A comparison of the efficacy and safety of irbesartan/HCTZ combination therapy with irbesartan and HCTZ monotherapy in the treatment of moderate hypertension

Neutel, Joel M.; Franklin, Stanley S.; Lapuerta, Pablo; Bhaumik, Amitabha; Ptaszynska, Agata

doi:10.1038/sj.jhh.1002293

Cited by 32 publications

(24 citation statements)

References 26 publications

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“…Th e INCLUSIVE TRIAL (66) had 3% serious adverse events with 3 occurring in the placebo arm, 4 in the HCTZ monotherapy 12.5 mg/day, 8 in the irbesartan/HCTZ 150/12.5 mg/day, and 7 in the irbesartan/HCTZ 200/25 mg/day. All were judged as unrelated to the medication except for one event of hypotension in the irbesartan/HCTZ 150/12.5 mg/day which was probably drug related (66).…”

Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

“…All were judged as unrelated to the medication except for one event of hypotension in the irbesartan/HCTZ 150/12.5 mg/day which was probably drug related (66). Lapuerta et al (115) actually reported more adverse events with irbesartan monotherapy than irbesartan/HCTZ combination therapy 300/25 mg/day (36.1% versus 29.9%).…”

Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

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The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The 8 available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure (BP) lowering effects have been demonstrated when ARBs are combined with thiazide diuretics or dihydropyridine calcium channel blockers, augmenting hypertension control. Furthermore, therapeutic use of ARBs goes beyond their antihypertensive effects with evidence-based benefits in heart failure and diabetic renal disease particularly among ACE inhibitor intolerant patients. On the other hand, combining renin-angiotensin system blocking agents, a formerly common practice among medical subspecialists focusing on the management of hypertension, have ceased to do so as there is not only evidence of cardiovascular benefit, but modest evidence of harm, particularly with regard to renal dysfunction. The ARBs are very well tolerated as monotherapy as well as in combination with other anti-hypertensive medications that improve adherence to therapy and have become a mainstay in the treatment of stage 1 and 2 hypertension.

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Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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“…The RAPiHD moderate study enrolled patients with moderate hypertension, defined as SBP of 160 to 179 mmHg and DBP of <110 mmHg in untreated patients; or SBP ≥ 150 to <180 mmHg and DBP ≥ 95 to <110 mmHg in patients uncontrolled on monotherapy 48. Following a 3-week placebo washout period, patients were randomized 3:1:1 to irbesartan/HCTZ 300/25 mg (n = 328), irbesartan 300 mg monotherapy (n = 106) or HCTZ monotherapy 25 mg (n = 104).…”

Section: Efficacy Of Fd Irbesartan/hctz Combinationmentioning

confidence: 99%

Fixed combination of irbesartan and hydrochlorothiazide in the management of hypertension

Bramlage¹

2009

VHRM

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Approximately 25% of the adult population worldwide is hypertensive and thus at risk of cardiovascular morbidity and mortality. Despite the availability of many antihypertensive drugs, at least 50% of patients do not achieve blood pressure (BP) targets and thus remain at increased cardiovascular risk. Fixed-dose (FD) irbesartan/hydrochlorothiazide (HCTZ) is an antihypertensive combination therapy approved for the treatment of patients whose BP is not adequately controlled on monotherapy and for initial treatment of patients likely to need multiple drugs to achieve their BP goal. The effi cacy and tolerability of FD irbesartan/HCTZ has been demonstrated in both patient populations in large multicenter studies. In patients failing antihypertensive monotherapy, FD irbesartan/HCTZ (150/12.5 mg) has been shown to be more effective than FD valsartan/HCTZ (80/12.5 mg) and at least comparable to FD losartan/HCTZ (50/12.5 mg). In patients with moderate or severe hypertension receiving FD irbesartan/HCTZ as initial therapy, this combination achieved more rapid BP reductions compared with irbesartan monotherapy and enabled a greater proportion of patients with severe hypertension to achieve their BP target. FD irbesartan/HCTZ is thus a valuable addition to the clinician's armamentarium for the management of hypertension and should help more patients achieve their BP target. Keywords: blood pressure control, blood pressure target, combination therapy, angiotensin receptor blockers Management issues in treating hypertensionHypertension is a major cause of morbidity and mortality and an important public health challenge worldwide. It has been estimated that hypertension is responsible for approximately two-thirds of all strokes and 50% of heart attacks worldwide. 1In addition, hypertension causes 7.1 million premature deaths per year worldwide and is responsible for 4.5% of the global burden of disease.1 This startling impact of hypertension on health worldwide in part refl ects the high prevalence of hypertension. According to a recent review of published literature, approximately a quarter of the adult population worldwide (26.4%) was hypertensive in 2000 and this is expected to increase to 29.2% by 2025.2 Appropriate management of hypertension is therefore an important priority worldwide, especially given the impact that effective blood pressure (BP) control can have on morbidity and mortality.Effective BP control has been shown to signifi cantly reduce morbidity and mortality, as demonstrated in a meta-analysis of data from trials of active antihypertensive treatment compared with placebo.3 According to this analysis, active antihypertensive treatment in hypertensive patients signifi cantly reduced the risk of fatal and nonfatal stroke by approximately 40% and coronary heart disease (CHD) by approximately 15%, while all-cause mortality was reduced by approximately 15% and cardiovascular mortality by approximately 20%. In addition, a meta-analysis of data from 61 prospective observational studies has shown that t...

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“…In a pooled analysis 18 of the two RAPiHD studies (moderate and severe), 10,24 37.0% adverse events occurred, which were ascribed to the medication in 12.5% of the patients (0.9% serious). These figures were only slightly raised compared with irbesartan monotherapy.…”

Section: Compliance and Tolerabilitymentioning

confidence: 99%

Significance of initial blood pressure and comorbidity for the efficacy of a fixed combination of an angiotensin receptor blocker and hydrochlorothiazide in clinical practice

Schmieder

Schwertfeger²,

Bramlage³

2009

VHRM

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Background: Two-thirds of all patients with arterial hypertension need drug combinations to achieve blood pressure (BP) goals. Fixed combinations have high efficacy and result in high patient compliance. 300 mg irbesartan plus 25 mg hydrochlorothiazide (HCTZ) has been investigated only in clinical trials but not in daily practice. Methods: A multicenter, noninterventional, noncontrolled observational study with 8123 patients seen by 1604 physicians in daily practice. BP reduction (office measurements), co-morbid disease and tolerability were documented over a 6-month observational period. Results: At mean baseline BP of 161 ± 15/94 ± 10 mmHg, administering of fixed combination resulted in a substantial BP reduction averaging 28 ± 15/14 ± 10 mmHg (P  0.001). Decrease of systolic BP ran parallel with increasing systolic baseline BP (Spearman's Rho -0.731; P  0.0001; diastolic BP vs diastolic baseline BP Rho 0.740; P  0.0001), independent from patient characteristics (age, obesity, diabetes or nephropathy) but enhanced with short history of hypertension (P  0.0001 vs long history), prior beta blockers (P = 0.001 vs prior angiotensin receptor blockers [ARBs]), prior calcium channel blockers (P = 0.046 vs prior ARBs) and no prior medication (P = 0.012 vs prior ARBs). High compliance (98%) and low incidence of adverse events (0.66%) were documented. Conclusions: The fixed combination of 300 mg irbesartan with 25 mg HCTZ was efficacious and tolerable in an unselected patient population in primary care.

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A comparison of the efficacy and safety of irbesartan/HCTZ combination therapy with irbesartan and HCTZ monotherapy in the treatment of moderate hypertension

Cited by 32 publications

References 26 publications

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

Fixed combination of irbesartan and hydrochlorothiazide in the management of hypertension

Significance of initial blood pressure and comorbidity for the efficacy of a fixed combination of an angiotensin receptor blocker and hydrochlorothiazide in clinical practice

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