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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 13, 2015

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Proton-Pump Inhibitors Associated with Increased MI Risk, Data-Mining Study Suggests
FDA Advisers Recommend First-in-Class Cholesterol-Lowering Meds
Menopausal Hormone Therapy: Putting the Timing Hypothesis to the Test
Dosing for Preemies?
Cardiovascular Effect of Sitagliptin in Type 2 Diabetes
Pumping Iron, Physical Function, and Breast Cancer Survivors

MM: Why is this information important? We don't know the root cause of the problem but we can project that PPI's, by chronically subduing gastric pH may be causing increased and otherwise undetected GI inflammation that communicates to other organ systems. This "hidden inflammation" may be the cause of this significant increased risk of MI. The projection of multiplied risks of co-morbid diseases supports this inherent danger rather than disputing it. PPI's are not placebos. That have a significant effect on the body with the potential of relieving "short-term" GI discomfort and the potential risk of delivering "long-term" damage.
It is unfortunate that the greed of Big Pharma has created this worldwide epidemic of side effects by proclaiming these products to be maintenance drugs rather than the short term relief products that they should be designated as.

Proton-Pump Inhibitors Associated with Increased MI Risk, Data-Mining Study Suggests
By Amy Orciari Herman
Patients may ask about a widely reported study suggesting that proton-pump inhibitors (PPIs) are associated with increased risk for myocardial infarction in the general population. Findings from the data-mining analysis were published this week in PLoS One.
Using medical records from multiple sources from 1994 through 2012, researchers studied nearly 3 million patients. Among those with gastroesophageal reflux disease, exposure to a PPI was associated with a 16% increase in MI risk. In addition, a separate analysis from a prospective cohort found a twofold increase in cardiovascular mortality with PPI use. These findings were significant regardless of clopidogrel use (which was used as a marker of a prior cardiovascular event).
In contrast, H2 blockers — also used to treat GERD — were not associated with increased risk.
The authors say the study "suggests that the risk of PPIs may extend beyond previously studied high risk individuals."
Asked to comment, Dr. David Johnson of NEJM Journal Watch Gastroenterology pointed out "the multiple risks of comorbid diseases in patients with significant GERD (e.g., obesity and related metabolic diseases)." He wrote, "In a database analysis such as this, there is significant risk for stratification bias: these other disease states with well-recognized cardiovascular risk could not be taken into account, thereby presenting a skewed bias towards suggesting a harmful effect."
Why We Chose This as Our Top Story:
André Sofair, MD, MPH and William E. Chavey, MD, MS: This potential risk regarding PPIs has been known for years. Even though the methodology used is not the most elegant, this study provides further data that should give us greater caution when starting or continuing PPI therapy in our patients.
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MM: The monoclonal antibody class of drugs, which these new drugs are a member of, can be amazing when it comes to fighting cancer, macular degeneration or other life threatening illnesses but they also carry a host of other potential dangers and must be used cautiously in the general public. Overuse of these products, not by individuals, but by clinicians can lead to wholesale disaster. One of the dangers of this product being used by a patient group such as those with hypercholesterolemia is that it is almost a universal problem and the indiscriminate use of this kind of product, especially as it is designed by definition to be a maintenance drug, can lead to much greater harm than good as evidenced by the overuse of PPI's in the general population.
FDA Advisers Recommend First-in-Class Cholesterol-Lowering Meds
By Kelly Young
An advisory committee has recommended that the FDA approve two new medications to lower cholesterol in certain patient groups. If approved, the injectable drugs would be the first available proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, which help the liver remove LDL cholesterol from the blood.
The panel voted on Tuesday to recommend approval of the monoclonal antibody alirocumab (Praluent), the Wall Street Journal reports. Then on Wednesday, the panel voted to recommend approval of evolocumab (Repatha).
Studies have found that alirocumab reduces LDL cholesterol by 40% to 60%, compared with placebo, while evolocumab was associated with a roughly 60% LDL reduction.
Panel members recommended that both drugs initially be limited to patients with familial hypercholesterolemia until more data are available on whether the drugs actually reduce cardiovascular events.
The drugs are expected to cost up to $1000 a month, according to the Wall Street Journal. Alirocumab is designed to be injected every 2 weeks, and evolocumab could be injected every 2 or 4 weeks.
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MM: it is reassuring that women who have recently entered menopause or who are peri-menopausal should show CV benefit to HRT but what is also good is that the study has not demonstrated increased CV risk to those who have had a later introduction of HRT. I contend that there are numerous added benefits to BHRT in both of these patient groups and that the benefits have been demonstrated to far outweigh the risks in properly screened patients.
Menopause 2015 Apr; 22:391
Menopausal Hormone Therapy: Putting the Timing Hypothesis to the Test
ELITE trial directly compares the effect of HT on atherosclerosis progression in younger versus older menopausal women.
The timing hypothesis postulates that hormone therapy (HT) either has little effect on or hastens progression of atherosclerosis in women a decade or more past menopause onset but slows atherosclerotic progression in recently menopausal women. To test this hypothesis, investigators for the Early versus Late Intervention Trial with Estradiol (ELITE) randomized 643 healthy women (<6 years or ≥10 years past menopause) without cardiovascular disease (CVD) to oral estradiol or placebo for 6 to 7 years.
The first and last participants were randomized in 2005 and 2008, respectively. To assess HT's impact on subclinical atherosclerosis, the investigators have monitored carotid artery intima-media thickness (CIMT) and performed cardiac computed tomography. The present report describes baseline characteristics of participants and notes that CIMT correlated well with established CVD risk factors.
Comment: Although ELITE's findings have not yet been published as a full report, the investigators presented their results at the 2014 American Heart Association meeting (Circulation 2014; 130:A13283). They noted that, while HT reduced atherosclerosis progression in the recently menopausal group, this benefit was not seen in the group that had been postmenopausal for ≥10 years. Similar to the Women's Health Initiative (JAMA 2013; 310:1353), these findings support the timing hypothesis by showing that HT seems to lower risk for CVD when used by recently menopausal women. I look forward to publication of the final ELITE results, which promise to constitute a landmark study.
Citation(s):Hodis HN et al. Methods and baseline cardiovascular data from the Early versus Late Intervention Trial with Estradiol testing the menopausal hormone timing hypothesis. Menopause 2015 Apr; 22:391.
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Dosing for Preemies?
It is often necessary to use drugs that have never been tested in preemies; now, a group of pediatricians is working to answer such basic questions as how much of a drug is safe to give to an infant. There is an element of guesswork in deciding on dosing levels for certain medications and, as a result, treatments can vary between hospitals and in different parts of the country. The Pediatric Trials Network began in 2010 to study a number of drugs in a series of clinical trials; many of which are already the standard treatment in small children. These trials are trying to determine the safest, most effective doses and regimens for the drugs instead of trying to find new uses. As a result, the FDA has revised the prescribing label for meropenem so that it can be used in infants younger than 3 months of age to treat complicated intra-abdominal infections. Drugs studied include metronidazole, meropenem, fluconazole, acyclovir, ampicillin, hydroxyurea, and sildenafil.
(Editor's Note: Compounding can be very important in the process of individualizing doses for preemies.)
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MM: I 've listened to patients and clinicians tell me how great this class of diabetic treatment drugs is and I've never quite understood why they were applauding it. I've attended continuing educational seminars where this drug has been discussed and couldn't figure out what I was missing. Apparently, I wasn't missing anything at all and the drug manufacturers have once again managed to fool the FDA and the general public.
N Engl J Med 2015 Jun 8
Cardiovascular Effect of Sitagliptin in Type 2 Diabetes
Sitagliptin did not improve cardiovascular outcomes in patients with established cardiovascular disease.
In a recent randomized trial, the diabetes drug saxagliptin (Onglyza; a dipeptidyl peptidase (DPP)-4 inhibitor) was associated with a modest but statistically significant increase in hospital admissions for heart failure (NEJM JW Gen Med Oct 1 2013 and N Engl J Med 369:1317). Now, industry-supported researchers have examined the cardiovascular safety of another DPP-4 inhibitor, sitagliptin (Januvia), in nearly 15,000 type 2 diabetic patients with established cardiovascular disease and glycosylated hemoglobin (HbA1c) levels of 6.5% to 8.0% while taking one or two glucose-lowering agents.
Patients were randomized to add either sitagliptin or placebo to their diabetes regimens, and treating clinicians were encouraged to adjust regimens to achieve individually appropriate HbA1c targets.
During a median follow-up of 3 years, HbA1c levels averaged 0.3% lower with sitagliptin (Januvia), than with placebo. The primary composite outcome (cardiovascular-related death, nonfatal myocardial infarction or stroke, or hospitalization for unstable angina) occurred in 11.4% and 11.6% of patients in the two groups, respectively; sitagliptin (Januvia),  was statistically noninferior, but not superior, to placebo. Rates of hospitalization for heart failure were 3.1% in both groups. Although this study did not focus on microvascular outcomes, incidences of diabetic eye conditions, neuropathy, microalbuminuria, and renal failure were similar in the two groups.
Comment: The sponsoring company already had announced in April 2015 that this trial achieved its primary goal — demonstrating that sitagliptin (Januvia), is safe from the cardiovascular perspective. However, showing that a diabetes drug is not worse than placebo with respect to cardiovascular outcomes is not sufficient to support its use. The ultimate goal is to improve important clinical outcomes, and this trial showed no lower incidence of either macrovascular or microvascular outcomes with sitagliptin(Januvia),. Therefore, the role of this drug — which costs about US$5,000 annually for patients who must pay out of pocket — in treating patients with type 2 diabetes remains unclear.
Citation(s):Green JB et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med 2015 Jun 8; [e-pub].
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MM: Whether you are a man or a woman, it is not appropriate to simply hide in bed and pull up the covers with a diagnosis of cancer. People who socialize, exercise and participate in life's activities are happier, more fulfilled and generally healthier than those who retreat. This is an important study in that it demonstrates the benefits of exercise to those with a cancer diagnosis. Exercise also seems to support the immune system and its modulation thereby demonstrating more reasons to look at this adjunct treatment modality.
J Clin Oncol 2015 May 11
Pumping Iron, Physical Function, and Breast Cancer Survivors
Women who completed a 12-month weight-lifting program had less physical deterioration than those who received standard care.
To determine whether modest exercise could preserve or improve physical function for nonmetastatic breast cancer survivors, investigators conducted a 12-month, single-blind, randomized, controlled trial in which 295 women were assigned to a twice-per-week weight-lifting program or standard baseline activity (controls).
During the first 13 weeks, the weight-lifting group participated in supervised sessions that included stretching, aerobic warm-up, and lifting exercises for the upper and lower body; for the remaining 39 weeks, the group followed the same program without supervision. Characteristics of the weight-lifting and control groups were similar (mean age, about 56 years; more than 60% were white; nearly half had stage I/II disease; half had some degree of lymphedema; and about 5 years had passed since diagnosis). Adjuvant therapy received and baseline physical function were similar in both groups. The incident deterioration of physical function was defined as a ≥10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire.
Significantly fewer women in the exercise group than in the control group experienced incident deterioration (8.1% vs. 16.3%; relative risk, 0.49; P=0.04).). Participants who did not complete the full program were more likely to be younger, have greater upper and lower body strength, and have a higher body-mass index.
Comment: This study affirms that physical activity in the form of weight lifting lowers the risk for physical deterioration. Whether this exercise is equivalent or superior to other physical interventions cannot be determined from this study. Given that the program did not begin until about 5 years after the diagnosis, it is conceivable that earlier interventions might have had a greater impact on physical function, endurance, and coping.
Citation(s):Brown JC and Schmitz KH.Weight lifting and physical function among survivors of breast cancer: A post hoc analysis of a randomized controlled trial.
J Clin Oncol 2015 May 11; [e-pub].

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