Wednesday, October 24, 2007

Older is Wiser

From Science Daily dated 08.19.98 - just found randomly.

Remembering Your Medications: Older are Wiser

"Being too busy, not being old, is what leads people to make mistakes in taking their medications," says Denise C. Park, a psychologist at the U-M Institute for Social Research who presented her findings this month at the annual meeting of the International Congress of Applied Psychology.

As the population ages, the problem of forgetting to take the pills your doctor ordered--the right number of the right kind at the right times--will affect more and more people who are trying to manage diabetes, depression, high blood pressure, arthritis and other chronic age-related conditions.

According to Park, the conventional view has been that as patients age, their medication adherence rates drop, just when their need to manage complicated medication schedules increases.

With funding from the National Institute on Aging, Park and colleagues carried out a study designed not only to learn who really is most likely to make mistakes, but also what kinds of errors occur and why they're being made.
For eight weeks, the researchers studied 121 men and women between the ages of 34 and 84, all diagnosed with moderately severe rheumatoid arthritis.

"We selected that illness because we expected medication adherence to be very good," says Park. "Taking the medications commonly prescribed leads to real relief from pain, stiffness, and other symptoms. And that gives people a strong motivation to take medications on schedule." Participants in the study took four types of medication, on average.

At the start of the study, researchers tested all the participants to determine their levels of depression and anxiety, and to see what their attitudes were about arthritis and disease in general. They also asked how helpful participants thought it was to take the specific medications they had, and medications in general. Participants also went through a range of tests assessing their memory, recall and other measures of mental functioning.

Park and her colleagues developed the "Busy Life Style Questionnaire," to measure the chaos and unpredictability in the daily lives of participants. Among the items were questions asking how often you have too many things to do each day to get them all done, how often you're so busy that you miss scheduled breaks or rest periods, or stay up later than normal, and how often you follow other regular routines, including eating meals at about the same time each day, or engaging in regular activities at home, such as reading the paper, watching a particular television show, or talking with family members.
After these initial assessments, participants received the prescriptions they were taking in new containers, special bottles with caps containing tiny electronic monitoring chips that recorded exactly when the bottles were opened.

After eight weeks, all the participants turned in the new containers. The information in the bottle-cap chips was downloaded into a computer file and analyzed.

Overall, the researchers found a surprisingly high level of adherence. Nearly 40 percent of participants didn't make a single medication error during the two months studied. Of all the mistakes that were made, more than 98 percent were errors of omission; only 1.2 percent took an extra dose.

Perfect adherence was more common among older than younger adults, Parks found. Fully 47 percent of those over the age of 55 made no mistakes, compared with only 28 percent of those between the ages of 34 and 54.

What usually led to mistakes was being too busy, Park notes. Being slightly unhappy also contributed, combined with the belief that taking the medication as prescribed may make you feel better physically but won't make you feel any better emotionally.

"Being a very busy person is the single biggest risk factor we found," says Park. "Having a life that's overly full leaves little time to attend to health concerns."

For doctors, the implications of the research are clear. "Consider prescribing simpler drug regimens for busy, middle-aged patients, not for older patients," says Park.

For middle-aged people too busy to take care of their health by remembering to take their medications on time, Park suggests using memory aids like written reminders or beeping wristwatches.

Tuesday, October 16, 2007

Lamotrigine XR Proven Effective for Epileptics - GSK funded Study

I found this on a couple of sites but liked this MedScape article the best. One thing I do not understand about epileptics and patients with chronic illnesses in general is why they do not take their medications knowing the results. One of my friends in epileptic, something that I had forgotten until the day after another friend's wedding. She had a seizure at the Sunday brunch. This was a fit I had never seen and it was quite scary for all of us there, and can only imagine the effect on her. I am pretty sure it was a result of her non-adherence to her medication. Luckily many of her friends were there who had experienced her seizing before so they knew how to treat her.

As with all XR drugs, they aim to improve medication adherence, yet pharmaceutical companies usually start developing and testing XR fomulas when their patent is close to expiration. I am all for medication adherence (as we know) however why wasn't this the first drug to be released? Hey, we spent $800M on a drug and sold it for 6 years, but here is a better version because a generic is now available for the first version and we want to make more money and keep you as a patient. Yes, I know the answer and it always be the case until we are in the future world where all medications are free, have no side effects, and there is no global warming, polution, etc....

Just for fun, see who funded the study and who employs the MDs at the end.

October 15, 2007 — Once-daily adjunctive lamotrigine extended-release (XR) was effective in controlling partial seizures, according to the results of a double-blind, placebo-controlled, randomized trial reported in the October 15 issue of Neurology.

"The goal of enhancing dosing convenience and thereby compliance has motivated the development of lamotrigine extended-release (XR), an enteric-coated, slow-release formulation," write D.K. Naritoku, MD, from Southern Illinois University in Springfield, and colleagues. "Whereas conventional immediate-release (IR) lamotrigine tablets are recommended for twice-daily dosing when used with enzyme-inducing AEDs [antiepileptic drugs] or as monotherapy and for once- or twice-daily dosing when used with valproate, the pharmacokinetic properties of lamotrigine XR make it suitable for once-daily dosing in epilepsy regardless of concomitant AED."

In this parallel-group trial, 243 patients older than 12 years diagnosed with epilepsy with partial seizures and taking 1 to 2 baseline antiepileptic drugs were randomized to adjunctive once-daily lamotrigine XR or placebo. After the baseline phase, 239 patients entered a 7-week, double-blind escalation phase. During the 12-week, double-blind, maintenance phase, doses of study medication and concomitant antiepileptic drugs were maintained.

Of the 239 patients who entered the escalation phase and received study medication, 118 received lamotrigine XR, and 121 received placebo. Compared with placebo, lamotrigine XR was more effective in terms of median percent reduction from baseline in weekly partial seizure frequency (primary endpoint, entire 19-week treatment phase: 46.1% vs 24.2%; P = .0004; escalation phase: 28.0% vs 16.3%; P = .028; maintenance phase: 58.0% vs 26.7%: P < .0001).

The percentage of patients with at least a 50% decrease in frequency of partial seizures (42.2% vs 24.2%; P = .0037) and time to 50% or more reduction in partial seizure frequency (P = .0007) also favored lamotrigine XR over placebo. For secondarily generalized seizures, findings were comparable.

The most frequently reported adverse events were headache (17% with lamotrigine XR vs 15% with placebo) and dizziness (18% with lamotrigine XR vs 5% with placebo). Health outcome measures were not significantly different between groups. There were no serious rashes, and laboratory test results and electrocardiogram findings were unremarkable in both groups.

"Once-daily adjunctive lamotrigine extended-release compared with placebo effectively reduced partial seizure frequency and was well tolerated in this double-blind study," the authors write. "Results support the clinical utility of this new once-daily formulation."

Study limitations include small sample sizes for end-of-study health outcomes questionnaires, with resulting low power for detecting treatment differences.

GlaxoSmithKline, the maker of lamotrigine, sponsored and conducted this study, employs 2 of the authors, funded 1 of the authors, and has various financial relationships with 2 other authors.

Thursday, October 11, 2007

Topamax to Cure Alcoholism and Binge Drinking

Found information on the JAMA article and study in many different media outlets. This is from FirstWord and hits the high notes. I find it very funny that one of the side effects was migranes. The average drinker went from 12 drinks to 8 a day. To me, 12 drinks is a lot to manage in a day. Also that it helps with withdrawal makes sense since it is a treatment for epilepsy and a major part of withdrawal is the shakes!

Also below is the JAMA abstract for those who are interested.

Study: Johnson & Johnson's Topamax may help reduce alcohol dependency
by Alison Fischer
Study results demonstrated that more heavy drinkers who received Johnson & Johnson's Topamax (topiramate) quit drinking by the end of the trial, compared with those who received placebo, according to findings published in the current issue of JAMA.

The company-sponsored, 14-week study enrolled 371 men and women who were heavy drinkers. About half the participants received placebo, and half Johnson & Johnson's drug. The findings showed that 27 of 183 patients taking Topamax stopped drinking by the end of the trial, compared with 6 of 188 patients given placebo. The data also demonstrated that Topamax was more effective at reducing the percentage of heavy-drinking days, compared with placebo.

The drugmaker indicated that it does not plan to conduct further testing or seek FDA approval for Topamax as a treatment for alcohol dependency. Nonetheless, in an editorial accompanying the study, Mark Willenbring, a director at the National Institute on Alcohol Abuse and Alcoholism, stated that "we now have very high-quality evidence that shows efficacy. The medical world doesn't wait for the indication."

However, Sidney Wolfe, director of the Health Research Group at Public Citizen, raised concerns that a press kit about the study from the University of Virginia promoted use of Johnson & Johnson's drug as a treatment for alcoholism. Wolfe asked the US regulatory agency to stop an "illegal and dangerous promotional campaign'' linked to the study, adding that "it is not the research or the publication of the study that is illegal but the promotional material that goes beyond the research to solicit new sales for the drug."

A spokesperson for Johnson & Johnson commented that company "does not support any reference to off-label use of our products. We only promote the use of Topamax for the approved indications of migraine prevention and epilepsy."

JAMA Abstract
Context: Hypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitation of -aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system.

Objective: To determine if topiramate is a safe and efficacious treatment for alcohol dependence.

Design, Setting, and Participants: Double-blind, randomized, placebo-controlled, 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence, conducted between January 27, 2004, and August 4, 2006, at 17 US sites.

Interventions: Up to 300 mg/d of topiramate (n = 183) or placebo (n = 188), along with a weekly compliance enhancement intervention.

Main Outcome Measures: Primary efficacy variable was self-reported percentage of heavy drinking days. Secondary outcomes included other self-reported drinking measures (percentage of days abstinent and drinks per drinking day) along with the laboratory measure of alcohol consumption (plasma -glutamyltransferase).

Results: Treating all dropouts as relapse to baseline, topiramate was more efficacious than placebo at reducing the percentage of heavy drinking days from baseline to week 14 (mean difference, 8.44%; 95% confidence interval, 3.07%-13.80%; P = .002).

Prespecified mixed-model analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (mean difference, 16.19%; 95% confidence interval, 10.79%-21.60%; P < .001) and all other drinking outcomes (P < .001 for all comparisons).

Adverse events that were more common with topiramate vs placebo, respectively, included paresthesia (50.8% vs 10.6%), taste perversion (23.0% vs 4.8%), anorexia (19.7% vs 6.9%), and difficulty with concentration (14.8% vs 3.2%).

Conclusion: Topiramate is a promising treatment for alcohol dependence.

Tuesday, October 9, 2007

Achtar Price to Go up to $23,000 a Vial

This just strikes me as wrong, and is going to have a huge impact on adherence. From the Philadelphia Inquirer.

PHILADELPHIA _ There's one drug most doctors turn to first when babies have catastrophic seizures: a natural hormone sold under the name H.P. Acthar. It's the gold standard to stop seizures that can ruin a child's chance for a normal life.

On Aug. 27, the lone maker of that drug raised the price from $1,650 a vial to more than $23,000 a vial, sending the price for an average patient to $100,000 or more.

The 14-fold increase stunned some caregivers and seemed to crystallize their frustrations over drug pricing.

"It's an obscene increase. I could almost see doubling or tripling the price but (14) times seems ridiculous," said Sarah Erush, clinical manager of pharmacy at the Children's Hospital of Philadelphia.

Robert R. Clancy, a neurologist who directs the hospital's Pediatric Regional Epilepsy Program, said, "Everyone understands it's a business and they need to have a fair profit. But to go from $1,600 to $23,000 strikes me as old-fashioned greed."

The maker, Questcor Pharmaceuticals Inc. of Union City, Calif., says it had no choice. The company, which has been losing nearly $1 million a month receives more than 90 percent of its revenues from Acthar. It had $12.8 million in total revenues last year.

"We had to take this kind of a pricing increase to insure that Acthar remains available," said Steve Cartt, Questcor's executive vice president for corporate development. "The company was in a bad situation."

Cartt said the firm has revamped a patient assistance program to make more Acthar available at no cost to help uninsured parents, and it has started two copay assistance programs.

But the price hike has already caused at least one insurer to put in a more stringent pre-authorization process. Experts say it's likely that many patients will find it harder to get this drug.

The increase is an extreme example of how drugs are priced in the United States: There is no regulation of drug prices. Companies can charge what the market will bear, and commercial insurers, who cover most employees' prescriptions, often follow Medicare's lead in covering drugs.

Prescription drugs are "a legal monopoly. We expect monopolists to behave like monopolists," said Mark V. Pauly, a health economist at the Wharton School. "The argument is the higher profits will stimulate further beneficial research."

Large spikes in drug prices are not uncommon, especially when the potential market is small.

In 2006, Ovation Pharmaceuticals raised the price of indomethacin, an injected anti-inflammatory drug often used in premature babies, from $100 to $1,875 for three vials, prompting howls of protest. "This is a rather astounding increase in price for a drug that has a stable niche market and requires no advertising," declared Alan H. Jobe, a doctor at Cincinnati Children's Hospital, in the journal Pediatrics.

Ovation spokeswoman Sally Benjamin Young said the drug, which privately-held Ovation acquired from Merck & Co. Inc. in 2006, had had few price adjustments since it was introduced in 1985. The hike was needed to support better testing, packaging and manufacturing, and to insure a more stable supply, she said.

Experts say it's not uncommon for new drugs, especially for rare diseases, to cost more than $100,000 a year. The high price is needed, economists say, so the firm can be encouraged to enter the field.

What sets apart Acthar is that it's a very old drug. The compound (Adrenocorticotropic hormone) was first synthesized in the 1940s by Armour & Co., the canned meat firm, which harvested it from pigs' pituitary glands.

The drug, used for years to treat Infantile Spasms, was made by Rhone-Poulenc Rorer and then by its successor, Aventis. It was never a big seller, and the former owner nearly stopped making it in the mid-1990s _ only to see it brought back after a storm of pediatricians complained that there was no substitute.

Questcor bought the rights to the drug in 2001. The company sought formal approval for Infantile Spasms from the Food and Drug Administration, but it issued a "non-approvable" letter in May. The agency didn't think the existing clinical trials were good enough, Cartt said, adding that the firm is exploring what kind of tests the FDA will need.

Even without formal FDA approval, Acthar remains the drug of choice for babies with Infantile Spasms. It's the most likely drug to end the seizures, which, if unstopped, make the chances of normal development remote at best.

Acthar is also one of several drugs that helps with sudden flare-ups in multiple sclerosis patients though its use is small.

FDA To Hire More Staffers for Generic Application Processing

I just thought this was interesting. Off the AP Wire.

WASHINGTON_The Food and Drug Administration on Thursday unveiled a plan to speed up the approval of generic drugs and address a backlog of hundreds of applications.

FDA officials outlined a half dozen recent changes that it said will streamline how the agency processes applications for cheaper versions of branded drugs.

Perhaps most significantly, FDA said it would immediately begin processing applications for generic drugs that have lost patent protection. Previously these applications would sit in a queue behind applications for drugs that might still be patented for years.

FDA also said it hopes to hire additional employees beyond the 215 staffers who currently review generic drug applications. Whether FDA has funding to hire new reviewers depends on whether Congress approves the agency's budget request later this year.

Unlike makers of traditional drugs, generic drug companies do not pay user fees to help offset the cost of hiring drug reviewers. Efforts to set up generic drug user fees have been opposed by the Generic Pharmaceutical Assocation, whose members include Barr Pharmaceuticals Inc., Mylan Laboratories Inc. and Teva Pharmaceutical Industries Ltd.

The industry group reacted coolly to FDA's initiative, saying the best way to speed up generic drug approvals is to outlaw tactics which branded companies use to protect their drug patients.

"For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results," said Kathleen Jaeger, the group's president. "There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market."

Aclasta Gets EU Approval

Just a quicky from PharmaLive. This should really improve adherence - if they go to the MD on time!

Switzerland's Novartis AG said today the EU has approved Aclasta the first once-yearly treatment for women with postmenopausal osteoporosis. The drug was approved by the FDA in August under the name of Reclast. Last month a study showed the drug used by elderly patients who have had a hip fracture reduced deaths by 28 percent and new fractures by 35 percent over a two-year period.

Friday, October 5, 2007

Beliefs about medicines and self-reported adherence among pharmacy clients.

Below is an abstract I can across this morning. Unfortunately I am traveling to the memorial service for the great American poet, William Meredith, at my alma mater and do not have the time to read or research everything today. Just wanted to give you a clip of some interesting work - although (again) it is self-reported, the numbers are more in line with the average.

Department of Public Health and Community Medicine, Göteborg University, Box 453, SE-405 30 Göteborg, Sweden.
Beliefs about medicines and self-reported adherence among pharmacy clients.

OBJECTIVES: To analyse any association between general beliefs about medicines and self-reported adherence among pharmacy clients. Further, to examine general beliefs about medicines by background variables.

METHODS: The data were collected by questionnaires including the general section of the Beliefs about Medicines Questionnaire (BMQ), the self-reporting Medication Adherence Report Scale (MARS) and the following background variables: gender, age, education, country of birth and medicine use. The General BMQ measures beliefs about medicines as something harmful (General-Harm), beneficial (General-Benefit) and beliefs about how doctors prescribe medicines (General-Overuse).

RESULTS: Of the 324 participating pharmacy clients, 54% were considered non-adherent. An association was found between General-Harm and adherence. Adherent behaviour and higher level of education were associated respectively with more beneficial and less harmful beliefs about medicines. Those born in the Nordic countries regarded medicines as more beneficial. Current users of herbal medicines and non-users of medicines were more likely to believe that doctors overprescribed medicines.

CONCLUSIONS: General-Harm was associated with adherence to medication among Swedish pharmacy clients. Country of birth, education and medicine use influenced beliefs about medicines.

PRACTICE IMPLICATIONS: Increased awareness of the patient's beliefs about medicines is needed among healthcare providers. We should encourage patients to express their views about medicines in order to optimize and personalize the information process. This can stimulate concordance and adherence to medication.

Thursday, October 4, 2007

Half of Hypertensive CA Adults Take Drugs for Blood Pressure

This is a press release from the American Heart Association. I have been at a conference this week, but wanted to post this information. My comments will come at a later date.

About half of California adults diagnosed with high blood pressure, or hypertension, do not take medication to lower it, researchers reported today at the American Heart Association’s 61st Annual Fall Conference of the Council for High Blood Pressure Research.

Of those who do, regularly seeing a doctor makes a big difference in their medication adherence.

In a study of California adults, of 42,044 respondents, 11,467 of them said a doctor had told them they had high blood pressure. When adjusted for age, this yielded a prevalence rate of 24.5 percent.

Researchers also found, on an age-adjusted basis, that 49.4 percent of those diagnosed with hypertension, a potentially life-threatening disease, were not taking drugs to lower it. People who had seen a physician during the prior year were more than five times more likely to be on medication than were those who had not.

“That was informative,” said David J. Reynen, M.P.P.A., M.P.H., lead author of the study. “It really underscores the importance of having routine care.”

High blood pressure is a major risk factor for heart attacks and strokes, and it increases a person’s risk of heart failure, kidney disease and blindness.

Doctors recommend drug treatment when a person’s blood pressure consistently measures 140/90 millimeters of mercury (mm Hg) or higher.

Reynen and his colleagues at the California Department of Public Health’s Heart Disease and Stroke Prevention Program in Sacramento wanted a clearer picture of high blood pressure in their state. They proposed a series of questions to be included in the California Health Interview Survey, which is conducted by telephone every two years, and then analyzed the results.

“Unfortunately, the data are collected in such a way that we don’t know to what degree the individual respondents have hypertension,” Reynen said. “One in four adults in California, including one in three African Americans, is hypertensive,” he said. “We talk about people needing to know their numbers. That means not just whether your blood pressure is high or low, but your actual numbers. This study reinforces that.”

The researchers used age-adjustment to standardize the survey results so they could more accurately compare various groups.

Among those surveyed with high blood pressure, the analysis showed that the age-adjusted odds of a person taking drugs to lower blood pressure are:

5.23 times higher for people who saw a physician within the past year compared to those who did not;
2.47 times higher for those with diabetes than those without the disease;
2.05 times higher for those who had health insurance than those who did not;
1.71 times higher for African Americans than for whites (the racial/ethnic groups, respectively, with the highest and lowest high blood pressure rate);
1.46 times higher for people who described their health as poor or fair compared to those in good health;
1.40 times higher for patients diagnosed with heart disease than those without it;
1.38 times higher for smokers than nonsmokers;
1.27 times higher for U.S.-born individuals than foreign-born;
1.21 times higher for people with some form of formal education after graduating high school than those with less formal education.

“Understanding these factors may allow us to develop better strategies to increase the use of blood-pressure-lowering drugs among those with high blood pressure,” Reynen said.

The age-adjusted prevalence of high blood pressure and drug treatment sometimes varied considerably among the various groups surveyed:

African Americans had the highest prevalence of high blood pressure (35 percent), followed by American Indians (29.8 percent), Pacific Islanders (27.2 percent), those of other race/ethnicity (25.9 percent), Latinos (25.0 percent), Asians (24.5 percent) and whites (23.1 percent).

African Americans had the highest rate of drug use to control their high blood pressure (56.6 percent), followed by American Indians (53.1 percent), Asians (52.1 percent), Pacific Islanders (52 percent), whites (49 percent), Latinos (45.8 percent) and those of other race/ethnicity (44.4 percent).

“Physicians should be mindful of these kinds of associated factors when developing treatment plans, and public health officials should be mindful of them when developing public health interventions,” Reynen said. “Knowing someone’s racial/ethnic group may be helpful to us when we try to target messages to this population to tell them they need to see a physician if they have high blood pressure.”