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PubMed1984

Reserpine plus hydrochlorothiazide and sotalol plus hydrochlorothiazide in Black and Indian hypertensive patients.

Fifty patients (25 Blacks and 25 Indians) suffering from mild-to-moderate hypertension (supine diastolic blood pressure 100 - 105 mmHg) were studied in order to compare the antihypertensive effect of a combination of a beta-blocker (sotalol hydrochloride 160 mg/d) plus a thiazide derivative (hydrochlorothiazide 25 mg/d) ( Sotazide ; B-M) with that of a combination of reserpine 0,1 mg/d ( Serpasil ; Ciba) plus hydrochlorothiazide 25 mg/d ( Dichlotride ; Frosst MSD). The combination of reserpine plus hydrochlorothiazide was found to be as effective as that of sotalol plus hydrochlorothiazide in lowering the blood pressure in both the Black and the Indian patients. Two patients taking the combination containing reserpine developed side-effects, but this did not occur in any of those taking the combination containing sotalol. We feel that in developing countries, where the cost of therapy is important, reserpine in a dosage of less than 0,1 mg/d plus a thiazide derivative in low dosage is preferable to a beta-blocker plus a thiazide derivative in the treatment of hypertension.

Blood Pressure↗

PubMed1977

Long term effect of timolol and hydrochlorothiazide, or hydrochlorothiazide and amiloride, in essential hypertension.

Twenty-four patients with mild to moderate hypertension were treated for up to 60 weeks with hydrochlorothiazide and either placebo, timolol, or timolol and amiloride. The effect of adding timolol and amiloride to hydrochlorothiazide was evaluated in a double blind trial. In 22 of the 24 patients a supine diastolic blood pressure below or equal to 95 mm Hg was produced by hydrochlorothiazide and timolol. Replacing a potassium supplement with amiloride increased the antihypertensive effect.

Adult↗

PubMed1999

Comparison of acebutolol with and without hydrochlorothiazide versus carvedilol with and without hydrochlorothiazide in black patients with mild to moderate systemic hypertension.

In the present study, we assessed the antihypertensive efficacy of acebutolol 200 mg versus carvedilol 25 mg once daily, given as monotherapy for 3 months to 40 black patients (20 patients in each group, mean age 53+/-10 years, 24 women) with mean blood pressure (BP) during the day >90 and <110 mm Hg. Patients in whom blood pressure could not be controlled took medication, which was increased at 3-month intervals as follows: step 2, acebutolol 200 mg or carvedilol 25 mg plus hydrochlorothiazide 12.5 mg once daily; step 3, acebutolol 400 mg or carvedilol 50 mg plus hydrochlorothiazide 25 mg once daily. Overall, significant but modest BP reduction was achieved with both beta blockers at 3 months. In the acebutolol group, 24-hour BP decreased from 142+/-15/94+/-7 mm Hg to 138+/-16/89+/-8 mm Hg (p<0.005 for diastolic BP at 3 months vs baseline). Mean day BP decreased from 145+/-15/98+/-5 mm Hg to 140+/-14/93+/-7 mm Hg (p<0.05 for systolic BP and p<0.0005 for diastolic BP at 3 months vs. baseline). In the carvedilol group, 24-hour BP decreased from 145+/-11/93+/-6 to 138+/-16/87+/-9 mm Hg (p<0.05 for systolic BP and p<0.005 for diastolic BP at 3 months vs baseline). Mean day BP decreased from 149+/-10/99+/-5 to 141+/-16/91+/-87 mm Hg (p<0.05 for systolic BP and p<0.0005 for diastolic BP at 3 months vs baseline). At 12 months, most patients required combination therapy to achieve BP control. The control (mean day diastolic BP <90 mm Hg) and response (mean day diastolic BP decrease > or =10 mm Hg) rates at 12 months were 59% and 82% in the acebutolol and 78% and 78% in the carvedilol groups, respectively. In conclusion, acebutolol or carvedilol in combination with hydrochlorothiazide, rather than acebutolol or carvedilol alone, should be considered as first-line antihypertensive therapy in black patients with mild to moderate hypertension.

Acebutolol↗

PubMedDate not supplied

Double-blind comparison of triamterene plus hydrochlorothiazide and spironolactone plus hydrochlorothiazide in the treatment of hypertension.

The results from this double-blind, multi-investigator study showed that a combination of 50 mg triamterene plus 25 mg hydrochlorothiazide and a combination of 25 mg spironolactone plus 25 mg hydrochlorothiazide were equally efficacious in lowering blood pressure in hypertensive outpatients, and that they produced the same type and incidence of adverse effects. Likewise, the two drug combinations produced similar effects on blood chemistry and hematology. There were no significant differences between the two combination drugs in efficacy laboratory studies, or adverse effects.

Adult↗

PubMed1994

Evaluation by 24-hour ambulatory blood pressure monitoring of efficacy of benazepril 20 mg plus hydrochlorothiazide 25 mg fixed combination as compared to captopril 50 mg [corrected] plus hydrochlorothiazide 25 mg fixed combination in treating mild to moderate hypertension: a double-blind, within-patient, placebo-controlled study.

In a double-blind, placebo-controlled, three-period cross-over, randomized study we evaluated the efficacy and tolerability of a fixed combination of benazepril 20 mg and hydrochlorothiazide 25 mg (BN + HCT) as compared with the fixed combination of captopril 50 mg and hydrochlorothiazide 25 mg (CP + HCT) by ambulatory blood pressure monitoring (ABPM) in patients with mild to moderate hypertension. Eighteen outpatients, 16 men and 2 women aged 41-58 years, were randomized to receive BN + HCT, CP + HCT, or placebo, all administered once daily for 4 weeks according to a three-period cross-over arranged in a 3 x 3 latin square design. Patients were checked after an initial 3-week washout period and every 4 weeks thereafter. At each visit, 24-h ABPM was performed by a noninvasive device (Spacelabs 5300); causal BP and heart rate (HR) were also measured. Both fixed combinations had a clear-cut antihypertensive effect in comparison with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed1991

Controlling hypertension: lisinopril-hydrochlorothiazide vs captopril-hydrochlorothiazide. An Italian multicentre study.

The efficacy and tolerability of a combination of lisinopril 20 mg and hydrochlorothiazide 12.5 mg once daily (L/HCTZ) was compared with a combination of captopril 50 mg and hydrochlorothiazide 25 mg once daily (C/HCTZ) in a multicentre, open, randomized, parallel-group study involving mild to moderate hypertensive patients. A total of 87 patients were randomized to lisinopril and 87 to captopril. Six weeks of treatment with lisinopril or captopril lowered supine BP by 13.3/8.8 mm Hg and 8.7/6.5 mm Hg, respectively. After 4 weeks of combination treatment, BP 24 hours post dose fell to 144.0 +/- 1.3/88.1 +/- 0.7 mm Hg in the L/HCTZ group vs 146.8 +/- 1.3/90.3 +/- 0.7 mm Hg in the C/HCTZ group (P less than 0.05 DBP; differences in SBP were not significant, ns). The proportion of patients normalized (DBP less than or equal to 90 mm Hg) was 79.5% vs 72% for L/HCTZ and C/HCTZ, respectively (ns). A total of 93.6% of patients on L/HCTZ achieved a fall in DBP of greater than or equal to 10 mm Hg, compared with 86.7% of patients on C/HCTZ (ns). One patient on lisinopril withdrew because of coughing. No statistically significant differences were observed between L/HCTZ and C/HCTZ with regard to adverse events. In conclusion, L/HCTZ was as well tolerated as C/HCTZ, but produced a greater fall in DBP.

Adolescent↗

PubMed1991

Treating mild-to-moderate hypertension: a comparison of lisinopril-hydrochlorothiazide fixed combination with captopril and hydrochlorothiazide free combination.

The fixed combination comprising lisinopril 10 mg and hydrochlorothiazide 12.5 mg once daily (L/HCTZ) was compared with captopril 25 mg and hydrochlorothiazide 25 mg once daily (C/HCTZ) in a randomized, double-blind, parallel-group study. After a 2-4 week placebo run-in period patients were randomized to L/HCTZ (n = 82) or C/HCTZ (n = 83) for 8 weeks. After 8 weeks, peak blood levels of both treatments showed lowered sitting BPs (-22.8/-14.3 mm Hg for L/HCTZ vs -22.8/-14.0 mm Hg for C/HCTZ), and standing BPs (-22.6/-13.1 mm Hg vs -21.6/-12.8 mm Hg, respectively). Between-drug differences were not significant (ns). At trough blood levels L/HCTZ lowered sitting BPs more than C/HCTZ, -23.6/-14.9 mm Hg vs -16.0/-11.3 mm Hg (P less than 0.02/less than 0.03), respectively. The effect on standing BP was similar, -22.0/-13.8 mm Hg vs -15.1/-10.3 mm Hg (P less than 0.03/less than 0.05) for L/HCTZ and C/HCTZ, respectively. Both treatments slightly increased heart rate (ns). Serum potassium fell more with C/HCTZ than with L/HCTZ (P less than 0.005). The fasting glucose level rose with L/HCTZ and fell with C/HCTZ. Uric acid, triglycerides and fasting cholesterol levels rose in both groups (ns). There were no differences between treatments with respect to adverse events. L/HCTZ appears to be a well-tolerated combination with efficacy on once-daily dosing superior to that of C/HCTZ.

Adult↗

PubMed1985

Comparison of hydrochlorothiazide and hydrochlorothiazide plus bevantolol in hypertension.

The added hypotensive effect of bevantolol, a new cardioselective beta-blocker, was studied in 244 patients with mild to moderate essential hypertension following prior treatment with hydrochlorothiazide or placebo. After four weeks of monotherapy with 50 mg/day or 100 mg/day of hydrochlorothiazide or placebo, the mean diastolic blood pressure of the patients in these groups decreased from baseline by 8.6, 8.8, and 4.3 mmHg, respectively. During the subsequent four weeks of dual therapy with 400 mg/day of bevantolol added to the regimen, additional and uniform mean decreases of 7.5, 7.3, and 7.5 mmHg occurred, providing total mean diastolic pressure decreases from baseline of 16.1, 16.1, and 11.8 mmHg in the three groups, respectively. These diastolic pressures were significantly lower during dual therapy than during monotherapy and lower in both diuretic groups than in the placebo group during monotherapy and dual therapy (P less than 0.001). Fewer adverse reactions occurred during dual therapy than during monotherapy. The addition of bevantolol to a thiazide diuretic regimen provided safe and significantly better control of mild to moderate hypertension than did the diuretic alone.

Adrenergic beta-Antagonists↗

PubMed1986

Antihypertensive effects of acebutolol plus hydrochlorothiazide and hydrochlorothiazide alone in black patients.

Fifty black (Zulu) men, aged 20-60 years, with mild-to-moderate essential hypertension participated in a double-blind randomized parallel-group study lasting 12 weeks. Study drugs were acebutolol 200 mg plus hydrochlorothiazide 12.5 mg (Secadrex; Maybaker) (SDX) or hydrochlorothiazide 25 mg (HCT) given as a single tablet once daily under supervision. Following a 4-week washout period and after protocol exclusions and withdrawals, a total of 37 patients took the active preparations for 6 weeks, 33 for 7 weeks and 32 for 8 weeks. Of 17 patients treated with SDX, 16 responded satisfactorily; 20 patients were treated with HCT and 18 responded satisfactorily. No important biochemical or haematological changes occurred and no serious adverse reactions were noted. Mild-to-moderate essential hypertension was effectively controlled in a significant proportion of both treatment groups.

Acebutolol↗

PubMed1995

[Comparison of the efficacy of enalapril + hydrochlorothiazide and captopril + hydrochlorothiazide combinations in mild-to-moderate arterial hypertension by ambulatory measurement of blood pressure].

This two-centre trial compared the efficacy of combinations of enalapril + hydrochlorothiazide (E + H) and captopril + hydrochlorothiazide (C + H) on mild-to-moderate hypertension, after a two-week placebo period, in 26 patients with mild-to-moderate HT (DBP between 95 and 114 mmHg) not controlled by previous treatment, randomized under double-blind conditions into two groups for two 4-week crossover treatment periods separated by a 4-week wash-out period. One group received E + H (20 mg/12.5 mg) followed by C + H (50 mg/25 mg) and the other group received C + H (50/25) followed E + H (20/12.5), once a day. The efficacy of the two treatments was evaluated by 24-hour ambulatory blood pressure monitoring (ABPM) at the start of the study and after each treatment period. Plasma renin activity, aldosterone and angiotensin converting enzyme were assayed under the same conditions. Analysis was based on 26 cases, as none of the patients were withdrawn from the trial. No difference was observed between the two groups in terms of the main biometric and laboratory characteristics. Blood pressure evaluated by ABPM and intermittently was not significantly different between the two groups at the time of inclusion in the study. On intermittent Bp determinations, E + H and C + H decreased diastolic and systolic blood pressure, with no significant difference between the two treatments. On ABPM, the two treatments significantly decreased mean systolic, diastolic and mean blood pressure during the diurnal, nocturnal and circadian periods.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1994

Antihypertensive effectiveness of low-dose lisinopril-hydrochlorothiazide combination. A large multicenter study. Lisinopril-Hydrochlorothiazide Group.

OBJECTIVE: To test the antihypertensive and metabolic effects of lisinopril, 10 mg/d (L); hydrochlorothiazide, 12.5 and 25 mg/d (H12.5 and H25); and its combination with lisinopril (L/H12.5 and L/H25) against placebo in patients with mild to moderate (stage I and stage II) hypertension. DESIGN: Multicenter, double-blind, placebo-controlled outpatient study of 12 weeks' duration. PATIENTS: After 4 weeks of single-blind placebo treatment, 505 patients whose sitting diastolic blood pressure was 100 to 114 mm Hg were randomized into the study--467 patients completed it (placebo, 71; L, 80; H12.5, 79; H25, 77; L/H12.5, 79; and L/H25, 81). The patients were seen in the clinic every 2 weeks, where measurements of their sitting and upright blood pressure and heart rate were taken 24 +/- 2 hours after drug administration. Complete blood cell counts with differential cell counts, blood chemistry studies, urinalyses, and electrocardiograms were done at baseline and during the study. Roentgenograms were done once at baseline. RESULTS: Compared with placebo, all drug regimens decreased sitting and upright blood pressure (P < .001) and had no effect on sitting and upright heart rate. The greatest effect was obtained with the combinations of L/H12.5 and L/H25. There was no difference between L/H12.5 and L/H25 or between H12.5 and H25. There were no serious clinical side effects except cough, which was slightly higher with L, L/H12.5, and L/H25. The only metabolic side effects were in serum potassium level, which was lower with H25 (P < .01), and serum glucose level, which was higher with H25 and L/H25 (P < .01). CONCLUSIONS: The data suggest that (1) monotherapy of hypertension with L, H12.5, H25, L/H12.5, and L/H25 was effective and well tolerated; (2) the best results were achieved with L/H12.5 and L/H25; (3) lower doses of hydrochlorothiazide either alone or in combination with lisinopril were equipotent with higher doses and were free of metabolic side effects.

Blood Pressure↗

PubMedDate not supplied

Pharmacokinetic comparison of a combination tablet of enalapril and hydrochlorothiazide with enalapril and hydrochlorothiazide tablets administered together and separately.

Enalapril and hydrochlorothiazide (HCT) are established single agent treatments for mild hypertension and cardiac failure and are a potent combination in more severe or resistant cases. We have compared the pharmacokinetics of enalaprilat (the active metabolite of enalapril) and HCT in a four-way comparison of a combination tablet of enalapril (10 mg)/HCT (25 mg) with a single dose of an enalapril tablet (10 mg), a single dose of a HCT tablet (25 mg) and simultaneous administration of separate tablets of enalapril (10 mg) and HCT (25 mg) in normotensive volunteers (n = 12, 21-26 years). Each subject received all four treatments and the study was conducted as a randomized, latin square, open design with at least 1 week washout between studies. Overall, HCT was bioequivalent under all conditions and enalaprilat was bioequivalent when given in combination with HCT either as one tablet or as two separate tablets. However, when given with HCT, the mean AUC and Cmax of enalaprilat were reduced up to 20 per cent compared with enalapril administered alone. This is unlikely to be of clinical significance as the differences did not reach statistical significance and the total enalaprilat excreted in the urine over 96 h was similar after all treatments.

Adult↗

PubMed2003

Antihypertensive effects of two fixed-dose combinations of losartan and hydrochlorothiazide versus hydrochlorothiazide monotherapy in subjects with ambulatory systolic hypertension.

BACKGROUND: The efficacy of losartan (L) in combination with hydrochlorothiazide (HCTZ) has been demonstrated to reduce blood pressure. However, there are limited data on the effects of L/HCTZ combinations versus HCTZ monotherapies in reducing ambulatory systolic blood pressure. The aim of this study was to compare the effects of these treatment approaches in patients with ambulatory systolic hypertension. METHODS: Patients were randomized to receive L 50 mg (n = 60) or HCTZ 12.5 mg (n = 60) for 6 weeks. Patients were then force-titrated to L 50/HCTZ 12.5 mg and to L 100/HCTZ 25 mg or were sham-titrated to HCTZ 12.5 mg and force-titrated to HCTZ 25 mg, respectively. Clinic and 24-h ambulatory blood pressure (ABP) were measured at baseline and after each 6-week treatment period. RESULTS: We found that L 50 and HCTZ 12.5 induced significant and similar decreases in clinic and ABP. The combinations of L 50/HCTZ 12.5 and L 100/HCTZ 25 provided significantly greater decreases in clinic and ABP than did HCTZ monotherapies. The L 50/HCTZ 12.5 and L 100/HCTZ 25 combinations provided significant additional decreases in systolic/diastolic ABP during daytime (-5.3/-2.0 mm Hg; P <.001 and -5.8/-3.4 mm Hg; P <.001) and the other periods of the 24-h interval compared with the levels achieved by the previous treatment, indicating a clear dose-response relationship. However, increasing the dose of HCTZ from 12.5 mg to 25 mg was not associated with additional ABP reductions. CONCLUSIONS: Combinations of L 50/HCTZ 12.5 and L 100/HCTZ 25 provided greater reductions in clinic and ABP than HCTZ monotherapies, with a clear dose-response relationship with regard to ABP. These results support the use of ABP monitoring when assessing the efficacy of antihypertensive therapies.

Aged↗

PubMed2001

Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.

BACKGROUND: Recent surveys reveal continuing deficiencies in the awareness, treatment, and control of hypertension. In many cases, failure to achieve blood pressure targets may be attributable to the use of antihypertensive monotherapy. OBJECTIVES: This study was undertaken to identify combinations of telmisartan, a new oral angiotensin II type 1-receptor antagonist, and hydrochlorothiazide (HCTZ) that might provide greater antihypertensive efficacy than monotherapy with either agent in the treatment of mild to moderate hypertension. It also examined the dose-response surface for the 2 drugs alone and in combination. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that employed all cells of a 4 x 5 factorial design. After a 4-week, single-blind, placebo run-in period, men and women between 18 and 80 years of age with mild to moderate hypertension (defined as mean supine diastolic blood pressure [DBP] between 95 and 114 mm Hg during the last 2 weeks of the placebo run-in period and systolic blood pressure [SBP] between 114 and 200 mm Hg immediately before randomization) were eligible to enter the 8-week, double-blind, double-dummy treatment period. Study comparisons were between once-daily telmisartan monotherapy (20, 40, 80, or 160 mg), HCTZ monotherapy (6.25, 12.5, or 25 mg), 12 combinations of these telmisartan/HCTZ doses, and placebo. The focus was on 2 combinations: telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg. The primary efficacy variable was change in supine trough DBP from baseline to the last evaluable measurement during double-blind treatment. Plasma renin activity and safety parameters, including treatment-emergent adverse events, physical findings, electrocardiograms, and serum electrolyte levels (which are known to increase with HCTZ treatment), were also assessed. RESULTS: Of 1293 patients screened, 818 (63.3%) were enrolled at 47 centers. Of these 818, 749 (91.6%) completed the study. The intent-to-treat population (randomized with > or = 1 postrandomization blood pressure measurement) consisted of 807 patients (98.7%). Telmisartan 80 mg/HCTZ 12.5 mg significantly decreased mean supine trough SBP/DBP by 23.9/14.9 mm Hg, a benefit of 8.5/3.4 mm Hg compared with telmisartan 80 mg and of 17.0/7.6 mm Hg compared with HCTZ 12.5 mg (both comparisons, P < 0.01). Telmisartan 40 mg/HCTZ 12.5 mg significantly reduced mean supine SBP by 18.8 mm Hg, a benefit of 6.6 mm Hg compared with telmisartan 40 mg and 11.9 mm Hg compared with HCTZ 12.5 mg (both, P < 0.01). This same combination significantly reduced mean supine DBP by 12.6 mm Hg, a benefit of 5.3 mm Hg compared with HCTZ 12.5 mg (P < 0.01), but was not significantly different from telmisartan 40 mg. Telmisartan 80 mg/HCTZ 12.5 mg was significantly more effective than telmisartan 40 mg/HCTZ 12.5 mg in reducing mean supine DBP and SBP (both, P < 0.05). The response surface and responder analyses confirmed the additive antihypertensive efficacy of the combination of telmisartan and HCTZ. All regimens were well tolerated. CONCLUSIONS: Once-daily telmisartan 80 mg/HCTZ 12.5 mg was effective and well tolerated when used to reduce SBP and DBP in patients with mild to moderate hypertension. In addition to enhancing efficacy, this combination protected against potassium depletion, a common side effect of thiazide monotherapy.

Adolescent↗

PubMedDate not supplied

Efficacy, tolerability, and effects on quality of life of losartan, alone or with hydrochlorothiazide, versus amlodipine, alone or with hydrochlorothiazide, in patients with essential hypertension.

A randomized, double-masked, parallel-group, multicenter clinical trial was conducted to compare the efficacy, tolerability, and effects on quality of life associated with treatment regimens including the angiotensin II receptor antagonist losartan, with hydrochlorothiazide (HCTZ) added as needed, with regimens including the dihydropyridine calcium channel blocker amlodipine with HCTZ added as needed. The trial included patients whose sitting diastolic blood pressure (SiDBP) measurements were between 95 and 114 mm Hg, inclusive, at placebo baseline. Patients were randomized to receive either losartan or amlodipine in a double-masked, double-dummy fashion. A 4-week placebo washout period was followed by a 12-week active treatment period. Patients in the losartan arm (n = 97) were initially given 50 mg of oral (PO) losartan once a day (QD); the medication could be titrated to 50-mg losartan/ 12.5-mg HCTZ PO QD after 4 weeks, followed by 50-mg losartan plus 25-mg HCTZ PO QD after 8 weeks as necessary. Patients in the amlodipine group (n = 93) received 5-mg amlodipine PO QD, which could be titrated to 10 mg PO QD after 4 weeks, followed by 10 mg plus 25-mg HCTZ PO QD after 8 weeks. Medication was titrated upward as necessary to achieve trough SiDBP < 90 mm Hg. Efficacy, tolerability, and quality-of-life scores were assessed after 12 weeks of therapy with each regimen. Trough SiDBP reductions after 4, 8, and 12 weeks of therapy were clinically comparable (losartan group: 7.3, 10.4, and 11.1 mm Hg, respectively; amlodipine group: 7.9, 11.2, and 11.8 mm Hg, respectively). Similar reductions in systolic blood pressure were also seen for both treatment groups. The percentage of patients reaching goal SiDBP (defined as trough SiDBP < 90 mm Hg or SiDBP > or = 90 mm Hg with a > or = 10 mm Hg drop from placebo baseline) was comparable for the two groups, with 68% of patients in the losartan group and 71% of patients in the amlodipine group reaching goal. Significantly more patients in the amlodipine group had drug-related adverse experiences (27% vs 13%). In particular, drug-related edema was more common in patients receiving the amlodipine regimen than in those receiving the losartan regimen (11% vs 1%). Patients in the amlodipine arm reported significantly more bother due to edema, regardless of whether edema was present at baseline, than did patients in the losartan arm (12% vs 2%), although overall quality of life was not different in the two treatment groups. This study demonstrates that a regimen of losartan with HCTZ added as needed, when compared with a regimen of amlodipine with HCTZ added as needed, provides comparable efficacy and superior tolerability and less bother to patients with respect to edema.

Adult↗

PubMed2001

Efficacy and safety of omapatrilat with hydrochlorothiazide for the treatment of hypertension in subjects nonresponsive to hydrochlorothiazide alone.

This multicenter, double-blind study evaluated efficacy and safety of the vasopeptidase inhibitor omapatrilat, which simultaneously inhibits neutral endopeptidase and angiotensin converting enzyme, when given in conjunction with hydrochlorothiazide (HCTZ) to subjects nonresponsive to HCTZ alone. The study enrolled 657 subjects with mild to severe hypertension. After a 2-week placebo lead-in period and a 4-week HCTZ phase, 274 subjects were randomized to receive omapatrilat (10 or 20 mg, electively titrated to 20 or 40 mg, respectively, at week 4 if seated diastolic blood pressure [SeDBP] was > or =90 mm Hg) or matching placebo in addition to 25 mg of HCTZ as continuing therapy. The primary outcome measure was change in SeDBP from baseline to week 8. At week 8, placebo plus HCTZ-adjusted additional reductions in SeDBP in the omapatrilat 10/20 mg and 20/40 mg treatment groups (4 and 5 mm Hg, respectively) were significant (P < .001), as were changes in seated systolic blood pressure in both omapatrilat-treated groups (7 and 10 mm Hg, respectively; P < .001). Seated diastolic blood pressure was normalized (<90 mm Hg) in 38% of subjects in the placebo group compared to 59% and 64% of subjects in the omapatrilat groups (P < or = .008). Adverse events, serious adverse events, and discontinuations attributed to adverse events were infrequent. There were no clinically relevant changes in serum creatinine or potassium. Omapatrilat was effective and well tolerated when added to HCTZ in subjects whose blood pressure was not controlled with HCTZ alone.

Adult↗

PubMed1987

Controlled multicenter study of the antihypertensive effects of lisinopril, hydrochlorothiazide, and lisinopril plus hydrochlorothiazide in the treatment of 394 patients with mild to moderate essential hypertension.

Lisinopril (LIS) is a lysine analog of enalaprilat, the active metabolite of enalapril, an angiotensin-converting enzyme inhibitor (ACEI). Unlike enalapril, the precursor of enalaprilat, LIS is not a prodrug but has equal ACEI efficacy and potency and a slightly longer duration of action after oral administration. Short-term (12 weeks) and long-term (24 weeks) blood pressure control has been studied with LIS, hydrochlorothiazide (HCTZ), and LIS + HCTZ when given once a day. Drug treatment had three phases: (i) 2-4 weeks of single-blind placebo washout; (ii) 12 weeks of double-blind comparison therapy with LIS 20, 40, and 80 mg vs. HCTZ 12.5, 25, and 50 mg, vs. LIS + HCTZ 20 + 12.5, 40 + 25, and 80 + 50 mg; (iii) 13-24 weeks single-blind LIS vs. LIS + HCTZ. Starting double-blind therapy at the lowest dose, all three groups doubled the dose at weeks 4 and 8 if BP was not controlled with sitting diastolic BP (SDBP) less than 90 mm Hg. At the end of 12 weeks of double-blind therapy, uncontrolled HCTZ-only and LIS-only treatment groups were advanced to combination LIS + HCTZ therapy but uncontrolled LIS + HCTZ patients were dropped. Mean BP reductions (systolic/diastolic, mm Hg) for all three groups after 12 weeks of double-blind comparison therapy were: (i) LIS (n = 162), -16.6/-12.5; (ii) HCTZ (n = 155), -10.4/-6.8; (iii) LIS + HCTZ (n = 74), -23.9/-18.2 with p less than 0.01 for all groups compared to baseline.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1979

Bioavailability and disposition of metoprolol and hydrochlorothiazide combined in one tablet and of separate doses of hydrochlorothiazide.

1. The plasma levels and the urinary excretion of hydrochlorothiazide (HCT) have been studied after administration of single doses of 12.5 and 25 mg of the drug in solution and in combination with 100 mg of the selective beta 1-adrenoreceptor antagonist metoprolol in a rapidly dissolving tablet. 2. Metoprolol did not significantly influence the bioavailability or the time-course of HCT. 3. HCT had no significant effect on the time-course or the plasma levels of metoprolol. The average half-life, 4.4 +/- 0.9 h, is about the same as previously observed for separate doses of this drug. 4. It seems unlikely that repeated doses of the combination product studied will lead to biopharmaceutic or pharmacokinetic interactions of clinical importance.

Biological Availability↗