Acebutolol Hydrochloride and Adenovirus Type 4 and Type 7 Vaccine Live Oral

• Generic Name: acebutolol
• Dosage Forms: n.a.
• Other Brand Names: Sectral

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).

β-Blockers generally not preferred for first-line therapy of hypertension according to current evidence-based hypertension guidelines, but may be considered in patients who have a compelling indication (e.g., prior MI, ischemic heart disease, heart failure) for their use or as add-on therapy in those who do not respond adequately to the preferred drug classes (ACE inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, or thiazide diuretics). A 2017 ACC/AHA multidisciplinary hypertension guideline states that β-blockers used for ischemic heart disease that are also effective in lowering BP include bisoprolol, carvedilol, metoprolol succinate, metoprolol tartrate, nadolol, propranolol, and timolol.

Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).

The 2017 ACC/AHA hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.

Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.

Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).

The goal of hypertension management and prevention is to achieve and maintain optimal control of BP. However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.

The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) of <130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk. In addition, an SBP goal of <130 mm Hg generally is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg. These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.

Other hypertension guidelines generally have based target BP goals on age and comorbidities. Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk and have used higher BP thresholds and target BPs in elderly patients compared with those recommended by the 2017 ACC/AHA hypertension guideline.

Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the 2017 ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.

Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient's BP treatment goal.

For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors. ASCVD risk assessment is recommended by ACC/AHA for all adults with hypertension.

ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).

For secondary prevention in adults with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.

Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg. Individualize drug therapy in patients with hypertension and underlying cardiovascular or other risk factors.

In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP. Initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes recommended in adults with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.

Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to β-blockers. However, diminished response to β-blockers is largely eliminated when administered concomitantly with a thiazide diuretic.

Cardiac Arrhythmias

Treatment of frequent ventricular premature complexes (VPCs), including uniform and multiform VPCs and/or coupled VPCs, and R-on-T complexes in patients with primary arrhythmias or arrhythmias secondary to various cardiac disorders (e.g., CAD, acute MI, valvular disease).

Management of various supraventricular tachyarrhythmias.

Angina

Management of chronic stable angina pectoris.

Acute MI

Secondary prevention following acute MI to reduce the risk of reinfarction and mortality.

• Generic Name: adenovirus vaccine
• Dosage Forms: n.a.
• Other Brand Names: Adenovirus Type 4 and Type 7 Vaccine Live Oral

Prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7. Labeled by FDA for use in military populations 17 through 50 years of age; not commercially available for use in other individuals. (See Restricted Distribution under Dosage and Administration.)

Adenoviruses, especially adenovirus type 4 and type 7, commonly cause acute respiratory disease (e.g., runny nose, fever, sore throat, breathing problems, cough, headache, croup, bronchitis). Certain adenovirus serotypes cause other illnesses (e.g., conjunctivitis, keratoconjunctivitis, otitis media, gastroenteritis, cystitis). Disseminated or life-threatening infections can occur (e.g., severe pneumonia, hepatitis, meningitis, encephalitis). Adenoviruses spread person to person via direct contact, respiratory droplet transmission, or food and/or water contaminated with feces. Fomites also may be involved in transmission since adenoviruses survive for long periods outside of the body, including on environmental surfaces, and are unusually stable when exposed to chemical and physical agents or adverse pH conditions.

Military recruits are at increased risk of acute respiratory illnesses during basic training because of several factors, including close sleeping and training environments where transmission of respiratory pathogens is facilitated, congregation of young adults arriving from wide geographic distributions who may enter basic training carrying pathogens capable of being spread to others who are immunologically susceptible, and stressful nature of basic training and military operations. Adenoviruses, especially adenovirus type 4 and type 7, are a well documented cause of acute respiratory illness in military recruits; adenoviruses reportedly cause 50–80% of cases of acute respiratory disease in this population. Outbreaks of adenovirus-associated disease also occur in other populations (e.g., healthcare-associated outbreaks), but the combination of sustained transmission and relatively high and predictable attack rates of adenovirus-associated respiratory disease appears to be unique to military basic trainees.

US Department of Defense (DOD) requires that all enlisted US military recruits 17 through 50 years of age receive a single dose of adenovirus type 4 and type 7 vaccine live oral at the earliest opportunity upon arrival at initial entry training (basic military training), unless contraindicated (see Contraindications under Cautions). May also be recommended for other military personnel at high risk for adenovirus infection, but not required for cadre working at enlisted basic training sites.