- Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC-MS/MS and its application in bioequivalence studies. [Journal Article]
- JPJ Pharm Anal 2014; 4(2):144-152
- A validated ultra-performance liquid chromatography mass spectrometric method (UPLC-MS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma...
A validated ultra-performance liquid chromatography mass spectrometric method (UPLC-MS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma. The analysis was performed on UPLC-MS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM) mode. The analytes were extracted using a liquid-liquid extraction (LLE) method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mm×4.6 mm, 5 µm) column with organic mixture:buffer solution (80:20, v/v) at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC) and HCT immediate release tablets with reference product in human subjects.
- Safety and effectiveness of candesartan and candesartan/HCT fixed dose combination in patients with hypertension. [Multicenter Study]
- AMActa Med Indones 2013; 45(3):193-201
- CONCLUSIONS: results of this open observational study showed that candesartan and candesartan/HCT were well tolerated and effective in both treatment-naive patients and uncontrolled hypertensive patients with previous antihypertensive treatment.
- New simple spectrophotometric method for determination of the binary mixtures (atorvastatin calcium and ezetimibe; candesartan cilexetil and hydrochlorothiazide) in tablets. [Journal Article]
- JPJ Pharm Anal 2013; 3(2):118-126
- A new simple spectrophotometric method was developed for the determination of binary mixtures without prior separation. The method is based on the generation of ratio spectra of compound X by using a...
A new simple spectrophotometric method was developed for the determination of binary mixtures without prior separation. The method is based on the generation of ratio spectra of compound X by using a standard spectrum of compound Y as a divisor. The peak to trough amplitudes between two selected wavelengths in the ratio spectra are proportional to concentration of X without interference from Y. The method was demonstrated by determination of two drug combinations. The first consists of the two antihyperlipidemics: atorvastatin calcium (ATV) and ezetimibe (EZE), and the second comprises the antihypertensives: candesartan cilexetil (CAN) and hydrochlorothiazide (HCT). For mixture 1, ATV was determined using 10 μg/mL EZE as the divisor to generate the ratio spectra, and the peak to trough amplitudes between 231 and 276 nm were plotted against ATV concentration. Similarly, by using 10 μg/mL ATV as divisor, the peak to trough amplitudes between 231 and 276 nm were found proportional to EZE concentration. Calibration curves were linear in the range 2.5-40 μg/mL for both drugs. For mixture 2, divisor concentration was 7.5 μg/mL for both drugs. CAN was determined using its peak to trough amplitudes at 251 and 277 nm, while HCT was estimated using the amplitudes between 251 and 276 nm. The measured amplitudes were linearly correlated to concentration in the ranges 2.5-50 and 1-30 μg/mL for CAN and HCT, respectively. The proposed spectrophotometric method was validated and successfully applied for the assay of both drug combinations in several laboratory-prepared mixtures and commercial tablets.
- LC-MS/MS method for simultaneous estimation of candesartan and hydrochlorothiazide in human plasma and its use in clinical pharmacokinetics. [Journal Article]
- BBioanalysis 2012; 4(10):1195-204
- CONCLUSIONS: The advantages of the described technique included a single method with a shorter run time (2.5 min), simple extraction technique, LLOQ of 1 ng/ml for CAN and 2 ng/ml for HCTZ and lower sample volume (0.10 ml), which overcomes drawbacks of two single methods for each analyte, such as higher analysis time, LOQ and sample volume, as in previously published methods. The developed assay was applied to an oral pharmacokinetic study in humans.
- Pharmacokinetic interaction study with fixed high dose combinations of candesartan cilexetil and hydrochlorothiazide. [Randomized Controlled Trial]
- IJInt J Clin Pharmacol Ther 2011; 49(12):750-5
- CONCLUSIONS: There was no pharmacokinetic interaction found between the high doses of candesartan 32 mg and HCT 25 mg.
- Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. [Randomized Controlled Trial]
- CTClin Ther 2011; 33(8):1043-56
- CONCLUSIONS: The candesartan-HCT combination was associated with a statistically significant lowering of BP compared with candesartan monotherapy. Clinicaltrials.gov: NCT00621153.
- Antihypertensive efficacy and tolerability of candesartan-hydrochlorothiazide 32/12.5 mg and 32/25 mg in patients not optimally controlled with candesartan monotherapy. [Randomized Controlled Trial]
- BPBlood Press Suppl 2008; 2:22-30
- CONCLUSIONS: Candesartan-HCT 32/12.5 mg and candesartan-HCT 32/25 mg are highly effective and provide improved blood pressure reduction and blood pressure control relative to candesartan 32 mg monotherapy, with maintained tolerability, in hypertensive patients whose blood pressure is not optimally controlled with candesartan monotherapy. Furthermore, candesartan-HCT 32/25 mg is more effective than candesartan-HCT 32/12.5 mg in this population.
- Olmesartan medoxomil: a review of its use in the management of hypertension. [Review]
- DDrugs 2008; 68(9):1239-72
- Olmesartan medoxomil (Olmetec, Benicar) is an angiotensin II type 1 (AT(1)) receptor antagonist (angiotensin receptor blocker [ARB]) that inhibits the actions of angiotensin II on the renin-angiotens...
Olmesartan medoxomil (Olmetec, Benicar) is an angiotensin II type 1 (AT(1)) receptor antagonist (angiotensin receptor blocker [ARB]) that inhibits the actions of angiotensin II on the renin-angiotensin-aldosterone system, which plays a key role in the pathogenesis of hypertension. Oral olmesartan medoxomil 10-40 mg once daily is recommended for the treatment of adult patients with hypertension. In those with inadequate BP control using monotherapy, fixed-dose olmesartan medoxomil/hydrochlorothiazide (HCTZ) [Olmetec plus, Benicar-HCT] combination therapy may be initiated. Extensive clinical evidence from several large well designed trials and the clinical practice setting has confirmed the antihypertensive efficacy and good tolerability profile of oral olmesartan medoxomil, as monotherapy or in combination with HCTZ, in patients with hypertension, including elderly patients with isolated systolic hypertension (ISH). Notably, BP control is sustained throughout the 24-hour dosage interval, including during the last 4 hours of this period. In clinical trials, olmesartan medoxomil monotherapy provided better antihypertensive efficacy than losartan, candesartan cilexetil or irbesartan monotherapy, and was at least as effective as valsartan treatment, with a faster onset of action than other ARBs in terms of reductions from baseline in diastolic BP (DBP) and, in most instances, systolic BP (SBP). Combination therapy with olmesartan medoxomil plus HCTZ was superior to that with benazepril plus amlodipine, as effective as that with losartan plus HCTZ, noninferior to that with atenolol plus HCTZ, but less effective than that with telmisartan plus HCTZ, in individual trials. Data from ongoing clinical outcome trials are required to more fully determine the relative position of olmesartan medoxomil therapy in the management of hypertension. In the meantime, the consistent antihypertensive efficacy during the entire 24-hour dosage interval and good tolerability profile of olmesartan medoxomil, with or without HCTZ, make it a valuable option for the treatment of adult patients with hypertension, including the elderly.
- [Effect of candesartan cilexetil with hydrochlorothiazide on blood pressure and ST-segment depression in patients with arterial hypertension]. [Journal Article]
- DMDtsch Med Wochenschr 2007 Jan 19; 132(3):81-6
- CONCLUSIONS: Replacing candesartan + hydrochlorothiazide for previously ineffective antihypertensive drugs in patients with uncontrolled arterial hypertension significantly reduced both blood pressure and ST-segment depression during daily life.
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- [Investigations of the antihypertensive long-term action of candesartan cilexetil in different dosages under the influence of therapy-free intervals]. [Randomized Controlled Trial]
- AArzneimittelforschung 2005; 55(9):505-13
- CONCLUSIONS: The objectives of the present study were completely met by confirming statistically and clinically the assumption of a clear, long-lasting, safe and metabolically neutral action of CC both for low and high dosages with or without HCT. The intended lowering of blood pressure is effective and well tolerable also repeatedly during the 48-h, therapy-free interval (missed dose trial) which corresponds to a frequent omission of the daily tablet dose and thus well reflects the daily practice in antihypertensive therapeutic regimens.