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Ideally generic 100mg neurontin, these self-help Choice of Drug and Dosage Form interventions are practiced before illness occurs and they can help prevent or delay illness discount neurontin 600mg with mastercard. However buy neurontin 400 mg online, most indi- For relief of acute angina and prophylaxis before events that viduals are unmotivated until illness develops buy 600 mg neurontin otc, and per- cause acute angina order neurontin 400 mg line, nitroglycerin (sublingual tablets or haps after it develops as well. These interventions are translingual spray) is usually the primary drug of choice. For example, for a client Sublingual or chewable tablets of isosorbide dinitrate also who already has angina, a supervised exercise program may be used. For long-term prevention or management of helps to develop collateral circulation. Smoking has nu- recurrent angina, oral or topical nitrates, beta-adrenergic block- merous ill effects on the client with angina and decreases ing agents, or calcium channel blocking agents are used. Combination drug therapy with a nitrate and one of the other During an acute anginal attack in a client known to have drugs is common and effective. Clients taking one or more angina or CAD: long-acting antianginal drugs should carry a short-acting • Assume that any chest pain may be of cardiac origin. Titration of Dosage • Record the characteristics of chest pain and the presence of other signs and symptoms. Dosage of all antianginal drugs should be individualized to • Have the client take a fast-acting nitroglycerin prepara- achieve optimal benefit and minimal adverse effects. This is tion (previously prescribed), up to three sublingual tablets usually accomplished by starting with relatively small doses or three oral sprays, each 5 minutes apart, as necessary. Tolerance to Long-Acting Nitrates Outside of a health care setting, call 911 for immediate assistance. Clients who take long-acting dosage forms of nitrates on a • Leave sublingual nitroglycerin at the bedside of hospi- regular schedule develop tolerance to the vasodilating (anti- talized clients (per hospital policy). The clients more likely to develop should be within reach so they can be used immediately. Record the number of tablets used daily, and ensure an Although tolerance decreases the adverse effects of hypoten- adequate supply is available. As a result, episodes of chest pain may occur more Evaluation often or be more severe than expected. In addition, short- acting nitrates may be less effective in relieving acute pain. Opinions seem divided about the best way to prevent or • Observe and interview regarding the number of episodes manage nitrate tolerance. The brand names often differ very little (eg, Procar- causes are hypertension and atherosclerosis of the coro- dia is a brand name of immediate-release nifedipine; nary arteries. The chest pain usually lasts less than Procardia XL is a long-acting formulation). It is extremely 5 minutes and episodes can be managed for years with- important that the correct formulation is used consistently. However, if the pain is severe or prolonged, a heart attack and heart dam- Self- or Caregiver Administration age may develop. You need to seek information about ✔ Take or give as instructed; specific instructions differ with your heart condition to prevent or decrease episodes of the type of antianginal drug being taken. This increases drug effectiveness need a combination of drugs for the best effects. The dosage forms were developed for specific a nitroglycerin solution that you spray into your mouth) to routes of administration and are not interchangeable. You should seek emergency care ✔ For sublingual nitroglycerin tablets, place them under immediately if rest and three sublingual tablets or oral the tongue until they dissolve. Take at the first sign of sprays 5 minutes apart do not relieve your chest pain. If The long-acting medications are not effective in relieving chest pain is not relieved in 5 minutes, dissolve a sudden anginal pain. If pain is not relieved ✔ As with any medications for serious or potentially serious within another 5 minutes, dissolve a third tablet.

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Other anti- adrenergic drugs include guanethidine and related drugs neurontin 300 mg overnight delivery, Converting enzyme which act at postganglionic nerve endings; and two other ACE inhibitors alpha blockers (phentolamine and phenoxybenzamine) discount neurontin 300 mg with mastercard, block enzyme which occasionally are used in hypertension resulting from action catecholamine excess best 600 mg neurontin. Individual antiadrenergic drugs are Angiotensin II ARBs block discussed in Chapter 19 discount neurontin 300mg otc. The mechanism of action and secretion water growth use in the management of tachydysrhythmias and angina pec- retention (Remodeling) toris are discussed in Chapters 52 and 53 cheap 400 mg neurontin mastercard. In hypertension, the drugs mainly dilate peripheral arteries and decrease periph- eral vascular resistance by relaxing vascular smooth muscle. Increased peripheral vascular resistance Increased intravascular fluid volume Most of the available drugs are approved for use in hyper- Increased blood pressure tension. Nifedipine, a short-acting calcium channel blocker, has been used to treat hypertensive emergencies or urgencies, often by puncturing the capsule and squeezing the contents under the Figure 55–1 Angiotensin-converting (ACE) enzyme inhibitors in- tongue or having the client bite and swallow the capsule. Such hibit angiotensin-converting enzyme and thereby prevent formation of angiotensin II; angiotensin II receptor blockers (ARBs) prevent an- use is no longer recommended, because this practice is associ- giotensin II from connecting with its receptors and thereby prevent it ated with an increased risk of adverse cardiovascular events from acting on body tissues containing those receptors (eg, blood precipitated by rapid and severe decrease in blood pressure. As a group, the calcium channel blockers are well absorbed from the gastrointestinal tract following oral administration and are highly bound to protein. SNS stimulation produces widespread effects in the body, the effects relevant to this discussion are the increases in heart rate, force of myocardial contraction, cardiac output, Diuretics and blood pressure that occur. When the nerve impulse is in- hibited or blocked at any location along its pathway, the re- Antihypertensive effects of diuretics are usually attributed to sult is decreased blood pressure (see Chap. In fact, diuretics usually produce Alpha1-adrenergic receptor blocking agents (eg, prazosin) the same effects as severe dietary sodium restriction. In many dilate blood vessels and decrease peripheral vascular resis- cases of hypertension, diuretic therapy alone may lower blood tance. One adverse effect, called the first-dose phenomenon, cardiac output decrease. With long-term administration of a results in orthostatic hypotension with palpitations, dizziness, diuretic, cardiac output returns to normal, but there is a per- and perhaps syncope 1 to 3 hours after the first dose or an in- sistent decrease in peripheral vascular resistance. To prevent this effect, first doses and first in- been attributed to a persistent small reduction in extracellular creased doses are taken at bedtime. Another effect, associated water and plasma volume, decreased receptor sensitivity to with long-term use or higher doses, leads to sodium and fluid vasopressor substances such as angiotensin, direct arteriolar retention and a need for concurrent diuretic therapy. Cen- vasodilation, and arteriolar vasodilation secondary to elec- trally acting sympatholytics (eg, clonidine) stimulate pre- trolyte depletion in the vessel wall. When these drugs are taken, less to a diuretic alone, the diuretic may be continued and another norepinephrine is released and sympathetic outflow from the antihypertensive drug added, or monotherapy with a differ- vasomotor center is reduced. Stimulation of presynaptic ent type of antihypertensive drug may be tried. Reduced sympathetic activity commonly used in the management of hypertension. Loop CHAPTER 55 ANTIHYPERTENSIVE DRUGS 803 diuretics (eg, furosemide) or potassium-sparing diuretics • Oral contraceptives, corticosteroids, appetite sup- (eg, spironolactone) may be useful in some circumstances; pressants, nasal decongestants, non-steroidal anti- see Chapter 56 for discussion of diuretic drugs. Vasodilators (Direct Acting) • Check blood pressure accurately and repeatedly. As a rule, multiple measurements in which systolic pressure Vasodilator antihypertensive drugs directly relax smooth is above 140 mm Hg and/or diastolic pressure is above muscle in blood vessels, resulting in dilation and decreased peripheral vascular resistance. They also reduce afterload and 90 mm Hg, are necessary to establish a diagnosis of may be used in management of heart failure. These drugs have a limited effect surements cannot be overemphasized because there on hypertension when used alone because the vasodilating are many possibilities for errors. Some ways to im- action that lowers blood pressure also stimulates the SNS and prove accuracy and validity include using correct triggers reflexive compensatory mechanisms (vasoconstric- equipment (eg, proper cuff size), having the client tion, tachycardia, and increased cardiac output), which raise rested and in the same position each time blood pres- blood pressure. This effect can be prevented during long-term sure is measured (eg, sitting or supine with arm at therapy by also giving a drug that prevents excessive sym- heart level), and using the same arm for repeated mea- pathetic stimulation (eg, propranolol, an adrenergic blocker). These drugs also cause sodium and water retention, which • In most cases of early hypertension, elevated blood may be minimized by concomitant diuretic therapy. If symptoms do occur, they are usually nonspecific (eg, headache, weakness, fatigue, tachycardia, dizziness, palpitations, INDIVIDUAL DRUGS epistaxis). Antiadrenergic drugs are discussed in Chapter 19 and pectoris, myocardial infarction, or heart failure. Antihypertensive agents are pain, tachycardia, dyspnea, fatigue, and edema may shown in the Drugs at a Glance: Antihypertensive Drugs; occur.

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The requirements for paediatric study designs are for this and other reasons different from studies in PUBLICATIONS adults generic 600 mg neurontin fast delivery. To obtain a sufficient number of subjects requires Readability of pediatric biomedical research infor- a large number of study centres buy discount neurontin 800 mg online. Participation in is usually higher than for studies in adults–both biomedical research: the consent process as viewed by children 800mg neurontin visa, adolescents purchase 400mg neurontin fast delivery, young adults order neurontin 600 mg visa, and physi- to pharmaceutical companies, as sponsors of the cians. For • Ethical Conduct of Studies to Evaluate Drugs in instance, explaining the nature of a study–to Pediatric Populations. Pedi- obtain permission from parents and ensure their atrics (1995) 95: 286–94. Unlicensed and Caring for the children during their visits to off label drug use in neonates. Arch Dis Childh: the study centre also requires creativity, patience Fetal Neonatal Edit (1999) 80: F142–5. Pediatric drug development; the Interna- tional Conference of Harmonization Focus on Clin- Faced with heavy workloads, paediatricians may ical Investigation in Children. Drug Inform J (2000) often be reluctant to assume what looks like 34: 809–19. But a shortage of investigators is not the only problem that OFFICIAL DOCUMENTS/GUIDELINES slows paediatric trials. It takes many subjects to satisfy the requirements for an adult drug to be • Review and award codes for the NIH inclusion of adequately studied in children–and frequently the children policy March 26, 1999. CPMP/ICH/2711/99, January 2001, adopted guards of Children in Clinical Investigations of July 2000. FDA-Regulated Products: Interim Rule, Federal • European Commission, Better Medicines for Chil- Register 66 (79) 20589 (24 April 2001). ARTHUR Department of Epidemiology and Public Health, University of Leicester, Leicester, UK As few diseases or conditions present for the first 80 years of age, found only 38% of studies time in later life, there are few treatments pre- included subjects over 75 years of age. However the increasing like- the use of a maximum age for eligibility and lihood of illness other than that under treatment obviously such trials provide little information and greater mental and physical frailty with age- about the efficacy of treatments in older age ing means that older people can be inherently groups. However implicit exclusion is also com- different to younger adults and the numerous mon, through criteria such as the presence of co- physiological changes that accompany the ageing morbid conditions. In addition certain recruitment process may alter the way in which older people methods may result in study populations with respond to drugs. In these cases the 65+ age group will form over 15% of the it may be difficult for the clinician to be aware of total population and over 20% in Japan. In the the paucity of older people studied, resulting in UK, those aged 65 years and over make up 18% the late recognition of serious side effects when of the population but they receive nearly half of drugs tested on predominantly younger adult pop- all prescriptions. Green  2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5 56 TEXTBOOK OF CLINICAL TRIALS number of barriers at each stage of a trial: The process of patient selection and recruit- eligibility, recruitment, gaining informed consent ment mostly aims to produce an homogeneous and follow-up. In addition we will discuss strate- study population with the purpose of increas- gies for increasing the number of older people in ing the statistical power to detect the effects of clinical trials, so that in future, those responsible drugs. Indeed, although tight eligibility criteria may aim to produce very similar par- ELIGIBILITY ticipants, inter-patient variability is such that a truly homogeneous group of patients is difficult, Despite recommendations to the contrary, older if not impossible, to identify. Important prog- people are still being excluded from clinical nostic variables will be measured at baseline, research on the basis of age alone, shown by an but even if study participants are the same on analysis of studies reported in four leading jour- these criteria, they will still vary in the course nals (BMJ, Gut,theLancet and Thorax) which of their disease and on unmeasured prognostic factors. Even when treatment trials strongly related to advancing age, found that tri- are specifically designed for older people, overly als published later were more likely to exclude stringent exclusion criteria can produce highly older subjects. Moreover, since more women than skewed and non-representative patient popula- men survive to older age and in some cases, such tions. Since there Operating an upper age limit for trials has is considerable scope for improving such symp- often been used to limit the problem of co- toms with drugs that enhance cognition, these trials may well be missing opportunities. A patients who may respond particularly well to the review of pertinent studies suggests that this drug under test. A trial comparing the efficacy may be misguided since the physiological and of sertraline and nortriptyline in major depres- functional characteristics of the patient, rather sion included patients aged 60 years and over, than chronological age per se, appear to be the but a subgroup analysis of the 76 patients aged most important in drug interactions. The advantages of CLINICAL TRIALS INVOLVING OLDER PEOPLE 57 wide eligibility criteria for entering patients into Although the experience of earlier trials on clinical trials are summarised in Box 4. Large study sizes reduce random error, strategies, though mass mailing, media advertis- providing more reliable overall results. There- screening, participant referrals and other recruit- fore greater clinical and public ment methods have been compared in a trial of health impact. Greater opportunity to test sub- the efficacy of weight loss and sodium reduction for preventing hypertension in the elderly.

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