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Medical research on monopril
J Cardiovasc Pharmacol. 2008 Jun; 51(6): 590-595
Ferguson JM, Minas J, Siapantas S, Komesaroff PA, Sudhir K
The ideal therapy for patients with isolated systolic hypertension remains unclear; diuretics, calcium channel blockers, and angiotensin-converting enzyme (ACE) inhibitors are all used in clinical practice. The aim of this study was to determine whether a fixed-dose ACE inhibitor/diuretic combination would reduce ambulatory blood pressures (BP) and arterial stiffness in isolated systolic hypertension more than antihypertensive monotherapy. In this randomized, double-blind study, 8 weeks of fosinopril/hydrochlorothiazide combination (10/12.5 mg titrated up to 20/12.5 mg) was compared with the calcium channel blocker (amlodipine, 5 mg titrated up to 10 mg) and diuretic (indapamide, 2.5 mg) monotherapy in 28 patients with isolated systolic hypertension. Each patient received all 3 therapies. Assessments included 24-hour ambulatory BP, clinic BP, and applanation tonometry-derived augmentation index. At 8 weeks, the fall in average 24-hour systolic BP and night time systolic BP were significantly greater in the fosinopril-hydrochlorothiazide group, compared to amlodipine and indapamide. The decrease in augmentation index and central aortic systolic BP was also greater in the fosinopril-hydrochlorothiazide group, compared to either amlodipine or indapamide. There was no difference between therapies in decrease in clinic systolic or diastolic BP, or diastolic ABP (average 24-h, diurnal, or nocturnal). Compared with either calcium channel blocker or diuretic therapy, a fixed-dose ACE inhibitor-diuretic combination induces greater reductions in systolic ABP, particularly at night, favorable effects that may be related to a decrease in the intensity of or delay in arterial wave reflections. ACE inhibitor-diuretic combination therapy is a useful approach to cardiovascular risk reduction in isolated systolic hypertension.
Clinical consequences of generic substitution of lamotrigine for patients with epilepsy.
Neurology. 2008 May 27; 70(22 Pt 2): 2179-86
LeLorier J, Duh MS, Paradis PE, Lefebvre P, Weiner J, Manjunath R, Sheehy O
OBJECTIVES: To measure the proportions of patients switching from generic to branded drugs among users of antiepileptic drugs (AED) compared to other therapeutic areas and to investigate medical services utilization associated with generic switching of lamotrigine. METHODS: Medical and pharmacy claims data from Régie de l'Assurance Maladie du Québec database from April 1998 to July 2006 were used. Patients with an epilepsy diagnosis (International Classification of Diseases-9 345) and treated with lamotrigine for >60 of the 90 days before the entry date of generic lamotrigine in Quebec (February 1, 2003) were selected. The proportion of patients switching back to brand were calculated for lamotrigine, for other AEDs (clobazam, carbamazepine CR, gabapentin) and for non-AED chronic medications (carvedilol, fosinopril, simvastatin). Medical resource utilization was compared between periods of branded vs generic use of lamotrigine. RESULTS: Of 671 patients treated with branded lamotrigine, 187 patients (27.9%) switched to a generic, and 51 of these patients (27.5%) switched back to the branded medication. Rates of switchback were from 20.8% to 44.1% for various AEDs and from 7.7% to 9.1% for non-AEDs. Relative to the branded lamotrigine use period, generic lamotrigine use period was associated with a 5.1% increase in mean daily dose of lamotrigine (239.1 vs 251.4 mg; p = 0.0149), a higher number of dispensations for other AEDs (20.4 vs 23.9 dispensations per person-year; p < 0.001) as well as non-AED drugs (26.4 vs 32.8 dispensations per person-year; p < 0.0001), a higher utilization rate of medical services (8.7 vs 9.8 visits per person-year; p < 0.0001), and a longer hospital length of stay (3.29 days vs 4.86 days per person-year; p < 0.0001). CONCLUSION: A higher propensity to switch back to branded medications was observed among antiepileptic drug users compared to users of antihypertensives and antihyperlipidemics, similar to findings from Andermann et al. Switch to generic lamotrigine was significantly associated with increased physician visits and hospitalizations.
CMAJ. 2008 May 6; 178(10): 1303-11
Pilote L, Abrahamowicz M, Eisenberg M, Humphries K, Behlouli H, Tu JV
BACKGROUND: Existing clinical trial data do not address whether all angiotensin-converting-enzyme (ACE) inhibitors are similarly beneficial in improving survival and reducing the rate of readmission among patients with congestive heart failure. We sought to answer this question using administrative databases from Canada's 3 most populous provinces. METHODS: Using linked hospital discharge and prescription claims databases in Quebec, Ontario and British Columbia, we identified all patients 65 years or older who were admitted to hospital because of congestive heart failure between Jan. 1, 1998, and Mar. 31, 2002, and who had not been admitted for the same reason in the 3 years preceding the study period. We analyzed the association between the type of ACE inhibitor prescribed within 30 days after discharge and subsequent mortality using Cox proportional hazards models. We then adjusted for demographic, clinical, physician and hospital-related variables, with additional time-dependent variables representing current drug use and dosage. We chose ramipril as the reference category for comparison with the other ACE inhibitors because it has increasingly been prescribed to patients with congestive heart failure. RESULTS: A total of 43 316 patients with congestive heart failure filled prescriptions for ACE inhibitors within 30 days after discharge from hospital. Demographic, clinical and prescription-related characteristics were similar among users of each type of ACE inhibitor. In the time-dependent model, the mortality associated with 5 ACE inhibitors was similar to that with ramipril: adjusted hazard ratios (and 95% confidence intervals [CIs]) were 0.95 (0.89-1.02) for lisinopril, 0.92 (0.85-1.00) for fosinopril, 0.99 (0.88-1.11) for quinapril, 0.90 (0.77-1.06) for perindopril and 1.00 (0.80-1.24) for cilazapril. However, use of enalapril or captopril was associated with higher mortality compared with ramipril: adjusted hazard ratios (and 95% CIs) were 1.10 (1.04-1.16) for enalapril and 1.13 (1.01-1.26) for captopril. INTERPRETATION: When prescribing ACE inhibitors to patients, physicians should consider a possible 10%-15% increase in mortality with captopril and enalapril compared with ramipril among patients with congestive heart failure.
Klin Med (Mosk). 2008; 86(3): 58-65
Agaev MM
THE PURPOSE: Studying of influence of monopril, propranolol and heparin on central hemodynamics, cardiodynamics, volume of defeat and clinical current of myocardial infarction (MI) in the early and late hospital period of disease. 50 patients with an initial front MI with Q wave in the age of from 30 till 70 years are surveyed. By the method of randomization (on a sex, age, extensiveness and localization of necrosis, prescription of stenocardic pains etc.) patients were divided into 2 groups with 25 patients in each. In treatment of 1st group it was used monopril+ propranolol+heparin, of 2nd--propranolol+heparin. With help of EchoCG and DopplerEchoCG studied ESV, EDV, EF, CI, SI, an index of abnormalities of local contractility of left ventricle (ALC), have revealed ventricular extrasystole (VEX) with the help of registration of an electrocardiogram on a magnetic tape during day, and also have established dynamics of BPs, BPd, parameters of PETG--ST, NST, AST, (Rh and features of clinical current of MI during inpatient rehabilitation. Results. Introduction of propranolol and heparin and intake of monopril promoted decrease both BPs, and BPd, however, hypotonia and clinically significant hypotension was not observed. At the same time, reduction of parameters of defeat of a myocardium--(ST, NST, AST, increase of (Rh and also EF, not authentic increase of CI, SI, reduction of ESV, EDV, IALC of LV and impending VEX was marked. Positive dynamics of the specified parameters promoted favorable current of MI, reduction of quantity of patients with postinfarction stenocardia, and also interfered with development of CHF in the late hospital period of MI. During stationary rehabilitation were not registered recurrences and mortality. Dynamics of the above-stated parameters in 2nd group was expressed, but to a lesser degree, than in 1st group. Clinical current of MI in 1st group proceeded more favorably, than in 2nd group.
Indian J Exp Biol. 2008 Mar; 46(3): 180-4
Nayak V, Patil PA
Fosinopril, ramipril and losartan significantly decreased the duration (sec) of immobility in forced swim test and were comparable to amitriptyline. The duration of immobility were significantly decreased in fosinopril, ramipril and losartan in the tail suspension test and were comparable to amitriptyline. Only losartan significantly increased the rearing number of entries, time spent (sec) in open arm and in light area in comparison to control animals. Fosinopril and ramipril and not lisinopril showed significant antidepressant activity while losartan showed a significant antidepressant and anxiolytic activity. Present findings suggest that these drugs could be better antihypertensives in hypertensive patients with comorbidity like depression or anxiety.
Clin Drug Investig. 1998; 15(2): 101-9
Veglio F, Gastaldi L, Frascisco M, Coda L, Melchio R, Rabbia F, Chiandussi L
The aim of this study was to assess the differential response in left ventricular mass and resistive index (RI) of renal and carotid arteries in mild to moderate essential hypertensive patients after 1 year of ACE inhibitor therapy. Twenty-six patients (mean age 42.9 +/- 10.9 years) underwent 24-hour ambulatory blood pressure monitoring, echocardiography and renal and carotid echo-Doppler (by measuring RI, as an expression of arterial impedance) after a placebo period and 12 months of fosinopril treatment (20 mg/day). Our study showed a significant decrease in 24-hour BP (p < 0.05), left cardiac mass (p < 0.05) and RI of common carotid and hilum renal arteries (p < 0.05). In contrast, there were no significant reductions in the interlobar renal RI (as an expression of unchanged intrarenal resistance) and in the internal carotid artery RI. While the 24-hour BP decrease was strongly correlated with the left cardiac mass modifications (r = 0.73, p < 0.005), no significant relationship was observed with the renal and carotid artery parameters. In conclusion, the present study demonstrated that long-term treatment with fosinopril produced a differential response in left ventricular mass and arterial RI in patients with mild to moderate essential hypertension. In addition, the arterial impedance modifications of common carotid and hilum renal artery were largely unrelated to the 24-hour BP reduction.
Clin Drug Investig. 1998; 15(2): 91-9
Saini R, Romanini M, Mos L
This 6-month multicentre, randomised, double-blind, parallel group clinical trial compared the tolerability and antihypertensive efficacy of a once-daily combination of fosinopril 20mg/hydrochlorothiazide 12.5mg (FOS/HCTZ) with a combination of amiloride 5mg/hydrochlorothiazide 50mg (AMI/HCTZ) in 217 patients with mild to moderate essential hypertension. Adverse events related to hypotension or to specifically targeted clinical laboratory values were observed infrequently with FOS/HCTZ compared with AMI/HCTZ: with FOS/HCTZ, only 4 of 104 patients (3.9%) experienced such events, compared with 16 of 113 (14.1%) in the AMI/HCTZ group (p < 0.001). While statistically significant differences were found between the two treatment groups for changes from baseline in serum potassium, cholesterol, triglyceride and glucose values, the metabolic profile was uniformly unfavourable towards the AMI/HCTZ group; for example, reductions in potassium and elevations in cholesterol, triglyceride and glucose were more pronounced with the AMI/HCTZ group than with the FOS/HCTZ group. Both antihypertensive regimens produced statistically significant reductions from baseline in seated diastolic blood pressure that were equivalent at most points of measurement during double-blind treatment. Therapeutic response rates were high (>/=95%) and were similar for both regimens throughout the study. Because the relative risk for adverse events was markedly less over the long term with FOS/HCTZ than with AMI/HCTZ, the combination of fosinopril and hydrochlorothiazide may offer significant tolerability advantages over amiloride plus hydrochlorothiazide for such patients.
Clin Drug Investig. 1998; 15(1): 21-8
Saini R, Romanini M, Veglio F
A multicentre, randomised, double-blind, parallel-group study of the tolerability and antihypertensive efficacy of once-daily fosinopril 20 mg/hydrochlorothiazide 12.5mg (FOS/HCTZ) compared with once-daily hydrochlorothiazide 25mg (HCTZ) was conducted in 142 patients with non-insulin-dependent diabetes mellitus (NIDDM) and mild to moderate essential hypertension. After 12 weeks of treatment, both groups had statistically significant mean changes from baseline in seated diastolic and systolic blood pressures (FOS/HCTZ, -15.0mm Hg; HCTZ, -11.9mm Hg for seated diastolic blood pressure). The difference between treatment groups was statistically significant (p < 0.001). In addition, normalisation of seated diastolic blood pressure was achieved in 85% of FOS/HCTZ patients compared with 71% of HCTZ patients. A statistically significant difference (p < 0.05) in favour of FOS/HCTZ was observed for the total number of favourable responses (normalisation or >/=10mm Hg reduction in seated diastolic blood pressure) at week 12 and for the end-point analysis. One FOS/HCTZ patient and 5 HCTZ patients discontinued treatment because of adverse events. No clinically significant changes in serum glucose, potassium or cholesterol were observed. A slight but statistically significant increase in fasting triglycerides occurred with FOS/HCTZ compared with HCTZ (+26.1 vs +13.5 mg/dl, respectively; p < 0.05). These results show that the combination of fosinopril and hydrochlorothiazide has considerable potential as an effective antihypertensive regimen that does not significantly alter glucose or lipid metabolism in patients with NIDDM.
Diabetes Care. 2008 Feb; 31 Suppl 2: S194-201
Basi S, Fesler P, Mimran A, Lewis JB
J Cardiovasc Pharmacol. 2008 Jan; 51(1): 24-31
Tao X, Zhang YJ, Shen FM, Guan YF, Su DF
AIM: To study the effects of fosinopril on sinoaortic denervation (SAD)-induced pulmonary vascular remodeling and on phosphodiesterases (PDE) 1 in rats. METHODS: SAD was performed in male Sprague-Dawley rats at the age of 10 weeks. The experiment included sham-operated (Sham), SAD, and fosinopril-treated SAD groups. Fosinopril (15 mg/kg/d) was given in rat chow. After 16 weeks of treatment, the pulmonary arteries were taken for investigations, including pharmacological study, measurement of cGMP, light microscopy, immunohistochemistry, Western blotting, and quantitative real-time RT-PCR. RESULTS: Compared with Sham rats, blood pressure variability (BPV) was significantly increased in the SAD group. However, the mean pulmonary artery pressure (mPAP) was not significant change among 3 groups. After SAD, maximal contraction of pulmonary artery rings to phenylephrine was markedly decreased; the most prominent morphological change in the lung included thickening vascular walls, increasing number of smooth muscle cells, and greater wall-to-lumen ratio; the tissue concentrations of cGMP was reduced significantly; PDE1A or PDE1C expression was upregulated significantly, and endothelial nitric oxide synthase (eNOS) expression was downregulated significantly. Fosinopril treatment prevented these changes induced by SAD. CONCLUSION: Pulmonary artery remodeling (structural and functional abnormalities) was induced by SAD. Fosinopril, an angiotensin-converting enzyme inhibitor, mainly via potentiating eNOS pathway and inhibiting AngII formation, effectively prevented increased blood pressure variability and vascular remodeling of the pulmonary artery after SAD by regulating the activity levels or expression of eNOS, cGMP, and PDE1s.