observed with T80 mg plus A10 mg (-26.4/-20.1 mm Hg; P<.05 compared with both monotherapies). BP control was also greatest in the T80-mg plus A10-mg group (76.5% [overall control] and 85.3% [diastolic BP control]), and BP response rates >90% with this combination. Peripheral edema was most common in the A10-mg group (17.8%); however, this rate was notably lower when A was used in combination with T: 11.4% (T20/A10), 6.2% (T40/A10), and 11.3% (T80/A10).
Asunto(s)
Amlodipino/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Antihipertensivos/administración & dosificación , Bencimidazoles/administración & dosificación , Benzoatos/administración & dosificación , Bloqueadores de los Canales de Calcio/administración & dosificación , Hipertensión/tratamiento farmacológico , Amlodipino/efectos adversos , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Antihipertensivos/efectos adversos , Bencimidazoles/efectos adversos , Benzoatos/efectos adversos , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/efectos adversos , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Edema/inducido químicamente , Femenino , Humanos , Masculino , Persona de Mediana Edad , Telmisartán , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with moderate-to-severe hypertension frequently require > or = 2 antihypertensives to achieve blood pressure (BP) control. An angiotensin receptor blocker (ARB) plus a calcium channel blocker (CCB) seems particularly attractive for these difficult-to-control patients. METHODS: Patients with Stage 1 or 2 hypertension were randomized to telmisartan 0, 20, 40, or 80 mg plus amlodipine 0, 2.5, 5, or 10 mg for 8 weeks. Only those with a diastolic BP (DBP) > or = 100 mm Hg at baseline were included in this subgroup analysis. The primary endpoint was the change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies. Secondary endpoints included the change in the in-clinic seated trough systolic BP (SBP), BP response, and control rates. RESULTS: A total of 1078 patients (mean [standard deviation] baseline in-clinic BP: 154.7 +/- 11.7/103.5 +/- 3.5 mm Hg) were analyzed. In-clinic DBP and SBP reductions were significantly greater with combination therapies than respective monotherapies. The greatest least-square mean (standard error) SBP/DBP reductions (-26.5 +/- 1.2/-21 +/- 0.8 mm Hg) were observed with telmisartan 80 mg plus amlodipine 10 mg; 77% and 85% of patients in this treatment group achieved BP control (< 140/90 mm Hg) and DBP control (< 90 mm Hg), respectively. Peripheral edema was reported in 17.2% of patients in the amlodipine 10 mg group; however, this was substantially lower when telmisartan was used in combination: 7% (telmisartan 40 mg/amlodipine 10 mg) and 9.5% (telmisartan 80 mg/ amlodipine 10 mg). CONCLUSIONS: Telmisartan plus amlodipine provides effective BP lowering at all clinically relevant doses (up to -26.5 mm Hg SBP), and almost 9 out of 10 patients may achieve DBP control. Peripheral edema is up to 59% less when telmisartan 40 mg is used in combination with amlodipine 10 mg compared with amlodipine 10 mg monotherapy alone.