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Neonotes Adults

Figure 1 Specific binding of digoxin to erythrocytes from neonates and adults. a) Numbers of

digoxin molecules bound per erythrocyte, b) dissociation constant for digoxin binding (from

Kearin et al., 1980).

DRUG RESPONSE AT EXTREMES OF AGE 127

ratio and a threefold higher erythrocyte/plasma concentration in infants. It was

recently shown (Kearin, Kelly & O'Malley, 1980)that the number of specific digoxin

binding sites on erythrocytes, commonly equated with Na+,K+· ATPase sites, from

neonates is two to three times that in adults and that the binding has a lower affmity

(Figure la and b). Ifthe erythrocyte Na+,K+· ATPase reflects the myocardial situation

our fmdings are consonant with there being a decrease in intrinsic sensitivity to

digoxin in neonates.

Central nervous system

Qualitative changes in response to amphetamine and phenobarbitone are weil

known. Thus amphetamine has a paradoxical sedating effect in 'hyperactive'

children. Phenobarbitone on the other hand is said to produce hyperactivity in

children although there has been little detailed investigation of the underlying

mechanism or indeed ofits true prevalence . One placebo controlled study in children

treated with phenobarbitone for febrile seizures (Carnfield, Chaplin, Doyle, Shapiro,

Cummings & Carnfield, 1979) reported increased daytime 'fussiness', 'irritability'

and a sleep disturbance. Qualitative differences in response to other anticonvulsants

have not been reported. It is difficult to say ifthe spectrum ofside effects produced by

these drugs changes in children. Nystagmus due to diphenylhydantoin has been said

to occur only infrequently in children but may be seen when blood levels are in the

therapeutic range (Berman, 1976). This suggests that observed lack of nystagmus

reflects underdosage in children.

Neuromuscular b/ocking drugs

There are significant and interesting differences in response to neuromuscular

blocking drugs in children (Nugent, Laravuso & Rogers, 1979). Neonates have an

increased responsiveness to nondepolarizing blocking drugs such as tubocurarine. On

the other hand infants and young children are more resistant than adults to the

neuromuscular block produced by the depolarizing muscle relaxants such as

succinylcholine and decamethonium. Muscle fasiculations following succinylcholine

are generally not apparent in young children. The reasons for these differences are

unknown. There are also significant differences in effects of spinal anaesthesia in

children, the time to regain motor function after spinal anaesthesia being less (Dohi,

Naito & Takahasi, 1979).

The elderly

Increases in adverse drug reactions with age have been observed both in hospitalised

patients (Klein et al., 1976; Seidl, Thornton, Smith & Cluff, 1966) and in patients

requiring admission to hospital (Hurwitz, 1969; Caranasos et al., 1974). While

increased levels of free drug at the site of action probably are important with some

drugs and also there is more prescribing in the elderly, it seems likely that for many

drugs there is an increased susceptibility to adverse drug reactions . The role of

pharmacodynamics in this is not clear.

Recent advances in understanding the basic mechanisms ofdrug action , especially

at the receptor level, are being increasingly applied to old age. As a result significant

advances are being made in understanding the pattern of effect of drugs, especially

cardiovascular drugs in the elderly.

The ß-adrenoceptor in old age

In recent years a significant amount of work has been published dealing with

alterations in ß-adrenoceptor function in ageing animals. Results of these studies

128 K. O'MALLEY & J. G. KELLY

have suggested possible investigations in man and have enabled clarification ofsome

meehanisms underlying ehanges in adrenergic funetion in old age.

Work in animals has suggested deereases in adrenergieally produeed metabolie and

tissue eontraetile responses with inereasing age (Fleish, Maling & Brodie, 1970;

Lakatta, Gerstenblith, Angeli, Shoek & Weisfeldt, 1975; Bitensky, Russell & Blaneo,

1970). These ehanges seem to refleet deereases in adrenoeeptor density (Bylund,

Tellez-Inon & Hollenberg, 1977; Greenberg & Weiss, 1979). In addition the ability of

ageing tissues to alter reeeptor density is attenuated. Greenberg & Weiss (1979) have

shown that while aged rats ean deerease ß-adrenoeeptor numbers in response to

the inereased amounts of noradrenaline oeeurring after desmethylimipramine treatment they have an impaired ability to inerease numbers after depletion of

noradrenaline by reserpine. Their data also support the hypothesis that numbers of

ß-adrenoeeptors decrease with age without changes in the affmity of neurotransmitter binding to the reeeptors .

Similar observations have been made in man . Deereases in noradrenaline-indueed

lipolysis in isolated fat eells oeeur in old age (Berger, Preiss, Hess-Wortman & Gries ,

1971). It has been shown (Figure 2) that isoprenaline-stimulated produetion of eyclie

AMP by isolated human lymphoeytes is markedly redueed in the elderly (Dillon,

Chung, Kelly, & O'Malley, 1980).One report (Shoeken & Roth, 1977)has deseribed a

deerease in numbers of Iymphoeyte /J-adrenoeeptors with advaneing age. Bertel,

Buhler, Kiowski & Lutold (1980) and Vestal, Wood & Shand (1979) have demonstrated that the dose of isoprenaline required to inerease heart rate by 25 beats

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Figure 2 Cyclic AMPproduction resulting from isoprenalin e stimulation oflymphocytes from

young and elderl y subjects (from Dilion et al., 1980).

DRUG RESPONSE AT EXTREMES OF AGE 129

min-I increases with advancing age in both normal and hypertensive subjects.

Vestal et al. (1979)further demonstrated that resistance to the efTects of propranolol

increases with age. These results suggest that there is a generalised decrease in

ß-adrenoceptor-mediated function in old age.

Cardiovascular drugs

Many of the above changes will be reflected in alterations in cardiovascular function

and in the efTects of drugs on this system . In addition, however, structural changes in

blood vessels might account for a mechanical limitation to drug response (Tuttle,

1966). Diminutions in cardiovascular homeostatic function with age may complicate

treatment.

Pharmacokinetics of digoxin change markedly and predicably with advancing age

(Cusack, Kelly, O'Malley, Noel, Lavan & Horgan, 1979) but there is little evidence

to suggest that intrinsic response to digoxin changes. There are no alterations in

specific tissue binding properties of ouabain in old age (Erdmann & Hasse, 1973)and

this probably also applies to digoxin. Increased incidence ofhypokalaemia especially

during diuretic treatment would lead to an increase in toxicity of digoxin but there is

little recent evidence to suggest that either of these occurs preferentially in the

elderly . While there appear to be no major age related changes in pharmacokinetics

ofwarfarin, the elderly are subject to a higher degree of anticoagulation with this drug

(O'Malley, Stevenson, Ward, Wood & Crooks, 1977). This appears due to an

increased inhibition of vitamin K dependent clotting factor synthesis in the elderly

(Shepherd, Hewick , Moreland & Stevenson, 1977).

Central nervous system

Elderly people are often thought to be particularly sensitive to the central nervous

system depressant efTects of drugs. Possible reasons are, a) increased penetration of

drugs into the central nervous system (CNS), b) reduced elimination of CNS active

drugs and c) increased intrinsic sensitivity to the efTects of drugs . While some information is available concerning alterations in elimination of centrally active drugs

in old age, there is little known ofthe role ofthe remaining two factors . In any event it

would be difficult to distinguish between alterations in distribution of drug and

sensitivity.

A standard dose of pethidine produces higher plasma concentrations in e1derly

subjects (Chan, Kendall, Mitchard, Wells & Vickers, 1975)but it is difficult to establish if an increase in sensitivity contributes to the increased incidence of adverse

reactions to pethidine.

The benzodiazepines are among the drugs most prescribed in the elderly. A study

by Castleden, George , Marcer & Hallett (1977) compared the efTects of nitrazepam

and placebo on psychomotor performance in young and elderly subjects. Thirty six

hours after nitrazepam the old people made twice as many mistakes than on placebo

while there was no difTerence between the efTects of nitrazepam and placebo in the

young subjects at this time. However even after placebo the old people made considerably more mistakes than did young people. The disposition of nitrazepam was

similar in both age groups . These results suggest an increase in efTect ofnitrazepam in

old people but of course it is not possible to distinguish between changes in penetration of nitrazepam into the central nervous system and alterations in tissue

sensitivity. Hewick & Shaw (1978) administered the same dose of 14C labelIed

nitrazepam to young and elderly rats . The plasma concentration, plasma c1earance,

plasma half-life and apparent volume of distribution were similar in both groups .

However, the sedative efTect was greater in the old rats and the concentrations of

radioactivity in brain tissue from the old rats were two to three times greater than in

130 K . O'MALLEY & J. G. KEL LY

th at fro m th e young rats, ind ica ting that inc reased centra l nervou s system concentrations were responsible for th e inc reas ed effect.

Hypertension

H yperten sion occ urs at all ages but poses special probl em s in the elde rly, Wh ile th e

association between high blood pr essure an d cardiovascul ar risk is weil establ ished it

is not kn own at what leve l ofblood pressure drug treatment is of'be nefrt to the elde rly

pat ient. It see ms likely th at in th e elderly high blood pressure has a di fferent ba sis to

th at occ urri ng in younger adults. Systolic hypertension dom inate s since many

pat ients have d isproportionat ely high systolic pressure (SP) co m pa red with diastol ic

pr essure (D P), Koch -Weser (1973) has defmed disproportion at e systolic hypert ension

as SP > (D P - 15) x 2. This is du e to a decrease in a rterial compliance , a disorder

which see ms at least in part to be reve rsible (Simon, Safar, Levenson , Kh eder &

Levy, 1979). Also th e best mean s of lowering blood pr essure in th e elde rly is not

kno wn . Ind eed , th ere is littl e understanding of the ph a rm acok ineti cs and ph armacodynamics ofanti hyperte nsive drugs in thi s age group (O'M all ey & O 'Bri en , 1980) .

Conclusions

In sum ma ry, at both extremes of age th ere are changes in drug dispo sition wh ich

acc o unt for some changes in the magnitude and durat ion of drug effect. Relatively

littl e is kno wn of cha nges in intrinsic responsiven ess but our kn owledge of

ß-ad renoceptor med iat ed effects suggests a dimin ished responsiveness in the elderly .

H ypert ension is an excelle nt exa mple of a disorder in which th e pathogene sis is

d ifferent in eac h age gro up, particul arl y in th e case of th e elde rly , where littl e

is known of the disp ositi on or ph a rm acod ynamics ofantih ypert ensive drugs.

Ou r know ledge of drug effects is gro ssly de ficient in th e elde rly, but th is is even

mo re so in th e very young. W hile there are man y co nstraints on resea rch int o drug

effects particul arl y in th e yo ung it is difficult to escape the conclu sion tha t th e relative

plethora of ph a rm acokinet ic studies reflects the ease with whic h they ca n be don e

whereas th e study of drug effects awaits the atte ntion of more dete rmined c1inical

ph armacologists. On ly when ma ny more studies on drug effects are ca rried out in th e

releva nt c1 inic al setti ng will it be possible to approach thera pe utics in very young and

very old pat ients with co nfidence .

References

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isolated fat cellsof non-obese aged humans(72 yr). Gerontol., 17, 312-322 .

Berman, P. H. (1976). Management of seizure disorders with anticonvulsant drugs. Current

concepts. Ped. Clin . N. Am., 23,443-45 9.

Bertel, 0 ., Buhler, F. R., Kiowski, W. & Lutold, B. E. (1980). Decreased beta adrenoceptor

responsiveness as related to age, blood pressure and plasma catecholamines in patients

with essential hypertension. Hypertension. 2, 130-138.

Bitenskyu, M. W., Russell, V. & Blanco, M. (1 970). Independent variation of glucagon and

epinephrine responsive components of hepatic adenyl cyclase as a function of age, sex and

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Boston Collaborative Drug Surveillance Program. (1972). Drug Surveillance: Problems and

Challenges. Ped. Clin. N. Am ., 19, 117-1 29.

Bylund, D. M., Tellez-lnon, M. T. & Hollenberg, M. D. (1977). Age-related parallel decline in

beta-adrenergic receptors, adenylate cyclase and phosphodiesterase activity in rat erythrocyte membranes. L ife Sci. . 21, 403-410.

Camfield, C. S., Chaplin, S., Doyle, A. B., Shapiro, S. H., Cummings, C. & Camfteld, P. R.

(19 79). Side elTects of phenobarbital in toddlers: behavioral and congenitive aspects. J.

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DRUG RESPONSE AT EXTREMES OF AGE 131

Caranasos, G . J., Stewart, R. B. & Cluff, L. E. (1974). Drug induced illness leading to hospitalization. J. Am. med. Ass., 228, 713-717.

Castleden, C. M., George, C. F., Marcer, D. & Hallett, C. (1977). Increased sensitivity to

nitrazepam in old age. Brit. med. J., 1, 10-12.

Chan, K., Kendall, M. J., Mitchard, M., Wells, W. D. E. & Vickers, M. D. (1975). The efTect of

ageing on plasma pethidine concentration. Brit. J. c1in. Pharmac., 2,297-302.

Cusack, B., Kelly , J. G ., O'Malley, K., Noel, J., Lavan, J. & Horgan, J. (1979). Digoxin in the

elderly: Pharmacokinetic consequences ofold age. Clin. Pharmac. Ther., 25, 772 -776.

Dillon, N., Chung, S., Kelly. J. & O'Malley. K. (1980). Age and beta adrenoceptor-mediated

function. Clin. Pharmac. Ther.. 27, 769-772.

Dohi, S., Naito, H. & Takahasi, T. (1979). Age-related changes in blood pressure and duration of

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Erdmann, E. & Hasse, W. (1973). Quantitative aspects ofouabain binding to human erythrocyte

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Fleish , J. H., Maling, H. M. & Brodie , B. B. (1970). Beta receptor activity in aorta: variations

with age and species. Circu/ation Res., 26,151-162 .

Gorodischer, R., Jusko, W. J. & Yaffe, S. J. (1976). Tissue and erythrocyte distribution of

digoxin in infants. Clin. Pharmac. Ther., 19,256-263.

Greenberg, L. H. & Weiss, B. (1979). Ability of aged rats to alter beta adrenergic receptors of

brain in response to repeated administration of reserpine and desmethylimipramine. J.

Pharmac. exp. Ther., 211,309-316.

Hewick, D. S. & Shaw, V. (1978). Tissue distribution of radioactivity after injection of I4C

nitrazepam in young and old rats. J. Pharm. Pharmac., 30, 318-319.

Hurwitz, N. (1969). Admissions to hospital due to drugs. Brit. med. J., 1,539-540 .

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explanation ofdecreased sensitivity to digoxin? Clin. Pharmac. Ther., in press .

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M. & Hoigne, R. (1976). The frequency of adverse drug reactions as dependent upon age,

sex and duration ofhospitalization./nt. J. c1in. Pharmac., 13,187-195.

Koch-Weser, J. (1973). Correlation ofpathophysiology and pharmacotherapy in primary hypertension. Am. J. Cardiol., 32,499-510.

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