Online Pharmacy, Canadian Pharmacy & Health Related News

Drugmakers Increasingly Using Patient Testimonials To Appeal To Consumers.

By Jeremy Cockerill | March 2, 2010

The Wall Street Journal (2/25, Rockoff) reports that drugmakers are increasingly trying to capitalize on trends in peer influence in drug marketing by using more patient testimonials in ads. In fact, Pfizer Inc. began running print and TV ads for its smoking-cessation drug Chantix [varenicline] that featured patient stories after focus groups showed the testimonials tested well. Jim Sage, a Pfizer marketing official, noted, “The role of the peer is important because it really provides a positive example” to help people quit smoking.

Statins Linked To Improvements In Peak Flow, Reduction In Asthma Rescue Inhaler Use.

By Jeremy Cockerill | March 2, 2010

Source: DIA Daily

MedPage Today (2/28, Phend) reported, “Statins may have yet another beneficial role besides lowering lipids: asthma control.” In fact, “adult asthma patients who started a lipid-lowering drug for cardiovascular reasons saw a meaningful improvement in peak flow and reduction in asthma rescue inhaler use soon afterward, Odelya E. Pagovich, MD, of Beth Israel Medical Center in New York City, and colleagues told attendees at American Academy of Allergy, Asthma, and Immunology meeting.” While “statins as asthma monotherapy are out of the question, they might be valuable add-on treatments if the results are validated in a clinical trial, Pagovich said.”

Statin primary prevention efficacy ‘equivalent in women and men’

By Jeremy Cockerill | March 1, 2010

Source: MedWire News

Statins are effective for the primary prevention of cardiovascular disease (CVD) events in women, shows a gender-specific analysis of the JUPITER trial and an updated meta-analysis of relevant trials.

The study represents the first clear evidence of the equivalent efficacy of statins for primary prevention in both men and women, and is likely to expand the eligibility criteria for statin therapy in women.

“Clinicians will undoubtedly use the data… to prescribe statin therapy much earlier for women who meet the entry criteria of the JUPITER study, and this change will improve CV outcomes in women,” said the authors of an editorial accompanying the report.

The research, which appears in the journal Circulation, was a prespecified analysis of gender-specific outcomes in the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial.

This multicenter randomized trial included 6801 women aged 60 years or over and 11,001 men aged 50 years or over; all had normal lipid levels but raised levels of high-sensitivity C-reactive protein (hsCRP).

As reported previously by MedWire News, JUPITER showed that treatment with rosuvastatin 20 mg/day, as compared with placebo, nearly halved the risk for major CVD events, a composite of nonfatal myocardial infarction (MI), nonfatal stroke, unstable angina, revascularization, or CV death.

Rosuvastatin also significantly reduced other endpoints, including MI, stroke, revascularization/unstable angina, nonfatal MI, nonfatal stroke, or CV death, and all-cause mortality.

The new JUPITER analysis, by Samia Mora (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and team, found that absolute CVD rates per 100 person–years were lower for women assigned to rosuvastatin and placebo (0.57 and 1.04, respectively) than for men (0.88 and 1.54, respectively).

Nevertheless, the relative risk reduction associated with rosuvastatin treatment was similar in women and men, at hazard ratios of 0.54 and 0.58, respectively.

Analysis of individual endpoints revealed that rosuvastatin therapy in women offered a significant reduction in revascularization/unstable angina and nonsignificant reductions in other endpoints.

Mora’s team then pooled these new JUPITER data with those from four other randomized placebo-controlled trials of statin therapy predominantly or exclusively for primary prevention. This meta-analysis, with data on 20,147 women and more than 276 CVD events, is nearly double the size of the previous meta-analysis on this issue.

It shows that statins reduced the risk for CVD events by 21% and total mortality by 15%; when only the three exclusively primary prevention trials were included, the relative risk reductions were 33% for CVD events and 22% for total mortality.

Mora et al conclude: “Statin treatment of apparently healthy women with elevated hsCRP and nonelevated low-density lipoprotein (LDL) cholesterol resulted in similar and significant proportional reductions in CVD compared with men.

“When these results are taken together with the results of the updated meta-analysis in women, statin therapy resulted in about a one-third relative reduction in primary CVD in women, a benefit similar to that seen in previous meta-analyses of men.”

Editorialists Claire Duvernoy (University of Michigan, Ann Arbor) and Roger Blumenthal (Johns Hopkins University, Baltimore, Maryland), called the study “compelling” and say it strengthens the evidence-base for statin therapy in asymptomatic middle-aged and older women with CV risk factors.

They added: “We await publication of the formal cost-effectiveness analyses from the landmark JUPITER data set, as well as data on the long-term safety of high-potency statin therapy.”

Statin therapy benefits diabetes patients with CHD, but normal cholesterol

By Jeremy Cockerill | February 24, 2010

Source: MedWire News

Study results show that diabetic patients with coronary heart disease (CHD), but normal cholesterol levels, benefit more from standard-dose statin therapy than nondiabetics with CHD.

“Diabetic patients have as high a risk of first myocardial infarction (MI) as nondiabetic patients with a previous MI,” say Sunao Kojima (Kumamoto University, Japan) and colleagues.

“Therefore, medical treatment of diabetic patients is very important to prevent the development and progression of cardiovascular complications,” they add.

To test the benefits of statins for cardiovascular disease (CVD) prevention in normocholesterolemic (total cholesterol of 180–240 mg/dl; 4.65–6.21 mmol/l) individuals with CHD with (n=301) or without (n=715) Type 2 diabetes, the investigators carried out a randomized open trial from 2002 to 2004.

Of the patients with Type 2 diabetes, 155 were prescribed statins and 146 were not. In a similar fashion, 348 of the nondiabetics were given statins and 367 were not.

Kojima et al report that low-density lipoprotein (LDL) cholesterol decreased by a similar amount in both diabetics and nondiabetics.

However, the number needed to treat to prevent a major CVD event (cardiovascular death, nonfatal acute MI, unstable angina, heart failure, and stroke) and the relative risk reduction for such an event was 8 and 67%, respectively, in the group with Type 2 diabetes versus 30 and 24% in the group without diabetes, a statistically significant difference.

“The data suggest that diabetes mellitus patients may enjoy the pleiotropic effects of statins, independent of the LDL cholesterol lowering effects of these agents,” conclude the authors.

The results of this study are published in the Circulation Journal.

Simplified Darunavir Therapy Successful in Experienced Patients

By Jeremy Cockerill | February 23, 2010

Once-daily dosing of the protease inhibitor darunavir (Prezista) appeared to be at least as effective as twice-a-day regimens among treatment-experienced patients with no darunavir-associated resistance mutations, researchers reported here.
Study subjects received an optimized nucleoside backbone regimen and were randomized to either once- or twice-daily darunavir boosted with ritonavir.

Some 72.1% achieved undetectable HIV viral load on once-daily therapy, compared with 70.9% of patients who were treated twice-a-day (P<0.001 for noninferiority), Pedro Cahn, MD, medical director at Fundación Huesped in Buenos Aires, reported at the Conference on Retroviruses and Opportunistic Infections.

"These findings suggest that once-daily darunavir/ritonavir (Norvir) could be considered an option for patients whose previous treatments are failing,” he said.

The outcomes — the percentage of patients who achieved undetectable viral loads — overlapped at all time points studied: four weeks, eight weeks, 12 weeks, 24 weeks, 36 weeks and when the trial ended at 48 weeks.

At the end of the trial, CD4-positive cell counts increased about 100 cells/mm3 over baseline in the once-daily group, compared with 94 cells/mm3 for those on the twice-daily regimen.

For their study, Cahn and colleagues recruited adult antiretroviral-experienced patients with more than 1,000 copies/mL of circulating HIV but who had at least a CD4-positive cell count of 50/mm3.

The patients’ viruses were required to be free of darunavir resistance-associated mutations, and the patients had to have been stable for at least 12 weeks on a highly active antiretroviral therapy.

The researchers assigned 296 patients to receive darunavir 800 mg once a day, along with a ritonavir 100 mg booster plus optimized background regimens.

Another 294 patients were assigned to receive darunavir 600 mg plus ritonavir 100 mg twice a day on top of an optimized background regimen.

Cahn said the researchers sought to build on previous work that suggested the long, 15-hour half-life of darunavir made it a candidate for once-daily dosing.

The primary objective of the treatment was to establish that the simplified treatment was noninferior to the twice-a-day dosing of darunavir, assessing efficacy by the percentage of patients who were able to achieve an undetectable viral load, using the 50 copy/mL assay at 48 weeks of treatment.

About 40% of the patients in the study were women, and the mean age was 40 years. About 35% of the patients were white, while 28% were black, and about 16% were Hispanic.

Some 26% of the patients had previously been exposed to the protease inhibitor lopinavir (Kaletra) and 21% had been exposed to the protease inhibitor indinavir (Crixivan). Cahn said that 45% of the study population had no protease inhibitor experience before entering the trial.

Responding to questions from the audience, Cahn said that follow-up studies might be able to determine if there were differences in outcomes based on previous protease inhibitor use.

Cahn said there were similar toxicities and discontinuations in both study arms.

In addition to showing similar effectiveness, the incidence of grade 2-4 lipid elevations with once-daily darunavir/ritonavir was about half that seen with the twice-daily therapy, Cahn said.

“Virologic failure rarely resulted in resistance,” he said. One patient in the study developed primary protease inhibitor resistance-associated mutations and darunavir resistance-associated mutations following virologic failure.