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CLINICAL The April issue of the South African Medical Journal contains the new guidelines for the prevention, diagnosis and treatment of hypertension in South Africa. 1 These guidelines are very comprehensive and give practical advice on lifestyle changes, risk stratification and treatment options. These guidelines are available at www.hypertension.org.za. All healthcare workers in South Africa should adhere to these guidelines to standardise the approach to every hypertensive patient. This article summarises some of the highlights and doesn’t replace the original text. Latest South Africa HYPERTENSION GUIDELINES released Blood pressure measurement Cardiovascular risk stratification Standardising blood pressure measurement is clearly outlined in this guideline. Of utmost importance are the recommendations for validated blood pressure devices. Only upperarm devices are recommended and pharmacists should only stock devices that are validated by the SA Hypertension Society. A comprehensive list of validated devices is available at www.dableducational.com. SAPJ will soon publish a comprehensive list of validated devices that are available in South AFrica. Moreover, pharmacists should check the devices in their clinics, have them calibrated and communicate new guidelines to clinic sisters. Implementing lifestyle changes will not only reduce the risk of developing hypertension and reduce blood pressure levels, but will also reduce the risk of developing any other cardiovascular diseases. Patients may already have some major risk factors (abdominal obesity, dyslipidaemia, type 2 diabetes mellitus, family history of early cardiovascular disease and smoking). Four factors are taken into consideration when classifying a patient into a specific risk category namely, blood pressure levels, the presence of 1-2 or >3 major risk factors, the presence of target organ damage and/or diabetes mellitus, and the presence of other associated clinical conditions (heart failure, coronary heart disease, stroke or transient ischaemic attacks, peripheral artery disease and retinopathy). Lifestyle changes No longer should hypertension be monitored with a blood pressure reading only. Adequate monitoring of hypertensive patients includes adherence to lifestyle modifications and compliance with drug regimens. The guidelines give practical advice on these lifestyle modifications. The key message is that lifestyle changes can lower blood pressure, prevent hypertension as well as other cardiovascular diseases. The lifestyle modifications include weight reduction, restriction of daily alcohol and sodium consumption, adherance to a specific diet plan (reduced fat intake and increased intake of fruits, vegetables and wholegrain foods), physical exercise and smoking cessation. 8 The five risk categories are: average risk, low added risk, moderate added risk, high added risk and very high added risk. Most patients with low and moderate added risk can be managed at primary healthcare level and should be seen every 6 months. Additional investigations The following investigations should be performed at the first visit and should be repeated yearly if normal: urine dipsticks, microalbuminuria, blood glucose and random total cholesterol. The following should be done at every visit: average blood pressure (of two SA Pharmaceutical Journal – May 2006 CLINICAL readings), weight and BMI and waist circumference. Patients should be referred to the general practitioner for the following yearly tests: blood (creatinine and potassium levels) and a resting ECG to detect left ventricular hypertrophy. • Treatment Patients are managed according to the specific risk categories. The targets for blood pressure on lifestyle modification and drug treatment are <140/90 mmHg for all stages of hypertension and <130/80 mmHg for high-risk patients (those with diabetes and renal disease and congestive heart failure). Drug treatment should be commenced in the following cases: • Low added risk despite a period of 6-12 months of lifestyle modifications and observation. • Moderate added risk despite a period of 3-6 months of lifestyle modifications and observation. • High or very high added risk. Drug choices • Uncomplicated hypertension cases are now treated with diuretics, ACEinhibitors and calcium channel blockers. • Step one therapy: low-dose thiazide diuretics (12.5 mg – 25 mg) or thiazide-like diuretics. • Step two and three therapy: cost and compelling indications should be considered first. If still uncomplicated, then ACE-inhibitors (or angiotensin receptor blockers [ARBs] in ACE-intolerant cases) OR calcium channel blockers (dihydropyridines or non dihydropyridines) should be added to the thiazide diuretic. • The combination of thiazide diuretics and beta-blockers are now discouraged especially in cases where patients have abdominal obesity because of the risk of developing type two diabetes. • Beta-blockers, such as atenolol, are no longer considered as routine step one to step three therapies due to their risk of inducing type two diabetes and relative ineffectiveness in reducing certain hard endpoints. They also did not alter 10 • several outcomes reduced stroke by about half of what was expected by BP reduction. Beta-blockers also do not reduce cardiovascular mortality or myocardial infarct mortality when given for hypertension. Although other beta-blockers, such as the alpha-beta blocker carvedilol, have no cardiovascular outcome studies in hypertension, it has been shown to have a positive metabolic profile. Currently the results of the ONTARGET trial 2 are awaited to further differentiate the use of ACEinhibitors plus ARBs. According to these guidelines the ACE-inhibitors and ARBs are equally effective and cost and tolerability may be the only determining factors. Compelling indications for certain drug groups • Angina: beta-blocker OR rate lowering calcium channel blocker. • Previous myocardial infarct: betablocker AND ACE-inhibitor (or ARB). Verapamil if beta-blockers are contra-indicated. • Heart failure: ACE-inhibitor (or ARB) AND certain beta-blockers AND aldosterone antagonist. Loop diuretics for volume overload. ARB plus ACE-inhibitor – specific indications. • ECG-confirmed left ventricular hypertrophy: ARB (preferred) OR ACE-inhibitor. • Secondary prevention of stroke: Low dose thiazide-like diuretic AND ACE-inhibitor or ARB. • Diabetes without microalbuminuria or proteinuria: ACE-inhibitor OR ARB, usually in combination with diuretic. • Chronic kidney disease: ACEinhibitor OR ARB, usually in combination with diuretic. • Isolated systolic hypertension: lowdose thiazide or thiazide-like diuretic OR long-acting calcium channel blocker. Combination therapy 1. Effective blood pressure lowering combinations are: - Diuretic and beta-blocker (although not advocated for step one to step three). - Diuretic and ACE-inhibitors or ARBs. - 2. 3. 4. 5. 6. CCBs plus ACE-inhibitors. Beta-blockade plus alphablockade. Black patients respond best to diuretics in combination with other drugs. Synergisms exist between ACEinhibitors or ARBs combined with either calcium channel blockers or diuretics. Amlodipine plus ACE-inhibitor (perindopril) was used in ASCOT 3 and showed superiority to atenolol plus a thiazide diuretic. In the VALUE-trial4 the CCB-diuretic combination was better in reducing myocardial infarctions than the ARB-diuretic combination, but induced more type 2 diabetes. In PROGRESS 5 the combination of an ACE-inhibitor and a diuretic was better than an ACE-inhibitor alone. Metabolic syndrome This syndrome is characterised by obesity, dyslipidaemia and type 2 diabetes together with hypertension. The hypertension guideline provides definite criteria and goals for treatment of this disease entity. Management of severe hypertension A patient with a blood pressure of >180/110 has severe hypertension and should always immediately be classified into one of three categories. 1. Asymptomatic severe hypertension – no signs of acute target organ damage. The patients should be observed in a care setting (GPs rooms or clinic) for 1 hour. If the blood pressure is still elevated – administer a thiazide diuretic plus a dihydropyridine CCB. Re-evaluate and follow-up within a week or earlier. Refer if the blood pressure is not controlled within 2-4 weeks. 2. Hypertensive urgency: Symptomatic (headache, shortness of breath and oedema). Refer to hospital. 3. Hypertensive emergency: Most have blood pressure levels higher than 220/140 mmHG and the acute elevation is associated with ongoing target organ damage. This may include damage to a) kidneys (anuria or blood in urine), b) brain (stroke – any paralysis or paresis, check pupil sizes, or SA Pharmaceutical Journal – May 2006 CLINICAL changed level of consciousness or severe headache), c) heart (heart attack, unstable angina, arrhythmias, acute heart failure), and/or d) eyes (visual disturbances, retinopathy on ophtalmoscopy). These patients need urgent emergency medical attention and should be transported to hospital in an ambulance. • • Management of resistant (refractory) hypertension Defined as blood pressure that is >140/90 mmHg despite three antihypertensive drugs. Pharmacists play a crucial role in determining compliance with medication and lifestyle changes and in identifying drug-induced hypertension. An excellent table that summarises common causes of resistant hypertension is included in the guidelines. Special considerations in certain populations • Blacks and Indians: Blacks respond better to thiazide diuretics and CCBs. They may respond poorly to beta blockers or ACE-inhibitors when prescribed as monotherapy. Type two diabetes and the metabolic syndrome are more prevalent in the Indian population. Children and adolescents: The hypertension guidelines are mainly for adults, but a table is included that allows healthcare workers to identify cases at risk. Using the correct cuff size is very important. Hypertension in children needs immediate specialist attention. Patients living with HIV/AIDS: Taking blood pressure of patients on HAART is very important, because this regimen is known to increase systolic blood pressure. Drug interactions between ARV’s (protease inhibitors and nonnucleoside reverse transcriptase inhibitors) and CCBs are well documented. Conclusion The pharmacist plays an enormous role in the successful treatment and management of hypertensive patients. Compliance and availability of drugs are two major aspects of successful therapy. The national guidelines should be studied to standardise the pharmacist’s approach to the hyper- tensive patient. Compliance with lifestyle modifications and drug therapies should always be advocated. Interactions with over-the-counter drugs and other chronic medications should always be excluded. Compiled by DGS Greeff, Medical Writer, Medpharm Publications REFERENCES 1. Seedat YK, Croasdale MA, Milne FJ et al. South African Hypertension Guideline 2006. S Afr Med J 2006;96(4)337-362. 2. Teo, K, Yusuf S, Sleight P, et al. Rationale, design, and baseline characteristics of 2 large simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial.Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. Am Heart J 2004; 148: 52-61. 3. Dahlof B, Sever PS, Poulter NR, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendrofulmethiazode as required, in theAngloScandinavian Cardiac Outcomes Trial-BP Lowering Arm (ASCOT-BPLA): a multicentre randomized controlled trial. Lancet 2005; 366: 895-906. 4. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363: 2022-2031. 5. PROGRESS Collaborative Group. Randomised trial of a perindopiril-based blood-pressure lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358: 1033-1104. Drug ALERT Oral decongestant use during pregnancy A recently published large epidemiological study in 4213 women has found no association between the use of oral decongestant medicines in pregnancy and an increased risk of malformations. Between 1995 and the end of 2002, pregnant women who had used an oral decongestant, mainly phenylpropanolamine, were identified. Most women (2442) had used the medicine during early pregnancy while 1771 used it in later pregnancy. Among the infants exposed to oral decongestant medicines: • There were 117 identified malformations (4.7%) compared with an expected number from the general population of 121.3 malformations in the infants born to women who had used the oral decongestant in early pregnancy. • In later pregnancy, the rates of prematurity, being small-for date or stillbirth were all lower than expected. The authors concluded that the use of oral decongestants during pregnancy is not associated with any statistically significant increase in the risk of malformations in the infant. Unexpectedly, the use of these medicines was shown to be associated with a better outcome when used in later pregnancy. While this finding may be an artefact of multiple testing, it could also be explained by use for pregnancy rhinitis, which may in turn be a marker for healthy placental function. REFERENCE: Glare J. Oral decongestant use during pregnancy not associated with increased malformation risk. Am J Obs Gynecol 2006;194:480-485. 12 Information supplied by Amayeza Info Services : Tel : (011) 678 2332 SA Pharmaceutical Journal – May 2006