Spain’s National Health System decided to fund the cost of Exubera insulin inhalers for diabetics.

Patients will pay no more than 3€ for the Pfizer inhaled insulin, and a new report says that pharmacies in Spain now have the drug in stock.

A new article in the New England Journal of Medicine poses a hyopthetical question for many physicians: when should they consider prescribing Pfizer’s FDA-approved Exubera inhaled insulin?

The NEJM article is written by Graham McMahon and Ronald Arky, two endocrinologists in the Endocrinology, Diabetes, and Hypertension department at Brigham and Women’s Hospital in Boston.

It appears to carry weight for doctors, particularly given that 1) it is in the NEJM, one of the most trusted medical journals in the world, and therefore relied upon by practitioners seeking advice for treating patients in their practices, and 2) because it provides a “case vignette that includes a therapeutic recommendation”, i.e., a scenario asking physicians to read the hypothetical, analyze clinical data and treatment guidelines, and evaluate the authors’ recommendations.

Here is the hypothetical that McMahon and Arky present:

A 52-year-old man with an 8-year history of type 2 diabetes mellitus visits his primary
care provider for advice. His glucometer readings at home have been high
despite treatment with a sulfonylurea, a thiazolidinedione, and metformin at maximal
doses. He has never smoked. His glycated hemoglobin value is 8.6% and his
fasting blood glucose concentration ranges between 170 and 220 mg per deciliter
(9.4 and 12.2 mmol per liter). His blood pressure, weight, and lipid profile are within
recommended target ranges. The patient and his physician discuss therapeutic
options and agree that insulin treatment should be initiated. The physician wonders
whether the patient might benefit from inhaled insulin and refers him to an
endocrinologist for evaluation.

They take a broad overview of the case that seems helpful for general practitioner’s who have Pfizer, Inc. (NYSE:PFE) drug sales reps trying to get them to write Exubera inhaled insulin prescriptions. They examine:

• The clinical problem of diabetes;
• Pathophysiology and Effect of insulin therapy and the use of oral agents;
• Clinical Evidence of Exubera’s effect (drawing on short-term studies where “more than 90% of the patients were white”);
• Clinical Use examining evaluation and drug approvals by the FDA and EU, Exubera drug formulary coverage by insurance companies, potential costs to patients, and a comparison to injectable insulin for Type 1 and Type 2 diabetics;
• Adverse effects and potential risks of Exubera usage;
• Areas of Uncertainty, including the development of antibodies to Exubera, and the fact that “the longer-term safety and efficacy of this form of [inhaled insulin] therapy have not yet been established.”

So what do they recommend? While this blog will not quote the entire article, and encourages readers to browse the complete NEJM article online, in your practice, or at the nearest hospital or university, we will tell you that the doctors conclude by saying: “we do not recommend the use of inhaled insulin in this patient.”

It’s worth a good read. As an added bonus, the authors also have a nifty video explaining Exubera inhaled insulin dosing and usage. Dr. McMahon explains, in a pleasant Irish accent, how the pulmonary drug delivery system works.

The United Arab Emirates’ Ministry of Health gave Pfizer, Inc. (NYSE:PFE) conditional approval to make Exubera inhaled insulin available to diabetics in the Gulf state.

According to Dr. Issa bin Jakka al Mansouori, the MOH’s Director of the Drug Control Department, the diabetes drug’s approval is currently listed as conditional “because the company manufacturing it is yet to provide further documentations to us.” An Abu Dhabi newspaper reports that Exubera should be available in the country within six months.

The number of diabetics in the UAE between the ages of 20 and 70 is currently estimated as being 19.5% of the total population. Since there are roughly 3.5 million people living in the UAE, that suggests some 700,000 people living there have diabetes. The government reports that just over 20% of the people living in the country are actually UAE citizens.

The results of a study done by Pfizer, Inc. (NYSE: PFE) to test the efficiacy and safety of Exuber inahled insulin on Type 2 diabetics over a 2-year period were announced today at the European Association for the Study of Diabetes (EASD).

According to Pfizer, the findings showed that the company’s Exubera inhaled insulin:

is well tolerated, provides comparable glycemic control, less weight gain, and greater [Fasting Plasma Glucose] reductions when compared with [injectable] insulin over 2 years in adult patients with type 2 diabetes.

The study looked examined adults between 35 and 70 years-old with Type 2 diabetes; 319 were put on Exubera inhaled insulin, and 316 used subcutaneous insulin inections.

Nektar Therapeutics (NASDAQ: NKTR), the co-developer with Pfizer of Exubera, issued a press release praising the study’s results. You can read it by clicking on this link:

Nektar Reports that Pfizer Announced New Analyses Showing that Exubera Is Effective in Diabetes Patients Who Have Respiratory Infections or Who are Exposed to Passive Cigarette Smoke

The study’s abstract is shown below:

Sustained efficacy and tolerability of inhaled human insulin (Exubera®). Therapy over 2 years: patients with type 2 diabetes

W. Cefalu¹, J. Rosenstock², S. Klioze³, H. Foyt⁴, M. Ogawa⁴, L. St Aubin³, W. Duggan³;

¹Division of Nutrition and Chronic Diseases, Pennington Biomedical Research Center, Baton Rouge, ²Dallas Diabetes and Endocrine Center, Dallas, ³Pfizer Inc, Research and Development, Groton, ⁴Pfizer Inc, Research and Development, Ann Arbor, United States.

Background and Aims: The availability of inhaled human insulin (INH; Exubera® (insulin human [rDNA origin]) Inhalation Powder) may increase patient acceptance of insulin, improve glycemic control, and potentially reduce the burden of insulin therapy in diabetes. In patients with type 2 diabetes mellitus (T2DM), one previous 24-week study showed comparable efficacy between INH and subcutaneous (SC) insulin, and another 104-week study demonstrated superior glycemic control of INH compared with oral agents (OAs). Small treatment group differences in lung function (measured using routine pulmonary function testing [PFT]) were observed in both studies, but long-term studies are critical to better characterize pulmonary safety.The aim of this study was to investigate the long-term (2-year) efficacy and safety profile of INH therapy in patients with T2DM.

Materials and Methods: An open-label, parallel-group, multicenter study where patients (aged between 35 and 75 years) were randomized to INH (n = 319) or SC insulin (n = 316). Primary end point was pulmonary function measured using highly standardized PFT. Secondary end points included glycosylated hemoglobin (HbA1c), hypoglycemia, fasting plasma glucose (FPG), and body weight.

Results: Treatment group differences in changes from baseline in forced expiratory volume in 1 second (FEV1) and carbon monoxide diffusing capacity (DLco) were small (< 1.5% of mean baseline), occurred early (Month 3 data: -0.043 L [90% confidence interval (CI), -0.065, -0.020] for FEV1 and -0.194 mL/min/mm Hg [-0.437, 0.050] for DLco), and remained stable with no progression for up to 2 years (-0.023 [-0.047, 0.002] and 0.165 [-0.102, 0.432], for FEV1 and DLco, respectively). Glycemic control was maintained in both groups with HbA1c improvements from 7.7% and 7.8% to 7.3% and 7.3% in INH and SC, respectively, and the percentage of patients who achieved target HbA1c < 7% was comparable between groups (INH, 47.5% and SC, 45.2%). The incidence of hypoglycemic events was lower with INH than with SC insulin (0.8 vs 1.0 events/subject-month, respectively), and the incidence of severe hypoglycemic events was comparable in the 2 groups (0.4 vs 0.6 events/100 subject-month, respectively). After 24 months, INH resulted in greater reductions in FPG compared with SC insulin (from 8.4 to 7.5 vs 8.2 to 8.2 mmol/L [151.2 to 135.6 vs 148.2 to 147.1 mg/dL], respectively), and less body weight gain (mean± SD, 1.7 ± 4.7 kg vs 3.0 ± 5.2 kg). Adverse events were generally comparable with the exception of cough in the INH group, which was mild in most patients, nonproductive, and closely associated with dosing.

Conclusion: This study demonstrated that INH is well tolerated, provides comparable glycemic control, less weight gain, and greater FPG reductions when compared with SC insulin over 2 years in adult patients with type 2 diabetes.