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Medical research on lisinopril-hctz
Aliskiren: new drug. Arterial hypertension: no evidence of clinical efficacy.
Prescrire Int. 2008 Apr; 17(94): 47-50
(1) Pharmacological management of arterial hypertension is based on antihypertensive drugs with proven efficacy on morbidity and/or mortality endpoints. (2) Aliskiren is the first renin inhibitor to reach the market. (3) There are no published trials of aliskiren with clinical endpoints. Five double-blind short-term (8 weeks) placebo-controlled trials showed a moderate effect on blood pressure. This effect was not superior to that of other antihypertensive drugs with which aliskiren was compared: hydrochlorothiazide, amlodipine, irbesartan, losartan, valsartan, lisinopril and rampiril. (4) When added to another antihypertensive drug, aliskiren had little or no additional effect on blood pressure. In particular, there is no firm evidence that adding aliskiren to amlodipine 5 mg/day is any more effective than doubling the dose of amlodipine. (5) Aliskiren has not been tested in patients with renovascular hypertension or severe hypertension, but pharmacological data suggest that aliskiren might be less effective in these individuals. (6) Overall, the adverse effect profile of aliskiren does not seem to be any better than that of other antihypertensive drugs. Aliskiren contributes to the onset of angioedema, cough, diarrhea and abdominal pain, hyperuricaemia, gout attacks, kidney stones and skin rash. Pharmacovigilance should focus specifically on certain adverse effects that are known to occur with other drugs acting on renin-angiotensin axis, such as angioedema, muscle disorders and anaemia, even though few such cases were observed with aliskiren during clinical trials. (7) Aliskiren is contraindicated during pregnancy, as are other antihypertensive drugs acting on the renin-angiotensin axis. (8) In practice, it is better not to use aliskiren to treat hypertensive patients because better-assessed antihypertensive drugs with longer follow-up are available.
Hyponatremia associated with tolterodine therapy.
Am J Health Syst Pharm. 2008 Jun 1; 65(11): 1054-6
Madewell KA, Kuo P
PURPOSE: The case of a patient who developed hyponatremia after recent initiation of tolterodine is reported. SUMMARY: An 86-year-old woman arrived at the hospital due to an acute change in her mental status. The patient's daughter found her mother slumped over and stated that she was unresponsive for approximately four minutes. The admitting diagnosis was transient ischemic attack or syncope. Baseline laboratory tests revealed an abnormal basic metabolic panel, including a serum sodium concentration of 125 mmol/L and a serum chloride concentration of 88 mmol/L. The results of a complete blood count and thyroid function tests were within normal limits. Unsuccessful attempts at sodium correction included initial fluid restriction and, later, the administration of 0.9% sodium chloride injection over 24 hours. Physiological causes of hyponatremia were ruled out. The attending physician and team pharmacist reviewed the patient's medication profile for potential causes of hyponatremia. Hydrochlorothiazide, a home medication for the patient, was discontinued at hospital admission and ruled out as a cause of her hyponatremia. A documented association between lisinopril, mirtazapine, or omeprazole and hyponatremia exists in various case reports. However, per the patient's primary care physician, tolterodine was the only modification of an otherwise stable medication profile at an outpatient office visit approximately four weeks prior to admission. Once tolterodine was discontinued, the patient's hyponatremia quickly resolved. Tolterodine was discontinued on hospital day 5, and the hyponatremia was corrected by the next day. CONCLUSION: An 86-year-old woman developed hyponatremia after recent initiation of tolterodine therapy.
J Pharm Biomed Anal. 2008 Jul 15; 47(3): 508-15
Kumar V, Shah RP, Singh S
"Polypill" is a fixed-dose combination (FDC) containing three or more drugs in a single pill. The same is under development for the treatment and prevention of cardiovascular diseases. In the present study, gradient LC methods were developed for simultaneous determination of the possible components of a polypill, i.e., lisinopril, aspirin and one each among atenolol/hydrochlorothiazide and atorvastatin/simvastatin/pravastatin, in the presence of a total of 13 major interaction/degradation products. The drugs and the products were well separated using a reversed-phase (C-8) column and a mobile phase comprising of acetonitrile: phosphate buffer (pH 2.3). Other HPLC parameters were flow rate, 1ml/min; detection wavelength, 210nm; column oven temperature, 60 degrees C; and injection volume, 5mul. The methods were validated for linearity, precision, accuracy, and specificity. These were further modified to make them compatible for LC-MS studies by removal of the phosphate buffer and adjustment of pH by formic acid. The suitability of the methods for LC-MS studies was established by matching the theoretical mass values of the drugs with those obtained experimentally. These methods were used to determine mass values of the major interaction/degradation products, which helped to know the source of their origin.
Renin inhibition with aliskiren.
Clin Exp Pharmacol Physiol. 2008 Apr; 35(4): 426-30
Wuerzner G, Azizi M
1. Initial attempts to inhibit renin in humans have faced numerous difficulties. Molecular modelling and X-ray crystallography of the active site of renin have led to the development of new orally active renin inhibitors, such as aliskiren. 2. Aliskiren has a low bioavailability (between 2.6 and 5.0%) compensated by its high potency to inhibit renin (IC50: 0.6 nmol/L) and a long plasma half-life (23-36 h), which makes it suitable for once-daily dosing. 3. The once-daily administration of aliskiren to hypertensive patients lowers BP as strongly as standard doses of established angiotensin II type 1 (AT1) receptor blockers (losartan, valsartan, irbesartan), hydrochlorothiazide, angiotensin converting enzyme inhibitors (ramipril and lisinopril) or long acting calcium channel blockers (amlodipine). In combination therapy, aliskiren further decreases blood pressure when combined with either hydrochlorothiazide, amlodipine, irbesartan or ramipril. 4. The biochemical consequences of renin inhibition differ from those of angiotensin I-converting enzyme (ACE) inhibition and Ang II antagonism, particularly in terms of angiotensin profiles and interactions with the bradykinin-nitric oxide-cyclic guanosine monophosphate pathway and possibly the (pro)renin receptor. 5. Blockade of the renin angiotensin system (RAS) with ACE inhibitors, AT1 receptor blockers or a combination of these drugs has become one of the most successful therapeutic approaches in medicine. However, it remains unclear how to optimize RAS blockade to maximize cardiovascular and renal benefits. In this context, renin inhibition to render the RAS fully quiescent is a new possibility requiring further study.
Combined therapy with a calcium channel blocker and an angiotensin II type 1 receptor blocker.
J Clin Hypertens (Greenwich). 2008 Jan; 10(1 Suppl 1): 27-32
Bakris GL
Fixed-dosed combination regimens consisting of a calcium channel blocker and an angiotensin II type 1 receptor blocker represent a new addition to the available antihypertensive treatment options. Clinical trials demonstrate that both the dihydropyridine calcium channel blocker amlodipine and angiotensin II receptor blockers are effective agents for the management of hypertension in individuals with or without cardiovascular disease. When combined, these 2 classes of agents have complementary effects on blood pressure, as each targets separate signaling pathways in the vasculature pivotal to the regulation of vascular function. In clinical trials this combination has demonstrated better efficacy, defined by time to reach blood pressure targets as well as levels of blood pressure achieved, compared with the individual agents. In a comparative trial, a combination of amlodipine plus valsartan (an angiotensin II receptor blocker) also produced greater reductions in blood pressure compared with a combination of lisinopril (an angiotensin-converting enzyme inhibitor) and hydrochlorothiazide. The combination of amlodipine and an angiotensin II receptor blocker is well tolerated, including in patients with stage 2 hypertension and the elderly.
Beijing Da Xue Xue Bao. 2007 Dec 18; 39(6): 619-23
Chen YY, Sun NL, Zhang WZ, Wu HY, Zhang L, Yu ZQ, Zhang FC, Xiang XP, Liu HL, Shen FR, Tao J, Zhao JA
OBJECTIVE: To evaluate the efficacy, safety and tolerance of Felodipine controlled release tablets and Felodipine controlled release tablets associated combination each with Metoprolol, Lisinopril or Hydrochlorothiazide in the 12 weeks treatment of mild to moderate essential hypertension in China. METHODS:Multicenter, random samples, and open study have been processed. RESULTS: (1)After 12 weeks associated combination treatment of antihypertension, the percentages of the persons who had attained the target were 80.2% of ITT group in Felodipine controlled release tablets associated combination with Hydrochlorothiazide, 74.1% of ITT group in with Metoprolol,and 80.5% of ITT group in with Lisinopril, respectively. (2)Mean reductions of systolic/diastolic blood pressure from baseline were 16.8/10.6 mm Hg in combination with Hydrochlorothiazide, 16.6/10.7 mm Hg in combination with Metoprolol,and 18.0/12.8 mm Hg in combination with Lisinopril each. There was no significant difference among these three groups (P>0.05). With the Felodipine controlled release tablets treatment alone, the mean reductions from baseline was 24.8/17.5 mm Hg. But in combination with Lisinopril, the blood pressure could lower more quickly, and then could reach the target more rapidly. (3)In the ITT group, the drug compliance with Felodipine controlled release tablets was 97.7%, with those in combination with Hydrochlorothiazide 89.8%, with those in combination with Metoprolol 100.0%, and with those in combination with Lisinopril 96.4%. The main adverse event related to Felodipine was headache, and to Lisinopril was cough. CONCLUSION: Antihypertensive drug Felodipine controlled release tablets are good and effective. And Felodipine controlled release tablet associated combination each with Metoprolol, Lisinopril or Hydrochlorothiazide can make most patients reach the treatment target, with safety, good tolerance, and high compliance.
Bosn J Basic Med Sci. 2007 Nov; 7(4): 377-82
Gerc V, Begović B, Vehabović M, Voronkov LG, Vataman E, Musić L, Buksa M, Kusljugić Z, Ilyash MG, Ena LM, Tchelujko VI, Dyaduk AI, Bagrij AE, Andrievskaja SA, Vehabović A, Knezević B, Hima F
The aim of this trial was to examine the efficacy and safety of antihypertensive fixed combination lisinopril plus hydrochlorothiazide (Lopril H, Bosnalijek dd) in the treatment of essential arterial hypertension. In our trial we included 297 patients, aged 54.65+/-9.6 years, with treated or untreated hypertension and with high risk of cardiac events, in an opened trial of therapy based on lisinopril plus hydrochlorothiazide. Upon the examination by physicians, patients were divided into three groups in accordance with European Society of Cardiology guidelines for the management of arterial hypertension. Patients from five European countries were followed up for a period of 12 weeks. Duration of treatment was 12 weeks. We adjusted daily doses of lisinopril plus hydrochlorothiazide after every clinical examination and recorded adverse effects of drugs. After 12 weeks of treatment, 288 patients (96%) were evaluated for efficacy, tolerability and safety. In almost 81.5% patients with mild, moderate and severe hypertension, we recorded a reduction in blood pressure to approximately normal values SBP and DBP (140/90 mmHg). Drug-related side-effects occurred in 11 patients (3.66%). The most commonly reported adverse effects associated with lisinopril plus hydrochlorothiazide were cough (5) and dry mouth (5). This research has proved good efficacy of fixed combination lisinopril plus hydrochlorothiazide with more than 97% patients. Based on subjective estimation by patients: this drug improved quality of life in all cases.
Influence of tablet splitting on content uniformity of lisinopril/hydrochlorthiazide tablets.
Bosn J Basic Med Sci. 2007 Nov; 7(4): 328-34
Vranić E, Uzunović A
Dose-related adverse effects of medications are a major problem in modern medical practice. The "correct" dose, based on drug company guidelines in package inserts, may not be correct for many patients. Tablet splitting or dividing has been an accepted practice for many years as a means of obtaining the prescribed dose of medication. As model tablets for this investigation, two batches of lisinopril- hydrochlorothiazide scored tablets labeled to contain 20/12.5 mg were used. The aim of this study was to establish possible influence of tablet splitting on content uniformity of lisinopril/hydrochlorthiazide tablets. Determination of the content uniformity of lisinopril and hydrochlorthiazide in our batches, was carried out by HPLC method. The results of content uniformity studies for halves of tablets containing combination of lisinopril-hydrochlorthiazide (supposed to contain 50% of stated 20/12.5 mg in the whole tablet) were: 49.60 +/-3.29% and 49.29+/-0.60 % (lisinopril); 50.33+/-3.50% and 50.69+/-1.95% (hydrochlorthiazide) for batch I and II, respectively. We can conclude that the results obtained in this study support an option of tablet splitting, which is very important for obtaining the required dosage when a dosage form of the required strength is unavailable, and for better individualization of the therapy.
J Hum Hypertens. 2007 Oct; 21(10): 780-7
Strasser RH, Puig JG, Farsang C, Croket M, Li J, van Ingen H
Patients with severe hypertension (>180/110 mm Hg) require large blood pressure (BP) reductions to reach recommended treatment goals (or=105 mm Hg and
Clin Ther. 2007 Feb; 29(2): 279-89
Poldermans D, Glazes R, Kargiannis S, Wernsing M, Kaczor J, Chiang YT, Yen J, Gamboa R, Fomina I
BACKGROUND: Most patients with hypertension in the United States and Europe fail to achieve the recommended target blood pressure (BP) of 20/10 mm Hg above the goal. Combination therapy with agents having complementary mechanisms of action, such as a calcium channel blocker and an angiotensin II-receptor blacker, would be a potentially useful therapeutic option. OBJECTIVES: This study evaluated the overall safety profile of combination therapy with amlodipine plus valsartan compared with a combination of lisinopril plus hydrochlorothiazide (HCTZ) in patients with stage 2 hypertension (mean sitting diastolic BP [MSDBP] >or=110 and