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PubMed2005

Liquid chromatography-electrospray tandem mass spectrometry method for determination of indapamide in serum for single/multiple dose bioequivalence studies of sustained release formulations.

Indapamide and internal standard (5-chloro-2-methoxy-N-[2-(4-sulphamoylphenyl)ethyl]benzamide) were isolated from plasma by a single step liquid-liquid extraction in t-butyl methyl ether. The chromatographic separation was achieved on a reversed-phase C(18) monolithic column with a mobile phase consisting in a methanol/aqueous 0.1% formic acid mixture and a flow rate of 0.8 ml/min, in isocratic conditions, within 11 min. Target compounds were transferred in an ion trap analyzer via an atmospheric pressure electrospray interface (AP-ESI). The mass analyzer was used in a selected reaction monitoring (SRM) mode, in order to enhance on detection selectivity. Whole method produces quantitation limit for indapamide of 1 ng/ml. Method was successfully applied to assess bioequivalence of two sustained release marketed pharmaceutical formulations of indapamide 1.5 mg coated tablets, carried-out in a single/multiple doses, randomized design.

Antihypertensive Agents↗

PubMed1996

Indapamide is superior to thiazide in the preservation of renal function in patients with renal insufficiency and systemic hypertension.

The long-term effects of indapamide or hydrochlorothiazide on blood presssure and renal function were examined in patents with impaired renal function and moderate hypertension. Both drugs controlled hypertension and blood pressure remained normal during the 2 years of the study. Despite this comparable control of hypertension, indapamide therapy was associated with a 28.5 +/- 4.4% increase in creatinine clearance, whereas treatment with hydrochlorothiazide was associated with a 17.4 +/- 3.0% decrease in creatinine clearance. The results of the study indicate that indapamide is superior to hydrochlorothiazide in the treatment of patients with impaired renal function and moderate hypertension.

Adult↗

PubMed2000

Acute transient myopia induced by indapamide.

PURPOSE: To report on a case of acute transient myopia associated with ciliochoroidal detachment induced by indapamide. METHOD: Case report. Clinical examination, ultrasonography, and fluorescein angiography were performed during the acute phase of disease and convalescence. RESULTS: After indapamide was discontinued, acute bilateral myopia, which was associated with anterior chamber shallowing and diffuse choroidal thickening, resolved spontaneously 8 days after onset. The initial angiography showed scattered islands of delayed fluorescein filling that disappeared without any permanent change by day 30. CONCLUSION: Indapamide can induce spontaneously resolving transient myopia associated with diffuse choroidal thickening.

Acute Disease↗

PubMed2002

Indapamide induced syncope in a patient with long QT syndrome.

A 60-year-old woman who had been successfully treated with atenolol and cardiac pacing for hypertension and long QT syndrome developed recurrent episodes of palpitations and syncope. Several days prior to these episodes, indapamide 2.5 mg/day was taken for better control of hypertension. The episodes were associated with prolongation of QT interval and mild hypokalemia (3.1 MEQ/L). Indapamide was immediately stopped, but the QT remained prolonged 2 days later, although the potassium level was normalized. This case suggests that indapamide can cause potassium independent prolongation of the QT interval, resulting in arrhythmia induced syncope.

Antihypertensive Agents↗

PubMed1999

Quantitative determination of indapamide in pharmaceuticals and urine by high-performance liquid chromatography with amperometric detection.

A high-performance liquid chromatographic method with amperometric detection for the determination of the diuretic indapamide using a muBondapak C18 column is developed. The mobile phase consists of an acetonitrile-water mixture (45:55, 5 mM) in KH2PO4-K2HPO4 (pH 4.0). The compound is monitored at +1200 mV with an amperometric detector equipped with a glassy carbon working electrode. A liquid-liquid or solid-liquid extraction is performed prior to chromatographic analysis to avoid the interferences found in urine matrix. Percentages of recovery are 88.3 +/- 5.6 and 82.9 +/- 7.8 for liquid-liquid and solid-liquid extraction, respectively. The developed method has a linear concentration range from 25 to 315 ng/mL with a reproducibility in terms of relative standard deviation of 4% for a concentration level of 0.5 microgram/mL and a quantitation limit of 1 ng/mL. The method is applied to the determination of indapamide in tablets and urine obtained from hypertensive patients after the ingestion of Tertensif (indapamide 2.5 mg).

Adult↗

PubMed1996

Fixed-dose combination of perindopril with indapamide in spontaneously hypertensive rats: haemodynamic, biological and structural effects.

OBJECTIVE: The present study was designed to test the effects of chronic combined treatment with low doses of an angiotensin converting enzyme inhibitor (perindopril) and of the diuretic indapamide in spontaneously hypertensive rats (SHR). METHODS: Adult SHR were treated with placebo or increasing doses of the combination of the drugs (0.3, 1 and 3 mg/kg per day; ratio of doses 0.32). In a separate set of experiments, the effects of the drugs combined (1 mg/kg per day) was compared with those induced by each drug alone. RESULTS: The drug combination dose-dependently decreased systolic blood pressure and its hypotensive effect was more marked than those induced by each treatment administered alone (untreated 208 +/- 5 mmHg, indapamide 185 +/- 5 mmHg, perindopril 150 +/- 3 and the combination 123 +/- 7 mmHg). A 12-week treatment with the drug combination (1 mg/kg per day) was not accompanied by any change in diuresis or urinary excretion of Na or K. The same treatment decreased cardiac hypertrophy and collagen. At the vascular level, the drug combination decreased aortic, carotid and femoral media cross-sectional areas, as well as aortic and carotid collagen density. This latter effect was accompanied by a significant increase in carotid artery compliance assessed in vivo at constant pressure. Finally, in isolated aortae, chronic combined drug treatment was associated with an increased basal release of nitric oxide and a decrease in the hypertension-induced endothelium-dependent contractions in response to acetylcholine. CONCLUSION: These experiments suggest that chronic combined treatment with low doses of an angiotensin converting enzyme inhibitor and a diuretic such as indapamide may be of value in the treatment of hypertension.

Acetylcholine↗

PubMed2003

Very-low-dose combination of perindopril and indapamide: efficacy on blood pressure and target-organ damage.

OBJECTIVE: To review the safety and efficacy of the very-low-dose combination of perindopril 2 mg and indapamide 0.625 mg (Per2/Ind0.625) in essential hypertension, in relation to blood pressure control and target-organ damage. STUDY SELECTION: We included in this review several double-blind, randomized studies in hypertensive patients, including five main studies from the European registration file and two clinical trials on regression of target-organ damage [large artery stiffness: the Preterax in Regression of Arterial Stiffness in a Controlled Double-Blind Study (REASON); microalbuminuria in patients with type 2 diabetes: the Preterax in Albuminuria Regression (PREMIER) study]. MAIN OUTCOME MEASURES: Systolic (SBP) and diastolic (DBP) blood pressures measured at trough with a mercury sphygmomanometer, an automatic device (OMRON), and 24-h ambulatory blood pressure measurements (ABPM). Arterial stiffness, assessed from pulse wave velocity measurement and augmentation index (REASON study). Microalbuminuria (PREMIER study). RESULTS: The Per2/Ind0.625 combination was selected from the dose-finding studies. Twelve weeks after the participants were assigned to study groups, the reductions in SBP, measured with an OMRON device, were 12.3 +/- 15.0 mmHg with Per2/Ind0.625, 8.0 +/- 16.5 mmHg with perindopril 2 mg (P = 0.001), 9.4 +/- 14.3 mmHg with indapamide 0.625 mg (P = 0.023) and 2.1 +/- 16.8 mmHg with placebo (P < 0.001) (mean +/- SD; all P values are for comparisons with Per2/Ind0.625). The reductions in DBP were 6.8 +/- 9.2 mmHg, 5.0 +/- 9.5 mmHg (P = 0.02), 4.7 +/- 8.2 mmHg (P = 0.004) and 2.4 +/- 9.6 mmHg (P < 0.001) in the Per2/Ind0.625, perindopril 2 mg, indapamide 0.625 mg and placebo groups, respectively. During the long-term study, among 235 patients who achieved initial blood pressure normalization with the fixed combination, 79.8% sustained their normalized status over 1 year, with no significant difference regarding safety criteria. During the REASON study, Per/Ind reduced pulse wave velocity to a similar extent as atenolol, and augmentation index to a greater extent. During the PREMIER study, Per/Ind reduced microalbuminuria to a greater extent than did enalapril. CONCLUSIONS: The proven efficacy on blood pressure and regression of target-organ damage with a good safety profile confirm that the new fixed-low-dose combination Per2/Ind0.625 is a valuable option in the first-line treatment of hypertension.

Angiotensin-Converting Enzyme Inhibitors↗

PubMedDate not supplied

Evaluation of indapamide in the treatment of hypertension.

A randomized double-blind, crossover trial was carried out in twenty hypertensive patients to evaluate the hypotensive efficacy and safety of indapamide. Indapamide in doses of 2.5 mg per day in combination with other antihypertensive agents was as effective in reducing the blood pressure in hypertensive patients as one tablet of Moduretic (50 mg hydrochlorothiazide and 5 mg amiloride). Indapamide induced no changes in serum potassium or uric acid levels and there were no major side effects.

Adult↗

PubMed1996

Indapamide is as effective as captopril in the control of microalbuminuria in diabetes.

Microalbuminuria is a predictor of overt diabetic nephropathy and macrovascular disease. Thirty-one diabetic patients with persistent urinary albumin excretion rate (AER) of 20-200 mu g min-1 were randomised to receive indapamide 2.5 mg or captopril 37.5 mg daily for 12 weeks. After a 4-week washout, patients received the alternate agent for 12 weeks. Resting blood pressure (BP), AER, cholesterol, triglycerides, and HbA1c were measured at baseline, after 6 and 12 weeks of each treatment, and after a 4-week washout period following each treatment arm. Results from patients who completed at least one treatment arm were analysed by repeated-measures analysis of variance (ANOVA). AER (median value and interquartile range) decreased significantly from baseline after treatment with indapamide and captopril [60(27-106) vs. 40(14-112) and 33(17-100); p < 0.005], but there was no difference between the effects of the two agents. Mean systolic BP (SBP) was also significantly reduced with treatment, and no difference was noted between the effects of the two agents. No correlation between changes in AER and SBP was noted with either agent. Diastolic blood pressure (DBP), cholesterol, triglycerides, and HbA1c did not change during the study. These results suggest that indapamide is an effective alternative to angiotensin-converting enzyme (ACE) inhibitors in the treatment of diabetic patients with microalbuminuria.

Albuminuria↗

PubMed1998

Twenty-four hour antihypertensive efficacy of indapamide, 1.5-mg sustained release: results of two randomized double-blind controlled studies.

The antihypertensive efficacy of a 1.5-mg sustained-release formulation (SR 1.5) of indapamide, a diuretic related to thiazide, has been pointed out by using conventional sphygmomanometric measurement 24 h after dosing in clinic, in two large European randomized, double-blind, controlled studies (2 and 3 months). One of these studies was then extended to 12 months, as a complementary open study. Quality-controlled ambulatory blood pressure monitoring (ABPM) data for a total of 216 patients from these studies are presented, including subgroups of hypertensives and responders. Indapamide SR 1.5 achieves an adequate 24-h blood pressure control by significantly reducing the 24-h, diurnal, and nocturnal blood pressures versus baseline, confirming the sphygmomanometric data. The benefit at 2 and 3 months is maintained at 1 year, which confirms the long-term efficacy of SR 1.5 mg. The trough-to-peak ratio--not previously calculated for a diuretic according to international guidelines--meets Food and Drug Administration requirements and confirms the 24-h efficacy of indapamide SR 1.5.

Adolescent↗

PubMedDate not supplied

The effects of delapril in combination with indapamide on glomerular filtration rate in elderly hypertensive patients.

We performed a placebo-controlled trial on the effects of a combined antihypertensive treatment with delapril, a new nonsulfhydryl angiotensin-converting enzyme inhibitor, and indapamide, a sulfonamide diuretic. We studied 28 elderly patients aged 65-85 years (mean age, 69 +/- 1 years) who took 30 mg delapril in combination with 1.25 mg indapamide once daily for 24 weeks. In the present study (performed simultaneously with our trial on the effects of delapril/indapamide on left ventricular mass in elderly patients with hypertension and on the same patients), we report the effects of this drug combination on glomerular filtration rate. Sitting arterial pressure (mean +/- SE) decreased from 156 +/- 1. 5/101 +/- 1 mm Hg at baseline to 133 +/- 1/73 +/- 1 mm Hg at the end of the 24-week treatment period (p < 0.0001). No significant changes in heart rate or episodes of orthostatic hypotension were observed. Glomerular filtration rate increased from 91.8 +/- 4.42 mL/min at baseline to 106.3 +/- 4.5 mL/min (p < 0.001) at the end of treatment. Our results show that the combination of delapril and indapamide is effective in the elderly hypertensive patient, with a favorable effect on the prevention of deterioration of kidney function.

Aged↗

PubMed1998

Effects of delapril in combination with indapamide on blood pressure and left ventricular mass in elderly hypertensive patients.

We present a single-blinded, placebo-controlled trial of the effects on blood pressure and left ventricular mass and of the safety of a combined antihypertensive treatment with delapril, a new nonsulfhydryl angiotensin-converting enzyme inhibitor, and indapamide, a sulfonamide diuretic. We studied 28 elderly patients aged 65-85 years (mean age, 69 +/- 1) with sitting systolic/diastolic blood pressure of 160-200/95-115 mm Hg (at the end of the placebo period). After a 2-week placebo run-in, patients took 30 mg delapril in combination with 1.25 mg indapamide once daily for 24 weeks. Twenty-four-hour ambulatory blood pressure was monitored and M- and B-mode echocardiography were performed before and after 24 weeks of treatment. Blood pressure decreased from 156 +/- 1.5/101 +/- 1 mm Hg before treatment to 133 +/- 1/73 +/- 1 mm Hg after treatment. The total blood pressure burden also decreased; the percentage of measurements with a systolic blood pressure > or = 140 mm Hg and a diastolic blood pressure > or = 90 mm Hg decreased from 48.7% +/- 5%/31.5% +/- 4.3% to 23.5% +/- 4%/20.5% +/- 2.9% (p < 0.0005 and p < 0.05). The area under the curve of the 24-hour blood pressure decreased from 250 +/- 41/103 +/- 21 mm Hg to 97 +/- 21/37 +/- 8.5 mm Hg (p < 0.001 and p < 0.005). The left ventricular mass index (LVMI) in the 15 patients with pretreatment left ventricular hypertrophy was reduced after therapy from 167.5 +/- 8.5 g/m 2 to 152.2 +/- 7.6 g/m 2 (p < 0.05). A positive correlation was observed between percent changes of the area under the curve of the 24-hour diastolic blood pressure and percent changes of LVMI (r = 0.6; p < 0. 05) in the 15 patients with left ventricular hypertrophy. Only 2 patients reported side effects: 1 developed skin rash and 1 developed headache. The safety of the treatment was confirmed by laboratory tests. In elderly hypertensive patients, the combination of delapril and indapamide at low doses reduced blood pressure and had favorable effects on LVMI with few side effects.

Age Factors↗

PubMed2000

Ambulatory blood pressure profiles in patients treated with once-daily diltiazem extended-release or indapamide alone or in combination.

This randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of single daily dose diltiazem extended-release (XR) and indapamide, given alone and combined, in 255 male and 170 female patients with mild to moderate hypertension. Blood pressure was assessed both manually in the office and by 24-hour ambulatory blood pressure monitoring (ABPM) techniques. Between-treatment efficacy comparisons were based on ABPM plots and changes from baseline in supine systolic (SuSBP) and diastolic (SuDBP) blood pressure after 6 weeks of double-blind treatment. Periodic 12-lead electrocardiograms (ECG), clinical laboratory tests, and physical examinations were used to assess safety. Both diltiazem XR 180, 240, and 360 mg and indapamide 2.5 mg monotherapy reduced ambulatory blood pressure to a greater extent than placebo. The ABPM data demonstrate that 2.5 mg indapamide produces an additional reduction in diastolic blood pressure when combined with fixed doses of diltiazem XR (120, 180, and 240 mg). The reduction was consistent over the entire 24-hour recording period for all combinations. Compared with monotherapy groups, higher therapeutic response rates (SuDBP < or = 90 mm Hg or Delta SuDBP > or = 10 mm Hg decrease from baseline) were also observed with combination therapy. Office blood pressure data qualitatively and quantitatively supported the observations made from the ABPM data. There were no unexpected adverse events or side-effect trends and no dose-response or clinically significant laboratory, ECG, or physical examination adverse effects. The combination therapy regimens were well tolerated with safety profiles comparable with those of the individual therapies.

Adult↗

PubMed1984

Effect of indapamide on the renin-aldosterone system, and urinary excretion of potassium and calcium in essential hypertension.

The effect of indapamide, 2.5 mg daily, on blood pressure, electrolyte balance and the renin-aldosterone system was studied in 11 patients with essential hypertension. During indapamide treatment blood pressure decreased and the renin-aldosterone system was stimulated. A moderate hypokalaemia seen during indapamide treatment was not correlated to changes in plasma aldosterone concentration. Fractional excretion of potassium was unchanged during treatment, while renal calcium excretion was reduced. No effect on calcium in serum was observed.

Adult↗

PubMed1993

Indapamide inhibits endothelium-dependent contractions in the aorta of the spontaneously hypertensive rat.

Experiments were designed to determine whether or not indapamide, an antihypertensive agent with vasodilator properties, inhibits endothelium-dependent contractions. Rings of aortae with and without endothelium from spontaneously hypertensive rats (SHR) were suspended in conventional organ chambers for the measurement of isometric force. Acetylcholine and adenosine diphosphate-beta-S in the presence of a nitric oxide synthase inhibitor, caused endothelium-dependent contractions, which were inhibited by indapamide. The compound (10(-4) M) also slightly reduced the contractions of rings without endothelium evoked by U-46,619, which activates thromboxane-endoperoxide receptors. These results demonstrate that indapamide inhibits endothelium-dependent contractions in the SHR aorta, and suggest that the inhibition is due, at least in part, to the action of the drug on the hypertensive vascular smooth muscle.

15-Hydroxy-11 alpha,9 alpha-(epoxymethano)prosta-5↗

PubMedDate not supplied

Pharmacokinetics of sustained and immediate release formulations of indapamide after single and repeated oral administration in healthy volunteers.

The pharmacokinetics of a 2.5 mg immediate release (IR) formulation of indapamide was compared to a 1.5 mg sustained release (SR) formulation of indapamide after single and repeated oral administration dose using double blind randomised cross-over studies. In the first study, 12 subjects received a single dose of each treatment: IR fasted, SR fasted or with food. In the second study one tablet of either formulation was administered daily for one week at breakfast. In each study, blood samples were collected pre dose (Cmin) and up to 120 h after the last dose. Urine was collected over the dosing interval (24 h). Following a single oral administration the SR formulation had a lower dose-normalised Cmax compared to the IR formulation (17.6 +/- 6.3 vs. 39.3 +/- 11.0 ng x mL(-1), respectively), a much longer t(max) (12.3 +/- 0.4 vs. 0.8 +/- 0.3 h) and a greater t75 (15.3 +/- 6.1 vs. 1.8 +/- 1.4 h) but there were no differences in dose-normalised AUC (559 +/- 125 and 564 +/- 146 ng x h x mL(-1)) nor in t(1/2z) values (14.8 +/- 2.8 vs. 18.4 +/- 13.4 h). The SR formulation clearly demonstrated sustained release characteristics as compared to the IR formulation. Food co-administration had no effect on dose-normalised AUC for the SR formulation. After repeated administration, steady-state was achieved by day 5. The absorption rate of the SR formulation was lower and the 24 h peak-to-trough fluctuation was 4-fold lower compared to the IR formulation. After dose correction there wasno change in AUC, (726 +/- 207 and 690 +/- 183 ng x mL(-1) x h for SR and IR, respectively). The elimination parameters (t(1,2z), Ae(tau), and CLr) remained unchanged. The SR formulation showed sustained release of indapamide with a reduction in peak concentration, while steady-state level was not affected by formulations. The two formulations have the same bioavailability.

Administration, Oral↗

PubMedDate not supplied

Direct vascular actions of methyclothiazide and indapamide in aorta of spontaneously hypertensive rats.

In vitro experiments were designed to assess the inhibitory effect of the thiazide diuretics methyclothiazide (MCTZ), the hydrochlorothiazide (HCTZ), and the thiazide-related diuretic indapamide (IND) on contractile responses to norepinephrine (NE) and arginine vasopressin (AVP) of aortic rings from spontaneously hypertensive rats (SHR) and normotensive Wistar Kyoto rats (WKY). Changes in the tension of aortic ring preparations were measured isometrically. MCTZ (10(-4) M) induced endothelium-dependent inhibition of the vasoconstrictor responses to NE and AVP only in aortas from SHR, and the maximal vasoconstrictive effect of NE and AVP was decreased by 59 +/- 11% and 32.3 +/- 13%, respectively. Indapamide (10(-4) M) also induced endothelium-dependent inhibition of the contractile response to AVP in aortic rings from SHR, and the maximal vasoconstrictive effect of AVP was decreased by 33 +/- 5%. In contrast, HCTZ did not inhibit the contractile response to either NE or AVP, even at the highest concentration. This study provides evidence that methyclothiazide and indapamide inhibit the contractile response induced by norepinephrine and/or arginine vasopressin on SHR aortic preparations via an endothelium-dependent mechanism.

Animals↗

PubMed1986

Effect of thermal history on the glassy state of indapamide.

The effects of thermal history, e.g. cooling rate, annealing, etc., on the thermal behaviour of indapamide glass were determined by differential scanning calorimetry (DSC). The glass was prepared by heating indapamide crystals (m.p. 162 degrees C) to 180 degrees C, and then cooling the melt to room temperature. The glass transition temperature (Tg) of the material was 98 degrees C. An endotherm, due to thermal relaxation of the glass, was observed in the DSC thermogram when indapamide glass was prepared by slow cooling or was annealed isothermally at a temperature below Tg. Such enthalpy relaxation may be observed during ageing of pharmaceutical glasses and might influence their physico-chemical properties.

Calorimetry, Differential Scanning↗