Minder hart- en vaatklachten diabetespatiënten met JANUVIA van MSD

Gegevens van een gezamenlijke analyse, die werden gepresenteerd op het 21ste Wereld Diabetes Congres, wijzen een lagere incidentie van gerapporteerde serieuze cardiovasculaire incidenten uit bij patienten met type 2 diabetes, die behandeld werden met sitagliptine in vergelijking tot degenen, die behandeld werden met een sulfonylureum.

Volgens deze gecombineerde analyse van gegevens over cardiovasculaire veiligheid van drie eerder gepubliceerde, gerandomiseerde, blinde klinische onderzoeken onder patienten met type 2 diabetes die 100 mg sitagliptine per dag (n = 1,226) kregen toegediend, ofwel een sulfonylureum (glipizide of glimepiride, n = 1,225) als monotherapie of als toevoeging op metformine, deden zich geen negatieve cardiovasculaire reacties voor in de sitagliptine-groep, terwijl er zich bij 11 patienten van de sulfonylureum-groep zich tenminste een serieus cardiovasculair incident voordeed.
Engelstalig bericht:
Pooled Analysis: Fewer Major Adverse Cardiovascular Events in Type 2 Diabetes Patients Treated with MSD’s JANUVIA ® (sitagliptin) Compared to a Sulphonylurea

Data presented at the International Diabetes Federation 21st World Diabetes Congress
In a pooled analysis presented at this week’s International Diabetes Federation (IDF) 21st World Diabetes Congress,a lower incidence of reported major cardiovascular events (MACE)* was observed in patients with type 2 diabetes treated with sitagliptin compared to those treated with a sulphonylurea (SU).

In this pooled analysis of cardiovascular (CV) safety data from three previously published randomized, blinded clinical studies, which included patients with type 2 diabetes who had been randomized to either sitagliptin 100 mg/day (n = 1,226), or an SU (glipizide or glimepiride, n = 1,225) as monotherapy or add-on to metformin, there were no reports of a major adverse CV event (i.e., ischemic events and CV deaths) in the sitagliptin group, and 11 patients in the SU group were reported to have experienced at least one major adverse CV event.

“Although a retrospective pooled analysis with distinct limitations, this analysis shows that patients with type 2 diabetes treated with sitagliptin had fewer major adverse cardiovascular events compared to patients treated with sulphonylureas,” said Barry J. Goldstein, M.D., Ph.D., vice president, Diabetes and Endocrinology, Merck. “These data are important, but prospective studies are needed. Results of a previously published pooled analysis of 19 clinical trials to evaluate the safety and tolerability of sitagliptin did not show an increased risk of CV events with sitagliptin 100 mg/day compared to placebo or other medicines.”

Study design

Custom MACE events included collected adverse experience reports related to ischemic events and CV deaths were assessed by pooling three double-blind studies, which randomized patients at baseline to sitagliptin 100 mg/day (n = 1,226) or an SU (n = 1,225). Two trials evaluated these agents when added to ongoing metformin therapy (30 weeks in duration [glimepiride] and 104 weeks [glipizide]). The third study was a monotherapy trial that was 104 weeks in duration [glipizide]).

At baseline, the 2,451 patients had a mean age of 56 years, HbA1c of 7.6 percent, and a median duration of type 2 diabetes of five years. Baseline characteristics were similar between the two treatment groups. The cumulative patient exposure was 1,269 patient-years in the sitagliptin group and 1,274 patient-years in the SU group.

Incidence of CV-Related Events with sitagliptin Versus SU in Patients with Type 2 Diabetes

In this pooled analysis, the incidence rate for reported MACE events was 0 per 100 patient years in the sitagliptin group (0 events) and 0.9 per 100 patient years in the SU group (11 events, between-group difference [95% CI] = -0.9 [-1.6, -0.5]). For CV-related death, the incidence rate was 0 per 100 patient-years (0 deaths) with sitagliptin, and 0.4 per 100 patient years (5 deaths) in the SU group (-0.4 [-0.9, -0.1]).

JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as initial therapy, alone or in combination with metformin, or a PPARγ agonist, or as an add-on to metformin, PPARγ agonist, sulphonylurea, sulphonylurea + metformin or PPARγ agonist + metformin when the current regimen, with diet and exercise does not provide adequate glycemic control. The medication can also be used as an adjunct to diet and exercise to improve glycemic control in combination with insulin (with or without metformin).

Important selected safety information about JANUVIA

JANUVIA is contraindicated in patients who are hypersensitive to any components of this product.JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. Because these reports are made voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of JANUVIA. If pancreatitis is suspected, JANUVIA and other potentially suspect medicinal products should be discontinued.

As the experience is limited, patients with moderate to severe renal impairment should not be treated with JANUVIA. JANUVIA is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy. JANUVIA should not be used during pregnancy or during breast-feeding.

As with other antihyperglycemic agents, when JANUVIA was used in combination with a sulphonylurea or with insulin, medications known to cause hypoglycemia, the incidence of sulphonylurea- or insulin-induced hypoglycemia was increased over that of placebo. To reduce the risk of sulphonylurea- or insulin-induced hypoglycemia, a lower dose of sulphonylurea or insulin may be considered.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first three months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.

In clinical studies as monotherapy and in combination with other agents, the adverse experiences reported regardless of causality assessment in ≥5 percent of patients and more commonly than placebo or the active comparator included hypoglycemia, nasopharyngitis, upper respiratory tract infection, headache, and peripheral edema. For additional adverse experience information, see the product circular.

Before initiating therapy, please consult the full prescribing information

About MSD

Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

*Custom major adverse events (MACE) that incorporated non-adjudicated ischemic events and CV deaths

Redactie Medicalfacts / Alida Budding - Hennink

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