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| __NOTOC__
| | #REDIRECT [[Olmesartan#Clinical Studies]] |
| {{Olmesartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Clinical Studies==
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| ===14.1 Adult Hypertension===
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| The antihypertensive effects of Benicar have been demonstrated in seven placebo controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 Benicar; 548 placebo) with essential [[hypertension]]were studied. Benicar once daily lowered diastolic and systolic blood pressure. The response was dose-related, as shown in the following graph. A Benicar dose of 20 mg daily produces a trough sitting BP reduction over placebo of about 10/6 mmHg and a dose of 40 mg daily produces a trough sitting BP reduction over placebo of about 12/7 mmHg. Benicar doses greater than 40 mg had little additional effect. The onset of the antihypertensive effect occurred within 1 week and was largely manifest after 2 weeks.
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| |[[File:Olmesartan03.jpg|thumb|800px]]
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| Data above are from seven placebo-controlled studies (2145 Benicar patients, 548 placebo patients). The blood pressure lowering effect was maintained throughout the 24-hour period with Benicar once daily, with trough-to-peak ratios for systolic and diastolic response between 60 and 80%.
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| The blood pressure lowering effect of Benicar, with and without [[hydrochlorothiazide]], was maintained in patients treated for up to 1 year. There was no evidence of [[tachyphylaxis]]during long-term treatment with Benicar or rebound effect following abrupt withdrawal of olmesartan medoxomil after 1 year of treatment.
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| The antihypertensive effect of Benicar was similar in men and women and in patients older and younger than 65 years. The effect was smaller in black patients (usually a low renin population), as has been seen with ACE inhibitors, beta-blockers and other angiotensin receptor blockers. Benicar had an additional blood pressure lowering effect when added to [[hydrochlorothiazide]].
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| There are no trials of Benicar demonstrating reductions in cardiovascular risk in patients with [[hypertension]], but at least one pharmacologically similar drug has demonstrated such benefits.
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| ===14.2 Pediatric Hypertension===
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| The antihypertensive effects of Benicar in the pediatric population were evaluated in a randomized, double-blind study involving 302 hypertensive patients aged 6 to 16 years. The study population consisted of an all black cohort of 112 patients and a mixed racial cohort of 190 patients, including 38 blacks. The etiology of the [[hypertension]]was predominantly essential [[hypertension]](87% of the black cohort and 67% of the mixed cohort). Patients who weighed 20 to <35 kg were randomized to 2.5 or 20 mg of Benicar once daily and patients who weighed ≥35 kg were randomized to 5 or 40 mg of Benicar once daily. At the end of 3 weeks, patients were re-randomized to continuing Benicar or to taking placebo for up to 2 weeks. During the initial dose-response phase, Benicar significantly reduced both systolic and diastolic blood pressure in a weight-adjusted dose-dependent manner. Overall, the two dose levels of Benicar (low and high) significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg from the baseline, respectively. These reductions in systolic blood pressure included both drug and placebo effect. During the randomized withdrawal to placebo phase, mean systolic blood pressure at trough was 3.2 mmHg lower and mean diastolic blood pressure at trough was 2.8 mmHg lower in patients continuing Benicar than in patients withdrawn to placebo. These differences were statistically different. As observed in adult populations, the blood pressure reductions were smaller in black patients.
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| In the same study, 59 patients aged 1 to 5 years who weighed ≥5 kg received 0.3 mg/kg of Benicar once daily for three weeks in an open label phase and then were randomized to receiving Benicar or placebo in a double-blind phase. At the end of the second week of withdrawal, the mean systolic/diastolic blood pressure at trough was 3/3 mmHg lower in the group randomized to Benicar; this difference in blood pressure was not statistically significant (95% C.I. -2 to 7/-1 to 7).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33770d80-754f-11de-8dba-0002a5d5c51b | publisher = | date = | accessdate = 21 February 2014 }}</ref>
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| </div>
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| ==References==
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| {{Reflist}}
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| {{Angiotensin II receptor antagonists}}
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Imidazoles]]
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| [[Category:Tetrazoles]]
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| [[Category:Carboxylate esters]]
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| [[Category:Alcohols]]
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| [[Category:Biphenyls]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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