geoscience.net logo
+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial


, : Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Clinical Therapeutics 23(6): 833-850, June

Background: Recent surveys reveal continuing deficiencies in the awareness, treatment, and control of hypertension. In many cases, failure to achieve blood pressure targets may be attributable to the use of antihypertensive monotherapy. Objectives: This study was undertaken to identify combinations of telmisartan, a new oral angiotensin II type 1-receptor antagonist, and hydrochlorothiazide (HCTZ) that might provide greater antihypertensive efficacy than monotherapy with either agent in the treatment of mild to moderate hypertension. It also examined the dose-response surface for the 2 drugs alone and in combination. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that employed all cells of a 4X5 factorial design. After a 4-week, single-blind, placebo run-in period, men and women between 18 and 80 years of age with mild to moderate hypertension (defined as mean supine diastolic blood pressure (DBP) between 95 and 114 mm Hg during the last 2 weeks of the placebo run-in period and systolic blood pressure (SBP) between 114 and 200 mm Hg immediately before randomization) were eligible to enter the 8-week, double-blind, double-dummy treatment period. Study comparisons were between once-daily telmisartan monotherapy (20, 40, 80, or 160 mg), HCTZ monotherapy (6.25, 12.5, or 25 mg), 12 combinations of these telmisartan/HCTZ doses, and placebo. The focus was on 2 combinations: telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg. The primary efficacy variable was change in supine trough DBP from baseline to the last evaluable measurement during double-blind treatment. Plasma renin activity and safety parameters, including treatment-emergent adverse events, physical findings, electrocardiograms, and serum electrolyte levels (which are known to increase with HCTZ treatment), were also assessed. Results: Of 1293 patients screened, 818 (63.3%) were enrolled at 47 centers. Of these 818, 749 (91.6%) completed the study. The intent-to-treat population (randomized with gtoreq1 postrandomization blood pressure measurement) consisted of 807 patients (98.7%). Telmisartan 80 mg/HCTZ 12.5 mg significantly decreased mean supine trough SBP/DBP by 23.9/14.9 mm Hg, a benefit of 8.5/3.4 mm Hg compared with telmisartan 80 mg and of 17.0/7.6 mm Hg compared with HCTZ 12.5 mg (both comparisons, P<0.01). Telmisartan 40 mg/HCTZ 12.5 mg significantly reduced mean supine SBP by 18.8 mm Hg, a benefit of 6.6 mm Hg compared with telmisartan 40 mg and 11.9 mm Hg compared with HCTZ 12.5 mg (both, P<0.01). This same combination significantly reduced mean supine DBP by 12.6 mm Hg, a benefit of 5.3 mm Hg compared with HCTZ 12.5 mg (P<0.01), but was not significantly different from telmisartan 40 mg. Telmisartan 80 mg/HCTZ 12.5 mg was significantly more effective than telmisartan 40 mg/HCTZ 12.5 mg in reducing mean supine DBP and SBP (both, P<0.05). The response surface and responder analyses confirmed the additive antihypertensive efficacy of the combination of telmisartan and HCTZ. All regimens were well tolerated. Conclusions: Once-daily telmisartan 80 mg/HCTZ 12.5 mg was effective and well tolerated when used to reduce SBP and DBP in patients with mild to moderate hypertension. In addition to enhancing efficacy, this combination protected against potassium depletion, a common side effect of thiazide monotherapy.

US$19.90

PMID: 11440284

DOI: 10.1016/s0149-2918(01)80072-2


Other references

Agusto, F.B.; Bewick, S.; Parshad, R.D., 2012: Mosquito management in the face of natural selection. The sterile insect technique (SIT) is an appealing method for managing mosquito populations while avoiding the environmental and social costs associated with more traditional control strategies like insecticide application. Success of SIT, however...

Velichko, A.A.; Zelikson, E.M.; Morozova, T.D.; Nechaev, V.P.; Porozhnyakova, O.M.; Chichagova, O.A., 1997: Paleogeographic conditions during the Atlantic period of the Holocene in the Central Russian plain. Doklady Akademii Nauk 355(4): 540-543, Aug

Becker B., 1977: Multiple dose studies with timolol maleate. Investigative Ophthalmology & Visual Science: 110

Feldman R.; Nadeau J.; Limbird L.; Robertson D.; Fitzgerald G.A.; Wood A.J.J., 1981: Dynamic regulation of beta adrenergic receptor agonist affinity by physiological changes in catecholamines. Clinical Research 29(5): 859A

Ozdemir, N.; Kaya, F.Nur.; Gurbet, A.; Yilmazlar, A.; Demirag, B.; Mandiraci, B.Onbasi., 2013: Comparison of intraarticular bupivacaine and levobupivacaine with morphine and epinephrine for knee arthroscopy. To compare the efficacy of intraarticularly injected bupivacaine with levobupivacaine when administered in combination with morphine and adrenaline for post-operative analgesia and functional recovery after knee surgery. Sixty American Society of...

Hartog, M.; Doyle, F.; Fraser, R.; Joplin, G.F., 2010: Partial pituitary ablation with implants of gold-198 and yttrium-90 for acromegaly. British Medical Journal 2(5458): 396-398

Hornung, M.; Franke, J.; Gafoor, S.; Sievert, H., 2016: Cardioembolic Stroke and Postmyocardial Infarction Stroke. Ischemic stroke following acute myocardial infarction (AMI) is a rare but serious complication due to left ventricular thrombus formation and atrial fibrillation. Early revascularization of the culprit coronary lesion is essential. Treatment trend...

Sibony, O., 2006: Premature birth and fetal growth retardation. La Revue du Praticien 56(15): 1725-1730

Reshetnikov, O.V.; Kurilovich, S.A.; Denisova, D.V., 2014: Symptoms of gastroesophageal reflux disease and associated factors in adolescents: population survey. Gastroesophageal reflux (GER) is frequent among the general population affecting 10-20% of adults. However, there is a notable lack of epidemiological data describing prevalence of GER in children. The aims of the present study were to assess the...

Hernández, M.V.; Peris, P.; Sierra, J.; Collado, A.; Muñoz-Gómez, J., 1994: Tendinitis due to fluoroquinolones. Description of 2 cases. Two patients with tendinitis by ciprofloxacin are described. In both patients isolated involvement of the Aquilles tendon was produced. The symptoms initiated at 2 to 4 weeks of the beginning of treatment. The two patients had undergone chemothera...