Expert opinion on drug safety
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Expert Opin Drug Saf · Jun 2015
Review Comparative StudySafety of pembrolizumab for the treatment of melanoma.
The immune checkpoint inhibitor pembrolizumab is the first anti-programmed-death-1 (PD-1) drug licensed by the FDA. It has been approved for the treatment of advanced melanoma, thanks to its positive results in terms of efficacy and its favorable toxicity profile. However, it is not exempt from side effects. In general, these are usually mild and easily manageable but there are pembrolizumab-induced immune-related adverse events (irAEs) that can be severe. Therefore, the understanding, diagnosis and management of those side effects are essential for the optimal care of patients treated with pembrolizumab. ⋯ Pembrolizumab is generally a well-tolerated drug but irAEs are not infrequent. However, these are usually mild and easily manageable in most cases. Early diagnosis and correct management of side effects induced by immune checkpoint inhibitors such as pembrolizumab should be areas of further work in forthcoming years.
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Expert Opin Drug Saf · May 2015
ReviewSafety of teriflunomide for the management of relapsing-remitting multiple sclerosis.
Teriflunomide is a new oral disease-modifying drug (DMD), recently approved for the first-line treatment of relapsing multiple sclerosis (MS). Since MS is a chronic disease, which often necessitates long-term treatment, data not only on efficacy but also on long-term safety, including pregnancy-related issues, are very important. ⋯ Teriflunomide has the advantage of a convenient once-daily oral administration scheme and a large body of evidence suggesting a manageable safety profile (clinical development program with > 6800 patient-years of exposure and post-marketing experience with leflunomide). Further post-marketing data, especially regarding pregnancy outcomes and risks of infections, will help to define the exact place of teriflunomide in the treatment of MS in the future, especially compared with the other oral DMDs.
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Expert Opin Drug Saf · Apr 2015
ReviewSafety of dipeptidyl peptidase-4 inhibitors for treating type 2 diabetes.
Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) occupy a growing place in the armamentarium of drugs used for the management of hyperglycemia in type 2 diabetes, although some safety concerns have been raised in recent years. ⋯ The good tolerance/safety profile of DPP-4 inhibitors has been largely confirmed, including in more fragile populations (elderly, renal impairment) with almost no increased risk of infection or gastrointestinal AEs, no weight gain and a minimal risk of hypoglycemia. Although an increased risk of acute pancreatitis and pancreatic cancer was suspected, the complete set of available data appears reassuring so far. Cardiovascular safety of DPP-4 inhibitors has been proven but an unexpected increased risk of heart failure has been reported which should be confirmed in ongoing trials and better understood. Further postmarketing surveillance is recommended.
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Expert Opin Drug Saf · Apr 2015
Pixantrone: a novel anthracycline-like drug for the treatment of non-Hodgkin lymphoma.
The current treatment approach of high-grade non-Hodgkin lymphoma (NHL) relies to a large extent on anthracycline-based regimens yielding cure rates in ∼ 65 - 75% of patients. Despite being highly effective, these regimens are associated with significant long-term toxicity with a cumulative 10-year incidence of cardiovascular disease of 22%. Moreover, for the 25 - 35% of patients who fail first-line therapy there has been very little progress in terms of salvage regimens over the past 15 years. Re-treatment with anthracyclines-based regimens was, until now, not an option given the extensive cardiac toxicity of these agents. Pixantrone dimaleate (Pixantrone) is a novel anthracycline-like drug that offers an interesting alternative for the treatment of aggressive NHL. ⋯ Pixantrone is a potential alternative agent with a favorable safety profile for the treatment of relapsed and refractory NHL patients. It might benefit from combinations strategies and further development in the elderly and frail population.
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Expert Opin Drug Saf · Mar 2015
ReviewReview of drug safety and efficacy of arformoterol in chronic obstructive pulmonary disease.
The global initiative for chronic obstructive lung disease guidelines recommend maintenance therapy using long-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD) who have daily symptoms. Arformoterol is the (R, R) - enantiomer of the racemic formoterol and is more potent than (R, R/ S, S) - formoterol. ⋯ The introduction of the centers for medicare and medicaid services penalization for COPD readmissions may boost the appeal of long-acting bronchodilators as new discharge medications. With the advent of ultra long-acting bronchodilators, its potential as a once daily agent in isolation or combination with these new therapies needs further study.