Accuretic (Quinapril Hydrochloride) - Summary

ACCURETIC SUMMARY

ACCURETIC™
(quinapril HCl/hydrochlorothiazide) Tablets

ACCURETIC is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCURETIC should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

INDICATIONS AND USAGE

ACCURETIC is indicated for the treatment of hyperten-sion. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

In using ACCURETIC, 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 does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).

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.

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NEWS HIGHLIGHTS

Media Articles Related to Accuretic (Quinapril)

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

Research Indicates Gaps In Care For Diabetes, Cholesterol, Hypertension Among The Uninsured
Source: Cholesterol News From Medical News Today [2009.10.21]
A new study shows uninsured American adults with chronic illnesses like diabetes or high cholesterol often go undiagnosed and undertreated, leading to an increased risk of costly, disabling and even lethal complications of their disease. The study, published online in Health Affairs, analyzed data from a recent national survey conducted by the Centers for Disease Control and Prevention (CDC).

ESC Press Statement: Accelerated Bone Growth May Be An Indicator Of Hypertension In Children
Source: Hypertension News From Medical News Today [2009.10.21]
Children whose bones are "older" than their chronological age may be at an increased risk of hypertension, according to a study reported (19 October) in Hypertension: Journal of the American Heart Association.(1) As a result, the investigators suggest that markers of biological maturity should be evaluated in hypertensive children, and that physical activity and diet may deter the accelerated development of biological maturity.

Clues to Hypertension in Kids May Be Seen in Bones (HealthDay)
Source: Y! Health Bones, Joints & Muscles News [2009.10.20]
HealthDay - TUESDAY, Oct. 20 (HealthDay News) -- New research links high blood pressure in children to bones that are more mature than average, suggesting that advanced bone age may predict cardiovascular problems.

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Published Studies Related to Accuretic (Quinapril)

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.

Amlodipine added to quinapril vs quinapril alone for the treatment of hypertension in diabetes: the Amlodipine in Diabetes (ANDI) trial. [2007.02]
This randomized, comparative, parallel-group trial investigated strategies of blood pressure (BP)-lowering in patients with diabetes and hypertension. Patients not reaching goal BP (<130/80 mm Hg) after 4-week open-label treatment with quinapril 20 mg/d (n=374) received 40 mg/d quinapril (n=167) or 20 mg/d quinapril plus amlodipine besylate (5 mg/d; n=162) for 6 weeks...

Quinapril for treatment of hypertension in Turkey: dose titration and diuretic combination treatment strategies. [2007]
BACKGROUND and objective: Recently the PatenT (Prevalence, awareness, treatment and control of hypertension in Turkey) study showed that while the prevalence of hypertension in Turkey is high, effective control of BP is infrequently achieved. This study investigated the efficacy and safety of quinapril (as monotherapy or in combination with hydrochlorothiazide [HCTZ]) for achieving BP control (target <140/90 mm Hg) in Turkish subjects with mild to moderate hypertension... CONCLUSION: Quinapril was an effective and safe treatment for achieving and maintaining recommended BP targets in this sample population. These findings will provide clinicians in Turkey with valuable data on the use of quinapril for effective control and management of hypertension.

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Clinical Trials Related to Accuretic (Quinapril)

Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets following a single, oral 20/25 mg (1 x 20/25 mg) dose administration under fed conditions.

Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20 mg/25 mg tablets following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting conditions.

Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF [Not yet recruiting]
Atrial fibrillation (AF) is a very common arrhythmia causing many symptoms resulting in numerous hospitalizations. Catheter ablation is a technique that has evolved significantly to improve symptomatic recurrences, but does not offer a 100% cure rate. We hypothesize that the use of aggressive BP lowering will reduce the rate of recurrent AF after catheter ablation for AF. We plan a randomized clinical trial of aggressive BP lowering versus standard BP control to investigate this. The primary outcome will be time to recurrent AF.

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