Fixed combination of irbesartan and hydrochlorothiazide in the management of hypertension

Figures & data

Table 1 Summary of efficacy data for main studies of fixed-dose irbesartan/hydrochlorothiazide (HCTZ)

Study	Patients, n	Duration of therapy and irbesartan/HCTZ dose	Mean reduction in SBP/DBP, mmHg	SBP/DBP normalization rate, %
Bobrie et al^Citation39	Failing monotherapy, n = 464	8 weeks; 150/12.5 mg	13.0/9.5 vs 10.6/7.4 for valsartan/HCTZ, p < 0.01a	50.2 vs 33.2 for valsartan/HCTZ, p = 0.0003 b
INCLUSIVE^Citation41	Failing monotherapy, n = 844	18 weeks; titrated to 300/25 mg	21.5/10.4 (p < 0.001 vs baseline)	69c
Neutel et al^Citation46	Severe hypertension, n = 695	5 weeks; titrated to 300/25 mg		34.6 vs 19.2 for irbesartan monotherapy, p < 0.0001d
Neutel et al^Citation48	Moderate hypertension, n = 538	8 weeks; titrated to 300/25 mg	27.1/14.6 vs 22.1/11.6 for irbesartan monotherapy, p < 0.005	53.4 vs 40.6 for irbesartan monotherapy, p = 0.0254d

Notes: ^aSBP/DBP reduction according to home BP monitoring.

^bSBP/DBP normalization <135/85 mmHg.

^cSBP/DBP normalization <140/90 mmHg or 130/80 mmHg for patients with diabetes.

^dSBP/DBP normalization <140/90 mmHg.

Figure 1 Probability of achieving a SBP <140 mmHg at Weeks 7/8 across a range of baseline SBP following treatment with irbesartan/hydrochlorothiazide (HCTZ), irbesartan, and HCTZ. Results from the RAPiHD study. Reproduced with permission from Franklin S, Lapuerta P, Cox D, Donovan M. Initial combination therapy with irbesartan/hydrochlorothiazide for hypertension: an analysis of the relationship between baseline blood pressure and the need for combination therapy. J Clin Hypertens (Greenwich). 2007; 9(12 Suppl):15–22.⁵⁹ Copyright © 2007 John Wiley and Sons, Inc.

Figure 2 Mean reductions from baseline in SBP and DBP following initial fixed-dose irbesartan/hydrochlorothiazide (HCTZ) 300/25 mg treatment, according to age, body mass index (BMI), type 2 diabetes, and cardiovascular (CV) risk. Results from the RAPiHD study. Reproduced with permission from Weir MR, Neutel JM, Bhaumik A, Obaldia ME, Lapuerta P. The efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular risk. J Clin Hypertens (Greenwich). 2007; 9(12 Suppl):23–30.⁶⁰ Copyright © 2007 John Wiley and Sons, Inc.

Table 2 Safety data for main studies of fixed-dose irbesartan/hydrochlorothiazide (FD irbesartan/HCTZ): incidence of adverse events

	FD irbesartan/HCTZ	Irbesartan monotherapy
Study in patients failing monotherapy (INCLUSIVE)^Citation41 n = 844
Any adverse event	27% irbesartan/HCTZ 150/12.5 mg
	26% irbesartan/HCTZ 300/25 mg
Serious adverse event	1% irbesartan/HCTZ 150/12.5 mg;
	1% irbesartan/HCTZ 300/25 mg
Initial therapy in patients with severe hypertension^Citation46 n = 695
Any adverse event	30%	36%
Discontinuation due to adverse event	1.9%	2.2%
Serious adverse event	0.2%	0.4%
Initial therapy in patients with moderate hypertension^Citation48 n = 538
Any adverse event	47%	45%
Treatment-related adverse event	14%	11%
Discontinuation due to adverse event	6.7%	3.8%
Serious adverse event	1.8%a	0%

^aOf the 6 serious adverse events, only 1 was treatment related.

BobrieGDeloncaJMoulinCGiacominoAPostel-VinayNAsmarRA home blood pressure monitoring study comparing the antihypertensive efficacy of two angiotensin II receptor antagonist fixed combinationsAm J Hypertens200518111482148816280286

 PubMed Web of Science ®Google Scholar

NeutelJMSaundersEBakrisGLThe efficacy and safety of low- and high-dose fixed combinations of irbesartan/hydrochlorothiazide in patients with uncontrolled systolic blood pressure on monotherapy: the INCLUSIVE trialJ Clin Hypertens (Greenwich)200571057858616227760

 PubMedGoogle Scholar

NeutelJMFranklinSSOparilSBhaumikAPtaszynskaALapuertaPEfficacy and safety of irbesartan/HCTZ combination therapy as initial treatment for rapid control of severe hypertensionJ Clin Hypertens (Greenwich)200681285085717170610

 PubMedGoogle Scholar

NeutelJMFranklinSSLapuertaPBhaumikAPtaszynskaAA comparison of the efficacy and safety of irbesartan/HCTZ combination therapy with irbesartan and HCTZ monotherapy in the treatment of moderate hypertensionJ Hum Hypertens20082226627417928878

 PubMed Web of Science ®Google Scholar

FranklinSLapuertaPCoxDDonovanMInitial combination therapy with irbesartan/hydrochlorothiazide for hypertension: an analysis of the relationship between baseline blood pressure and the need for combination therapyJ Clin Hypertens (Greenwich)2007912 Suppl152218046108

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WeirMRNeutelJMBhaumikAObaldiaMELapuertaPThe efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular riskJ Clin Hypertens (Greenwich)2007912 Suppl233018046109

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