 Important Incremental Innovations in Therapy for Major
Diseases of Older Americans
Cardiovascular Conditions: Cardiovascular disease,
the leading cause of death in the United States, is extremely common
in older individuals. In addition to costs of treatment, billions
of dollars are spent annually in indirect costs associated with
premature death and disability. Ongoing innovation has led to advanced
dosage forms and delivery systems for existing cardiovascular agents
that can provide considerable therapeutic advantage-especially for
elderly patients. Controlled-release dosage forms can improve effectiveness,
safety, and adherence to dosage regimens. For treating high blood
pressure, once-daily dosing provides extended coverage and protects
against the risk of sudden death, heart attack, and stroke caused
by an abrupt rise in blood pressure in the early morning hours.
Stroke and Other Clotting Disorders: Stroke is the leading
cause of disability in seniors and the third leading cause of death.
The use of tissue plasminogen activator (t-PA) to treat stroke patients
demonstrates how ongoing innovation led to an important new use
of a medication originally designed for another purpose. Originally
approved for dissolving blood clots in heart attack patients, t-PA
was subsequently found to dissolve blood clots in the brain, restore
blood flow, and limit permanent brain damage.
Osteoporosis: Women are at risk of developing osteoporosis
because of rapid bone loss after menopause due to decreased estrogen
production. Hormone replacement therapy (HRT) is the standard prevention
for the decline in bone mass at menopause. Ongoing innovation has
made HRT available in many forms. Conjugated estrogen is the most
commonly prescribed estrogen therapy. Estradiol, the most potent
estrogen, is available as tablets, skin patches, a vaginal ring,
by injection, and as a pellet inserted under the skin twice a year.
Estropipate, a weaker form of estrogen, is available by vaginal
tablet and nickel-sized, water-resistant patches.
Urinary Incontinence: Incontinence is a significant cause
of disability among the elderly and is often the primary cause of
institutionalization due to the burden of care. Continued research
into treatments for incontinence has resulted in a once-daily, controlled-release
formulation of oxybutynin that maintains consistent release of medication
over 24 hours, thereby averting the peaks seen with immediate release
oxybutynin. Introduced in 1999, this medicine represents a substantial
improvement over immediate release oxybutynin, since it is equally
effective but has fewer side effects.
Diabetes: Diabetes affects more than 18 percent of older
Americans and can cause heart disease, severe kidney and nerve damage,
blindness, and the need for amputations. Ongoing innovation has
led to an array of insulin products ranging in their time of onset
and duration of action. Premixed insulins may aid elderly or impaired
patients who have difficulty preparing an injection from two vials,
are more convenient, improve compliance and dosage accuracy, and
reduce risk of hypoglycemia. Insulin nasal sprays, in development,
will aid individuals who are squeamish about injections, reduce
infections and accidental needle sticks, and will reduce cost and
disposal concerns by eliminating the need for needles and syringes.
Sulfonylurea agents, another mainstay of diabetes treatment, differ
widely in potency and dosage, duration of action, side effects,
and potential for interaction with other drugs, enabling physicians
to match effective treatments with elderly patients' overall health
and lifestyle.
Cancer: Breast cancer is the most frequently diagnosed cancer
in women, and is the leading killer of women between the ages of
34 to 45. In 1993, the economic cost of cancers primarily affecting
women was estimated to be more than $1.9 billion-with direct costs
accounting for $330 million and indirect costs accounting for nearly
$1.6 billion. Continuing research into raloxifene, a drug used for
prevention and treatment of osteoporosis, has resulted in the discovery
of an important new use for breast cancer. A large-scale, multi-center
study found that raloxifene reduced the risk of invasive breast
cancer by 72 percent in post-menopausal women who took this drug
for four years. New, improved aromatase inhibitor agents are proving
to be very effective in women with metastatic breast cancer.
The study, "The Value of Incremental Pharmaceutical Innovation
for Older Americans," by Albert Wertheimer, Ph.D., MBA, et
al., 2001, is available in the Resources & Publications section of this site.
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