June 2008

Compliance in Treatment of Bipolar Disorders Improved by Therapies Offering Better Tolerability

Summary: Research reveals significant compliance and persistency challenges among patients with bipolar disorders; drugs offering more positive tolerability profiles excel
  Compliance and persistency are particular challenges in the treatment of patients with bipolar disorders, including bipolar mania and bipolar depression, a disease where nearly half the patient population abandons therapy, according to new research by GfK Market Measures.

The challenges of compliance and persistency are common in the treatment of many diseases. However, the issues are magnified in patients with bipolar mania and bipolar depression because generally these patients see manic phases as highly pleasurable and invigorating. Therefore, avoiding effective medications that are specifically designed to suppress these euphoric feelings is especially common among these patients. In fact, GfK’s research revealed that 45 percent of bipolar disorder patients are noncompliant.

Further, these manic episodes and feelings of euphoria result in a large segment of patients falsely believing they are not ill, which naturally leads them to abandon therapy. GfK’s research supports this notion as nearly 60 percent of physicians reported their patients’ denial of their illness as a key reason for noncompliance. Moreover, nearly 50 percent of physicians reported patients’ poor tolerability of side effects, especially weight gain, as an excuse to discontinue treatment.

Against this backdrop, while issues of efficacy, particularly in controlling suicide ideation, remain the most critical among unmet needs in this market, better tolerability and improved patient compliance are other important needs cited by psychiatrists.

“Interestingly, our research showed that physicians will trade some efficacy of drugs for side effect relief, which is viewed as key in increasing compliance. Resulting from the focus on improved tolerability and compliance, we see two therapies in particular,

BMS’ Abilify and GSK’s Lamictal, that seem to be excelling less on their strong ‘powerful efficacy’ messages and more on their subtle benefits of ‘better tolerated’ and, importantly, ‘improved compliance’,” said Geoff Penney, Vice President and Category Business Leader, Psychiatry, GfK Market Measures. “Their success signals an opportunity for bipolar disorder drug manufacturers to improve even further in these areas, in order to meet market demands.” BMS’ Abilify has experienced continued success in the bipolar disorder market given its immediate benefits in cognitive improvement, or what some physicians describe as “brightening.” Abilify’s success stems from a rapid onset uplifting effect together with increased ratings in GfK’s research over the last three years for “good patient compliance,” which is a reflection of good tolerability ratings.

GSK’s Lamictal is establishing itself as an off-label, alternative treatment for bipolar depression. For the last 20 years, chronic treatments for psychiatric conditions have been limited to three treatment pathways (serotonin, norepinephrine and dopamine). Many physicians see hopeful promise for the GABA and glutamate systems as therapeutic targets in depression and mood disorders. Lamictal blocks glutamate release and this may be contributing to the brand establishing itself as an important, albeit off-label, alternative treatment for bipolar depression. According to GfK’s research, a contributing factor in Lamictal’s success is its positive tolerability profile, especially against long-established bipolar treatments such as lithium, Depakote ER, Zyprexa and Risperdal.

Reflecting insights from 141 inpatient- and outpatient-focused psychiatrists, fielded via Internet questionnaire during March 2008, GfK Market Measures’ 2008 Treatment of Bipolar Disorder Study provides a comprehensive analysis of the bipolar disorder market from the perspective of treating physicians.

Contact: Geoff Penney, VP, Category Business Leader, Psychiatry
gpenney@gfkmm.com


 
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Prasugrel’s Bleed Risk Not a Deterrent for Physicians Who Anticipate Its Use

Summary: Research reveals that despite the perception of increased bleeding compared with Plavix, a large portion of physicians are likely to prescribe new competing drug prasugrel for ACS patients
  Awareness and intent-to-prescribe levels are promising among physicians for the Phase III drug prasugrel, for patients with Acute Coronary Syndrome (ACS) being managed with Percutaneous Coronary Intervention (PCI). The agent is viewed by some as a formidable challenge for blockbuster and standard-of-care Plavix (clopidogrel), according to new research by GfK Market Measures.

A recent study investigating physician treatment decisions for patients with ACS showed that two-thirds of clinical and interventional cardiologists are aware of some clinical information about the agent prasugrel.

When physicians who were familiar with prasugrel were asked on an open-ended basis what they had heard about the agent, 65 percent volunteered they had heard about “bleed risk.” This reduced base of physicians who were knowledgeable of the risk nonetheless registered a high likelihood of prescribing prasugrel (46 percent reporting a likelihood of 5, 6 or 7 on a 7-point scale).

“This finding was somewhat surprising to us. We would not expect nearly 50 percent of those aware of this potentially negative quality about prasugrel to be inclined to prescribe the agent, especially since bleed risk is a constant concern in this market,” said Anna Marie Napolitano, Vice President and Category Business Leader, Cardiovascular, GfK Market Measures. “These results suggest that a great deal of physicians are willing to take on that risk in an effort to benefit from prasugrel’s efficacy claims as reported in the TRITON TIMI 38 clinical trial.”

Among the specialties, interventional cardiologists expressed the greatest interest in prasugrel’s use when it reaches the market, with 61 percent citing their intention to use it peri-procedurally to PCI compared with 37 percent of clinical cardiologists. In terms of displacing other drugs, a vast majority of these cardiologists anticipate it will displace Plavix and, to a lesser degree, Integrilin.

It was announced in February that the U.S. Food and Drug Administration had granted a six-month priority review for prasugrel, with a Prescription Drug User Fee Act (PDUFA) goal date set as June 26. Co-marketers Eli Lilly and Daiichi-Sankyo plan to market the drug as Effient.

Reflecting insights from 202 physicians, including emergency medicine physicians, interventional cardiologists and clinical cardiologists, fielded via Internet questionnaire during December 2007, GfK Market Measures’ 2008 Treatment of ACS: Use of PCI Study provides insights into physicians’ treatment decisions in Acute Coronary Syndrome, from the emergency room to the catheter laboratory, when Percutaneous Coronary Intervention is employed.

Contact: Anna Marie Napolitano, VP, Category Business Leader, Cardiovascular
anapolitano@gfkmm.com



 
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Increasing Prophylactic Usage in Combination With Acute Therapy Yields Better Relief for Migraine Patients

Summary: Research reveals neurologists more likely to prescribe combined therapy than PCPs; low satisfaction levels among moderate migraine patients signal opportunity for drug manufacturers
  Neurologists treating patients with moderate migraines are increasingly more likely to prescribe both an acute and prophylactic therapy upon diagnosis, while primary care physicians (PCPs) still predominately rely on acute-only regimens, despite low levels of satisfaction with treatment reported among this patient segment, according to new research by GfK Market Measures.

Among newly diagnosed migraine patients, usage of a combined acute/prophylactic therapy has continually grown among neurologists in recent years. GfK’s research reveals that neurologists report 56 percent of patients are receiving the combined therapy (up from 48 percent in 2006) and only 31 percent are receiving acute-only prescriptions. Conversely, migraine treatment regimens prescribed by PCPs are almost the reverse, as PCPs report only 28 percent of patients are receiving the combined therapy (up from 24 percent in 2006), while 53 percent are receiving acute-only prescriptions. While neurologists prefer to prescribe the combination therapy as first-line treatment in moderate migraine cases, PCPs tend to reserve the prophylactic therapy only for more severe migraine cases.

Although frequency of attacks is still a top criterion when considering if a patient is a candidate for a migraine prophylaxis, both neurologists and PCPs indicate that they are placing higher importance on the intensity of pain experienced by their migraine patients. This appears to be contributing to neurologists’ earlier usage of a combined prophylactic therapy. This trend may translate to increased patient satisfaction, an area where there is room for improvement, especially among the least-satisfied patient segment: those with moderate migraines.

Further support for physicians’ increased use of combined acute/prophylactic therapy with migraine sufferers may be derived from the results of GfK’s migraine study with patients. This study revealed that moderate patients (representing about half of all migraine sufferers) are the least likely group to believe their condition is “well controlled” at only 31 percent, compared to 58 percent of mild patients and 40 percent of severe patients.

As a result, those with moderate migraines tend to be less satisfied with drug therapy than other migraine patients. Only 43 percent of moderate patients report they are “very satisfied” with their prescription medications (both acute and prophylactic), whereas satisfaction levels are significantly higher for those with mild and severe migraines (65 and 57 percent, respectively).

“Significant opportunities exist for pharmaceutical manufacturers to further support patients with moderate migraines, as it is the single largest segment of migraine patients and, importantly, the group with the least satisfaction with its drug therapy options,” said Kim Lazarus, Vice President and Category Business Leader, Neurology, GfK Market Measures. “Of special note, our research shows that almost one in three patients with moderate-to-severe migraines is currently not treated with any prescription drug therapy – neither acute nor prophylactic. Further investigation is warranted into how to motivate these people to get them onto therapy. Our research shows the greatest potential for brand growth opportunity is among this key segment.”

Reflecting insights from 203 physicians, including neurologists and primary care physicians, fielded via Internet questionnaire January 2008, GfK Market Measures’ 2008 Migraine Physician Study provides a comprehensive analysis of the migraine market from the perspective of treating physicians.

Revealing insights from 404 migraine patients fielded via Internet questionnaire March 2008, GfK Market Measures’ 2008 Migraine Patient Point of Care Study provides a comprehensive analysis of the migraine market from the perspective of patients, complementing the analyses from the physician perspective.

Contact: Kim Lazarus, VP, Category Business Leader, Neurology
klazarus@gfkmm.com



 
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