WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue quinapril tablets as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
WARNINGS: Fetal Toxicity
Quinapril (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.
Quinapril tablets USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets USP.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina or diabetic kidney disease). These considerations may guide selection of therapy.
Quinapril tablets USP may be used alone or in combination with thiazide diuretics
In using quinapril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets does not have a similar risk (see
Angioedema in Black Patients
Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
Published Studies Related to Quinapril
Effect of quinapril on in-stent restenosis and relation to plasma apoptosis signaling molecules. [2010.01.01]
Angiotensin-converting enzyme inhibitors have been reported to inhibit in-stent restenosis. To assess the effect of angiotensin-converting enzyme inhibition on in-stent restenosis and its relation to apoptosis, 86 patients with chronic coronary artery disease who required stent implantation in the left anterior descending coronary artery or a major diagonal branch were studied...
LC-MS/MS assay of quinapril and its metabolite quinaprilat for drug bioequivalence evaluation: prospective, concurrential and retrospective method validation. [2009.04]
CONCLUSION: The method was found to be selective, precise, accurate and robust when applied to a large number of unknown samples.
Lack of efficacy of quinapril on vascular damage in limited cutaneous systemic sclerosis. [2008.06]
Gliddon et al... There were no detectable differences between patients treated with quinapril and those receiving placebo; however, although no severe adverse effects were observed, patients taking quinapril experienced significantly more adverse effects.
Prevention of vascular damage in scleroderma and autoimmune Raynaud's phenomenon: a multicenter, randomized, double-blind, placebo-controlled trial of the angiotensin-converting enzyme inhibitor quinapril. [2007.11]
OBJECTIVE: To evaluate the efficacy and tolerability of prolonged administration of quinapril, a long-acting angiotensin-converting enzyme inhibitor, in the management of the peripheral vascular manifestations of limited cutaneous systemic sclerosis (lcSSc) and in the prevention of the progression of visceral organ involvement in the disease... CONCLUSION: Administration of quinapril for up to 3 years had no demonstrable effects on the occurrence of upper limb digital ulcers or on other vascular manifestations of lcSSc in this patient population.
The role of quinapril in the presence of a weight loss regimen: endothelial function and markers of obesity in patients with the metabolic syndrome. [2007.09]
Forty-four patients with the metabolic syndrome were placed on a reduced-calorie and reduced-fat regimen to lose weight throughout a 56-week period. The patients were treated in a crossover fashion with placebo and the angiotensin-converting enzyme inhibitor quinapril for 24 weeks each... These results are potentiated with quinapril and are independent of changes in metabolic parameters.
Clinical Trials Related to Quinapril
Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension [Completed]
We will evaluate the combination of quinapril and alpha lipoic acid in patients with
diabetes mellitus and hypertension. We will determine whether the combination of quinapril
and lipoic acid as compared to quinapril and placebo provides benefit on systemic blood
pressure and proteinuria.
A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension [Completed]
The purpose of this study is to determine the response rate for the therapeutic goal
(diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week
6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20
mg plus hydrochlorothiazide 12. 5 mg; and to determine the mean decrease in diastolic and
systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions [Completed]
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single
dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril
20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy
Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer
Inc.) in healthy, adult, human, male, subjects under fed conditions.
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fasting Conditions [Completed]
The study was conducted as a open-label, balanced, randomized, two-treatment, two-period,
two-sequence, single-dose, crossover, bioavailability study comparing Quinapril
hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a
subsidiary of Ranbaxy pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing
quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis
Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by
Parke-Davis, Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects
under fasting condition.
QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia [Completed]
INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin
converting enzyme) inhibition (quinapril) in improving coronary microvascular function.
PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored
WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow
reserve limitations and evidence for myocardial ischemia in the absence of significant
coronary artery stenosis.
STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT
Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary
flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment,
site-specific variables, and site by treatment effects.
SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle
Angina Questionnaire adjusting for baseline values, site, and site by treatment effects.
SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and
occurrence of adverse events.
STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the
study has been provided. Interim analyses are planned after 15 patients have been enrolled
in each group.
ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT
EACH SITE Approximately 26
Reports of Suspected Quinapril Side Effects
Electrocardiogram QRS Complex Prolonged (7),
Swollen Tongue (7),
Rash Erythematous (6), more >>
Page last updated: 2011-12-09